Tracy
About a week ago, Gary posted on Mcwirb what amounts to a big loosening of
restrictions by OPRR: they allowed teleconferencing **IF** you carefully
documented that each member of the committee had full access to all written
material, plenty of time to review the material, and full access to any
other relevant data. I think that you can probably find that posting on
Mcwirb's web site.
So if your IRB answers to OPRR, I doubt they'd allow a vote by someone who
had no access to the discussion except via their buddy's good judgement.
Remember, OPRR has ruled that if someone steps out of the room to answer a
page or because of a conflict of interest with the subject being voted on,
then that member is absent and not part of a quorum.
Ron Low
----- Original Message -----
From: Tracy Arwood
To:
Cc:
Sent: Friday, April 28, 2000 10:32 AM
Subject: Proxy voting
> Is proxy voting permissible? At our meeting yesterday, a member had to
leave early and gave his proxy to another member to vote how he saw fit.
I can not find any reference to this in the regulations.
>
> Any help would be appreciated.
>
> Thanks!
>
> Tracy Smart Arwood
> Regulatory Compliance Administrator
> Mississippi State University
> 302 Bowen Hall
> Mailstop 9564
> 662-325-3994
> 662-325-8776 fax
> tarwood@spa.msstate.edu
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Philip Low
4/28/2000 10:43:00 AM
I don't know about the regulations, but this seems very wrong to me. I'd
be inclined to allow the departing member to leave a record of his/her
vote, if the member's mind was made up upon departure. But simply allowing
someone else to decide for you just ammounts to giving that person a
double vote, which seems unwarranted.
An interesting intermediary scenario involves leaving specific guidelines.
i.e. If stipulation X is added, then I vote for, otherwise I vote
against. The problem is that such things often require interpretation, as
their application is often not mechanical (e.g., what if the stipulation
ends up with a slightly different wording...)
Noam
Noam J. Zohar, PhD [Director, Graduate Program in Bioethics]
Department of Philosophy
Bar Ilan University
Ramat Gan 52900, Israel
nzohar@mail.biu.ac.il
Noam Zohar
4/28/2000 8:05:00 AM
I am the Chair of IRB-Human Subjects at a small college. The IRB is new,
developed by a group of us who wanted to engage in research with human
subjects. We seem to have Academic Affairs in compliance with federal law
and policies.
Our IRB is concerned about our role in research conducted by the College and
consultants hired by the College:
i.e. surveys of students who leave college
consultants conducting focus group interviews and selective surveys to gain
a sense of the College, how it is perceived, what its strengths and
weaknesses are . . .
persuant development of an experimental first year experience for select
students - no control and no sense of how selection will proceed.
Although these people are collecting information from human subjects for the
purpose of drawing conclusions, they do not believe that they must work with
our IRB. They have informed me that they are exempt.
Our IRB's opinion is that all such work must be proposed to us and that only
the IRB has the authority to deem the work exempt. We are further concerned
for the quality of the science in these efforts, particulary the balance
of risk to reward.
We would appreciate any ideas, help, suggestions any of you might have.
Thanks
Jim Sawhill, Ph.D.
Lyndon State College
may respond to: sawhillj@mail.lsc.vsc.edu
James Sawhill
4/28/2000 4:15:00 AM
Jim Sawhill wrote to discuss whether or not his college's IRB was
responsible for surveys sent out to alumni of his college, or focus
groups of almuni.
Jim didn't clarify whether or not his institution had an MPA or some
other agreement with governing bodies. If he does, we'd have to know
what it says. If you don't have any agreements, then his
responsibility is to uphold the college's own internal code of ethics.
If he does have an MPA, and it says the IRB will supervise all research
on humans, then we're back to the issue of what research is. Dale's
earlier comments are relevant, but may not solve the problem. If we're
consistent with our definition of research, then most CQI projects
are research. Sometimes, the intent of the CQI project is not to
publish, but to improve local patient care, or local teaching
techniques. Traditionally, these are not reviewed by IRBs. If
the researchers expect to publish their findings, then they expect
the results to be generalizable. Most MPA would include
that research under their umbrella.
Ron
Ronald Low
4/28/2000 4:15:00 AM
This has been a fascinating exchange. I have always believed that Moore
was correctly decided, for very practical reasons. Simply, creating a
property interest in tissue hardly resolves difficult issues about relative
contribution of research participants to the overall research process and
invention, and offering some share of potential revenues would be extremely
complex, represents a tax that could diminish (so the argument goes) the
incentives to do research, and could be an unreasonable (given the small
expectation of payoff) enticement or inducement for people to participate.
that said, i am writing up a case in which i recently became involved. in
this case, affected families convinced a doctor to perform research, they
provided financial support, they provided blood and other tissues
themselves, they helped identify and collect samples from other affected
families, and, after a gene was located, Dor Yeshorim provided thousands of
samples to permit prevalence estimation. the researcher patented the test,
and now the hospital owner of the patent is charging a relatively large
royalty and limiting the labs that can do the test.
interestingly, i find that the researcher and the financial sponsorship was
all fungible: any skilled researchers could have performed this work. the
only irreplaceable component was the 160 or so families from around the
world that contributed samples, and of course the screening samples
permitted rapid population risk estimation.
the families and those who provided samples were quite upset at the patent,
obviously. they participated to help avoid a terrible disease, not to
provide a financial windfall to a nonprofit hospital. the foundations that
provided money to support the research likewise were sponsoring a given
research project, not making a capital contribution to the hospital for
future payoff.
nonetheless, the patent rewards only those who provide financial (if the
funding institutions care to exercise a contractual power) and intellectual
capital, but not human resources (so called by the lead researcher), even
thought those participants were absolutely necessary for the research to
succeed.
in this case, there was no consent at all, so the issue of notice about the
prospective financial/commercial interest and restrictive use of the
patented test is moot. but the case I think makes a very clear case for a
substantial equitable claim by those participants in the research results
(made only more realistic because of the total lack of consent). my
colleague jason karlawish thinks the case also raises an issue about
community and participant involvement in determining, or negotiating about,
the benefits of research. here, there clearly was a mismatch between what
participants expected and what the researcher and his institution sought
and achieved.
jon merz
center for bioethics
university of pennsylvania
merz@mail.med.upenn.edu
Jon Merz
4/27/2000 10:00:00 AM
Change in FDA rules for in vitro testing
Has anyone followed the proposed FDA change in in vitro testing rules
proposed in December? Apparently, the FDA wants to eliminate, as much as
possible, the waiver of consent for research done on residual material.
There is a teleconference planned for June 7 with the FDA on the proposal.
Does anyone know when the proposed rule may go into effect?
Dan
Daniel L. Icenogle, MD, JD
Icenogle & Associates
1858 Sand Ridge Ct.
Verona, WI 53593-8814
608.832.0549 (voice and fax)
Electronic mail from Daniel L. Icenogle, MD, c/o Icenogle & Associates at
icenogle@execpc.com. This communication is intended for the use of the
addressee. It may contain information which is privileged or confidential
under applicable law. If you are not the intended recipient or the agent of
the recipient, you are hereby notified that any dissemination, copy or
disclosure of this communication is strictly prohibited. If you have
received this communication in error, please notify Icenogle & Associates at
(608) 832-0549 or via return Internet electronic mail at icenogle@execpc.com
and expunge this communication without making any copies. Thank you for
your cooperation.
Daniel L . Icenogle
4/27/2000 1:33:00 PM
Jerry's points are important, and the exchange underscores a rhetorical
challenge: It can be very hard to disclose, without creating the impression of
an improper waiver; details of wording can be key. And ironically, the
allowability of a wording may hinge on subtleties that will escape 99.994% of
subjects reading the CF.
Conceptually, it may help to think of the whole issue from the perspective of
conflict of interest rather than from the perspective of property rights. That
is, the more important message may be There's some chance that I or the sponsor
will develop a commercial product and thereby make big bucks from working with
your tissues; you should know that in deciding whether or not to participate.
Framing it that way may work better than trying to find a good way to say Don't
think you own these samples, because you don't.
Dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
4/27/2000 1:33:00 PM
Greetings again from New Zealand!
I have been following this subject with interest because we are getting this
type of application here.
Does anyone have experience with communities where the cultural norm is to
regard ownership of bodies and body parts or tissues as a FAMILY right not
an individual right, so that no one person can give consent for the use of
such tissues?
We are finding it difficult to get this point (and other issues) across to
multi-national drug companies from the northern hemisphere who do not seem
to understand that there is more than one way of seeing issues like this.
In this country we have special arrangements so that post mortems can be
done very speedily and complete bodies returned to families for funerals
where this cultural issue arises, so that the FAMILY can decide on the
funeral arangements.
Any experiences would be helpful.
Frank Gaze
Taranaki Ethics Committee
Frank And Margaret Gaze
4/27/2000 1:30:00 PM
Sharing information with Investigators
We don't use a primary reviewer system. We have the researchers come and
present a brief research overview, then the entire committee asks
questions. That being said, here is what we do with requests for changes
to the informed consent document.
I chair the meetings. I ask the members to raise the more substantial
issues regarding the ethics of the study and changes to the consent. We
deal with those in the form of motions. The Research Dept. staff is there
and records the motions and outcomes. If people have more minor wording
changes, (including wording changes that the attorney requests or the need
to add standard language that we use) we ask them to give those to the
Research Dept. staff. Often times I'll mark my agenda with sticky notes.
The staff compiles those changes and also incorporates them in the minutes.
Then, the staff composes letters to the researchers with all of the
requested changes. This seems to work very well for record keeping and for
saving time during the meetings.
I hope this helps.
Deborah Barnard on 04/26/2000 05:30:59 PM
Please respond to mcwirb@mcwirb.org
To: mcwirb@mcwirb.org
cc: (bcc: Ellen W Bernal/SVMC/MHP/CHP)
Subject: Sharing information with Investigators
I need some help. Some real practical guidance.
My IRBs use the primary reviewer system. Now we're always careful to record
actual questions or requests for further information from each and every
member. However, each and every member wants to submit editorial
comments/chnages to the consent documents. How do other groups handle this?
Do you accept editorial comments from the primary reviewer only? If you
allow
editorial (we're talking commas, word choice issues, etc.) comments from
everyone - how do you get this information to the investigator without 1)
overwhelming him/her with pages of changes and 2) assuring that the PI can
follow what's being requested.
Finally, how do you reflect these requested changes in your minutes?
Deb Barnard
Rush
Chicago
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Ellen Bernal
4/27/2000 5:03:00 AM
Greetings again from New Zealand!
I have been following this subject with interest because we are getting this
type of application here.
Does anyone have experience with communities where the cultural norm is to
regard ownership of bodies and body parts or tissues as a FAMILY right not
an individual right, so that no one person can give consent for the use of
such tissues?
We are finding it difficult to get this point (and other issues) across to
multi-national drug companies from the northern hemisphere who do not seem
to understand that there is more than one way of seeing issues like this.
In this country we have special arrangements so that post mortems can be
done very speedily and complete bodies returned to families for funerals
where this cultural issue arises, so that the FAMILY can decide on the
funeral arangements.
Any experiences would be helpful.
Frank Gaze
Taranaki Ethics Committee
Frank And Margaret Gaze
4/27/2000 1:33:00 PM
Ancillary genetic studies
Hi All,
We commonly receive applications for clinical research ( industry-sponsored and federally-sponsored ) that include ancillary genetic studies. The application is submitted with a clinical protocol and investigator's brochure, and involves local investigators whom we know. The latter are not personally involved in the genetic study.
The protocol describes the collection of tissue samples, which are to be sent to a distant laboratory. The Consent Document describes the genetic component of the study, but typically in a cursory manner. A detailed protocol describing the nature of the genetic research is not submitted to the IRB. Of course, we do not know the distant researchers or whether their proposed research has been reviewed or approved by an IRB. By requesting such samples the distant laboratory is, in effect, creating a repository, the operational features of which are unknown to us.
How do you evaluate such studies ? What is my IRB's obligation with respect to the ancillary genetic study ?
I am aware of this item from the OPRR that addresses the establishment of repositories for research that involve federal funds :
http://grants.nih.gov/grants/oprr/humansubjects/guidance/reposit.htm
I believe its provisions are pertinent, at least in part, to this issue.
Regards,
Howard
Anonymous
4/27/2000 9:56:00 AM
Use of Medical Records for Research -- Need to Remove Identifiers?????
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
Of Isch, David
Sent: Thursday, April 27, 2000 10:49 AM
To: 'mcwirb@mcwirb.org'
Subject: Use of Medical Records for Research -- Need to Remove
Identifiers?????
I would be interested to know if institutions require removal of personal
identifiers previous to an employee (such as a nurse or social worker) using
them for a research project, particularly if the person is a provider of
direct care to the person whose record s/he is using.
David Isch
We do not require such removal. Our rationale is that if the employee would
be reviewing identifiable patient records anyway (such as for in-house QA
activities), then it is permissible for these employees to abstract patient
data for institution-approved external research projects. Of course, for
such research we require that any data leaving the medical records or
patient care areas are first rendered unidentifiable outside of the
institution - that is, data sheets are first assigned a code number and the
master list tying patient identifiers to those code numbers remains secured
at the insitution from which the data are obtained.
Timothy P. Stratton, Ph.D., R.Ph.
Associate Professor of Pharmacy Administration
School of Pharmacy and Allied Health Sciences
The University of Montana-Missoula
Member, UM IRB
ph: (406) 243-2339
fax: (406) 243-4353
e-mail: timstrat@selway.umt.edu
snail mail: Pharmacy Practice
32 Campus Drive #1522
Missoula, MT 59812-1522
timstrat@selway.umt.edu
4/27/2000 1:33:00 PM
Sharing information with Investigators
I need some help. Some real practical guidance.
My IRBs use the primary reviewer system. Now we're always careful to record actual questions or requests for further information from each and every member. However, each and every member wants to submit editorial comments/chnages to the consent documents. How do other groups handle this?
Do you accept editorial comments from the primary reviewer only? If you allow editorial (we're talking commas, word choice issues, etc.) comments from everyone - how do you get this information to the investigator without 1) overwhelming him/her with pages of changes and 2) assuring that the PI can follow what's being requested.
Finally, how do you reflect these requested changes in your minutes?
Deb Barnard
Rush
Chicago
Anonymous
4/27/2000 3:49:00 PM
Use of Medical Records for Research -- Need to Remove Identifiers ?????
To All:
We are having an internal debate about whether it is necessary to remove
personal identifiers from medical records previous to a researcher using the
record. This would be without consent of the patient under exempted
research (Research involving the collection or study of existing data,
documents, records, pathological specimens or diagnostic specimens, .... if
the information is recorded by the investigator in such a manner that
patients cannot be identified, directly or through identifiers linked to the
patients.)
I would be interested to know if institutions require removal of personal
identifiers previous to an employee (such as a nurse or social worker) using
them for a research project, particularly if the person is a provider of
direct care to the person whose record s/he is using.
Thank you for your assistance.
Cordially,
David Isch
Ethicist
Harris Methodist Fort Worth Hospital
1301 Pennsylvania Avenue
Fort Worth, Texas 76104
(817) 882-2155
davidisch@hmhs.com
David
4/27/2000 12:11:00 PM
Dear All,
I am responding to a string of messages started by O. Timmons and
continued by several others the last being Daniel Vasgird. The
proscription to which O. Timmons refers is to the use of exculpatory
language. Telling people they have no property rights to anything is not
exculpatory language and not proscribed by regulations. If you would
like to see a brief summary of the arguments in the field see my Ethics
and Regulation of Clinical Research, 2nd Edition, at pp. 110-111.
References are included to more extended treatments of the issue by (eg)
Murray and Levine.
Bob Levine
Robert J . Levine
4/27/2000 1:33:00 PM
Further to the proposed consent language that reads, “If a commercially
viable product results from the use of this specimen, you will not have any
ownership rights of proceeds”:
A question for Daniel Iconogle: what is the date or reference or citation
for the guideline, dear colleague letter, or whatever by which you say the
OPRR specifically approved non-waiver language dealing with a subject’s
possible ownership rights and the use in commerce of the subject’s blood,
tumor samples, etc.? The only reference I could find was the 11/15/96 OPRR
Guidance Document entitled “Exculpatory Language in Informed Consent
Documents.” Is this what you are referring to?
Anyhow, much like my 6 year old daughter pushing a cold lima bean across the
plate to a luncheon companion (thank you J.D. Salinger), I offer the
following:
* OPRR Guidance Document 11/15/96 gives examples of exculpatory
language that is not acceptable:
---- “By agreeing to this use, you should understand that you will give up
all claim to personal benefit from commercial or other use of these
substances”
---- “I voluntarily and freely donate any and all blood, urine, and tissue
samples to the U.S. Government and hereby relinquish all right, title, and
interest to said items.”
---- “By consent to participate in this research, I give up any property
rights I may have in bodily fluids or tissue samples obtained in the course
of the research.”
* The same Guidance Document gives the following as an example of
acceptable language:
---- “Tissue obtained from you in this research may be used to establish a
cell line that could be patented and licensed. There are no plans to
provide financial compensation to you should this occur.”
The Guidance given by OPRR in its 11/15/96 document is in the form of
examples, not formal black letter law. I personally believe the proposed
consent language comes perilously close to the language of the unacceptable
examples quoted above. I also suggest that the example quoted above that is
acceptable is not as clear as it could be ( i.e. “no plans”). Regardless, I
think IRBs (and the OPRR) should encourage clarity and ease of
understanding. Federal regulations regarding waiver of rights and
exculpatory language (45 CFR 46.116 and 21 CFR 50.20) speak of appearances
(“appear to waive”) and not just the reality of waiver. As I see it, this
cautions against ambiguity, seductive phraseology, and vague language that
may mean something to a sponsor but not be equally or fairly meaningful to
the subject.
Other questions for which I don’t have answers but which an IRB (or its
parent institution) might wish to consider are the following:
1. Is a consent-for-research document the appropriate legal vehicle by
which to seek a relinquishment of a subject’s possible ownership rights in
blood, tumor samples, etc.? Does this language accomplish a relinquishment?
Is it legally effective?
2. Is the prospective commercially viable product a benefit that should
enter into the risk/benefit equation and the decision-making or consent
process? If so, who is competent to judge whether the gap between sample
and product can be bridged and the technology transferred? Is the subject
at risk of waiving only a mere fantasy or a realistic ownership right?
3. If the language is indeed merely a “statement of fact,” why does the
sponsor wish to inject it into a consent-for-research document, or make it
part of the consenting process?
4. Is the language intended to put the subject on notice of the sponsor
’s intention regarding a future commercial use? If so, is the notice
effective? Does the subject understand he/she is being put on notice of a
“statement of fact?” Could the subject be estopped in the future from
objecting by virtue of this notice? And isn’t estoppel in this context just
another form of waiver, or appearance of waiver? Should the notice or
statement of fact make any reference to economic or dollar value of the
commercial product that might result (e.g. of speculative, undetermined,
significant value)?
5. Is the IRB appropriately qualified and is it able to evaluate these
issues? Should it?
6. Is it appropriate in the first place to use the research evaluation
process and the consenting process to attempt to effectuate a resolution of
a subject’s possible ownership rights in tissue samples and their later
commercial use?
7. Just as subjects in some research contexts may be determined to have
medical or psychological needs, might not a subject in certain
circumstances, this for example, have legal needs and should a subject in
such a situation be advised to seek legal counsel? At whose expense? Will
the institution pay? The sponsor?
8. What policies, if any, does the institution (medical center,
university, clinic etc.) have regarding: technology transfer; ownership,
use, licensing and patenting in respect to blood, tumor samples, tissue
samples and the commercial use of research results? Should the institution
have policies if it doesn’t already? Is the institution missing an
opportunity to assert ownership rights, if any, in this situation? Is the
IRB the arbiter between competing possible ownership rights of the
institution, the investigator, the sponsor, and the subject? In this case
here, how might institutional policies impact upon the language proposed
here for the consent-for-research document?
9. Does the disputed language not inject confusion and ambiguity,
rather than clarity, into the consenting process? If a court were at some
later date be called upon to interpret the language in question – and it
could be if the stakes were high enough –wouldn’t the court be inclined to
resolve ambiguities against the maker much as courts resolve ambiguities in
insurance contracts (contracts of adhesion, in negotiation of which the
sides have unequal bargaining power) against the insurer? And wouldn’t
litigation about this matter of necessity involve the institution in which
the research takes place, more so especially if an IRB had sanctioned the
use of the language in the consent-for-research document?
As I said, I don’t have answers for all these questions, and I may stand
corrected about some of my assumptions. At this point I almost wish I hadn’
t even started thinking about them. (This is the hidden price of having too
many Starbucks outlets nearby.) Anyhow, in any show of hands on this
matter, I vote against including the language in the consent form. On
balance, I think the subject (and probably the institution as well) is
better protected if the language is out of and not in the consent document.
Tom Dalglish J.D., Ph.D.
Community
Representative, Committee C
University of
Washington
(206) 543-0098
(University)
(206) 706-1000
(Office)
thomas k. dalglish
4/27/2000 5:06:00 AM
Sharing information with Investigators
Barbara,
Could you clarify your approach a bit--I'm assuming all these changes
(except grammar and typos) are put forth at the meeting and the full
board has agreed that they are warranted (if not, I'm assuming that the
PI can regard them as friendly suggestions as opposed to a stipulation
by the IRB)? Is a copy of the marked up consent form that is sent to
the PI attached to the minutes? Finally, from the perspective of your
staff's workload--just how are these changes given to you and how many
changes are there? Are you deciphering multiple editors' handwritten
rewording and insertions? I suspect this can be pretty cumbersome--how
big a staff are you and how many protocols are being reviewed?
Jo Anne Bennett, RN, PhD
Vice Chairperson
Institutional Review Board
New York City Department of Health
Box 65
346 Broadway, Room 707A
New York, NY 10013
(212) 442-3381
FAX: 212-442-3535
jbennett@dohlan.cn.ci.nyc.ny.us
>>> Barbara LoDico 04/26/00 06:21PM >>>
Deb,
We (IRB staff) collect all of the revisoins to the consent and
mark up one
copy which would include all changes made by the whole committee and
forward
that to the investigator. This is the simplest way that we can
accomplish
all comments to be reflected and it makes the job for the PI easier, as
they
can just revise the consent.
We also have a primary and secondary reviewer system, but the whole
committee's comments are included for all clarifications, consent
changes,
etc.
I hope this helps.
Barbara J. LoDico, IRB Administrator
Coordinator, Research and Sponsored Programs
New Jersey Medical School, MSB C-690
185 so. Orange Ave., Newark, NJ 07103
lodico@umdnj.edu
phone (973) 972-3608
fax (973) 972-3585
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org] On
Behalf Of
Deborah Barnard
Sent: Wednesday, April 26, 2000 5:31 PM
To: mcwirb@mcwirb.org
Subject: Sharing information with Investigators
I need some help. Some real practical guidance.
My IRBs use the primary reviewer system. Now we're always careful to
record
actual questions or requests for further information from each and
every
member. However, each and every member wants to submit editorial
comments/chnages to the consent documents. How do other groups handle
this?
Do you accept editorial comments from the primary reviewer only? If
you
allow
editorial (we're talking commas, word choice issues, etc.) comments
from
everyone - how do you get this information to the investigator without
1)
overwhelming him/her with pages of changes and 2) assuring that the PI
can
follow what's being requested.
Finally, how do you reflect these requested changes in your minutes?
Deb Barnard
Rush
Chicago
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Jo Anne Bennett
4/27/2000 4:20:00 AM
Sharing information with Investigators
Following a review of proposed research, by our Research Ethics Board, each member submits her/his comments to the Chair of the Board. Only substantive recommendations, e.g. methodological issues, are included in the final report, written by the Chair. If there are editing issues, there is a recommendation to the PI that the proposal be reviewed for errors.
Hope this helps,
Michael Wodlinger
*****************************************
Michael Wodlinger, PhD
Director, Research Services and
Graduate Studies
Nipissing University
100 College Drive, P.O. Box 5002
North Bay, Ontario
Canada P1B 8L7
705.474.3461 (ext. 4565) Fax: 705.474.1947
michaelw@unipissing.ca
Michael Wodlinger
4/27/2000 4:20:00 AM
Web-based patient recruitment
Cliff:
IRB review is not required by FDA. See the third paragraph of the sheet
Recruiting Study Subjects in the 1998 update to the FDA Information Sheets
for IRBs and Clinical Investigators.
http://www.fda.gov/oc/oha/irb/toc.html. The paragraph is reproduced below.
IRB review and approval of listings of clinical trials on the internet
would provide no additional
safeguard and is not required when the system format limits the information
provided to basic trial
information, such as: the title; purpose of the study; protocol summary;
basic eligibility criteria;
study site location(s); and how to contact the site for further information.
Examples of clinical trial
listing services that do not require prospective IRB approval include the
National Cancer
Institute's cancer clinical trial listing (PDQ) and the government-sponsored
AIDS Clinical Trials
Information Service (ACTIS). However, when the opportunity to add additional
descriptive
information is not precluded by the data base system, IRB review and
approval may assure that
the additional information does not promise or imply a certainty of cure or
other benefit beyond
what is contained in the protocol and the informed consent document.
All of the concerns you stated were considered when this decision was made.
Also, FDA had no evidence of coercive presentation of studies on the
internet that would be precluded by IRB review of postings. When I left FDA
on March 1, 00, the FDA position was that IRB review of web/internet
postings is not required, but that FDA reserves the right to reinstate IRB
review requirements if a pattern of coercion becomes apparent.
*This is not an official OPRR statement nor is it an official FDA statement*
Paul W. Goebel, Jr.
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
6100 Executive Boulevard, suite 3B01, MSC-7507
Rockville, MD 20892-7507
Phone: 301-402-4372
email: pg122v@nih.gov
Fax: 301-402-4256
OPRR url: http://grants.nih.gov/grants/oprr/oprr.htm
> -----Original Message-----
> From: CliffK2@aol.com [SMTP:CliffK2@aol.com]
> Sent: Wednesday, April 26, 2000 11:41 PM
> To: mcwirb@mcwirb.org
> Subject: Web-based patient recruitment
>
> I am interested in possibly posting a clinical trial on the web to recruit
> patients, but I have one question on IRB approval. In clinical trials,
> the
> local IRB must approve the wording for written advertisement to recruit
> trial subjects. Since web-based sites can be seen by any person with a
> browser, which IRB has to approve the wording? Is it one national IRB, or
> does every IRB involved in the study have to approve the wording? If the
> latter, that could get quite difficult.
>
> Thanks for the information.
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul Od
4/27/2000 5:12:00 AM
I continue the arduous process of revising and updating the policies and
procedures for our IRB.
We have something in our policies and procedures called conditional approval,
where, pending modifications in the protocol or changes in the consent form,
conditional approval may be given by the IRB to be followed up with expedited
review of the changes and modifications by the IRB Chairperson. I have not be
able to find any official basis for this type of action in the Code or
anywhere else. Am I just missing it?
If this is indeed a kosher approach to approving research, if the changes
requested by the IRB are minor and do not directly impact safety issues for
potential subjects, MUST this conditional approval be followed up by an
expedited review of the changes/modifications, or can the IRB simply give
approval that would be effective when the changes/modifications are completed??
Gary Dennison
4/27/2000 1:33:00 PM
Daniel Icenogle writes:
>I have to weigh in on this. First of all, let's make something perfectly
>clear. The language that many seem to find objectionable had been
>specifically approved by OPRR for use in this setting a number of years >ago
>as NOT A WAIVER, but, as mentioned by Jon Merz, a mere statement of a >fact.
>Many institutions are using similar or identical language and have done so
>for years.
We should note that the objectionable statement at issue which began this discussion was, if a commercially viable product results from use of this specimen, you will not have any ownership rights of proceeds. This is different from the OPRR-approved statement of fact quoted by Tom Dalglish, Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. There are no plans to provide financial compensation to you should this occur.
The distinction being made here is similar to that which is usually maintained in the other big waiver context, payment to the subject for research-related injuries. Often, the sponsor will put a statement in the consent form that they will not pay for research-related injuries. On the other hand, the subject still has the right to demand payment and sue, and may win such a suit. The subject cannot be required, in the consent form, to acknowledge that they have given up the ability to exercise that legal right.
Thus, it would seem reasonable, to (1) limit the consent form language to true statements of fact, e.g., that there is no intention to give the subjects any part of the profits, and (2) add a statement indicating that the subject may or may not have a legal right to part of the profits, and nothing in the consent form is intended to prevent them from exercising that legal right, if any.
Jerry Menikoff
University of Kansas
Jerry Menikoff
4/27/2000 7:48:00 AM
Sharing information with Investigators
Deb
Your problem has been mine for several years. Unable to find a
solution, my IRB members were beginning to revolt because of the
excesive time spent on style changes. I decided to do about what was
suggested to you already. All IRB members will come to the meeting
with sytle changes in hand. None will be discussed. If there are two
or more changes for any one word, sentence, etc, a sytle czar will
decide the best change and the committee will agree. Only substantive
protocol or informed consent issues will be dicussed at the meeting.
Tomorrow is the first such meeting. I hope it goes well otherwise
you may be seeing an advertisement for IRB chair on this list serve in
the very near future.
Norm
------------------ Reply Separator --------------------
Originally From: Deborah Barnard
Subject: Sharing information with Investigators
Date: 04/26/2000 04:30pm
I need some help. Some real practical guidance.
My IRBs use the primary reviewer system. Now we're always careful to
record
actual questions or requests for further information from each and
every
member. However, each and every member wants to submit editorial
comments/chnages to the consent documents. How do other groups handle
this?
Do you accept editorial comments from the primary reviewer only? If
you allow
editorial (we're talking commas, word choice issues, etc.) comments
from
everyone - how do you get this information to the investigator without
1)
overwhelming him/her with pages of changes and 2) assuring that the PI
can
follow what's being requested.
Finally, how do you reflect these requested changes in your minutes?
Deb Barnard
Rush
Chicago
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Norman Leopold
4/27/2000 4:20:00 AM
Sharing information with Investigators
Deb,
We have a required consent form that covers the order of info, the headings,
standard wording, stuff like that.
We have a primary consent reviewer, but all members have the right to have a
say.
We DO NOT discuss typos, commas, etc. The member makes a note on their copy
and gives it to my and my assistant.
The IRB Office types up a memo to the investigator, telling exactly what the
IRB wants changes. This accomplishes a couple of purposes:
- it's the IRB record of what we requested
- it's a completion check list for the IRB Office to confirm compliance
- it really helps the investigator/staff to get all the changes right
In our memo to the PI we state the heading the change is under, the page, the
paragraph, the word/sentence/context. We try not to leave any of this up to
chance.
We welcome the comments of our red pencil members, but they do not get to
hold the floor on this stuff. We only discuss substantive issues. The IRB
then requests that I provide final approval when the required changes have
been made and I have verified them, unless I request that a sub committee be
involved. We have cleared this procedure with the Feds.
Our consent change process has been running very smoothly for a number of
years; our IRB members get their say and are happy; the PIs get very clear
instructions on what to do; and the IRB Office and files have clear
verification of what we wanted/had changed.
Rebecca M. Clark
Children's Hospital
Scripps Hospitals
San Diego
Rebecca M. Clark
4/27/2000 3:49:00 PM
Dale
The obvious problem with Paul Goebel's statement is that is assumes that the
assignment of property interests in this setting is a black and white issue.
Although often property interests are creatures of the law, the fact is that
there is no black letter law concerning property interests that creates-or
bars-a property interest in this setting. In this void, the question of the
payment of royalties becomes a philosophical or justice issue. Perhaps one
day the courts or legislatures will definitively resolve it. Pending that,
we will continue to have this discussion about the appropriateness of
payments.
Dan
Daniel L. Icenogle, MD, JD
Icenogle & Associates
1858 Sand Ridge Ct.
Verona, WI 53593-8814
608.832.0549 (voice and fax)
Electronic mail from Daniel L. Icenogle, MD, c/o Icenogle & Associates at
icenogle@execpc.com. This communication is intended for the use of the
addressee. It may contain information which is privileged or confidential
under applicable law. If you are not the intended recipient or the agent of
the recipient, you are hereby notified that any dissemination, copy or
disclosure of this communication is strictly prohibited. If you have
received this communication in error, please notify Icenogle & Associates at
(608) 832-0549 or via return Internet electronic mail at icenogle@execpc.com
and expunge this communication without making any copies. Thank you for
your cooperation.
Daniel L . Icenogle
4/27/2000 4:18:00 AM
I continue the arduous process of revising and updating the policies and
procedures for our IRB.
We have something in our policies and procedures called conditional approval,
where, pending modifications in the protocol or changes in the consent form,
conditional approval may be given by the IRB to be followed up with expedited
review of the changes and modifications by the IRB Chairperson. I have not be
able to find any official basis for this type of action in the Code or
anywhere else. Am I just missing it?
If this is indeed a kosher approach to approving research, if the changes
requested by the IRB are minor and do not directly impact safety issues for
potential subjects, MUST this conditional approval be followed up by an
expedited review of the changes/modifications, or can the IRB simply give
approval that would be effective when the changes/modifications are completed??
Gary Dennison
4/27/2000 1:33:00 PM
OPRR guidance on exculpatory language may be found at
http://grants.nih.gov/grants/oprr/humansubjects/guidance/exculp.htm
Tom Puglisi, PhD
Director
Division of Human Subject Protections
Office for Protection from Research Risks
Tom Od
4/27/2000 1:33:00 PM
Web-based patient recruitment
I am interested in possibly posting a clinical trial on the web to recruit
patients, but I have one question on IRB approval. In clinical trials, the
local IRB must approve the wording for written advertisement to recruit
trial subjects. Since web-based sites can be seen by any person with a
browser, which IRB has to approve the wording? Is it one national IRB, or
does every IRB involved in the study have to approve the wording? If the
latter, that could get quite difficult.
Thanks for the information.
cliffk2@aol.com
4/27/2000 5:12:00 AM
Ancillary genetic studies
OPRR issued a guidance Issues to Consider in the Research Use of Stored
Data or Tissues 11/7/97
(http://grants.nih.gov/grants/oprr/humansubjects/guidance/reposit.htm) which
indicates that if a tissue repository receives support from HHS, it is
subject to oversight by an IRB, in addition to the IRB oversight of the
tissue collector. This guidance also gives a detailed list of the items that
should appear in the ICF for a donor-subject.
This doesn't address regulation of a commercial repository--so there may be
a substantial gap in regulatory oversight which needs to be addressed by a
local IRB.
Christina M. Gullion, Ph.D.
Biostatistician/Senior Scientist
Department of Clinical Research
Medical City Dallas Hospital
7777 Forest Lane, Suite C-740
Dallas TX 75230
phone: 972-566-4718, fax: 972-566-4715
> -----Original Message-----
> From: Howard Mann [SMTP:ldhmann@ihc.com]
> Sent: Monday, April 24, 2000 6:17 PM
> To: mcwirb@mcwirb.org
> Subject: Ancillary genetic studies
>
> Hi All,
>
> We commonly receive applications for clinical research (
> industry-sponsored and
> federally-sponsored ) that include ancillary genetic studies. The
> application
> is submitted with a clinical protocol and investigator's brochure, and
> involves
> local investigators whom we know. The latter are not personally involved
> in the
> genetic study.
>
> The protocol describes the collection of tissue samples, which are to be
> sent
> to a distant laboratory. The Consent Document describes the genetic
> component
> of the study, but typically in a cursory manner. A detailed protocol
> describing
> the nature of the genetic research is not submitted to the IRB. Of course,
> we
> do not know the distant researchers or whether their proposed research has
> been
> reviewed or approved by an IRB. By requesting such samples the distant
> laboratory is, in effect, creating a repository, the operational features
> of
> which are unknown to us.
>
> How do you evaluate such studies ? What is my IRB's obligation with
> respect to
> the ancillary genetic study ?
>
> I am aware of this item from the OPRR that addresses the establishment of
> repositories for research that involve federal funds :
>
> http://grants.nih.gov/grants/oprr/humansubjects/guidance/reposit.htm
>
> I believe its provisions are pertinent, at least in part, to this issue.
>
> Regards,
>
> Howard
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Gullion Christina
4/27/2000 9:56:00 AM
Attend IIR's Premier Conference on
Auditing for GCP Compliance:
Strategies for Ensuring Continuous Clinical Quality
in the Pharmaceutical Industry
The Pharmaceutical Division at the Institute for International Research (IIR) presents the Auditing for GCP Compliance: Strategies for Ensuring Continuous Clinical Quality conference on July 24-25, 2000 in Bethesda, Maryland.
This conference presents tools you need to ensure your audits are comprehensive and gets you up to speed on regulations involving informed consent and on the roles of IRBs and the NIH Office of Protection from Research Risks. Whether you:
* Audit your company's clinical trials and data
* Monitor the progress of clinical trials
* Perform clinical QA/QC activities during the course of clinical trials
* Coordinate clinical studies
* Investigate the conduct of the trial
knowing effective auditing techniques and how to be ready for an audit or inspection is the key to a proactive approach to GCP audits. As failure to comply can lead to disciplinary action and prosecution, GCP audits are essential for maintaining quality and compliance, and for detecting non-compliance.
Our speakers bring years of GCP compliance auditing and clinical quality assurance expertise to the table. Together, they address how to:
* Anticipate a compliance challenge before an inspection
* Outline a successful overseas auditing program for your foreign sites
* Detect the root cause of non-compliance
* Overcome current challenges involved in complying with the Informed Consent regulation
* Identify and prevent fraudulent activities in clinical trials
* Examine the role of IRBs and the need for audits led by Sponsors
* Pre-select and perform on-going audits of CROs
We also invite you to hear a featured presentation by Melody H. Lin, PhD, Deputy Director, NIH Office for Protection from Research Risks (OPRR).
Hear directly from successful clinical QA auditors and GCP compliance experts from within the pharmaceutical industry.
Pam Sobotka
4/27/2000 10:49:00 AM
Costs to Subjects - Model Language
Greetings. We are looking at changing the model language for the Costs to
Subjects section of our IRB consent form. Do any of you have model
language which you suggest to your PIs? Thank you in advance. Judy
Judith Argon
4/27/2000 7:50:00 AM
Human Subjects in Social Science Research
If you were in attendance at the December ARENA/PRIMR meeting in Boston
and one your areas of interest is in human subjects in social science
research, you may have run into Dr. Ivor Pritchard as a presenter in
those sessions dealing specifically with social science research.
We are fortunate to have convinced Dr. Pritchard to come to Lehigh
University on May 10, 2000, to give a talk titled Protecting Human
Research Subjects in Social Science Research: Applying the Common Rule.
This is an invitation to nearby institutions to attend this talk.
Following is additional information:
Protecting Human Research Subjects in Social Science Research: Applying
the Common Rule
May 10, 2000
presented by
DR. IVOR PRITCHARD
Senior Education Research Analyst
National Institute on Student Achievement, Curriculum, and Assessment
Office of Educational Research and Improvement (OERI)
U. S. Department of Education
The presentation, Protecting Human Research Subjects in Social Science
Research: Applying the Common Rule, is intended for faculty, staff and
students who wish to learn more about the regulations and procedures for
the use of human subjects in research. This will be an interactive
session with a case study or two for discussion purposes. The session
will be held at 1:30 pm in Room B023 (adjacent to the main lobby),
Iacocca Hall, Mountaintop Campus
Lehigh University
If you have questions, please contact the Office of Research and
Sponsored Programs at (610) 758-3022 or via e-mail at rt01@lehigh.edu.
Ruth Tallman
Office of Research and Sponsored Programs
Lehigh University
526 Brodhead Avenue
Bethlehem, PA 18015
Phone: (610)758-3024
FAX: (610)758-5994
E-mail: rt01@lehigh.edu
Ruth Tallman
4/27/2000 1:33:00 PM
This is a multi-part message in MIME format.
------=_NextPart_000_0004_01BFB055.CD0615A0
Content-Type: text/plain;
charset=iso-8859-1
Content-Transfer-Encoding: 8bit
Let me offer my thoughts on your questions.
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of
Thomas Dalglish
Sent: Thursday, April 27, 2000 8:26 AM
To: mcwirb@mcwirb.org
Subject: RE: Ownership of samples
Further to the proposed consent language that reads, “If a commercially
viable product results from the use of this specimen, you will not have any
ownership rights of proceeds”:
A question for Daniel Iconogle: what is the date or reference or citation
for the guideline, dear colleague letter, or whatever by which you say the
OPRR specifically approved non-waiver language dealing with a subject’s
possible ownership rights and the use in commerce of the subject’s blood,
tumor samples, etc.? The only reference I could find was the 11/15/96 OPRR
Guidance Document entitled “Exculpatory Language in Informed Consent
Documents.” Is this what you are referring to?
Yes.
Anyhow, much like my 6 year old daughter pushing a cold lima bean across the
plate to a luncheon companion (thank you J.D. Salinger), I offer the
following:
* OPRR Guidance Document 11/15/96 gives examples of exculpatory
language that is not acceptable:
---- “By agreeing to this use, you should understand that you will give up
all claim to personal benefit from commercial or other use of these
substances”
---- “I voluntarily and freely donate any and all blood, urine, and tissue
samples to the U.S. Government and hereby relinquish all right, title, and
interest to said items.”
---- “By consent to participate in this research, I give up any property
rights I may have in bodily fluids or tissue samples obtained in the course
of the research.”
* The same Guidance Document gives the following as an example of
acceptable language:
---- “Tissue obtained from you in this research may be used to establish a
cell line that could be patented and licensed. There are no plans to
provide financial compensation to you should this occur.”
The Guidance given by OPRR in its 11/15/96 document is in the form of
examples, not formal black letter law. I personally believe the proposed
consent language comes perilously close to the language of the unacceptable
examples quoted above. I also suggest that the example quoted above that is
acceptable is not as clear as it could be ( i.e. “no plans”). Regardless, I
think IRBs (and the OPRR) should encourage clarity and ease of
understanding. Federal regulations regarding waiver of rights and
exculpatory language (45 CFR 46.116 and 21 CFR 50.20) speak of appearances
(“appear to waive”) and not just the reality of waiver. As I see it, this
cautions against ambiguity, seductive phraseology, and vague language that
may mean something to a sponsor but not be equally or fairly meaningful to
the subject.
The key language, or absence of language, that would make the statement
acceptable, in my view, is that there is no use of words like “give up” or
“relinquish”.
Other questions for which I don’t have answers but which an IRB (or its
parent institution) might wish to consider are the following:
1. Is a consent-for-research document the appropriate legal vehicle by
which to seek a relinquishment of a subject’s possible ownership rights in
blood, tumor samples, etc.? Does this language accomplish a relinquishment?
Is it legally effective?
The language has never been tested in court, to my knowledge, so no one
knows if it is legally effective, but the intent is that it serves as a
statement of knowledge by the participant that no property interest is being
granted.
2. Is the prospective commercially viable product a benefit that should
enter into the risk/benefit equation and the decision-making or consent
process? If so, who is competent to judge whether the gap between sample
and product can be bridged and the technology transferred? Is the subject
at risk of waiving only a mere fantasy or a realistic ownership right?
I think these are questions for the participant to decide for him/her self.
3. If the language is indeed merely a “statement of fact,” why does the
sponsor wish to inject it into a consent-for-research document, or make it
part of the consenting process?
See #1.
4. Is the language intended to put the subject on notice of the sponsor
’s intention regarding a future commercial use? If so, is the notice
effective? Does the subject understand he/she is being put on notice of a
“statement of fact?” Could the subject be estopped in the future from
objecting by virtue of this notice? And isn’t estoppel in this context just
another form of waiver, or appearance of waiver? Should the notice or
statement of fact make any reference to economic or dollar value of the
commercial product that might result (e.g. of speculative, undetermined,
significant value)?
Yes. No one knows. Ask the subject. That is the intent of the use of the
language. Can you waive something you never had? I don’t see the legal
basis for any property interest existing outside of whatever may be granted
by the owner of the product. Perhaps, but is it ever knowable? In 1980,
could anyone have guessed the value of the Microsoft operating system?
5. Is the IRB appropriately qualified and is it able to evaluate these
issues? Should it?
No, I doubt there is any economic expertise. What the IRB is qualified to
do is ensure that the potential participant is made aware of the fact that a
commercial product may result and that no economic gain will fall to the
participant. Then the potential participant can decide whether to sign up.
6. Is it appropriate in the first place to use the research evaluation
process and the consenting process to attempt to effectuate a resolution of
a subject’s possible ownership rights in tissue samples and their later
commercial use?
It is the process to inform the potential participant of any and all
information that is reasonably material to the decision to participate.
7. Just as subjects in some research contexts may be determined to have
medical or psychological needs, might not a subject in certain
circumstances, this for example, have legal needs and should a subject in
such a situation be advised to seek legal counsel? At whose expense? Will
the institution pay? The sponsor?
No, I don’t think so. There is the one threshold question of whether
someone wants to participant in a study that may provide someone else with
income.
8. What policies, if any, does the institution (medical center,
university, clinic etc.) have regarding: technology transfer; ownership,
use, licensing and patenting in respect to blood, tumor samples, tissue
samples and the commercial use of research results? Should the institution
have policies if it doesn’t already? Is the institution missing an
opportunity to assert ownership rights, if any, in this situation? Is the
IRB the arbiter between competing possible ownership rights of the
institution, the investigator, the sponsor, and the subject? In this case
here, how might institutional policies impact upon the language proposed
here for the consent-for-research document?
While I do not see the IRB having any role in tech transfer or licensing, I
would be sure that the language on property interests should be consistent
with—or at least analyzed by the legal department as a component of—the more
general existing institutional policies on transfers and licensing.
9. Does the disputed language not inject confusion and ambiguity,
rather than clarity, into the consenting process? If a court were at some
later date be called upon to interpret the language in question – and it
could be if the stakes were high enough –wouldn’t the court be inclined to
resolve ambiguities against the maker much as courts resolve ambiguities in
insurance contracts (contracts of adhesion, in negotiation of which the
sides have unequal bargaining power) against the insurer? And wouldn’t
litigation about this matter of necessity involve the institution in which
the research takes place, more so especially if an IRB had sanctioned the
use of the language in the consent-for-research document?
You raise one of the key unknowns in this area—how would a court interpret
this language in a dispute over property interests? I have argued in other
settings that a consent form is a contract of sorts. If it were, then the
courts would apply standard contract jurisprudence. Whether this would be
viewed as a contract of adhesion is an unanswered question, particularly as
the participation is voluntary (while we must have insurance, for example).
However, many others have argued that the consent form should never be
presented as a contract. I think that the inclusion of this type of
language increases the contract nature of the consent form.
As I said, I don’t have answers for all these questions, and I may stand
corrected about some of my assumptions. At this point I almost wish I hadn’
t even started thinking about them. (This is the hidden price of having too
many Starbucks outlets nearby.) Anyhow, in any show of hands on this
matter, I vote against including the language in the consent form. On
balance, I think the subject (and probably the institution as well) is
better protected if the language is out of and not in the consent document.
Tom Dalglish J.D., Ph.D.
Community
Representative, Committee C
University of
Washington
(206) 543-0098
(University)
(206) 706-1000
(Office)
------=_NextPart_000_0004_01BFB055.CD0615A0
Content-Type: text/html;
charset=iso-8859-1
Content-Transfer-Encoding: quoted-printable
Further to the proposed consent language that reads, “If a =
commercially
viable product results from the use of this specimen, Let me offer my thoughts on your =
questions. <![if =
!supportEmptyParas]> <![endif]> <!=
--[if supportFields]> <![endif]--> -----Original
Message----- From: =
mcwirb-admin@mcwirb.org
[mailto:mcwirb-admin@mcwirb.org] On =
Behalf Of Thomas
Dalglish Sent: Thursday, April 27, =
2000
8:26 AM To: mcwirb@mcwirb.org Subject: RE: Ownership of =
samples <![if =
!supportEmptyParas]> <![endif]> Further to the proposed consent =
language that
reads, “If a =
commercially viable
product results from the use of this specimen, you will not have any =
ownership
rights of proceeds”: =
<=
/p> <![if =
!supportEmptyParas]> <![endif]> A question for Daniel Iconogle: what is the date or reference =
or
citation for the guideline, dear colleague letter, or whatever by which =
you say
the OPRR specifically approved non-waiver language dealing with a =
subject’s
possible ownership rights and the use in commerce of the subject’s =
blood, tumor
samples, etc.? The only =
reference
I could find was the 11/15/96 OPRR Guidance Document entitled =
“Exculpatory
Language in Informed Consent Documents.”
Is this what you are referring to?
<![if =
!supportEmptyParas]> <![endif]> Yes. <![if =
!supportEmptyParas]> <![endif]> Anyhow, much like my 6 year old =
daughter
pushing a cold lima bean across the plate to a luncheon companion (thank =
you
J.D. Salinger), I offer the following: <=
/p> <![if !supportLists]> =B7
<![endif]> OPRR Guidance Document 11/15/96 gives examples of exculpatory =
language
that is not acceptable: <=
/p> ---- “By agreeing to this use, =
you should
understand that you will give up all claim to personal benefit from =
commercial
or other use of these substances” <=
/p> ---- “I voluntarily and freely =
donate any and
all blood, urine, and tissue samples to the U.S. Government and hereby
relinquish all right, title, and interest to said =
items.” <=
/p> ---- “By consent to =
participate in this
research, I give up any property rights I may have in bodily fluids or =
tissue
samples obtained in the course of the =
research.” <=
/p> <![if !supportLists]> =B7
<![endif]> The same Guidance Document gives the following as an example of
acceptable language: ---- “Tissue obtained from you =
in this
research may be used to establish a cell line that could be patented and
licensed. There are no =
plans to
provide financial compensation to you should this =
occur.” <=
/p> <![if =
!supportEmptyParas]> <![endif]> The Guidance given by OPRR in its =
11/15/96
document is in the form of examples, not formal black letter law. I personally believe the =
proposed
consent language comes perilously close to the language of the =
un acceptable
examples quoted above. I =
also
suggest that the example quoted above that is acceptable is not =
as clear
as it could be ( i.e. “no plans”).
Regardless, I think IRBs (and the OPRR) should encourage clarity =
and
ease of understanding. =
Federal
regulations regarding waiver of rights and exculpatory language (45 CFR =
46.116
and 21 CFR 50.20) speak of appearances (“appear to waive”) =
and not just the
reality of waiver. As I =
see it,
this cautions against ambiguity, seductive phraseology, and vague =
language that
may mean something to a sponsor but not be equally or fairly meaningful =
to the
subject. =
<=
/p> <![if =
!supportEmptyParas]> <![endif]> The key language, or absence of =
language,
that would make the statement acceptable, in my view, is that there is =
no use
of words like “give up” or =
“relinquish”. <![if =
!supportEmptyParas]> <![endif]> <![if =
!supportEmptyParas]> <![endif]> Other questions for which I =
don’t have
answers but which an IRB (or its parent institution) might wish to =
consider are
the following: <![if !supportLists]> 1. =
<![endif]> Is a consent-for-research =
document the
appropriate legal vehicle by which to seek a relinquishment of a =
subject’s
possible ownership rights in blood, tumor samples, etc.? Does this language accomplish =
a
relinquishment? Is it =
legally
effective? <![if =
!supportEmptyParas]> <![endif]> The language has never been tested =
in court, to
my knowledge, so no one knows if it is legally effective, but the intent =
is
that it serves as a statement of knowledge by the participant that no =
property
interest is being granted. <![if =
!supportEmptyParas]> <![endif]> <![if !supportLists]> 2. =
<![endif]> Is the prospective =
commercially viable
product a benefit that should enter into the risk/benefit equation and =
the
decision-making or consent process?
If so, who is competent to judge whether the gap between sample =
and
product can be bridged and the technology transferred? Is the subject at risk of =
waiving only
a mere fantasy or a realistic ownership right? <=
/p> <![if =
!supportEmptyParas]> <![endif]> I think these are questions for the
participant to decide for him/her self.
<![if =
!supportEmptyParas]> <![endif]> <![if !supportLists]> 3. =
<![endif]> If the language is indeed =
merely a
“statement of fact,” why does the sponsor wish to inject it =
into a
consent-for-research document, or make it part of the consenting =
process? <=
/p> <![if =
!supportEmptyParas]> <![endif]> See =
#1. <![if =
!supportEmptyParas]> <![endif]> <![if !supportLists]> 4. =
<![endif]> Is the language intended to =
put the
subject on notice of the sponsor’s intention regarding a future =
commercial
use? If so, is the notice
effective? Does the =
subject
understand he/she is being put on notice of a “statement of =
fact?” Could the subject be estopped =
in the
future from objecting by virtue of this notice? And isn’t estoppel in this context just another =
form of
waiver, or appearance of waiver?
Should the notice or statement of fact make any reference to =
economic or
dollar value of the commercial product that might result (e.g. of =
speculative,
undetermined, significant value)? <=
/p> <![if =
!supportEmptyParas]> <![endif]> Yes.
No one knows. Ask =
the
subject. That is the =
intent of the
use of the language. Can =
you waive
something you never had? =
I don’t
see the legal basis for any property interest existing outside of =
whatever may
be granted by the owner of the product.
Perhaps, but is it ever knowable?
In 1980, could anyone have guessed the value of the Microsoft =
operating
system? =
<![if =
!supportEmptyParas]> <![endif]> <![if !supportLists]> 5. =
<![endif]> Is the IRB appropriately =
qualified and is
it able to evaluate these issues?
Should it? <![if =
!supportEmptyParas]> <![endif]> No, I doubt there is any economic
expertise. What the IRB =
is
qualified to do is ensure that the potential participant is made aware =
of the
fact that a commercial product may result and that no economic gain will =
fall
to the participant. Then =
the
potential participant can decide whether to sign =
up. <![if =
!supportEmptyParas]> <![endif]> <![if !supportLists]> 6. =
<![endif]> Is it appropriate in the first =
place to
use the research evaluation process and the consenting process to =
attempt to
effectuate a resolution of a subject’s possible ownership rights =
in tissue samples
and their later commercial use? <=
/p> <![if =
!supportEmptyParas]> <![endif]> It is the process to inform the =
potential
participant of any and all information that is reasonably material to =
the
decision to participate. <![if =
!supportEmptyParas]> <![endif]> <![if !supportLists]> 7. =
<![endif]> Just as subjects in some =
research
contexts may be determined to have medical or psychological needs, might =
not a
subject in certain circumstances, this for example, have legal needs and =
should
a subject in such a situation be advised to seek legal counsel? At whose expense? Will the institution pay? The =
sponsor? <=
/p> <![if =
!supportEmptyParas]> <![endif]> No, I don’t think so. There is the one threshold =
question of
whether someone wants to participant in a study that may provide someone =
else
with income. =
<![if =
!supportEmptyParas]> <![endif]> <![if !supportLists]> 8. =
<![endif]> What policies, if any, does =
the
institution (medical center, university, clinic etc.) have regarding:
technology transfer; ownership, use, licensing and patenting in respect =
to
blood, tumor samples, tissue samples and the commercial use of research
results? Should the =
institution
have policies if it doesn’t already?
Is the institution missing an opportunity to assert ownership =
rights, if
any, in this situation? =
Is the IRB
the arbiter between competing possible ownership rights of the =
institution, the
investigator, the sponsor, and the subject? In this case here, how might institutional policies =
impact
upon the language proposed here for the consent-for-research =
document? <=
/p> <![if =
!supportEmptyParas]> <![endif]> While I do not see the IRB having =
any role in
tech transfer or licensing, I would be sure that the language on =
property
interests should be consistent with—or at least analyzed by the =
legal department
as a component of—the more general existing institutional policies =
on transfers
and licensing. =
<![if =
!supportEmptyParas]> <![endif]> <![if !supportLists]> 9.
<![endif]> Does the disputed language not inject confusion and ambiguity, =
rather
than clarity, into the consenting process? If a court were at some later date be called upon to
interpret the language in question – and it could be if the stakes =
were high
enough –wouldn’t the court be inclined to resolve =
ambiguities against the maker
much as courts resolve ambiguities in insurance contracts (contracts of
adhesion, in negotiation of which the sides have unequal bargaining =
power)
against the insurer? And =
wouldn’t
litigation about this matter of necessity involve the institution in =
which the
research takes place, more so especially if an IRB had sanctioned the =
use of
the language in the consent-for-research document? <![if =
!supportEmptyParas]> <![endif]> You raise one of the key unknowns in =
this
area—how would a court interpret this language in a dispute over =
property
interests? I have argued =
in other
settings that a consent form is a contract of sorts. If it were, then the courts would apply standard =
contract
jurisprudence. Whether =
this would
be viewed as a contract of adhesion is an unanswered question, =
particularly as
the participation is voluntary (while we must have insurance, for =
example). However, many others have =
argued that the
consent form should never be presented as a contract. I think that the inclusion of this type of language =
increases
the contract nature of the consent form.
<![if =
!supportEmptyParas]> <![endif]> As I said, I don’t have =
answers for all these
questions, and I may stand corrected about some of my assumptions. At this point I almost wish I =
hadn’t
even started thinking about them.
(This is the hidden price of having too many Starbucks outlets
nearby.) Anyhow, in any =
show of
hands on this matter, I vote against including the language in the =
consent
form. On balance, I think =
the
subject (and probably the institution as well) is better protected if =
the
language is out of and not in the consent =
document. <=
/p> <![if =
!supportEmptyParas]> <![endif]> Tom Dalglish J.D., =
Ph.D. <=
/p>  =
; =
&=
nbsp; &n=
bsp; &nb=
sp; Community
Representative, Committee C  =
; =
&=
nbsp; &n=
bsp; &nb=
sp; University
of Washington  =
; =
&=
nbsp; &n=
bsp; &nb=
sp; (206)
543-0098 (University)  =
; =
&=
nbsp; &n=
bsp; &nb=
sp; (206)
706-1000 (Office) <![if =
!supportEmptyParas]> <![endif]> <![if =
!supportEmptyParas]> <![endif]>
------=_NextPart_000_0004_01BFB055.CD0615A0--
Daniel L . Icenogle
4/27/2000 1:33:00 PM
Sharing information with Investigators
Another help can be to build a repertoire of acceptable wordings for the most
commonly encountered problems.
There is a tension between the desire to avoid deferral of a committee decison
over minor wording changes and the desire to be sure that any changes made
genuinely resolve the concern. OPRR has generally opined that the required
changes should be clearly set forth in order for the re-review to be
administrative rather than done by the board. If you can provide sample
wordings, you can resolve this tension, but it's a huge amount of work to do
anew each time.
Dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
4/27/2000 1:42:00 PM
FOIA and Certificates of Confidentiality
As I have written on this in the past, as an administative law teacher I am very
surprised that researchers do not get hit with FOIA more often, especially those
in state institutions who are subject to state laws. What is unusual here is
that the court did not protect the patient indenties - that is a clear exception
to FIOA - sounds like the Feds dropped the ball in helping the company resist
the order.
Ed
Edward P. Richards
Center for Public Health Law
Professor - UMKC Law School
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
> -----Original Message-----
> From: Gullion Christina [mailto:Christina.Gullion@Columbia.net]
> Sent: Wednesday, April 26, 2000 9:57 AM
> To: 'MCWIRB@mcwirb.org'
> Subject: FOIA and Certificates of Confidentiality
>
>
> At the recent Society for Clinical Trials meeting, Don
> Stablein of EMMES
> Corporation presented an account of his company's somewhat nightmarish
> experience involving a Freedom of Information Act request
> from a newspaper
> to the NCI. The company had a copy of the data because they were
> reanalyzing it under contract with NCI. This is a vivid
> example of why a
> certificate of confidentiality might be needed to protect
> research subjects.
> If you want me to send you the postscript file for this
> presentation, please
> contact me privately. Alternatively, I think Dr. Nelson is
> going to try to
> post it at our website.
>
> Chris
> Christina M. Gullion, Ph.D.
> Biostatistician/Senior Scientist
> Department of Clinical Research
> Medical City Dallas Hospital
> 7777 Forest Lane, Suite C-740
> Dallas TX 75230
> phone: 972-566-4718, fax: 972-566-4715
>
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
Edward Richards
4/27/2000 4:20:00 AM
Human Subjects in Social Science Research
If you were in attendance at the December ARENA/PRIMR meeting in Boston
and one your areas of interest is in human subjects in social science
research, you may have run into Dr. Ivor Pritchard as a presenter in
those sessions dealing specifically with social science research.
We are fortunate to have convinced Dr. Pritchard to come to Lehigh
University on May 10, 2000, to give a talk titled Protecting Human
Research Subjects in Social Science Research: Applying the Common Rule.
This is an invitation to nearby institutions to attend this talk.
Following is additional information:
Protecting Human Research Subjects in Social Science Research: Applying
the Common Rule
May 10, 2000
presented by
DR. IVOR PRITCHARD
Senior Education Research Analyst
National Institute on Student Achievement, Curriculum, and Assessment
Office of Educational Research and Improvement (OERI)
U. S. Department of Education
The presentation, Protecting Human Research Subjects in Social Science
Research: Applying the Common Rule, is intended for faculty, staff and
students who wish to learn more about the regulations and procedures for
the use of human subjects in research. This will be an interactive
session with a case study or two for discussion purposes. The session
will be held at 1:30 pm in Room B023 (adjacent to the main lobby),
Iacocca Hall, Mountaintop Campus
Lehigh University
If you have questions, please contact the Office of Research and
Sponsored Programs at (610) 758-3022 or via e-mail at rt01@lehigh.edu.
Ruth Tallman
Office of Research and Sponsored Programs
Lehigh University
526 Brodhead Avenue
Bethlehem, PA 18015
Phone: (610)758-3024
FAX: (610)758-5994
E-mail: rt01@lehigh.edu
Ruth Tallman
4/27/2000 1:33:00 PM
FOIA and Certificates of Confidentiality
At the recent Society for Clinical Trials meeting, Don Stablein of EMMES
Corporation presented an account of his company's somewhat nightmarish
experience involving a Freedom of Information Act request from a newspaper
to the NCI. The company had a copy of the data because they were
reanalyzing it under contract with NCI. This is a vivid example of why a
certificate of confidentiality might be needed to protect research subjects.
If you want me to send you the postscript file for this presentation, please
contact me privately. Alternatively, I think Dr. Nelson is going to try to
post it at our website.
Chris
Christina M. Gullion, Ph.D.
Biostatistician/Senior Scientist
Department of Clinical Research
Medical City Dallas Hospital
7777 Forest Lane, Suite C-740
Dallas TX 75230
phone: 972-566-4718, fax: 972-566-4715
Gullion Christina
4/27/2000 4:20:00 AM
Sharing information with Investigators
Deb,
For grammatical and spelling errors, I don't include the changes in my request
for additional information, I just attach a copy of the informed consent form
with the corrections marked. If the reviewers are asking for changes in the
language, I put that in the formal request and suggest the reviewers rewrite.
Ruth Tallman
Office of Research and Sponsored Programs
Lehigh University
526 Brodhead Avenue
Bethlehem, PA 18015
Phone: (610)758-3024
FAX: (610)758-5994
E-mail: rt01@lehigh.edu
Deborah Barnard wrote:
> I need some help. Some real practical guidance.
>
> My IRBs use the primary reviewer system. Now we're always careful to record
> actual questions or requests for further information from each and every
> member. However, each and every member wants to submit editorial
> comments/chnages to the consent documents. How do other groups handle this?
> Do you accept editorial comments from the primary reviewer only? If you allow
> editorial (we're talking commas, word choice issues, etc.) comments from
> everyone - how do you get this information to the investigator without 1)
> overwhelming him/her with pages of changes and 2) assuring that the PI can
> follow what's being requested.
> Finally, how do you reflect these requested changes in your minutes?
>
> Deb Barnard
> Rush
> Chicago
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Ruth Tallman
4/27/2000 5:15:00 AM
Sharing information with Investigators
Dear Deborah,
Regardless of the review system that you employ, it is essential that you
have input from EVERY MEMBER of the committee. We most certainly point out
spelling errors, incorrect punctuation, grammer to the investigator. The
informed consent document is a reflection, to the public, of the standards
of your institution.
Word Choice issues I take to mean clarifications of the informed consent
content. This is the heart of the IRB's work. Part of our job is to
ascertain that the subject can understand what they are being asked to
participate in. At our institution, a lot of the research tat we review is
coming from drug and device companies. I have yet to see, in 23 years of
administering IRBs, a company consent form that cannot be improved upon with
a little work. Most PIs take what they are given and that's what they bring
to the Board.
Our minutes reflect all changes. We may say correct all typographical
errors a indicated and simplify the language that has been highlighted.
Suggestions are included on new wording.
Mary Catherine Spijkerman
Baylor University Medical Center
Dallas, TX
-----Original Message-----
From: Deborah Barnard [mailto:Deborah_L_Barnard@rush.edu]
Sent: Wednesday, April 26, 2000 4:31 PM
To: mcwirb@mcwirb.org
Subject: Sharing information with Investigators
I need some help. Some real practical guidance.
My IRBs use the primary reviewer system. Now we're always careful to record
actual questions or requests for further information from each and every
member. However, each and every member wants to submit editorial
comments/chnages to the consent documents. How do other groups handle this?
Do you accept editorial comments from the primary reviewer only? If you
allow
editorial (we're talking commas, word choice issues, etc.) comments from
everyone - how do you get this information to the investigator without 1)
overwhelming him/her with pages of changes and 2) assuring that the PI can
follow what's being requested.
Finally, how do you reflect these requested changes in your minutes?
Deb Barnard
Rush
Chicago
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Mary
4/27/2000 5:45:00 AM
Our IRB is interested in getting regular reports of off-site adverse events
for POG studies. Does anyone involved with POG studies know what mechanism
they have akin to a DSMB? The POG coordinators we work with don't seem to
know of such a board.
Wendy
4/26/2000 12:00:00 PM
I would be concerned where a commercial sponsor asks a subject to sign an
agreement consenting to the idea that “if a commercially viable product
results from the use of this specimen [referring to blood and tumor samples
taken from the subject], you [meaning the subject] will not have any
ownership rights of proceeds.”[Bracketed notes added.]
Both the FDA (21 CFR 50.20) and OPRR (45 CFR 46.116) utilize nearly
identical language prohibiting consent documents from containing “any
exculpatory language through which the subject [note: the FDA also says “or
the representative”] is made to waive or appear to waive any of the subject’
s legal rights…”. [Brackets and emphasis added.]
An OPRR Guidance Document dated 11/15/96 entitled “Exculpatory Language in
Informed Consent Documents” addresses this issue.
To me the proposed consent document clearly seeks to accomplish a
relinquishment by the subject of “any ownership rights,” however
speculative, that might result from the use of a subject’s specimen. How?
By getting the subject to sign an agreement (a consent document) to this
effect. Call it a waiver, a contract, a memorandum of understanding, a
release, or an “informed” consent, but whatever you call it the subject has
signed an agreement acquiescing to the stated language. What fuels this
interpretation is the sponsor’s apparent insistence on the language and
refusal to change it. That suggests to me that the sponsor and its counsel
have some goal in mind by its use.
The language contained in the proposed consent document is somewhat clumsy
and unclear. What if you (meaning the IRB) inserted language authorizing
use during the course of the research/investigation only and not thereafter
if and when any “commercially viable product” results? What if you offered
a license to use, instead of a surrender of ownership rights? What if you
required the sponsor to come back later to the subject for further
authorization for use in commerce instead of research? What if you sought
to require the sponsor to put a dollar value on the “proceeds” referred to
(e.g. “you will not have any ownership rights of proceeds estimated to be in
the range of three million dollars”)? I am not seriously suggesting you
offer any such changes, but I imagine that in any attempt to do so you might
learn more of the sponsor’s intent. As a practical matter, however, the
presently proposed language could in my judgment be used by the sponsor to
discourage or defeat any claim by any subject who might in the future claim
the “ownership” interest the sponsor is worried about.
In my opinion an IRB should not try to rewrite such a document as this. I
would worry about practicing law on behalf of the subject in doing so, and
would not want to get the IRB into that role. If the concern for the
subjects’ rights in this case is really serious perhaps the subjects need
legal counsel. If I were a member of the IRB in question I would vote
against the proposed language and recommend that it be stricken. It is
waiver language and most definitely risks the subjects’ legal rights. I
would further recommend checking to see if there are any applicable state
laws or institutional patent, technology transfer, or other policies that
might come in to play here.
Finally, some might find of interest an excellent piece by Dorothy Nelkin
and Lori Andrews in the September-October 1998 Hastings Center Report
entitled “Homo Economicus: Commercialization of Body Tissue in the Age of
Biotechnology.”
Tom Dalglish
J.D., Ph.D.
Community
Representative, Committee C
University of
Washington
(206) 543-0098
(University)
(206) 706-1000
(Office)
thomas k. dalglish
4/26/2000 12:09:00 PM
I believe it was Paul Goebel who once said about this specific issue:
-- If the subject has no property rights in the potential developments, the
language is unnecesary;
-- If the subject HAS property rights in the potential developments, the
language is improper.
In either case, it doesn't belong.
Dale
(And if I have misremembered the source, my apologies to whomever it was that I
SHOULD have credited)
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
4/26/2000 1:12:00 PM
Lack of Informed Consent Costs $3.8 million
MEDICAL RESEARCH LAWSUIT SETTLED
Saturday, March 11, 2000
Section: FLORIDA/METRO
Page: 1
BY: JOSE PATIN GIRONASO: of The Tampa Tribune TAMPA - A lawsuit accusing
USF doctors of experimenting on pregnant women without their consent is settled for $3.8 million. In her 26th week of pregnancy, Tina Perritt's water broke and she was rushed to Tampa General Hospital.
There, hospital workers gave her Demerol to alleviate labor pains. Shortly after, she was asked if she would sign a consent form allowing doctors to administer medicine that would save her baby. Feeling woozy and incoherent, she tried to read the three-page, single-spaced document, but she couldn't get through it, Perritt said in a deposition. Exasperated, she signed it after doctors told her several times she would lose her baby or it would have to be placed on a respirator.
The doctors, however, didn't tell Perritt she was signing a consent form for an experiment to allow them to use steroids to spur the lung development in fetuses and to increase the chances of her premature baby's survival, a lawsuit filed in 1990 against the hospital and the University of South Florida alleged.
The experiment wasn't considered risky and no adverse effects were documented, plaintiffs in the suit agree. However, the failure to inform Perritt and as many as 3,000 other pregnant women of various experiments conducted between 1986 and 1990 has cost Tampa General Hospital, USF and the state $3.8 million.
In a settlement announced Friday, the hospital and the university each have agreed to pay $1.1 million and a state insurance plan will pay $1.6 million over a four-year period to about 3,000 people who could collect from the class-action suit.
U.S. District Judge Henry Lee Adams Jr. must still sign off on the settlement, said Stephen Hanlon, attorney for the plaintiffs. Hanlon's law firm, Holland & Knight, will receive $1.1 million, but will donate $80,000 to consultants working to solve the hospital's financial woes.
The lawsuit named former USF physicians Walter Morales and Jeffrey Angel, as well as two former university administrators, as defendants. Neither doctor could be reached for comment. Officials from USF and TGH both said that since the lawsuit was filed, both institutions have initiated safeguards sought by the plaintiffs.
A lot of what was raised in this case, is now routine, said Michael Hoad, USF director of Health Sciences Public Affairs.
Perritt was admitted to TGH for nine days in March 1987, where the 18-year-old received three different types of experimental medicines, the lawsuit said.
After being discharged, the suit says she was told to return every two weeks to TGH's High Risk Clinic, where on 11 occasions she had amniocentesis, a surgical drawing of fluid from the uterus used to show the maturity of the fetus' lungs.
Perritt says the amniocentesis procedures caused an infection resulting in the premature birth of her daughter, who was born when she was eight months pregnant. Perritt's daughter is now 12 and is healthy, Perritt said at Friday's news conference.
Pregnant women usually receive amniocentesis only twice throughout their terms, said Karen Perrin, a former TGH nurse who noticed on the charts that a number of pregnant women were receiving multiple amniocentesis as part of a research study. She said the women told her that if they didn't receive the amniocentesis, their babies would die.
After finding no answers at the hospital, Perrin went to Hanlon in 1987.
It's scary to be a whistleblower, but it's worth it because that is how things get changed, said Perrin, now a USF associate professor for the college of public health. I would like nurses to know that they are the watchdogs of medicine, Perrin said. If they see something that looks unethical, they need to pursue it.
In addition to the financial penalty, TGH has agreed to produce consent forms that are easier to read; a California organization will assist in preparin
Anonymous
4/26/2000 8:36:00 AM
Your help in i dotting and t crossing please:
If
1.) a drug is being studied for it's dependency effects using a PET scan and it will be given by infusion, but is currently approved for only oral, inhalation, and topical administration.
and
2.) there is no intent to use the chemical for drug development or diagnostic purposes. The intravenous adminstration route is chosen in order to conduct the testing under the best controlled circumstances
and
3.) there have been other studies in humans and animals going back a few decades with this route, but no mention of an FDA IND.
Does the researcher need to submit an IND to the FDA prior to conducting the research?
Thanks,
Stephanie Porto RPh
Investigational Drug Service
Barnes-Jewish Hospital
Stephanie Porto
4/26/2000 2:25:00 PM
Sharing information with Investigators
Deb,
We (IRB staff) collect all of the revisoins to the consent and mark up one
copy which would include all changes made by the whole committee and forward
that to the investigator. This is the simplest way that we can accomplish
all comments to be reflected and it makes the job for the PI easier, as they
can just revise the consent.
We also have a primary and secondary reviewer system, but the whole
committee's comments are included for all clarifications, consent changes,
etc.
I hope this helps.
Barbara J. LoDico, IRB Administrator
Coordinator, Research and Sponsored Programs
New Jersey Medical School, MSB C-690
185 so. Orange Ave., Newark, NJ 07103
lodico@umdnj.edu
phone (973) 972-3608
fax (973) 972-3585
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org] On Behalf Of
Deborah Barnard
Sent: Wednesday, April 26, 2000 5:31 PM
To: mcwirb@mcwirb.org
Subject: Sharing information with Investigators
I need some help. Some real practical guidance.
My IRBs use the primary reviewer system. Now we're always careful to record
actual questions or requests for further information from each and every
member. However, each and every member wants to submit editorial
comments/chnages to the consent documents. How do other groups handle this?
Do you accept editorial comments from the primary reviewer only? If you
allow
editorial (we're talking commas, word choice issues, etc.) comments from
everyone - how do you get this information to the investigator without 1)
overwhelming him/her with pages of changes and 2) assuring that the PI can
follow what's being requested.
Finally, how do you reflect these requested changes in your minutes?
Deb Barnard
Rush
Chicago
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Barbara Lodico
4/26/2000 2:09:00 PM
I have to weigh in on this. First of all, let’s make something perfectly
clear. The language that many seem to find objectionable had been
specifically approved by OPRR for use in this setting a number of years ago
as NOT A WAIVER, but, as mentioned by Jon Merz, a mere statement of a fact.
Many institutions are using similar or identical language and have done so
for years.
If someone feels it is wrong to allow the use of his or her
DNA/blood/whatever in a project that may only make somebody else some money,
that person can refuse to consent to participate. Research regularly has a
commercial product as a goal. I realize that the use of genetic material or
product changes the emotional quotient, but the heart of the justice issue
is the same. Somebody is using a non-compensated source to develop a
product.
Moreover, there are many reasons why the payment of royalties to those whose
material is a part of this type of research has not been commonplace.
Rarely is there anything unique about that human source material—it simply
has to be human or from one of the many humans who have a particular gene or
marker—that is necessary for the research or product. The Moore situation,
involving a person who is uniquely a ready source of a gene product is
rarely, if ever, repeated. Often the research requires the material from
many people, perhaps a hundred, a thousand, perhaps more, not just one or
two. In addition, it is rarely the human material itself that is the
product—often it is a gene or marker that has been identified from human DNA
and is then reproduced using PCR or some other technique.
Yes, of course, the language is being inserted to defeat future claims
against profits by participants. Should participants being compensated? I
would ask why should they be compensated? What risk have they taken? What
time, intelligence, energy or creativity are they pouring into a project
with an uncertain outcome? What finances are they risking for an uncertain
return? Compensate people for their time and discomfort in donation—in
other words, compensate them for what they uniquely contribute.
Daniel L. Icenogle, MD, JD
Icenogle & Associates
1858 Sand Ridge Ct.
Verona, WI 53593-8814
608.832.0549 (voice and fax)
Electronic mail from Daniel L. Icenogle, MD, c/o Icenogle & Associates at
icenogle@execpc.com. This communication is intended for the use of the
addressee. It may contain information which is privileged or confidential
under applicable law. If you are not the intended recipient or the agent of
the recipient, you are hereby notified that any dissemination, copy or
disclosure of this communication is strictly prohibited. If you have
received this communication in error, please notify Icenogle & Associates at
(608) 832-0549 or via return Internet electronic mail at icenogle@execpc.com
and expunge this communication without making any copies. Thank you for
your cooperation.
Daniel L . Icenogle
4/26/2000 1:21:00 PM
In planning for a study involving potential instances of adult domestic
violence we wonder whether investigators have an ethical/legal obligation to
report when a subject discloses they are currently being physically
abused.
Our research provides no definitive answers. Massachusetts law does not name
researchers in lists of those who must report instances of child, elderly
or patient abuse. And it is not clear whether our (IRB) institution would be
immune from actions resulting from reporting (false) events. We may have
missed something, but we found OPPR silent on this issue. Nevertheless, it
seems like we ought to report cases to some agency.
How should we balance an ethical duty, if there is one, to report instances
of adult abuse and our pledge to protect the privacy of a research subject?
Thoughts on legal implications?
Thanks - Michael
J . Michael Oakes
4/25/2000 8:50:00 AM
Donna,
The problem I have with using terms such as within the limits of the law
or similar phrases is that people don't know what it means, including a lot
of researchers! If our goal is truly informed consent, why not state:
There is one (or more) exception to this (e.g. confidentiality
protections). If we become concerned about or observe abuse or neglect of a
vulnerable adult, we are required to report it to APS (or specific local
agency). Bold face is similar to what we have required in consent/assent
forms when abuse reporting may be an issue in the research.
We try to avoid nebulous terms such as according to applicable laws
because potential study participants don't know what laws it is supposed to
refer to, and thus cannot determine the possible risks to themselves (or
others) if they decide to participate. We also aim for reading levels of
6th-8th grade, even lower for developmentally disabled individuals, kids,
etc. Otherwise, I agree that the protection of someone who may be at risk
of harm should override confidentiality provisions in research.
Maggie
> -----Original Message-----
> From: Donna Bowling [SMTP:DBOWLING@swmail.sw.org]
> Sent: Tuesday, April 25, 2000 7:33 AM
> To: mcwirb@mcwirb.org
> Subject: Re: MCWIRB digest, Vol 1 #202 - 18 msgs----- Reporting Adult
> Abuse
>
> You should check the wording of your state law very carefully. In Texas
> the requirement to report abuse generally covers children, the disabled
> and the elderly (over 65). The obligation is phrased in terms of any
> person having reason to suspect abuse.
>
> There was some confusion in Texas regarding the obligation of a lawyer or
> pastor to report because of their obligation to protect confidential
> communications. The law was amended to clarify that these privileges do
> not trump the obligation to report. That has led to some interesting
> theoretical ethical discussions with our in-house chaplains.
>
> If asked the question here I would have no problem stating that the
> obligation to report abuse would override any promise of confidentiality
> to a research subject. For such reasons I have asked that the
> confidentiality paragraph in the consent forms read that confidentiality
> is promised in accordance with applicable law.
>
> Donna Bowling, Associate General Counsel
> Scott and White, Temple, Texas
> dbowling@swmail.sw.org
>
Maggie
4/25/2000 8:24:00 AM
I would think this misses the point. The concern is not that the law does not authorize reporting of the abuse--the concern is just the opposite, that the law WILL require reporting of the abuse, thus overriding the promise of confidentiality.
Given that participation in a research study is voluntary, and often not for the benefit of the research subject, the question is whether it is ethical to not warn the subject that they may be reported to the authorities as a result of their participation in the study. Indeed, wouldn't that be a risk that should be highlighted in the Risks section of the consent form? Thus, if you are doing a study in which you are dealing with information that is likely to raise such an issue, it would seem inappropriate to merely say in the consent form, as you suggest, that confidentiality is promised in accordance with applicable law. I doubt that many subjects would be aware that applicable law allowed the researchers to report abuse they discovered to the police, etc.
Jerry Menikoff
University of Kansas
>You should check the wording of your state law very carefully. In Texas >the requirement to report abuse generally covers children, the disabled and >the elderly (over 65). The obligation is phrased in terms of any person >having reason to suspect abuse.
>There was some confusion in Texas regarding the obligation of a lawyer or >pastor to report because of their obligation to protect confidential >communications. The law was amended to clarify that these privileges do >not trump the obligation to report. That has led to some interesting >theoretical ethical discussions with our in-house chaplains.
>If asked the question here I would have no problem stating that the >obligation to report abuse would override any promise of confidentiality to a >research subject. For such reasons I have asked that the confidentiality >paragraph in the consent forms read that confidentiality is promised in >accordance with applicable law.
>Donna Bowling, Associate General Counsel
>Scott and White, Temple, Texas
>dbowling@swmail.sw.org
Jerry Menikoff
4/25/2000 8:50:00 AM
Funding for National Cancer Trials - IRB Compensation
We handle a large number of cooperative cancer research trials. In the past we did not charge for any of the IRBs activities. Now we have a set fee for study review, approval, and oversight. We have not, however, been charging the cooperative cancer groups. There has been an implication that the funds are simply not there. With new directorship at the research institute, this has been brought into question. Can you tell me if any other institutions charge for overview of cooperative cancer research trials?
Anonymous
4/25/2000 8:09:00 AM
Seeking insight or information.
In the last week, the New York Times ran a story in the Science section on
a study done on some old blood samples drawn from military recruits in the
mid 1940's. It was essentially an exploratory study, to see if there was
evidence of Hepatitis C infection detectable in samples drawn well before
anyone knew of this type. It has provided some surprisingly confounding
information about the natural history of the disease--one man discovered
alive with apparent active viral replication and no signs of clinical
illness.
My question: The article alludes to but does not specify the inevitable
difference of opinions among ethicists about contacting those whose samples
came up positive, and indicates that it took the principal investigator a
year and a half to draft a letter that was considered acceptable. I am
wondering what ethical issue in this matter could have been that knotty as
to cause such a delay and re-drafting effort. Anyone know anything about
this?
Warren
-.,,_,.-:*'``'*:-.,,_,.-:*'``'*:-.,,_,.-:*'``'*:-.,,_,.-
Warren Kearney, M.D.
E-mail: kear0004@tc.umn.edu
2301 Minneapolis Ave
Minneapolis, MN 55406
(612) 729-1412
Warren Kearney
4/25/2000 4:09:00 AM
|<
...
11 12 13 14 15 16 17 18 19 20
...
>|
Pages: 15 of 200