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I am one PI on a post-marketing surveillance study of growth hormone.
There are several substudies involved in the study:
- Core Study: evaluating the long term safety and efficacy of
growth hormone. Basically, this portion is the typical database which
all growth hormone companies are now maintaining. Entry is based
entirely on a pediatric endocrinologist's standard diagnostic and
therapeutic recommendations. Growth hormone is obvious commercially
available, and is not an IND, and is not being used for novel
indications.
- Growth Prediction Substudy: Will use the information gathered
in the core study to predict, and subsequently verify, prediction of
final height based on observed parameters
- Neoplasia Substudy: monitoring for tumor recurrence in
children previously treated and in whom the tumor is inactive or stable.
- DNA Analysis Substudy: Analysis of DNA for any obvious
abnormalities which could lead to growth deficiency. This section of
the protocol obviously requires informed consent due to its nature.
My question concerns reporting of adverse events. Inasmuch as the
decision to treat a children with growth hormone is based on clinical
paradigms which are firmly established, is it necessary to submit AERs
concerning growth hormone to the IRB? A number of fellow investigators
recently noted that their IRBs would most definitely require such
reporting. The drug company has indicated that submission of the AER to
the IRB must be done. This seems unnecessary, as AERs on
non-investigational drugs used in prescribed manners would not fall
under the umbrella of the IRB, but more under FDA/drug company
monitoring. If we require reports on all drugs used in a study, we open
a Pandora's box of paper hell. Would we need to be informed if heparin
caused a problem in a pacemaker study, etc.....?
Comments.......
Thanks
Richard Banks, MD
Ch, Orlando Regional Healthcare System IRB
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I am one PI on a post-marketing surveillance study of growth hormone.
There are several substudies involved in the study:
- Core Study : evaluating
the long term safety and efficacy of growth hormone. Basically, this
portion is the typical database which all growth hormone companies are
now maintaining. Entry is based entirely on a pediatric endocrinologist's
standard diagnostic and therapeutic recommendations. Growth hormone
is obvious commercially available, and is not an IND, and is not being
used for novel indications.
- Growth Prediction Substudy :
Will use the information gathered in the core study to predict, and subsequently
verify, prediction of final height based on observed parameters
- Neoplasia Substudy :
monitoring for tumor recurrence in children previously treated and in whom
the tumor is inactive or stable.
- DNA Analysis Substudy:
Analysis of DNA for any obvious abnormalities which could lead to growth
deficiency. This section of the protocol obviously requires informed
consent due to its nature.
My question concerns reporting of adverse events. Inasmuch as
the decision to treat a children with growth hormone is based on clinical
paradigms which are firmly established, is it necessary to submit AERs
concerning growth hormone to the IRB? A number of fellow investigators
recently noted that their IRBs would most definitely require such reporting.
The drug company has indicated that submission of the AER to the IRB must
be done. This seems unnecessary, as AERs on non-investigational drugs
used in prescribed manners would not fall under the umbrella of the IRB,
but more under FDA/drug company monitoring. If we require reports
on all drugs used in a study, we open a Pandora's box of paper hell.
Would we need to be informed if heparin caused a problem in a pacemaker
study, etc.....?
Comments.......
Thanks
Richard Banks, MD
Ch, Orlando Regional Healthcare System IRB
--------------8E1C55AFB71574F580881D9F--
Rbanks21
5/9/2000 4:06:00 AM
Washington Post Editorial re:med research
At the risk of bringing down a firestorm, I must comment that much is asked
of IRBs but little is given. Most if not all IRB members are participating
as volunteers, taking time away from the duties for which they receive
salary or fees. At this institution the medical members are all physicians
in private practice. I imagine this is true of most non-university medical
institutions where research is conducted. Few members are formally trained
in either research regulation or bioethics, and none have time to keep up
with the debates and Q/A in this forum.
Most of the protocols we see at this IRB come from large multicenter
research organizations, such as POG or multi-national pharmaceutical
companies. In most cases when the Board objects to aspects of a protocol,
we have two options: swallow our concerns or reject the protocol. There are
no paths of influence from a local IRB to the central office producing a
protocol. We are routinely told (without evidence) that a protocol has
already been approved in dozens of centers. There is no mechanism for
verifying this or for pooling the findings of local IRBs, which might stop a
badly designed or ethically questionable protocol. What is even more
disturbing is that protocols supported by NCI and/or carried out on an
FDA-issued IND may raise serious ethical concerns, viz., the POG protocols
requiring submission of tissue samples in order to qualify for treatment
studies. How do these protocols get past review at these agencies?
Apparently, they are leaving it to the dozens of local IRBs individually to
grapple with them.
I question whether it is feasible to bring all the local Boards up to some
higher standard without substantial financial and logistical support for
formal training, for the time IRB members devote to reviews, and for
administrative support to handle the tons of paperwork involved and other
interactions with investigators. Perhaps the ideal of the local, amateur
IRB is just not a workable mechanism in a world of international research
monoliths.
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
5/9/2000 6:54:00 AM
Appearance of waiver of legal rights
21 CFR 50.20 provides that no informed consent may include any exculpatory
language through which the subject or the representative is made to waive or
appear to waive any of the subject's legal rights, or releases or appears to
release the sponsor from liability for negligence.
We are reviewing a consent form in which the sponsor agrees to pay for
medical costs incurred as a direct result of the study drug. The consent
then goes on to provide No other type of compensation such as lost wages or
payment for any discomfort due to any injury suffered as a direct result of
this study will be paid.
Although legally this is not a waiver or a release, we are concerned that a
subject may see it as such.
Your thoughts would be appreciated. Do other IRBs accept this type of
language?
Liz Schell
Associate General Counsel
Carilion Health System
Phone: 540-224-5064
Fax: 540-224-5793
Fax: 540-224-5793
Liz Schell
5/9/2000 6:55:00 PM
OPRR/FDA Conference in Philadelphia, PA (May 31, 2000)
CHALLENGES CONFRONTING IRBs ON THE PROTECTION OF HUMAN RESEARCH SUBJECTS
Wednesday, May 31, 2000
MCP Hahnemann University, Philadelphia, Pennsylvania
Information is available at the conference website at http://www.research.drexel.edu/irb_symp/
The brochure and registration form can be downloaded in pdf format from this page.
For further information, contact:
Marie Scheb
Office of Research Suite 100
Drexel and MCP Hahnemann Universities
3201 Arch Street
Philadelphia, Pa 19104
Tel: 215 895 2499
Fax: 215 895 0864
schebmf@drexel.edu
Anonymous
5/9/2000 3:42:00 AM
Appearance of Waiver -- A new Approach
Just today a researcher and I discussed a proposed consent form that stated
that the sponsor would be responsible for direct injury only if it starts
while the patient is taking the study drug. We agreed that we could not
allow that kind of wording, but I found it to be a novel approach -- and not
something I hope to see again.
Ginger French, Pharm.D.
IRB Consultant
Wesley Medical Research Institutes
Ginger French
5/9/2000 4:14:00 PM
Appearance of waiver of legal rights
About two years ago, there was a discussion on this forum of a local court
decision that wording of this type DID in fact constitute a binding waiver, and
therefore tossing out a subject's suit to recover damages in consequence of
negligence.
I never heard any follow-up, so I don't know if the case was appealed, if an
appeal filing led to an out-of-court settlement, if the claim was frivolous in
the first place, etc., etc.
So I'd be worried that both the subject and a court without expertise in
research consent could take this as a waiver.
Then, I'd really be interested to know if anybody on mcwirb has any f/u info on
that earlier case. I believe I first heard it referrred to in someone's oral
presentation at a workshop, but I don't remember ever hearing a citation ...
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
5/9/2000 4:14:00 PM
Appearance of waiver of legal rights
The Washington Supreme Court in Vodopest was indeed reversing lower court decisions, but it still is not clear that those decisions were saying what the other case you mentioned said. The trial court concluded that the exculpatory clause prevented a lawsuit for ordinary negligence, but did allow a lawsuit for gross negligence. The court of appeals upheld the determination that an ordinary negligence action could not be brought, but the reasoning of the majority (there was a dissent) was based on a determination that the plaintiff wasn't really participating in a research project. Thus, that holding doesn't really seem to address this question.
Jerry Menikoff
University of Kansas
Dale Hammerschmidt wrote:
Getting back to the case you know of --- was the Supreme Court upholding or overturning a lower court decision? If overturning, it may very well be the same case, and just have been staler than I thought when it came up for discussion.
Jerry Menikoff
5/9/2000 4:14:00 PM
PICC line upper ext. DVT--outcome
The St. Vincent Mercy Med. Center IRB met this morning and reaffirmed our
original decision about the upper extremity DVT study. The researchers
will give the results of the ultrasound studies to the subject and to the
attending physician. We put additional stipulations: the researchers will
publicize the study in the physician newsletter, inform the attending when
a patient decides to enroll, and if the ultrasound study(ies) are positive,
the P.I. will call the attending physician directly to discuss.
The physician IRB members were adamant that as attendings, they would want
to have the information--a judgment about what to do is an everyday
occurrence in medical practice. The Committee also rejected the idea of
getting the physician's permission to enroll the patient in a study and to
share the information. We felt this was burdensome and unnecessary.
Thanks to all for contributing your analysis and giving information about
near-fatal clinical situations of upper ext. DVT's.
Ellen Bernal, PhD
Chair
Human Experimentation Committee, SVMMC
Ellen Bernal
5/9/2000 4:12:00 AM
Appearance of waiver of legal rights
Dale: I, too, would be interested in hearing about that case. The only case I am aware of on this issue (obviously different than the one you mention, given the outcome) is Vodopest v. MacGregor, 913 P.2d 779 (1996), where the Supreme Court of Washington held that an exculpatory clause was void as against public policy: it could not be used to prevent the injured research subject from bringing an action for negligence.
Jerry Menikoff
University of Kansas
Dale Hammerschmidt wrote:
About two years ago, there was a discussion on this forum of a local court
decision that wording of this type DID in fact constitute a binding waiver, and therefore tossing out a subject's suit to recover damages in consequence of negligence.
Jerry Menikoff
5/9/2000 4:14:00 PM
Washington Post Editorial re:med research
At the risk of bringing down a firestorm, I must comment that much is asked
of IRBs but little is given. Most if not all IRB members are participating
as volunteers, taking time away from the duties for which they receive
salary or fees. At this institution the medical members are all physicians
in private practice. I imagine this is true of most non-university medical
institutions where research is conducted. Few members are formally trained
in either research regulation or bioethics, and none have time to keep up
with the debates and Q/A in this forum.
Most of the protocols we see at this IRB come from large multicenter
research organizations, such as POG or multi-national pharmaceutical
companies. In most cases when the Board objects to aspects of a protocol,
we have two options: swallow our concerns or reject the protocol. There are
no paths of influence from a local IRB to the central office producing a
protocol. We are routinely told (without evidence) that a protocol has
already been approved in dozens of centers. There is no mechanism for
verifying this or for pooling the findings of local IRBs, which might stop a
badly designed or ethically questionable protocol. What is even more
disturbing is that protocols supported by NCI and/or carried out on an
FDA-issued IND may raise serious ethical concerns, viz., the POG protocols
requiring submission of tissue samples in order to qualify for treatment
studies. How do these protocols get past review at these agencies?
Apparently, they are leaving it to the dozens of local IRBs individually to
grapple with them.
I question whether it is feasible to bring all the local Boards up to some
higher standard without substantial financial and logistical support for
formal training, for the time IRB members devote to reviews, and for
administrative support to handle the tons of paperwork involved and other
interactions with investigators. Perhaps the ideal of the local, amateur
IRB is just not a workable mechanism in a world of international research
monoliths.
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
5/9/2000 4:13:00 PM
Appearance of waiver of legal rights
Dan is absolutely correct. In fact, I've heard of cases in which sponsors paid just to avoid the negative publicity of being sued (especially bad just before a product launch).
One way around this whole problem is to phrase it something along the lines of The sponsor has not set aside any money to pay other expenses (lost wages, etc) besides the cost of medical treatment.
Kenneth Malcolm, MS, RAC
IdeaMed, LLC
>>> Dan Somers 05/09/00 08:37AM >>>
The language you mention, in addition to having the appearance of the
disallowed waiver of rights, is simply untrue. Sponsor will not pay and
sponsor does not pay both neglect the fact that, if successfully sued, the
sponsor WILL pay additional compensatory damages.
Kenneth Malcolm
5/9/2000 4:14:00 PM
Appearance of waiver of legal rights
> Because I was just presented with a consent form that has some language
> along the same lines that Liz Schell is discussing, I would like to also
> ask for others thoughts on this language. It states. In addition, because
> only a very small risk is involved in your participation, there will be no
> compensation for injury.
Phillip --
I share your concern. Sounds like an improper waiver to me.
We have not set aside any money to compensate for research-related injuries
(simply because we think they're unlikely). is better and more clearly
allowable than ...there will be no compensation for injury.
Whether or not there will _be_ compensation is up to the judge, not up to the CF
drafter.
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
5/9/2000 4:09:00 AM
Does it need IRB approval?
I need help on this one. I am sure it has been discussed in the past,
but I cannot find anything.
An investigator asked the following; I like to review the charts of MY
patients for the last x years, to establish (for instance) the
proportion of overweight females vs lean males (or some other
parameters); I have the information, they were (or still are) MY
PATIENTS. Do I need to ask permission from the IRB?
My answer was yes, it falls under the definition on 46.102(d), and
because the investigator has the files, the review cannot help it but
to have identifiers and therefore is not exempt under 46.101(b)4.
The investigator was (and still is) not convinced, and, twisting the
arguments around in my head, I am not so sure whether it can be
exempted or not.
I thank in advance to whomever will take time to answer.
Enzo
SUNY Downstate, Brooklyn
ebard@netmail.hscbklyn.edu
5/8/2000 3:49:00 AM
Does it need IRB approval?
Subject: Re: Does it need IRB approval??
As Paul Goebel is fond of saying, the devil may be in the details.
The records obviously have identifiers, but the person abstracting them is
within the circle of confidentiality and has proper access to them in any
event.
The question, I think, is whether a secondary record with identifiers is being
created, and thus whether there is an increment in confidentiality risk over
that of simple existence of the medical record.
So I'd say the question to ask is what the investigator is DOING with the
records once abstracted. I don't think IRB review is necessary for him to look
at his own patients' records, but some types of secondary records may require
IRB scrutiny.
Dale
Dale E. Hammerschmidt, M.D.
Associate Professor of Medicine, Univ. Minnesota
Editor, J. Lab. Clin. Med.
Director of Education in Research Ethics and Compliance
Box 480 Mayo Building; Minneapolis 55455
612-624-0123 (voice, Heme/Onc/BMT)
612-626-2640 (voice, Journal office)
612-626-2642 (fax)
hamme001@tc.umn.edu
Dale Hammerschmidt
5/8/2000 3:49:00 AM
Re: Rumor about New Director of OPRR
It is rumored that Secretary Shalala stated publicly last week during the National Health Council breakfast that the new director of OPRR will be a superstar from outside the government.
Anyone have any information?
Anonymous
5/8/2000 4:41:00 AM
Appearance of waiver of legal rights
Liz:
I would not approve the language you refer to. A previous discussion (Re:
ownership of samples) in this forum recently dealt with exculpatory clauses
in that context that might be of interest to you. Here, the appearance is
one of waiver. Check your own state law regarding damages in personal
injury/products liability/med mal situations. In Washington a person
injured as a result of another's fault or negligence is entitled to recover
provable lost earnings past and future, the same for medical expenses, and
damages for pain and suffering, loss of ability to enjoy life, and
disfigurement, if any. All, including causation, must be proven. The
sponsor's statement here that you quote could be flatly incorrect if your
state law allows for such compensation where the injury is shown to be a
direct result of the study. Why does the sponsor want to put an incorrect
statement of the law into a consent form, if not to reduce the sponsor's
exposure to the payment of damages? I see the language as an attempt to
solicit the subject's tacit agreement or understanding, or an effort to
create an estoppel situation, or to discourage the subject later from
asserting what may be perfectly legitimate rights to recover for his/her
injuries.
Another question comes to mind. I have no idea what the answer is. If the
IRB approved such language, and the injured subject could not pursue a claim
because of it against the sponsor, could the subject then turn to the IRB's
parent institution and pursue a claim against it for breach of the
IRB's/institution's fiduciary duty to protect the subject against such
language?
Sincerely
Tom Dalglish
Community Representative, Committee C
University of Washington
(206) 543-0098 (University)
(206) 706-1000 (Office)
If the causal connection exists between the study and the loss, a big if,
then the subject should be paid for all damages he/she is legally entitled
to under your state law.
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
Of Liz Schell
Sent: Monday, May 08, 2000 7:12 AM
To: mcwirb@mcwirb.org
Subject: Appearance of waiver of legal rights
21 CFR 50.20 provides that no informed consent may include any exculpatory
language through which the subject or the representative is made to waive or
appear to waive any of the subject's legal rights, or releases or appears to
release the sponsor from liability for negligence.
We are reviewing a consent form in which the sponsor agrees to pay for
medical costs incurred as a direct result of the study drug. The consent
then goes on to provide No other type of compensation such as lost wages or
payment for any discomfort due to any injury suffered as a direct result of
this study will be paid.
Although legally this is not a waiver or a release, we are concerned that a
subject may see it as such.
Your thoughts would be appreciated. Do other IRBs accept this type of
language?
Liz Schell
Associate General Counsel
Carilion Health System
Phone: 540-224-5064
Fax: 540-224-5793
Fax: 540-224-5793
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
thomas k. dalglish
5/8/2000 4:31:00 PM
Appearance of waiver of legal rights
Because I was just presented with a consent form that has some language
along the same lines that Liz Schell is discussing, I would like to also
ask for others thoughts on this language. It states. In addition, because
only a very small risk is involved in your participation, there will be no
compensation for injury. Aside from the fact that the second clause does
not, for me, follow necessarily from the first, I found this no
compensation for injury clause disconcerting. I was told this consent form
has already been approved by NIH and has been used for some time and is
being used now at a multitude of research sites. Thoughts, please.
Phillip Michaels
At 10:12 AM 5/8/2000 -0400, Liz Schell wrote:
>21 CFR 50.20 provides that no informed consent may include any exculpatory
>language through which the subject or the representative is made to waive or
>appear to waive any of the subject's legal rights, or releases or appears to
>release the sponsor from liability for negligence.
>
>We are reviewing a consent form in which the sponsor agrees to pay for
>medical costs incurred as a direct result of the study drug. The consent
>then goes on to provide No other type of compensation such as lost wages or
>payment for any discomfort due to any injury suffered as a direct result of
>this study will be paid.
>
>Although legally this is not a waiver or a release, we are concerned that a
>subject may see it as such.
>
>Your thoughts would be appreciated. Do other IRBs accept this type of
>language?
>
>
>
>
>
>Liz Schell
>Associate General Counsel
>Carilion Health System
>Phone: 540-224-5064
>Fax: 540-224-5793
>Fax: 540-224-5793
>
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Phillip Michaels
5/8/2000 4:29:00 PM
Post-mortem use of tissue in research
> You have to be careful about state law that may pre-empt
> federal law by
> providing additional protections.
Just being picky, but the state law does not preempt federal law. It can
provide additional protections - IF ALLOWED BY THE FEDERAL LAW! There are many
situations where the federal law is exclusive and additional state law
protections are preempted by the federal law. As example is pharmaceutical
labeling - the FDA controls the label on drugs shipped in interstate commerce
and I do not think the state could pass a law requiring additional warnings on
the label. This is also at issue in the labeling of GM foods, where some states
want to force labeling, which is currently against FDA and DOA regulations.
Ed
Edward P. Richards, J.D., M.P.H.
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
5/7/2000 5:58:00 AM
Post-mortem use of tissue in research
> You have to be careful about state law that may pre-empt
> federal law by
> providing additional protections.
Just being picky, but the state law does not preempt federal law. It can
provide additional protections - IF ALLOWED BY THE FEDERAL LAW! There are many
situations where the federal law is exclusive and additional state law
protections are preempted by the federal law. As example is pharmaceutical
labeling - the FDA controls the label on drugs shipped in interstate commerce
and I do not think the state could pass a law requiring additional warnings on
the label. This is also at issue in the labeling of GM foods, where some states
want to force labeling, which is currently against FDA and DOA regulations.
Ed
Edward P. Richards, J.D., M.P.H.
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
5/7/2000 5:56:00 AM
Does anyone know if there's an IRB directory in existence? This would list all the IRBs and any person or organization who is heavily involved with IRBs.
Thanks.
Anonymous
5/7/2000 5:58:00 AM
Surely the local, geographic (or whatever else they call themselves) IRBs
intend to remain unlisted. It's time for OPRR to turn its attention from
mainstream, authorized and accountable IRBs to these IRBs. By whom were
they auhtorized? To whom are they accountable? At $1,000+ a pop! Wonderful!
I guess the IRB model is comin' to an end, anyway....
SFS
----------
> From: Lori Pendleton
> To: mcwirb@mcwirb.org
> Subject: IRB directories?
> Date: Friday, May 05, 2000 12:22 PM
>
> Does anyone know if there's an IRB directory in existence? This would
list all
> the IRBs and any person or organization who is heavily involved with
IRBs.
>
> Thanks.
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Stuart F . Spicker
5/7/2000 5:56:00 AM
Post-mortem use of tissue in research
I have a question about tissue samples and other material (not whole body or
whole organs) that originated with people who are now dead. It is my
understanding from the federal regs that human research, hence IRB
involvement, requires the potential participant be alive. That is, that no
consent is needed to use tissue and other materials which are derived from
someone who is now dead. Is my understanding correct? Or are the rules for
establishing whether material is residual and anonymous material applicable
post-mortem?
Thanks for the info. I hope the subject does not offend anyone, but when a
client asks a question, you've got to find out the answer.
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
5/7/2000 5:58:00 AM
Surely the local, geographic (or whatever else they call themselves) IRBs
intend to remain unlisted. It's time for OPRR to turn its attention from
mainstream, authorized and accountable IRBs to these IRBs. By whom were
they auhtorized? To whom are they accountable? At $1,000+ a pop! Wonderful!
I guess the IRB model is comin' to an end, anyway....
SFS
----------
> From: Lori Pendleton
> To: mcwirb@mcwirb.org
> Subject: IRB directories?
> Date: Friday, May 05, 2000 12:22 PM
>
> Does anyone know if there's an IRB directory in existence? This would
list all
> the IRBs and any person or organization who is heavily involved with
IRBs.
>
> Thanks.
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Stuart F . Spicker
5/7/2000 5:58:00 AM
Howard,
Thanks for your reply.
As to your question: Is the surgical procedure itself the subject of the
investigational protocol?
Yes.
We have the drug and device reporting requirements under control, and there
are regs to refer to for those events. But protocols that are evaluating
novel surgical procedures seem to be in a different ball game, as least to
our committee.
The debate in our last IRB meeting was whether all surgical complications
should be reported as adverse reactions, or just the ones directly related
to the surgery. Then there was a debate about whether only those reactions
related to the experimental part of the surgery be reported. There was yet
another debate about whether the criteria should be expected or unexpected,
related (and related to what aspect) vs. unrelated, and for what window of
time post-surgery do the reporting requirements apply.
Can you (or anyone else) offer any guidance?
Karena Cooper, MSW
IRB Administrator
Saint John's Health Center
1328 Twenty-Second Street
Santa Monica, CA 90404
(310) 449 - 5283
(310) 829 - 6571 FAX
-----Original Message-----
From: Howard Mann [SMTP:ldhmann@ihc.com]
Sent: Thursday, May 04, 2000 4:08 PM
To: mcwirb@mcwirb.org
Subject: re: Surgical side effects
Re : Surgical side effects
Hi,
I believe the answer depends on the nature of the investigation. Is
the
surgical procedure itself the subject of the investigational
protocol?
I presume the surgical procedure is incidental to the
investigation. If so,
one would presume that informed consent for the surgical procedure
would be
obtained separately from consent to enroll the patient as a research
subject.
Thus, adverse events consequent on the surgical procedure itself are
not a
consideration with respect to reporting requirements.
Or, have I misconstrued your query entirely?
Regards,
Howard
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Karena
5/5/2000 7:15:00 AM
My IRB is struggling to refine a SOP for adverse event reporting of surgical side effects for biomedical studies that involve surgery.
The debate at the moment is whether expected as well as unexpected surgical side effects should be reported to the IRB.
And who determines which effects are expected vs. unexpected?
Any guidance, including links to relevant web sites, would be appreciated.
Thank you.
Karena Cooper, M.S.W.
IRB Administrator
Saint John's Health Center
Santa Monica, CA
Anonymous
5/5/2000 4:37:00 PM
VA awards systemwide IRB Accreditation contract to the National Committee for Quality Assurance (5/2/00)
FYI
The Department of Veterans Affairs has awarded a contract to a
non-government entity, the National Committee for Quality Assurance (NCQA),
to accredit VA IRBs nationwide.
The Los Angeles Times recently described this event in its May 3, 2000
article on page B-7.
-I would be interested to hear from anyone who is familiar with NCQA's level
of IRB expertise.
Peter Marshall
Cleveland VA IRB
pjmarshall@attglobal.net
Peter Marshall
5/5/2000 3:25:00 AM
Washington Post Editorial re:med research
Regarding Sheri Alpert's Washington Post Editorial, I was tempted to repost
a paragraph, then two, then all of it. Every paragraph is significant. The
ideas expressed provide much more depth to concerns I was trying to convey
in my posting on 5/3/00, subject, re: Post-mortem use of tissue in
research.
Howard Mann correctly perceived my concern when he stated, we should
perhaps first ask, What moral interests are at stake here? Antecedent to
rights-talk should be an exploration and articulation of the interests --
which? whose? -- that are at stake.
What this is then, is a leadership issue--the issue of who will provide the
moral/ethical leadership for research in this era of vast and speedy change
that tends to overwhelm us. The answer is in the mirror. The answer is in
the rooms where we gather for IRB and other reviews of proposed AND ongoing
research. The majority of the leadership will not be found in the
legislatures, the courts, nor the public and private bureaucracies. They
are far too reactive, thus behind the times by the time they act or enact.
We need to be proactive--thinkers, anticipators, decision-makers, leaders.
Just this week, one of the major news networks covered the case of a
physician who was found doing unethical research, and had had it
terminated. There were multiple problems--harm to subjects, conflict of
interest, ownership in the potential profits of a positive research
outcome. How much more of this and other inappropriate, unethical research
is going on every day--and remains undetected, or detected/suspected but
unchallenged? I suspect that less than 1 in 100 get caught. Some of the
reported research on unethical research, last year in the Journal, Science
(if I recall correctly) I think would tend to support that guess. Lack of
training, lack of knowledge, lack of resources, lack of commitment, lack of
administrative support, lack of collegial support, are all problems with
which, I suspect, many of us do contend and will continue to have to
contend in this IRB and human subjects arena. We will need the courage to
step up to the plate--and lead--when it would be so much easier to follow
someone else or just go with the flow of the crowd. But going with the flow
can result in harm to subjects.
I think this forum is great, and I admire those who are obviously working
on improving the deficiencies. It is obvious from the extensive and
thoughtful input here that there are many people here who are trying to
increase their own knowledge as well as that of others in the field. I'm
also sure that there are many others, who, more like me, have tended to
read far more than they contribute, so there is much good that is created
here.
I hope this doesn't come across as excessively preachy.
Regards and thanks to all,
Phillip Michaels
Phillip Michaels
5/5/2000 10:45:00 AM
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I am looking for information on a model....in particular whether one already
exists out there...
I am located in a relatively rural area. The school of medicine is
community structured and has a mission to improve rural health. To assist
this community of loosely affiliated county hospitals and medical practice
centers, I am thinking about establishing a community clinical trials
center. The goal would be to provide assistance/management for the more
isolated clinicians and those affiliated with smaller county hospitals to
become involved in and conduct clinical trials research (either collective
or singularly). Doing this would involve multiple, but small, collaborating
institutions. Thus, the envisioned center for clinical research would
service multiple facilities or institutions which cannot provide the staff,
facilities or expertise for their respective clinicians to become involved
in research.
Several universities have clinical research centers that service multiple
departments within their university. What I am looking for is an existing
working model that services several hospitals and/or universities. If the
model already exists, I do not want to re-invent it! But, I will be happy
to learn from their experiences.
The model will hopefully include such things as identifying potential trials
for the member organizations, assistance with application preparation, study
coordination (possibly even central study managers), centralized finance
administration (billing, budgeting), etc. The model should provide this
assistance across administrative (corporate) lines.
Any help in identifying an existing model of this nature will truly be
appreciated.
David
*******************************************************************
David L. Innes, Ph.D. Mercer University
Associate Vice President 1400 Coleman Ave.
University Research and Biosafety Macon, GA 31207
Voice: 912-301-4101
FAX: 912-301-4120
E-Mail: Innes_DL@Mercer.Edu
*******************************************************************
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 4.0 Transitional//EN> I am =
looking=20
for information on a model.... in =
particular whether one already exists out =
there... I am=20
located in a rela tively rural area. The school=20
of me dicine is community =
structured and=20
has a mission to improve rural health . To=20
assist th is community of loosely =
affiliated county hospitals and medical practice centers, I am thinking about =
establish ing a community =
clinical trials=20
center. The goal would be to provide =
assistance/management for the=20
more isolated clinicians and those affiliated with smaller county =
hospitals to=20
become involved in and conduct clinical trials research (either collective =
or=20
singularly). Doing this would involve multiple, but =
small,=20
collaborating institutions. Thus, the envisioned=20
cent er for clinical=20
research would service =
multiple=20
facilities or institutions which cannot =
provide the =
staff, facilities or=20
expertise for their respective clinici ans to become involved in=20
research. Several universities have clinical research =
centers=20
that service multiple departments within their=20
university. What I am =
looking=20
for is a n existing working model that services =
several hospitals and/or universities. If the model already exists, I do not =
want to=20
re-invent it! But, I will be happy to learn from their=20
experiences. The model=20
will hopefully include such things as identifying potential trials for =
the=20
member organizations, assistance with application preparation , study coordination =
(possibly even=20
central study managers), centralized=20
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model sh ould provide this assistance across=20
administrative (corporate) lines. Any help=20
in identifying an existing model of this nature will truly be=20
appreciated. David
*******************************************************************
David L. Innes, Ph.D. Mercer University
Associate Vice President 1400 Coleman Ave.=20
University Research and Biosafety =
Macon, GA 31207=20
Voice: 912-301-4101
FAX: 912-301-4120
E-Mail: Innes_DL@Mercer.Edu ****************************************************************=
***
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David Innes
5/5/2000 11:30:00 AM
Venous thrombosis of arm--share info?
Ellen Bernal wrote to ask opinions about sharing information about deep
venous thromboses found in the upper extremitites.
1) What did your PI list as potential benefits to the patient in the
protocol and informed consent forms? Is the reslease of information
consistent with the application?
2) I don't know all there is to know about mhsnr.oprg. Maybe your
research committee knows some deep dark secrets. Most places I've
worked, the clinicians use clinical information appropriately. The more
accurate information, the better the care.
3) upper extremity dvts can, rarely, cause big problems. I've seen one
case. You might contact Dale H. or other heme guys (gals)to disucss
other possible cases.
4) If I were the clinician and you witheld clinically relevant
information from me, I would be annoyed. From a clinician's point of
view, I would see no up side to enrolling patients. You might record
data showing that I missed a diagnosis--you wouldn't help me or the
patient at all.
The sniff test is giving me unpleasant readings from your research
committee.
Ron Low
Ronald Low
5/4/2000 7:02:00 AM
Venous thrombosis of arm--share info?
Thank you for these observations.
(1) Under benefits, the PI does in fact list I will be finding out if there is
a blood clot on my IV catheter. I will also be helping to determine how common
these blood clots are. So that in itself is inconsistent with not sharing the
information.
(2) Yes--one would think that physicians would like to receive information, even
though there is no definitive treatment or even knowledge of whether the
brachial DVT is harmful. I will be interested to hear what the physicians on
the Human Experimentation Committee say about this.
I was thinking that one possibility might be to forward the information to the
physicians separately instead of directly in the patient's record. This is what
we sometimes do with ethics committee meetings.
(3) Re: upper extremity DVT's, in your experience do the ones that cause
problems always manifest themselves in clinical signs and symptoms? Or, is it
possible that an upper extremity ultrasound might reveal subclinical ones that
could cause problems if not taken care of?
(4) I think that's how I'd feel if I were a physician. I know that as a
patient, I do like to receive full information.
Thanks again.
Ellen
ronald_low@netmail.hscbklyn.edu on 05/04/2000 12:29:43 PM
To: Mcwirb@mcwirb.org, Ellen W Bernal/SVMC/MHP/CHP
cc:
Subject: Re: Venous thrombosis of arm--share info?
Ellen Bernal wrote to ask opinions about sharing information about deep
venous thromboses found in the upper extremitites.
1) What did your PI list as potential benefits to the patient in the
protocol and informed consent forms? Is the reslease of information
consistent with the application?
2) I don't know all there is to know about mhsnr.oprg. Maybe your
research committee knows some deep dark secrets. Most places I've
worked, the clinicians use clinical information appropriately. The more
accurate information, the better the care.
3) upper extremity dvts can, rarely, cause big problems. I've seen one
case. You might contact Dale H. or other heme guys (gals)to disucss
other possible cases.
4) If I were the clinician and you witheld clinically relevant
information from me, I would be annoyed. From a clinician's point of
view, I would see no up side to enrolling patients. You might record
data showing that I missed a diagnosis--you wouldn't help me or the
patient at all.
The sniff test is giving me unpleasant readings from your research
committee.
Ron Low
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Ellen Bernal
5/4/2000 9:01:00 AM
Post-mortem use of tissue in research
Howard:
I don't see the dichotomy you do in this area between what you refer to as
rights-talk and the discussion of moral interests. Nor do I see any,
particularly, between professions (e.g. the Doctors of Jurisprudence you
allude to, and undefined others) in their concern for moral consequences.
We all stand on common terrain that in degrees is unfamiliar to us all.
Issues and positions fuse together or diverge on more holistic dimensions
than is implied by the dichotomy you draw. What the law is, or what it
means, are two different questions than a third: what the law should be.
Answers to all three questions might differ anyhow depending upon the moral
views of the beholder.
At some point, to get from what is to what should be you're going to have
use language to make policy, and like it or not we use law to articulate
policy. It's an endless loop from problem, to discussion, to decision, to
policy, to law, and back again. Introduce the issue of time, another
dimension, and the idea of getting caught or hung up anywhere on the loop
becomes a separate moral issue. Even IRB meetings have to end, and inaction
can be a moral decision.
In the discussion of the ownership of samples, and again regarding the
post-mortem use of tissue, I have adhered to the position that there is
nothing to prevent an IRB from taking jurisdiction over these matters,
discussing the moral considerations involved, and deciding not to approve
statement of fact language or from deciding affirmatively to require the
consent of a personal representative, next-of-kin, or other relative for the
post-mortem research use of identifiable tissue. I have my own moral view on
these questions. My greatest personal worry in this whole area, one which I
sense you share, is that while we anguish from different perspectives over
whatever may be termed moral considerations, others are mooting our debate
by staking out ownership claims, obtaining patents, and driving up the
economic costs of change so greatly that even if we wanted a different
outcome, it would be too late, or our objections would be ignored.
Sincerely,
Tom Dalglish J.D., Ph.D.
Community Representative, Committee C
University of Washington
(206)543-0098(University)
(206)706-1000(Office)
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
Of Howard Mann
Sent: Wednesday, May 03, 2000 7:36 PM
To: mcwirb@mcwirb.org
Subject: re: Post-mortem use of tissue in research
Hi All,
Phillip Michaels said :
May I add that whether the laws being considered are federal or state, it
may
serve IRBs (and all of us) well to consider the laws to be minimum
standards.
As I oft opine to colleagues on our committee, ethics (and laws) evolve.
Thus
it behooves us to try to anticipate where this evolution is headed, and how
we
go about protecting human subjects in an environment in which the law
always
has to play catch up--usually at considerable delay--to the events that we
are
experiencing daily.
Phillip, this is an eloquent allusion to a prevalent form of response to
contentious ethical issues. Standing in unfamiliar terrain, a respondent
asks,
Well, is there a law about this? Or, What do the regulations say? What often
follows is a painful parsing of language and fitful attempts at textual
deconstruction. We saw some of this in the thread concerning Ownership of
samples. ( Doctors of Jurisprudence, do not take offense -- your comments
and
insight are much appreciated :-) )
While queries concerning legal or regulatory guidance are pertinent -- as
IRB
members, we are acutely aware of our legitimate interests in the existence
of
such guidance -- we should perhaps first ask, What moral interests are at
stake
here? Antecedent to rights-talk should be an exploration and articulation of
the interests -- which? whose? -- that are at stake.
Thus, Phillip rightly alludes to the interests of the relatives of deceased
individuals in the context of genetic research. In a relevant situation,
their
moral interests are deserving of sensitive consideration.
Regards,
Howard
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
thomas k. dalglish
5/4/2000 8:55:00 AM
Hindsight...It doesn't seem to have qualified as exempt?
The simple answer, I guess, is that this is the reason for substantive
continuing review, and can be a reason for a f/u look even at studies originally
deemed exempt. IRBs are fallible.
I think there's no option but to come clean.
Send the investigator a letter saying that the study was examined on routine
periodic review, and it appears in retrospect not to have met the regulatory
criteria for exemption from full IRB review. Ask for an application. With a
generous dose of humility and obsequity, let him know that he cannot enroll
subjects until this is fixed (an inescapable conclusion of [needs review] and
[hasn't had it]). Bend over backwards to help him come into compliance as
quickly as possible.
In the long run, it could turn out OK. If the IRB admits its error and then
makes a big effort to help the investigator, it could be a step toward being
viewed as people who try to be helpful rather than bureaucrats who try to be
obstructionist.
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
5/4/2000 9:54:00 AM
Samples and Community/Participant Involvement in Determining Benefits
All:
Jon Merz wrote in this Forum on 4/27/00 about what I presume was
community(Dor Yeshorim) participation in research intended, among other
things, to determine the prevalence estimation of a particular gene. He
commented that his colleague Jason Karlawish thought the research raised
issues about community and participant involvement in determining or
negotiating about the benefits of research.
Has anyone had experience with the Northwest Territories Scientists Act?
My understanding is that it provides that no person can carry on scientific
research in the Territories or collect specimens in the Territories for use
in scientific research unless the person first obtains a license from the
government. The license may be granted subject to conditions or denied if
the research might be injurious to the natural and social environment, or
to any part thereof, of the Territories. Applicants for a license must make
a full disclosure (in a form) about the research, must conduct a dialogue
ahead of time with affected communities about the research, and must agree
to provide a report 6 months afterwards that will be distributed to the
residents and community affected describing the results of the research, in
language that is free of technical jargon and concise. When the license
authorizes the collection of specimens, the government may require the
surrender of the specimens to the government after the research is
concluded, for disposal in the manner the government considers proper. The
community must review and approve the license application before it will be
issued. Violation of the act carries a fine of $1,000 and or imprisonment of
not more than six months.
I have not researched the meaning of all the language quoted above, have had
no personal experience with the Act, and know of no one who has. Some of its
provisions are intriguing. Can anyone else clarify? Our IRB would require a
letter of cooperation from an affected community, under certain
circumstances (which indirectly might entail community approval), but I
don't know if we would go as far as the Scientists act in any conditions we
might establish.
References are to: The New York Times (Sunday, 9/1/74, page 6E); Scientists
Act, R.S. NWT 1974(3), c.S-4, as amended by O. NWT 1978(3),c.8, and S. NWT
1985(1), c.4; see also www.nwtresearch.com and www.gov.nt.ca.
Tom Dalglish J.D., Ph.D
Community Representative, Committee C
University of Washington
(206) 543-0098 (University)
(206) 706-1000 (Office)
thomas k. dalglish
5/4/2000 10:13:00 AM
Annual reports/block voting
Our IRB chairman has asked that I get opinions on the following:
For Annual Reports that are not eligible for expedited review, our IRB members review each report, then at the IRB meeting, a vote is taken on each individual report.
For Annual Reports that have received expedited review by the chairman, the IRB reviews and votes on them as a group (one vote for all reports).
Are we within the regs with this type of block voting for annual reports that have received expedited review?
Cynthia Mendoza
Covenant Health System
Lubbock, TX
cmendoza@covhs.org
Anonymous
5/4/2000 3:26:00 AM
Donna,
We ask how many subjects have been enrolled in the study since the last reveiw and also ask for the total number of participants to date. But we have never asked for the names of the subjects. I did not think this was required information for the IRB.
Can anyone else comment on this?
Thanks,
Elaine Wall
IRB
Guthrie Healthcare System
Sayre, PA
ewall@inet.guthrie.org
Donna Hogan wrote:
> At our institution, we require that the investigator submit a continuing review form along with a copy of the current consent form being used, a list of research subjects who have signed consent forms and the individual(s) who obtained the consents.
>
> We then generate from our database a summary report of all info (revisions/amendments, SAE's, etc.) that had previously been submitted for the study. A review committee of the IRB compares this to the investigator's continuing review submission. During
> this time, the investigator has opportunity to catch up on submitting any information that might have been overlooked during the last review cycle; and the IRB has opportunity to review the study's progress. We do not require copy of the protocol from th
> e investigator for continuing review, but do review the entire study file during this process.
>
> After the pre-review is complete, we finalize our database summary report and send out to the IRB to review prior to the meeting so that the members will be ready to discuss and take action.
>
> Donna Hogan, IRB Coordinator
> Methodist Healthcare
> Memphis, TN
>
> >>> Susie Hayes 04/13/00 04:05PM >>>
> When a project is due for continuing review, do board members get a copy of the
> original protocol with a request to continue. I notice that many institutions
> have continuing review forms that ask about changes, adverse events, number of
> subjects, etc., but is the original protocol re-reviewed at this time?
>
> Susie Hayes
> The University of Memphis
>
> _______________________________________________
> 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
Elaine Wall
5/4/2000 10:01:00 AM
Venous thrombosis of arm--share info?
Our institution reviews research protocols using two separate committees
(1) The Research Committee, which is primarily concerned with scientific
design (2) The Human Experimentation Committee, which I chair, is primarily
concerned with ethics review. Recently a situation has come up in which
the two Committees disagree about whether to provide the subject's
attending physician with information gathered for research purposes.
The study's aim is to estimate the incidence of deep venous thrombosis in
patients who have a peripherally inserted central catheter (PICC line)
inserted in a brachial vein. Some previous research has found a 12%
incidence of DVT in patients with axillary vein catheterization, even
though anticoagulation therapy is used. The study would do ultrasound
vascular studies of each enrolled subject at the time the PICC line is
inserted, and then every 7 days thereafter.
When a patient has a DVT in a lower extremity, treatment is given. But it
is not known what to do when a patient has a DVT in an upper extremity.
The question is--should the attending physician be given information about
the ultrasound findings when they were not clinically indicated?
The Human Experimentation Committee believes that the information should be
shared with the attending physician, perhaps along with an explanation that
the clinical significance and course of action for upper extremity DVT's is
unknown at this time. The HEC's usual feeling is that once information is
generated, it becomes the property of the subject.
The Research Committee, though, feels that sharing this information would
make the attending physician accountable for making a decision about
treatment. As a result, some patients might experience complications from
treatment that is not really indicated. Alternatively, if the doctor
decides not to treat, and the patient goes on to develop problems from the
upper ext. DVT, the doctor might be held responsible for that. (I have the
sense that some of the concern is a legal one.) The Research Committee
draws an analogy with a study of breast cancer, in which during surgery a
bone marrow sample is taken and the results are sent to a lab for analysis,
but the patient and doctor do not receive information.
I think that one compromise might be a dear Doctor letter saying in
effect, your patient has agreed to participate in a study of upper
extremity DVT. This involves ultrasounds, etc...It is currently unknown
whether upper extremity DVT's should be treated. Because the clinical
significance of upper extremity DVT is unknown, we are offering you a
choice as to whether or not you would like the information from your
patient's ultrasound studies.
I would appreciate any thoughts or comments--thanks.
Ellen Bernal
5/4/2000 12:28:00 PM
Hindsight...It doesn't seem to have qualified as exempt?
With finesse, is the quick answer!
Dulce, I am in a similar position--new to this Board and acting chair;
started a week before the previous chair departed for greener pastures
across town--and am making similar discoveries (yes, plural). Each case
is its own, of course. But depending on what the original
communications said; that's how one has to proceed, I think. That is,
did they cite the reg number that they based exemption on? Who made
the decision? Did the researchers ask for the exemption in the first
place? What did the communication to them say--no further IRB review
is necessary might confuse them more than if they were just told it had
been exempt and now you want to follow up. What is the risk involved?
--this last question says how quickly and decisively the action needs to
be taken now. Is it an FDA-regulated study or DHHS or both? Is it
expeditable? Does your Board SOPs allow for primary reviewers ?
I would suggest 1) take it to full Board--with special meeting if
necessary and prepare by 2) getting consultation with OPRR or FDA
office. Of course, you probably want to do some further auditing to
know how isolated this case is.
FIRST STEP /CONCURRENT step might be to notify the researcher that you
are following up as part of routine audit procedures and therefore
....... Of course, if s/he's savvy to the rules, s/he could ask well
why are you auditing something that's exempt from your purview... But
a researcher who does business appropriately should have no problem
being reviewed; it's just the extra hassle of now facing review and
the IRB decision whether to suspend enrollment and intervention
activities until review is completed. I assume that under the
circumstances, the latter could be done as expeditiously as possible as
soon as researcher provides materials.
You didn't indicate what is your position is--administrator or
chairperson. I think it's the chair's headache--I mean responsibility
to handle.
Good luck. Hope things go smoothly....Let me know what you decide and
how things turn out. I'll keep you posted too.
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
>>> Dulce Bramblett 04/13/00 04:10PM >>>
Preparation for a meeting brought about preparation of a protocol for
continuing review. At first glance the consent, one-half page in
length
screams inadequate. Further investigation shows the protocol was
approved
through and exempt review last May (prior to my involvement with the
IRB.)
Upon review of 45CFR46.101, I find no ground for exemption.
The study name alone seems to disqualify it: A Prospective,
Multicenter
Randomized Study Comparing.... (Two FDA approved polyethylene
acetabular
inserts are being compared in total hip arthroplasty.)
I would like suggestions from IRB affiliates of how you would handle
this
situation?
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Jo Anne Bennett
5/4/2000 9:54:00 AM
We do not ask for the original protocol. If an IRB member wants to see it,
we will provide it from the database. Generally a lenghty form is used and
we ask numerous questions and should there be any questions after the
review, the PI is sent a letter requesting clarification.
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
Of Susie Hayes
Sent: Thursday, April 13, 2000 3:06 PM
To: mcwirb@mcwirb.org
Subject: continuing review
When a project is due for continuing review, do board members get a copy of
the
original protocol with a request to continue. I notice that many
institutions
have continuing review forms that ask about changes, adverse events, number
of
subjects, etc., but is the original protocol re-reviewed at this time?
Susie Hayes
The University of Memphis
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Tryn Stimart
5/4/2000 10:01:00 AM
Venous thrombosis of arm--share info?
At 09:18 AM 5/4/2000 -0400, Ellen_Bernal@mhsnr.org wrote:
>I think that one compromise might be a dear Doctor letter saying in
>effect, your patient has agreed to participate in a study of upper
>extremity DVT. This involves ultrasounds, etc...It is currently unknown
>whether upper extremity DVT's should be treated. Because the clinical
>significance of upper extremity DVT is unknown, we are offering you a
>choice as to whether or not you would like the information from your
>patient's ultrasound studies.
>
>I would appreciate any thoughts or comments--thanks.
I have concerns about the above approach. There are ethical problems in
even giving the patient/subject the option of knowing or not knowing, or of
being informed that they will not be informed of findings related to the
research, but giving that option to the attending is even more problematic.
I see multiple problems with it.
1. How could such an approach be consistent with proper respect for
patients and subjects?
2. Does such an approach not violate the principle of patient autonomy? It
exacerbates an existing problem regarding patient-doctor relationships. We
have made significant, but insufficient, progress in moving toward patient
autonomy and away from 'excessive' physician paternalism (I am not among
those who think that paternalism is inherently evil). This would retard
that progress toward increasing patient autonomy and freedom of informed
participation in medical decision-making, whether or not there is known
treatment(s) for the medical problem.
3. What of researcher and physicians' obligations to uphold principles of
beneficence and non-maleficence? Arguably, the researcher, or anyone in the
clinical or research environment who discovers something regarding a
patient/subject's well-being, has an inherent obligation, in the interest
of doing good and avoiding harm, to pass that information to the patient
through the appropriate channels, which many would take to mean through the
attending.
4. What of justice? As I understand it, some ethicists are now resurrecting
the old argument about patients/subjects not even being allowed to engage
in research unless there is some potential for benefit to them personally.
I am not in that camp, but I tend to find justice absent in a situation in
which a patient/subject is providing a benefit for a researcher and/or
society, and is then left ignorant of personal health information that
professionals around her know.
5. What of integrity and honesty? Do we not want to inquire: How
professional is such behavior? How can a professional have integrity and
face a patient/subject knowing that they are withholding information (or
have personally chosen to be ignorant of such information) that is of
import to that patient/subject?
Hope this is helpful.
Regards,
Phillip Michaels
Phillip Michaels
5/4/2000 12:28:00 PM
Annual reports/block voting
But how do your determine which continuing reviews can be expedited?
And what do you do about those that are not expedited? The regs don't
appear to authorize block voting.
Thanks for sharing your on-line manual. I've put it on my surfing
agenda.
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
>>> Howard Mann 04/12/00 09:43PM >>>
Re: Annual reports/Block voting
Hi,
As Chairman of our Committee, I review and approve the studies eligible
for
expedited review.
We notify our members in the Meeting Agenda that I have done so,
pursuant to
our policy concerning Continuing Review as detailed in --in our case
--
http://www.ihc.com/ldsh/irb/FANDP.htm#CONTINUINGREVIEW
( Our Policies and Procedures manual relevant to common issues is
online )
The studies are enumerated in the Agenda. We do not conduct a vote on
this
process per se. I do not believe it is necessary.
See :
http://grants.nih.gov/grants/oprr/humansubjects/guidance/hsdc95-01.htm
Note the statement :
Review by the convened IRB, with recorded vote, is required
unless the research is otherwise appropriate for expedited review under
Section
46.110.
Regards,
Howard
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Jo Anne Bennett
5/4/2000 3:26:00 AM
At our institution, we require that the investigator submit a continuing review form along with a copy of the current consent form being used, a list of research subjects who have signed consent forms and the individual(s) who obtained the consents.
We then generate from our database a summary report of all info (revisions/amendments, SAE's, etc.) that had previously been submitted for the study. A review committee of the IRB compares this to the investigator's continuing review submission. During this time, the investigator has opportunity to catch up on submitting any information that might have been overlooked during the last review cycle; and the IRB has opportunity to review the study's progress. We do not require copy of the protocol from the investigator for continuing review, but do review the entire study file during this process.
After the pre-review is complete, we finalize our database summary report and send out to the IRB to review prior to the meeting so that the members will be ready to discuss and take action.
Donna Hogan, IRB Coordinator
Methodist Healthcare
Memphis, TN
>>> Susie Hayes 04/13/00 04:05PM >>>
When a project is due for continuing review, do board members get a copy of the
original protocol with a request to continue. I notice that many institutions
have continuing review forms that ask about changes, adverse events, number of
subjects, etc., but is the original protocol re-reviewed at this time?
Susie Hayes
The University of Memphis
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Donna Hogan
5/4/2000 8:52:00 AM
Eventually, the federal government may need to overhaul its entire system of protecting human volunteers in research, said George Grob, deputy inspector general for evaluation and inspections at the department. I.R.B.'s are overwhelmed with their responsibilities, and medical experiments have grown much more complicated and numerous than they were in the 1970's, when the current federal regulations were developed, he said, adding, The system has just not kept up with the world today.
The officials said they may ask Congress to amend existing law to give them additional tools to ensure compliance with federal rules. Daniel Michels, director of enforcement in the Food and Drug Administration's Office of Regulatory Affairs, noted that right now, federal officials have few options to force compliance other than what Mr. Michels called the atomic bomb of suspending an institution's research projects. He said officials are studying a proposal to introduce civil fines for violations as an intermediate penalty.
Anonymous
5/4/2000 4:34:00 AM
approving studies retrospectively
i am new to the IRB game and would like some advice on the following:
i have a study that was being monitored under one IRB, closed out and moved
to a different IRB and now has returned to the first IRB which has given
it's approval (treated as an initial review and reviewed by the full board).
My dilemma is that this new approval was given retrospectively back to the
initial closing date. I have a problem with this and was wondering if this
is something an IRB Board can do??
The reason this study had to be brought back to the original IRB is that
several sites did not recognize this second IRB. So there is a 2 month gap
in time that this retrospective approval will cover. I know there is no FDA
reg that says this can't be done, but there is noting that says we can.
Deborah Mick
Marin Cancer Institute
IRB Specialist
415/925-7965
email: mickd@wenet.net
Deborah Mick
5/4/2000 8:23:00 AM
Non -English Speaking Subjects
Hello everyone,
We are trying to find a better method to address the issue of non-English speaking research subjects. This is a complex issue for us because the L.A. Unified School District has documented 80 different language groups in the greater LA area, including: Spanish, Armenian, Russian, Chinese, Vietnamese, Korean, and Farsi. Therefore, it is difficult to find a reasonable functional and economically feasible resolution. Obviously, we do not require prospective translation of informed consent documents into all 80 languages. We are currently requiring translated consent documents (with much investigator resistance, anger, etc.) when a potential subject presents who does not speak English or when the investigator has prospectively identified a non-English speaking subject population. This solution, however, is not always feasible if a subject must, for example, begin a drug within 24 -48 hours of entry.
How does your IRB resolve the issues surrounding informed consent of non-English speaking subjects in more than minimal risk research that does NOT meet the requirement for waiver of written informed consent?
1. Does the IRB require investigators to translate the IRB approved informed consent document?
a. If so, does your institution provide a translation service? [If yes, how is it funded?]
b. If the institution does not fund the translation, who pays for the translation in federally funded or non-funded research and where do they get the money?
2. Part of our consideration is the use of the short form translated into the subject's language with English language summary and witnessed oral translation as described in 45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2) and approved by OPRR. Does your IRB allow the use of the short form?
a. If so, how does your IRB determine or distinguish when the short form may be used in lieu of a complete translated informed consent document? In other words will your IRB allow the short form in some types of research but not in others?
b. Do you use a checklist to facilitate the review? If so, will you share?
3. What are the major language groups of your institution's potential subject population?
4. Was your institution able to negotiate an indirect cost agreement with the Feds to use overhead recovery to fund translation of research documents, such as informed consent forms? If so, how was this done?
5. Do you know of an investigator who was succesful in creating a line item in a Federal grant budget proposal for translation of the informed consent form?
thank you for your help,
-steve
Steven Peckman
Associate Director-Human Subjects Research
Office for Protection of Research Subjects
University of California, Los Angeles
310.825.5344
speckman@oprs.ucla.edu
Anonymous
5/4/2000 2:59:00 PM
Venous thrombosis of arm--share info?
Ellen ---
I've had four patients have nearly fatal pulmonary embolization from
catheter-associated DVT of the upper extremity. Sudden death from embolization
of upper extremity DVTs has been reported in weight lifters (who may have venous
obstruction from hypertrophied strap muscles), and a body of literature is
developing in support of the suggestion that chronic upper extremity-originated
embolization may underlie many cases of idiopathic pulmonary hypertension and
many cases of failure of inferior caval filter prophylaxis.
So this whole discussion is problematic for me on the grounds that the medical
information seems to reflect a 1960s perspective on upper extremity clots rather
than a current perspective. The data are not nearly as extensive as are those
for lower extremity DVT, but most clotters (myself included) would now regard an
ultrasound-demonstrated UE-DVT as Important information rather than
Information of uncertain significance.
I'd not participate in such a study if the information were not being given. And
if I were writing the study, I'd probably (if I had enough of a sample size) try
to structure it to generate some information about which ones benefit from
treatment.
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
5/4/2000 10:10:00 AM
Lawmaker Suggests Placing Stipulations on Funds for Human-Subjects Research
Chron. of Higher Education: By JEFFREY BRAINARD
Congress may need to attach strings to appropriations for biomedical research unless federal officials move faster to improve oversight of studies involving human subjects, a key congressman said at a hearing on Wednesday.
Rep. John L. Mica, chairman of a House of Representatives government-reform subcommittee, accused the Department of Health and Human Services of foot-dragging in carrying out changes. Mr. Mica, a Republican from Florida, said officials had acted too slowly on recommendations made by the department's inspector general in a 1998 report. And he took officials to task over a follow-up report, issued by the inspector general last month, that found that the department has made minimal progress at instituting improvements.
Medical studies involving human volunteers have been under intense scrutiny over the past year because of some highly publicized problems, including the death of 18-year-old Jesse Gelsinger in September during a gene-therapy experiment at the University of Pennsylvania.
What is required to convince H.H.S. to take additional needed actions to prevent more harms and to save more lives? Mr. Mica said. He was not specific about what restrictions he might support on the $5-billion in federal funds being spent annually on biomedical research involving human volunteers. But he promised to continue pressing the agency for quicker results.
Officials at the Department of Health and Human Services said at the hearing that universities and other institutions that conduct biomedical research shared responsibility with the government for improving protections of participants in studies. William F. Raub, deputy assistant secretary for science policy, called on colleges to increase spending on their in-house panels -- known as institutional review boards, or I.R.B.'s -- that oversee such studies.
However, Mr. Mica bored in on the government's role, and Mr. Raub responded that improvements were in the works. The changes include efforts to increase enforcement of existing regulations by the department; reduce unnecessary rules that bog down the work of I.R.B.'s; and promote education of researchers about federal requirements for research involving human subjects.
Mr. Raub insisted that carrying out reforms was a top priority at the department. We view those steps as a strong beginning, but concur with the inspector general that much more needs to be done, he said.
The National Institutes of Health has already announced it will no longer require researchers to obtain I.R.B. approval for a proposed research project before applying to the N.I.H. for grant money to finance the study. The agency, which is part of the Department of Health and Human Services, is the largest single supplier of federal funds for biomedical research.
The N.I.H. approves only about one-third of all projects proposed by researchers in grant applications, and I.R.B. members had complained that the existing rule created unnecessary work for them. The change should lighten the workload of I.R.B.'s, freeing them to spend more time assessing the riskiest experiments, Mr. Raub said.
Nevertheless, Mr. Mica expressed exasperation that officials had not made some regulatory changes sooner, especially several that would not cost the government money. He also pressed Mr. Raub and his colleagues for information about how many new staff members they had requested for the 2001 fiscal year to help improve federal oversight. The officials could not immediately say.
Eventually, the federal government may need to overhaul its entire system of protecting human volunteers in research, said George Grob, deputy inspector general for evaluation and inspections at the department. I.R.B.'s are overwhelmed with their responsibilities, and medical experiments have grown much more complicated and numerous than they were in the 1970's, when the current federal regulations were developed, he said
Anonymous
5/4/2000 4:33:00 AM
Privately Funded Research in Europe
This is a multi-part message in MIME format.
------=_NextPart_000_002A_01BFB4D7.A1B31660
Content-Type: text/plain;
charset=iso-8859-1
Content-Transfer-Encoding: quoted-printable
This is a question for our European colleagues. This issue has come up =
twice recently in seminars I have given to European medical device =
manufacturers. (I work/live in Chicago.)
In the first case, a UK manufacturer (Little Device Company) has given a =
sum of money to a UK university. The money is to be used to finance a =
research project--including a clinical investigation--that a PhD student =
will conduct as part of his graduate research. The research is looking =
at a new indication for a technology owned by Little Device Company. If =
the application is promising, Little Device Company will commercialize a =
product based on application of the technology for the new indication. =
Question: Who is the sponsor? Is the clinical investigation regulated by =
the Medical Device Directive (as transposed by UK) and by EN 540? If =
not, how is it regulated, if at all?
In the second case, a Swiss company (Big Pharma) has a relationship with =
a German Clinic. Big Pharma is providing all of German Clinic's =
financial support this year in a partnership arrangement. Big Pharma =
wants to do basic clinical research on an upstream, early developmental =
medical device. If the technology is successful, Big Pharma will =
commercialize the device. German Clinic wants to represent the research =
to the Ethics Committee as being initiated by them and not acknowledge =
Big Pharma as a sponsor. This gets them out of regulation by the Medical =
Device Directive (as transposed by Germany) and EN 540. Question: who is =
the sponsor? If not Big Pharma, how is the research regulated, if at =
all?
Thanks for any help you can give me.
Nancy J Stark, PhD
Clinical Design Group
Chicago, IL
------=_NextPart_000_002A_01BFB4D7.A1B31660
Content-Type: text/html;
charset=iso-8859-1
Content-Transfer-Encoding: quoted-printable
<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 4.0 Transitional//EN> This is a question for our European =
colleagues.=20
This issue has come up twice recently in seminars I have given to =
European=20
medical device manufacturers. (I work/live in Chicago.) In the first case, a UK manufacturer =
(Little Device=20
Company) has given a sum of money to a UK university. The money is to be =
used to=20
finance a research project--including a clinical investigation--that a =
PhD=20
student will conduct as part of his graduate research. The research is =
looking=20
at a new indication for a technology owned by Little Device Company. If =
the=20
application is promising, Little Device Company will commercialize a =
product=20
based on application of the technology for the new indication. Question: =
Who is=20
the sponsor? Is the clinical investigation regulated by the Medical =
Device=20
Directive (as transposed by UK) and by EN 540? If not, how is it =
regulated, if=20
at all? In the second case, a Swiss company =
(Big Pharma)=20
has a relationship with a German Clinic. Big Pharma is providing all=20
of German Clinic's financial support this year in a partnership=20
arrangement. Big Pharma wants to do basic clinical research on an =
upstream,=20
early developmental medical device. If the technology is successful, Big =
Pharma=20
will commercialize the device. German Clinic wants to represent the =
research to the Ethics Committee as being initiated by them and not =
acknowledge=20
Big Pharma as a sponsor. This gets them out of regulation by the Medical =
Device=20
Directive (as transposed by Germany) and EN 540. Question: who is =
the=20
sponsor? If not Big Pharma, how is the research regulated, if at=20
all? Thanks for any help you can give =
me. Nancy J Stark, PhD Clinical Design Group Chicago, IL
------=_NextPart_000_002A_01BFB4D7.A1B31660--
Nancy J Stark
5/3/2000 6:35:00 AM
Post-mortem use of tissue in research
I was pleased to see Jeff Cooper's admonition to be careful. May I add that
whether the laws being considered are federal or state, it may serve IRBs
(and all of us) well to consider the laws to be minimum standards. As I oft
opine to colleagues on our committee, ethics (and laws) evolve. Thus it
behooves us to try to anticipate where this evolution is headed, and how we
go about protecting human subjects in an environment in which the law
always has to play catch up--usually at considerable delay--to the events
that we are experiencing daily. After all, the purpose, the function, the
mission of IRBs (and the laws that govern them) is the society's duty to
protect its citizens in a research environment. With the exploding growth
of genetic research AND information/data storage AND information
dissemination--potentially working in concert--there are extensive
implications for what may be required to protect not only the human
subjects involved in research, but also those who are related to them.
Phillip Michaels
At 06:38 AM 5/3/2000 -0500, you wrote:
>Dan,
>
>You have to be careful about state law that may pre-empt federal law by
>providing additional protections.
>
>In New York State, the definition of human subject includes deceased
>individuals. Also New York State law requires that identified genetic testing
>on deceased individuals can only be performed after written informed
>consent is
>obtain from the next-of-kin.
>
>In some situations knowledge of the genetic status of a deceased
>individual may
>result in harm to the relatives. Therefore I think IRBs should at least
>consider involving relatives in a consent process when performing identified
>genetic testing on deceased individuals.
>
>Jeff Cooper
>Chair, IRB
>Albany Medical Center
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Phillip Michaels
5/3/2000 12:35:00 PM
Does it need IRB approval?
I believe the answer depends on his intent - what does he want to do with
the information he gathers? Is he conducting research or is he merely
trying to better understand his own patient population.
-----Original Message-----
From: Howard Mann [mailto:ldhmann@ihc.com]
Sent: Tuesday, May 02, 2000 8:50 PM
To: mcwirb@mcwirb.org
Subject: re: Does it need IRB approval?
Hi,
The answer to your question, I believe, is contained in this thread :
Howard Mann Use of Medical Records for Research -- Need to Remove Identifiers ????? 4/27/00 4:42pm >Howard Mann Use of
Medical
Records for Research -- Need to Remove Identifiers ????? 4/27/00
4:42pm
Regards,
Howard
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Barbara -Mha
5/3/2000 8:32:00 AM
Does it need IRB approval?
I think the main question is does he plan to publish the data that he
gathers or is this an investigation to find out some pattern? Carol Nielsen
At 01:13 PM 05/02/2000 -0500, ebard@netmail.hscbklyn.edu wrote:
> I need help on this one. I am sure it has been discussed in the past,
> but I cannot find anything.
>
> An investigator asked the following; I like to review the charts of MY
> patients for the last x years, to establish (for instance) the
> proportion of overweight females vs lean males (or some other
> parameters); I have the information, they were (or still are) MY
> PATIENTS. Do I need to ask permission from the IRB?
>
> My answer was yes, it falls under the definition on 46.102(d), and
> because the investigator has the files, the review cannot help it but
> to have identifiers and therefore is not exempt under 46.101(b)4.
>
> The investigator was (and still is) not convinced, and, twisting the
> arguments around in my head, I am not so sure whether it can be
> exempted or not.
>
> I thank in advance to whomever will take time to answer.
>
> Enzo
> SUNY Downstate, Brooklyn
>
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Carol S. Nielsen
Director
Office for the Protection of Research Subjects
Northwestern University
Abbott Hall, 5th floor
Chicago, IL 60611
Telephone: 312-503-1805 or 312-503-9338
Fax: 312-503-0555
e-mail: cnielsen@northwestern.edu
Carol Nielsen
5/3/2000 6:29:00 AM
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