caroline
ain my opinion, the approval is from the time of initial review of the project.
splitting out subsets for separate approval is a can of worms and does not seem to
me to significantly or materially improve human subjects protection
give yourself a break!
stewart laidlaw, phd
Caroline Graber wrote:
> Our IRB recently considered a hemonc protocol ehich addressed several groups
> patients. The protocol was approved for one specific group of patients and we
> requested more information concerning the other groups. Those groups will be
> considered at the next meeting.
> What is the official approval date for this protocol? Do we wait until all
> groups are approved--or do we split it out and have several approval dates?
> What date should be used for scheduling the annual review?
>
> Thank you,
> Caroline Graber, RN, CIC
> IRB Coordinator
> East TN Children's Hospital
> Knoxville, TN
> 865-541-8191
> cgraber@etch.com
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Stewart Laidlaw Phd
4/18/2000 5:15:00 PM
Is Informed Consent Required?
Howard,
Your answer leaves wiggle room, maybe enough through which to drive a
research vehicle. The following question was addrssed by me by our
Chairman of Dept of Medicine. If I am collecting data on my own
patients using a FDA-aproved drug for an approved indication but on a
patient population not studied by the FDA studies, do I need an
informed consent? If the data is to be presented in publication
without identifiers, is IRB approval requested?
I suspect that according to your answer, the answer to both of the
above is yes. I suspect not.
Comments?
Norm
------------------ Reply Separator --------------------
Originally From: Howard Mann
Subject: re: Is Informed Consent Required?
Date: 04/18/2000 00:17am
Re: Is informed consent required ?
Hi,
I approach this kind of issue as follows:
1. Is this a matter within the jurisdictional purview of the IRB ? Is
this
research involving human subjects ?
If there are no identifiers associated with the data provided, it is
not
human subjects research as :
Private information must be individually identifiable (i.e.,
the identity of the subject is or may readily be ascertained by the
investigator or associated with the
information) in order for obtaining the information to constitute
research
involving human subjects.
(http://grants.nih.gov/grants/oprr/humansubjects/45cfr46.htm#46.102)
( Does anyone disgree with this point ? )
Of course, it does not meet the definition of research either.
2. What is my institution's policy concerning the provision of such
data to
extramural parties ?
I would refer the querying individual to the responsible institutional
officials for further information. My institution has its policy
concerning the
release of information to third parties ( attorneys, law enforcement
officials,
insurance company representatives, vendors, etc.) available for
perusal on our
Intranet.
All institutional personnel are also bound by a signed
non-disclosure
agreement, which addresses such issues.
Regards,
Howard
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Norman Leopold
4/18/2000 5:09:00 PM
Is Informed Consent Required?
Paul ---
How meaningful is the no in no identifiers? Not even coded identifiers to
avoid inadvertent duplicate entries?
General consent-to-treat forms and the AHA-recommended patient information
language (widely used by many hospitals) generally would not allow any
extramural use of information unless it is stripped of identifiers or unless
consent has been obtained.
The cynical side of me would ask for the agenda. Why are these data being
collected? Is the study of any use other than a marketing use (27% of cardiac
hospital admissions could have benefitted from our drug, but only 6% were
actually taking it)? If there are to be no identifiers, is this really a study
that would be meaningful if frequent fliers are counted multiple times?
The cynical side of me also asks about no financial incentives. Why would
anyone agree to do a significant amount of work to collect what appear likely to
be junk data for a drug company?
I'd guess there's more to this story...
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
4/17/2000 4:43:00 AM
Advising children about risk of death in Assent document
Dear Sara,
I would agree with you that most 7 year olds are too young to understand all the
information about risks of participating in a study. In fact, if the oncology study
has treatment benefits to the child, we typically do not ask for assent. The logic
is that by asking for assent, you are giving the child the right to opt out of
potentially life saving treatment and you would ethically be obligated to follow
through on the child's wishes. We request assent from children in oncology studies
that offer no direct treatment benefit and then the assent form is quite short and
developmentally appropriate.
Bob Wells, Ph.D.
Valley Children's Hospital
Sara Plaspohl wrote:
> During the past few months, our Oncology IRB has been reviewing a series of
> Children's Cancer Group protocols. At the last meeting, two of the studies
> under review had language within the Informed Consent document about the risk
> of death; however, the accompanying Assent document did not mention this risk
> in the long list of possible side effects. These two studies are for children
> with Hodgkin's Disease.
>
> The issue discussed by the group was whether or not the risk of death should be
> included in the Assent. Some members felt like the parents should bear the
> responsibility of deciding whether to communicate this to the child, while
> other members felt like a child age 7 or older should be informed of the
> possibility of death during the Assent process.
>
> The PI believes that telling the children about the risk of death may scare
> them so much that they cannot weigh the benefits against the risk. He also
> argues that other children may not comprehend the meanding and finality of
> death.
>
> I would appreciate input as to how other IRBs handle situations like this. For
> those of you who have included the risk of death in Assent documents, can you
> please offer examples of the language you used to do so?
>
> Thank you for your help,
> Sara Plaspohl
> Director, Office of Clinical Trials Compliance
> Memorial Health University Medical Center
> 4700 Waters Avenue
> Savannah, GA 31404
> (912)350-6866
> plaspsa1@memorialmed.com
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Bob Wells
4/17/2000 9:23:00 AM
DSMB: How much is enough?
Does anyone understand the current requirements regarding the IRB's
responsibility in obtaining information about Data Safety Monitoring
Boards (their existence, membership, decisions, meeting frequency,
etc.). Do these regulation apply to all studies, (e.g., FDA, OPRR,
NIH) or just selected studies. Should an inhouse protocol endeavor to
have a DSMB?
Thanks for your help
Craig Weiner, MD
Chair
Mercy Healthcare Sacramento Regional IRB
Craig
4/17/2000 6:47:00 PM
OPRR Compliance Activities: Common Findings and Guidance
http://grants.nih.gov/grants/oprr/findings.pdf
(46) states: OPRR has determined that individuals from the office of
research support whose duties create a real or apparent conflicitng
interest should not serve as voting IRB members.
At 11:42 AM 00/04/14, Mike Kelly wrote:
>Our IRB Administrator serves as an Alternate for either of our two
>non-scientific members. Her primary role at IRB meetings is usually to
>take the minutes and keep all of the amendments to amendments to motions
>straight. Having served that role myself in other organizations, I'm not
>convinced that cognitive timesharing allows the minutes-taker to adequately
>consider merits of the issues under discussion. The argument for having
>the Administrator as a non-science Alternate is that it has almost
>completely eliminated our quorum problems. If she were to be a non-science
>voting member, it would increase our quorum requirement by one.
>
>Mike Kelly
>Georgia Tech
>
>At 01:42 PM 4/13/2000 -0500, Deborah Barnard wrote:
> >I'm interested in learning how many institutions have IRB Adminsitrators who
> >are voting members of the IRB.
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sandy Schulte
Asst Vice Provost for Research Administration
University of Connecticut
Tel: 860-486-0985; FAX 860-486-5381
Sandy Schulte
4/17/2000 9:25:00 AM
We are just forming our IRB and will have our initial training and
orientation soon. As the Administrator, I am not a member. I will also
have clerical support to take notes and draft the minutes. I will oversee
this process. It has been my experience in dealing with convoluted issues,
this seems to be the best approach.
-----Original Message-----
From: Mike Kelly [mailto:mike.kelly@gtri.gatech.edu]
Sent: Friday, April 14, 2000 11:43 AM
To: mcwirb@mcwirb.org
Subject: Re: Voting Member or Not?
Our IRB Administrator serves as an Alternate for either of our two
non-scientific members. Her primary role at IRB meetings is usually to
take the minutes and keep all of the amendments to amendments to motions
straight. Having served that role myself in other organizations, I'm not
convinced that cognitive timesharing allows the minutes-taker to adequately
consider merits of the issues under discussion. The argument for having
the Administrator as a non-science Alternate is that it has almost
completely eliminated our quorum problems. If she were to be a non-science
voting member, it would increase our quorum requirement by one.
Mike Kelly
Georgia Tech
At 01:42 PM 4/13/2000 -0500, Deborah Barnard wrote:
>I'm interested in learning how many institutions have IRB Adminsitrators
who
>are voting members of the IRB.
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Anonymous User
4/17/2000 4:43:00 AM
Documentation of IRB minutes
Do the minutes for IRB meetings need to reflect the specific source of comments during the discussion? I am fairly new in my role, and have been told by contacts at other institutions that this is not necessary, and the minutes should protect the identity of those who make the comments about the protocol under review. However, this has been challenged by the manager of our Biomedical Research Department, who says it is important for the minutes to reflect whether a comment is made by the PI, study coordinator, IRB member, etc., and should identify the specific person making the comment or asking a question.
Should anonymity be upheld in the documentation of IRB discussion? I would appreciate advice from my MCWIRB colleagues.
Thanks,
Sara Plaspohl
Director, Office of Clinical Trials Compliance
Memorial Health University Medical Center
4700 Waters Avenue
Savannah, GA 31404
(912) 350-6866
plaspsa1@memorialmed.com
Anonymous
4/17/2000 3:58:00 PM
Documentation of IRB minutes
Sara,
A final note on the issue, as I am catching up on my emails. The FDA says we
need to record any issues that were discussed. They don't say we have to
name names. I simply note that It was noted that... or the issue was
raised that... or use words to that effect.
I do note what the PI replies were and that the PI made them. After all, the
minutes already record who was attending the meeting to present that study.
But I don't assign member names to discussion. It's the discussion that is
important, not who brought it up. And this give the IRB members the freedom
to be honest in their comments.
Rebecca M. Clark
Scripps Health/Children's Hospital IRBs
San Diego, CA
(858) 576-4008
rebcaclark@aol.com
Rebecca M. Clark
4/17/2000 3:58:00 PM
I'm interested in learning how many institutions have IRB Adminsitrators who are voting members of the IRB. At our institution, I serve as a non-voting member. If your IRB Administrator is a voting member, what was the reasoning behind this? If not, why not? Pros and cons?
Thanks.
ps - Don't forget to register for the OPRR/FDA Conference in Chicago, June 8th and 9th!!!!!!
Deborah Barnard, CCRC
Senior IRB Administrator
Rush-Presbyterian-St. Luke's Medical Center
Chicago, IL 60612
312-942-5498
Anonymous
4/17/2000 9:25:00 AM
Darkside of expanding review - was Investigator Liable?
To briefly restate the facts - investigator treats a cancer patient guided by a
protocol that is also part of a research plan. Plaintiff is suing (I assume for
malpractice, it was not stated in the original post) and is also suing the IRB
for improper review. No experimental drugs were used.
As long as no experimental drugs were used, plaintiff will have to prove
malpractice by showing that the doc deviated from some standard of care which
can be established in court. If the doc's treatment was within the standard of
care for cancer patients in general, i.e., was the same as the patient would
have received if there had been no protocol at all, then there is probably no
case. In this situation, the assault on the IRB is to get some issue before the
court where there was a breech of standard so the judge will get confused and
not dismiss the case.
If the treatment differs and an expert will say it was below the standard of
care, then there is malpractice. This would raise the issue of whether this IRB
supervision could have prevented the malpractice.
This is an interesting case because it raises the dark side of overly expansive
IRB reviews. I have seen a lot of discussion on the list about exempt research
and the like that indicates that some IRBs are extending their review to many
things that are clearly not covered by federal law. This has the risk of
creating a standard of review issue for the courts, i.e., you extend the
government's definition of research by your own practices, then the plaintiffs
hammer you for improper review. Worse, they then use your expansive definition
of research to hammer other IRBs for not conducting proper review. In this
situation it is no defense to say that you complied with the federal regs - the
courts regards such regs as a floor, not a ceiling, and are perfectly happy to
use more stringent standards if the plaintiff can show that some IRBs review
things that the government does not include.
Edward P. Richards, J.D., M.P.H.
Owner - LAWPROF (Registered Service Mark) List
Owner - HEALTHLAW-L
Professor - UMKC Law School
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
4/16/2000 7:23:00 AM
Is Informed Consent Required?
In our institution, this is considered covered by the preadmission
statement, does not require a consent and is given expedited approval.
These are considered a separate group we refer to as retrospective chart
reviews. If, however, they will be collecting this data prospectively (on
patients not yet admitted) then consent is required and it is regarded as a
full study.
-----Original Message-----
From: Paul Sesin [mailto:sesinp@southcoast.org]
Sent: Friday, April 14, 2000 12:58 PM
To: mcwirb@mcwirb.org
Subject: Is Informed Consent Required?
We have recently received a request by nursing personnel to become part of a
program entitled,Healthcare Partnership which is being sponsored by Merck
Pharmaceuticals. The study will have no patient identifiers and is
requesting
info such as Total Chlosterol, BP, Blood Glucose, and which cardiovascular
meds
was the patient on during their in-patient admission. My question is
whether
or not the supplying of this info to Merck is covered by the overall boiler
plate informed consent signed by all in-patients OR if the patients need to
give verbal or written informed consent. There are no financial incentives
connected with the collecting of this data. Thank you for your help.
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Joan
4/15/2000 8:36:00 AM
When reviewing for annual renewal we do not send out the protocol, however,
all of my members do get the annual renewal form, the informed consent
currently being used, and if we see an amendment that gets distributed as
well. Because I have a system of assigning items to committee members, I
will offer to provide the protocol to the reviewer if he or she feels the
need to refresh their memory. I usually take a copy of the protocol to
the IRB meeting just in case.
Hope this helps.
Susie Hayes
mphis.edu> cc:
Sent by: Subject: continuing review
mcwirb-admin@mcwir
b.org
04/13/00 03:05 PM
Please respond to
mcwirb
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
dhunsaker@iasishealthcare.com
4/15/2000 8:40:00 AM
Hi all
I shall weigh in here. Should the IRB re-review the protocol itself during
the continuing review?
answer: It depends.
How big is the workload?
Is it likely that it will be remembered?
How much contact has there been during the review period?
What kinds of study is it? Phase I or focus group?
Is it the kind of study that would change rapidly or very slowly if at all?
Were I to argue for it, I would argue that we should aak that the PI submit
the protocol. We should not dig it out. That way -- just as with asking
for the consent form being used -- we can double-check on what version the
PI thinks is current.
Were I to argue against it, I would argue primarily for the sake of trees,
common sense, and anti-bureaucracy. The IRB should have a good CR form.
It should give lots of info for the reviewers. If anything seems weird,
the IRB always retains the right to ask for more information.
I would think that periodically the IRB should want to have an update
just to bring all the bits and pieces of paper together again.
Erica
Erica Heath
President, IRC
415-485-0717
heath
4/15/2000 8:34:00 AM
On Thursday, April 13, 2000 5:06 PM, Susie Hayes
[SMTP:slhayes@msuvx2.memphis.edu] wrote:
> 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
With their continuing review application, we require PIs to submit a copy of
their *current* protocol, which we compare to the one we have on file.
Roger Bertholf
Chair, IRB-03
University of Florida
Roger
4/14/2000 12:35:00 PM
In the Jan. 10, 1995 Dear Colleague letter OPRR advisees that at
continuing review
the IRB should review, at a minimum, the protocol and any
amendments as well as a status report on the progress of the research,
including (a) the number of subjects accrued; (b) a description of any:
adverse events or unanticipated problems involving risks to subjects or
others, withdrawal of subjects from the research, or complaints about the
research; a summary of any recent literature, findings, or other relevant
information, especially information about risks associated with the
research; and (d) a copy of the current informed consent document.
They also allow primary reviewer mechanisms.
Having said that, I have been told by OPRR people that each IRB should
determine what it needs to see at
continuing review and the Dear Colleague letter is only a recommendation. I
work with two IRBs, and at
continuing review one looks at protocols and one does not.
David Borasky
Family Health International
Protection of Human Subjects Committee
Phone: (919) 405-1445
FAX: (919) 544-7261
www.fhi.org
David Borasky
4/14/2000 12:33:00 PM
Sharla Weatherall wrote:
> It is not necessary to supply a copy of the protocol to the members. The protocol itself has already been approved. The main concern when reviewing the studies is as to whether the benefits still outweigh the risks to the patient and as to whether the information is still needed in the study (ie. are there still active patients or is the study still open to new patients).>>
That may be dangerous advice, at least if you care what OPRR thinks of
your procedures. They have been on record at least since 1995 as
expecting the IRB to review at a minimum, the protocol and any
amendments as well as a status report on the progress of the
research... OPRR does acknowledge that primary reviewer systems may be
used, so long as all members receive a complete progress report and
consent form, with the primary reviewers reviewing the complete
protocol including any modifications...
For those of you only beholden to the FDA, they don't seem to be quite
as specific to the need for review of full protocol (per FDA Info
Sheets), but clearly expect review of both progress to date and changes
in the study... which may be tough to do without something resembling a
protocol.
Regardless of who receives exactly which documents, I believe the spirit
and the letter of the regs suggest that continuing review be
substantive and meaningful (again quoting OPRR), in a way that goes
beyond that described above.
Daniel K. Nelson, Director, Human Research Studies
Research Associate Professor of Pediatrics and Social Medicine
University of North Carolina-Chapel Hill
Chapel Hill, NC 27599-7097
Phone: 919-966-1344
fax: 919-966-7879
e-mail: dnelson@med.unc.edu
Daniel Nelson
4/14/2000 12:35:00 PM
Debbie Hunsaker asked if approval at one IRB for a given patient would
cover research done after the patient moved to a second institution.
Does the second institution have an MPA? Does the MPA state that the second
IRB will be responsible for ALL human research done there? If second IRB is
responsible, it would seem prudent to review that for which you will be held
responsible. I see nothing wrong in reviewing the records of the first IRB,
if they'll share them.
The fact that the protocol is closed to new accrual is irrelevant as best I
can tell.
Ron Low
SUNY Downstate
----- Original Message -----
From:
To:
Sent: Thursday, April 13, 2000 1:48 PM
Subject: Second Institution
> I have a question regarding the possibility of a subject entering a second
> institution. A patient has been enrolled at an approved (by another IRB)
> site, but will not be receiving study drug until she delivers her baby.
> Because of insurance reasons she is being transferred to another
> institution (which is not a part of the study). This study is now closed
> to enrollment.
>
> My question is, does this study need full board review by the receiving
> institution, or can we use the FDA guidelines for entering a second
> institution and allow the study article to be given at the receiving
> institution and have the P.I. at the approved institution to remain
> responsible for the test drug administration and gathering of data.
>
> This may change the picture, but the P.I. at the approved institution
would
> be the same at the receiving hospital. In other words, he is the
patient's
> personal physician and the P.I.
>
> Thanks in advance for your input.
>
> Debbie Hunsaker
> IRB Coordinator
> SLRMC
> dhunsaker@iasishealthcare.com
>
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Philip Low
4/14/2000 12:35:00 PM
HHS vs. FDA (was RE: I would like to know what policies... )
At 3:59 PM -0400 4/13/00, Kenneth Malcolm wrote:
>The situation is less clear, I think, when the HHS regulations are more
>stringent. My understanding is that instititutions with an MPA agree to
>conduct ALL research in compliance with the conditions of the MPA. OPRR's
>IRB Guidebook states under Assurance: An institution involved in
>biomedical or behavioral research should have in place a set of principles
>and guidelines that govern the institution, its faculty, and staff, in the
>discharge of its responsibilities for protecting the rights and welfare of
>human subjects taking part in research conducted at, or sponsored by, the
>institution, REGARDLESS (emphasis added) of the source of funding.
>
>Anyone know if that is correct?
i asked Gary Ellis about this. he told me that all but 5 institutions (who
are free to identify themselves here, if known) of the 400ish MPAs limited
their contractual obligations to only comply for federally funded research.
legally, that is the extent of OPRR's authority, so the lawyers for these
institutions were probably just playing hard ball, letter of the law stuff,
instead of ethics.
now, do these 5 institutions REALLY overlook compliance if a protocol is
not federally funded or fall under FDA regs? I hope not...
jon merz
center for bioethics
university of pennsylvania
merz@mail.med.upenn.edu
Jon Merz
4/14/2000 3:19:00 AM
At 01:42 PM 4/13/00 -0500, you wrote:
>I'm interested in learning how many institutions have IRB Adminsitrators who
>are voting members of the IRB. At our institution, I serve as a non-voting
>member. If your IRB Administrator is a voting member, what was the reasoning
>behind this? If not, why not? Pros and cons?
Our Administrator is a voting member. This has to do with 1) credibility
in the eyes of the community and 2) a recognition of the individual's a)
knowledge about research ethics and regulation and b) concern about the
welfare of human subjects (not just pushing paper).
Joel E. Frader, M.D.
Program in Medical Ethics and Humanities
Northwestern University Medical School
General Academic Pediatrics
Children's Memorial Hospital
Mailing Address: Phone:(773) 880-8361 (CMH)
General Academic Pediatrics Fax: (773) 281-4237
Children's Memorial Hospital email: j-frader@nwu.edu
2300 Children's Plaza, #16
Chicago, IL 60614
Joel Frader, M.D.
4/14/2000 3:22:00 AM
Our IRB Administrator serves as an Alternate for either of our two
non-scientific members. Her primary role at IRB meetings is usually to
take the minutes and keep all of the amendments to amendments to motions
straight. Having served that role myself in other organizations, I'm not
convinced that cognitive timesharing allows the minutes-taker to adequately
consider merits of the issues under discussion. The argument for having
the Administrator as a non-science Alternate is that it has almost
completely eliminated our quorum problems. If she were to be a non-science
voting member, it would increase our quorum requirement by one.
Mike Kelly
Georgia Tech
At 01:42 PM 4/13/2000 -0500, Deborah Barnard wrote:
>I'm interested in learning how many institutions have IRB Adminsitrators who
>are voting members of the IRB.
Mike Kelly
4/14/2000 12:35:00 PM
When we receive a renewal of an application for studies that we can
expedite, we pull the original file, attach copies of all approved IRB
applications and any approved modifications, etc. and supply the chair with
that information along with the renewal form and any attachments. For full
board renewals, a copy of the entire history is given to the primary
reviewer before the meeting so they can review the history before we
discuss it at our meetings. k.
>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
Kate M. Keever
Administrator, Human Subject's Protection Office
Behavioral and Health Sciences Institutional Review Boards
University of Michigan, Office of the Vice President for Research
1040 Fleming Administration Bldg., Ann Arbor, MI 48109-1340
Phone: 734-936-0933~~Fax: 734-647-9084~~e-mail: keever@umich.edu
Web address:
http://www.irb.research.umich.edu
We must be the change we wish to see in the world.
--Audre Lorde--
Kate Keever
4/14/2000 12:35:00 PM
In the Jan. 10, 1995 Dear Colleague letter OPRR advisees that at
continuing review
the IRB should review, at a minimum, the protocol and any
amendments as well as a status report on the progress of the research,
including (a) the number of subjects accrued; (b) a description of any:
adverse events or unanticipated problems involving risks to subjects or
others, withdrawal of subjects from the research, or complaints about the
research; a summary of any recent literature, findings, or other relevant
information, especially information about risks associated with the
research; and (d) a copy of the current informed consent document.
They also allow primary reviewer mechanisms.
Having said that, I have been told by OPRR people that each IRB should
determine what it needs to see at
continuing review and the Dear Colleague letter is only a recommendation. I
work with two IRBs, and at
continuing review one looks at protocols and one does not.
David Borasky
Family Health International
Protection of Human Subjects Committee
Phone: (919) 405-1445
FAX: (919) 544-7261
www.fhi.org
David Borasky
4/14/2000 12:35:00 PM
DSMB: How much is enough?
Robert Nelson wrote:
> To my knowledge, the only written guidelines on DSMBs is the National Cancer Institute's recommendation for a DSMB in a multi-institutional study...... One could argue that clear guidelines for the establishment and reporting of DSMBs (to IRBs) would make sense, rather than the individual reporting of serious and unexpected adverse events that inundate IRBs with a anecdotes that are difficult to interpret.>>
skip:
one could, indeed, argue that... and many of us do! thankfully, i think
some of these arguments are starting to be heard. the attention drawn
to deficiencies in the current system for AE reporting and assessment
(by gelsinger, et al) should go even further to giving us (IRBs)
something we can actually use in a meaningful way.
>> I am not aware that any such guideline exists or is in development, nor that the IRB is under any obligation to ask for or get these reports. Anyone have any information on this question?>>>
following are two NIH-wide policies (i.e. not restricted to NCI, to my
understanding) that address (1) data and safety monitoring and (2)
provision of DSMB reports to IRBs:
NIH POLICY FOR DATA AND SAFETY MONITORING (release date june 10, 1998)
GUIDANCE ON REPORTING ADVERSE EVENTS TO INSTITUTIONAL REVIEW BOARDS FOR
NIH-SUPPORTED MULTICENTER CLINICAL TRIALS (release date june 11, 1999)
... or are these what you were referring to as NCI guidelines?
dan
Daniel K. Nelson, Director, Human Research Studies
Research Associate Professor of Pediatrics and Social Medicine
University of North Carolina-Chapel Hill
Chapel Hill, NC 27599-7097
Phone: 919-966-1344
fax: 919-966-7879
e-mail: dnelson@med.unc.edu
Daniel Nelson
4/14/2000 12:41:00 PM
I have a question regarding the possibility of a subject entering a second
institution. A patient has been enrolled at an approved (by another IRB)
site, but will not be receiving study drug until she delivers her baby.
Because of insurance reasons she is being transferred to another
institution (which is not a part of the study). This study is now closed
to enrollment.
My question is, does this study need full board review by the receiving
institution, or can we use the FDA guidelines for entering a second
institution and allow the study article to be given at the receiving
institution and have the P.I. at the approved institution to remain
responsible for the test drug administration and gathering of data.
This may change the picture, but the P.I. at the approved institution would
be the same at the receiving hospital. In other words, he is the patient's
personal physician and the P.I.
Thanks in advance for your input.
Debbie Hunsaker
IRB Coordinator
SLRMC
dhunsaker@iasishealthcare.com
dhunsaker@iasishealthcare.com
4/14/2000 12:35:00 PM
HHS vs. FDA (was RE: I would like to know what policies... )
Clark, Elisabeth wrote:
>Gayatri implies that if there is no relationship with HHS then the MPA
>standards might not apply. How can an IRB permit two sets of standards to
>exist to govern review of research within the same committee, depending on
>sponsorship?
In fact, two sets of standards do apply, 21 CFR for research regulated by FDA and 45 CFR for research conducted under an MPA. These two sections of the CRF are very similar but there are differences in both the regulations themselves and in the agencies' intrepretations of them even when they are the same.
>Secondly, I caution that evidence of HHS support of a given research
>project is not always overt. Arrangements can exist between industry
>sponsors and HHS deemed sufficient to amount to actual HHS support of the
>study.
True, but in this case the FDA regulations are more stringent and should be followed if they are applicable to the study under discussion.
The situation is less clear, I think, when the HHS regulations are more stringent. My understanding is that instititutions with an MPA agree to conduct ALL research in compliance with the conditions of the MPA. OPRR's IRB Guidebook states under Assurance: An institution involved in biomedical or behavioral research should have in place a set of principles and guidelines that govern the institution, its faculty, and staff, in the discharge of its responsibilities for protecting the rights and welfare of human subjects taking part in research conducted at, or sponsored by, the institution, REGARDLESS (emphasis added) of the source of funding.
Anyone know if that is correct?
Kenneth Malcolm, MS, RAC
Kenneth Malcolm
4/14/2000 12:35:00 PM
Deborah,
I just did such a survey on this list. The results were 50-50. Often the reason
the IRB Administrator is not a voting member was conflict of interest. For those
IRB administrators who are voting members is to facilitate a quorum and/or to be
able to do some of the reviews and approve minor changes. In my case, I am a
voting member to relieve the committee of the approval of minor changes.
Ruth
Ruth Tallman
Lehigh University
rt01@lehigh.edu
610-758-3024
Deborah Barnard wrote:
> I'm interested in learning how many institutions have IRB Adminsitrators who
> are voting members of the IRB. At our institution, I serve as a non-voting
> member. If your IRB Administrator is a voting member, what was the reasoning
> behind this? If not, why not? Pros and cons?
>
> Thanks.
>
> ps - Don't forget to register for the OPRR/FDA Conference in Chicago, June 8th
> and 9th!!!!!!
>
> Deborah Barnard, CCRC
> Senior IRB Administrator
> Rush-Presbyterian-St. Luke's Medical Center
> Chicago, IL 60612
> 312-942-5498
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Ruth Tallman
4/14/2000 12:41:00 PM
I serve as a voting member (non-science) of our IRB. The thought behind
this was to establish continuity to the committee. Faculty are appointed
for a three-year term (staggering terms) and my role allows me to advise the
committee on past procedures and interpretations.
Debbie Comeaux, Compliance Specialist
Committee for the Protection of Human Subjects
University of Houston
Division of Research
Houston, TX 77204-2163
(713) 743-9215
-----Original Message-----
From: Deborah Barnard [mailto:Deborah_L_Barnard@rush.edu]
Sent: Thursday, April 13, 2000 1:42 PM
To: mcwirb@mcwirb.org
Subject: Voting Member or Not?
I'm interested in learning how many institutions have IRB
Adminsitrators who
are voting members of the IRB. At our institution, I serve
as a non-voting
member. If your IRB Administrator is a voting member, what
was the reasoning
behind this? If not, why not? Pros and cons?
Thanks.
ps - Don't forget to register for the OPRR/FDA Conference in
Chicago, June 8th
and 9th!!!!!!
Deborah Barnard, CCRC
Senior IRB Administrator
Rush-Presbyterian-St. Luke's Medical Center
Chicago, IL 60612
312-942-5498
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Debra Comeaux
4/14/2000 3:27:00 AM
HHS vs. FDA (was RE: I would like to know what policies... )
My understanding of 45 CFR 103(b)(1) is that it allows institutions to review
non-federally funded research under standards that protect human research
subjects but that do not necessarily comply with the specific requirements of
the common rule (e.g., minimum 5 members; continuing review at exactly 1 year
or earlier, etc.). It wouldn't, however, allow no review at all.
My reading of section 103 is that in addition to the statement of principles
governing the institution in the discharge of its responsibilities for
protecting the rights and welfare of human subjects... (45 CFR 103(b)(1)), the
institution is required to provide written procedures that it will follow in
its reviews (45 CFR 103 (b)(4)), which, in the case of non-federally funded
research (or, more specifically, research that does not fall under the Common
Rule), may be different from those followed for federally funded research.
I had always assumed that most if not all institutions follow the regulations
for all their human research, and the information Gary Ellis provided bears
this out.
Robin Levin Penslar
Ethics Review Officer
University of Toronto
(416) 946-3608
fax: (416) 946-5763
robin.penslar@utoronto.ca
Jon Merz wrote:
> At 3:59 PM -0400 4/13/00, Kenneth Malcolm wrote:
> >The situation is less clear, I think, when the HHS regulations are more
> >stringent. My understanding is that instititutions with an MPA agree to
> >conduct ALL research in compliance with the conditions of the MPA. OPRR's
> >IRB Guidebook states under Assurance: An institution involved in
> >biomedical or behavioral research should have in place a set of principles
> >and guidelines that govern the institution, its faculty, and staff, in the
> >discharge of its responsibilities for protecting the rights and welfare of
> >human subjects taking part in research conducted at, or sponsored by, the
> >institution, REGARDLESS (emphasis added) of the source of funding.
> >
> >Anyone know if that is correct?
>
> i asked Gary Ellis about this. he told me that all but 5 institutions (who
> are free to identify themselves here, if known) of the 400ish MPAs limited
> their contractual obligations to only comply for federally funded research.
>
> legally, that is the extent of OPRR's authority, so the lawyers for these
> institutions were probably just playing hard ball, letter of the law stuff,
> instead of ethics.
>
> now, do these 5 institutions REALLY overlook compliance if a protocol is
> not federally funded or fall under FDA regs? I hope not...
>
> jon merz
> center for bioethics
> university of pennsylvania
> merz@mail.med.upenn.edu
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Robin Penslar
4/14/2000 12:35:00 PM
Ethical Standards for Gene Therapy
FYI,
Jeff Cooper
ASGT Press Releases For Immediate Release
Contact: Elizabeth Dooley April 13, 2000
Ph. 414/278-1341
.American Society of Gene Therapy establishes ethical policy to guide
clinical trials
MILWAUKEE-The Board of Directors of the American Society of Gene Therapy
(ASGT) has approved a policy for ethical standards involving gene
therapy clinical studies. The policy, which was developed by the Ethics
Committee of ASGT, will help ensure the safety of all patients
participating in gene transfer studies and that researchers involved in
clinical studies are free from financial conflicts of interest. Members
of the Society have been notified of the new policy.
According to ASGT president, Savio L. C. Woo, Ph.D., This policy is a
significant step forward in addressing the safety and interests of the
many patients who volunteer in such trials. Patients should know that
investigators have their best interest in mind, are practicing in an
objective manner and are not in any way influenced by financial
incentives.
Potential conflicts of interest may arise in the course of all clinical
research, including gene therapy. In principle, the ethical standards
for clinical reserch in gene therapy should be the same as those
demanded in all areas of medicine. Therapeutic agents used in clinical
trials are often produced by for-profit companies, which can give rise
to circumstances that present a financial conflict of interest to the
investigators. An extreme case would be that a clinical reagent, be it a
small molecule, a protein or a gene transfer vector, that is
manufactured by a company wholly or partly owned by the Principal
Investigator conducting the clinical trial. The guiding principle is
clear: clinical investigators must be able to design and carry out
clinical research studies in an objective and unbiased manner, free from
conflicts caused by significant financial involvement with the
commercial sponsors of the study.
Clinical trials are often sponsored by industry, where legitimate costs
in conducting the research are covered. The Regulations on Objectivity
in Research and the Investigator Financial Disclosure Policy adopted by
the National Institutes of Health and the National Science Foundation on
July 3, 1996 have established that: Investigators are required to
disclose to the institution a listing of Significant Financial Interests
(and those of his/her spouse and dependent children) that would
reasonably appear to be affected by the research proposed for funding by
the Public Health Services. The institution will review those
disclosures and determine whether any of the reported financial
interests could directly and significantly affect the design, conduct,
or reporting of the research and if so, the institution must report the
existence of such conflicting interests to the PHS Awarding Component
and act to protect PHS-funded research from bias due to the conflict of
interest. The same documents also established significant financial
interests as equity ownership in companies exceeding 5%, and/or
aggregate payments received from companies in excess of $10,000/year.
Academic institutions have also established policies governing
investigators' financial conflits of interest that are consistent with
these federal regulations.
The American Society of Gene Therapy is not a regulatory body and it
should beware of becoming one. However, in order to pursue its mission
to promote gene therapy research and development, the following is the
statement approved by the Board of Directors: In Gene Therapy trials,
as in all other clinical trials, the best interest of the patients must
be always primary. International, national and institutional guidelines
on standards of care must be rigorously followed, approved protocols
strictly adhered to, serious adverse events promptly reported to all
appropriate regulatory and review bodies. Releva
Anonymous
4/14/2000 3:41:00 AM
Research Compliance Program
I would like to hear from the different institutions that have a research
compliance program . We are searching for information and guidance in
establishing a Research Compliance Office, and any information you can share
about how your institution went about accomplishing this important feat will
be greatly appreciated.
See the following questions for a starting point:
Number of FTE's?
To whom do the research compliance staff report?
What are research compliance staff responsible for monitoring, i.e. human or
animal protocols, radiation safety, etc.
Please offer any further information you may have on this subject. Send your
individual responses to pattilloaf@exchange.uams.edu
and I will summarize them for the listserver readership. Thank you!
Alma F. Pattillo, CIM
University of Arkansas for Medical Sciences
pattilloaf@exchange.uams.edu
4/14/2000 12:35:00 PM
Town Meeting at Cultural Diversity Workshop in Orlando
I posted information regarding this workshop on 3/23/00.
However, I was asked to inform those that are attending about a Town Meeting
with Dr. Marjorie Speers from the National Bioethics Advisory Commission
which will take place from 1:00 - 4:00pm on 5/3/00 at the Hotel Royal Plaza.
This information was not on the original conference agenda.
I was also asked to inform you that the hotel is about to close out its
block of rooms for the conference so if you are attending the conference you
might want to make your hotel reservations today.
If you have any questions, you can find more information at the USF link
below or call the University of South Florida CPE office at 813-974-4953.
Cultural Diversity in Clinical Research
May 3-5, 2000
Hotel Royal Plaza
Walt Disney World Resort
1905 Hotel Plaza Blvd.
P.O. Box 22203
Lake Buena Vista (Orlando), FL 32830-2203
This program is intended for IRB chairs, members, administrators,
researchers, members of the community and tribal leaders.
This workshop is sponsored by the University of South Florida College of
Medicine in collaboration with OPRR, Indian Health Service and the FDA and
in cooperation with Fisk University, Florida A&M University, Tuskegee
University National Center for Bioethics in Research and Health Care,
University of Florida, University of Miami and the Native American Nations:
Lower Muskogee Creek and the Seminole Tribe of Florida.
You can use this link to obtain further information.
http://cment.med.usf.edu/cpe/courses/brochures/diversity/index.html
Henry Zych
Division of Research Compliance
University of South Florida
Phone: (813) 974-7454
Fax: (813) 974-5618
E-mail: hzych@research.usf.edu
Campus Address -
MDC 35
12901 Bruce B. Downs Blvd.
Tampa, FL 33612
Location -
3500 E. Fletcher, Suite 518
Tampa, FL 33613
Henry Zych
4/14/2000 12:41:00 PM
HHS vs. FDA (was RE: I would like to know what policies... )
My understanding of 45 CFR 103(b)(1) is that it allows institutions to review
non-federally funded research under standards that protect human research
subjects but that do not necessarily comply with the specific requirements of
the common rule (e.g., minimum 5 members; continuing review at exactly 1 year
or earlier, etc.). It wouldn't, however, allow no review at all.
My reading of section 103 is that in addition to the statement of principles
governing the institution in the discharge of its responsibilities for
protecting the rights and welfare of human subjects... (45 CFR 103(b)(1)), the
institution is required to provide written procedures that it will follow in
its reviews (45 CFR 103 (b)(4)), which, in the case of non-federally funded
research (or, more specifically, research that does not fall under the Common
Rule), may be different from those followed for federally funded research.
I had always assumed that most if not all institutions follow the regulations
for all their human research, and the information Gary Ellis provided bears
this out.
Robin Levin Penslar
Ethics Review Officer
University of Toronto
(416) 946-3608
fax: (416) 946-5763
robin.penslar@utoronto.ca
Jon Merz wrote:
> At 3:59 PM -0400 4/13/00, Kenneth Malcolm wrote:
> >The situation is less clear, I think, when the HHS regulations are more
> >stringent. My understanding is that instititutions with an MPA agree to
> >conduct ALL research in compliance with the conditions of the MPA. OPRR's
> >IRB Guidebook states under Assurance: An institution involved in
> >biomedical or behavioral research should have in place a set of principles
> >and guidelines that govern the institution, its faculty, and staff, in the
> >discharge of its responsibilities for protecting the rights and welfare of
> >human subjects taking part in research conducted at, or sponsored by, the
> >institution, REGARDLESS (emphasis added) of the source of funding.
> >
> >Anyone know if that is correct?
>
> i asked Gary Ellis about this. he told me that all but 5 institutions (who
> are free to identify themselves here, if known) of the 400ish MPAs limited
> their contractual obligations to only comply for federally funded research.
>
> legally, that is the extent of OPRR's authority, so the lawyers for these
> institutions were probably just playing hard ball, letter of the law stuff,
> instead of ethics.
>
> now, do these 5 institutions REALLY overlook compliance if a protocol is
> not federally funded or fall under FDA regs? I hope not...
>
> jon merz
> center for bioethics
> university of pennsylvania
> merz@mail.med.upenn.edu
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Robin Penslar
4/14/2000 12:33:00 PM
I would like to know what policies others have adopted regarding the following:
Gayatri Choudhary wrote:
>An MPA is used for studies supported by HHS. I suspect if this study is
>sponsored by a pharmaceutical company, then probably the MPA is not
>applicable in this case.
Two comments about this interpretation of an MPA level of compliance.
My understanding of the purpose of an MPA is to establish a contractual
agreement between an institution and the HHS to state the institution's
committment to apply at minimum, the standards set out in the CFR and
provide assurance that these standards govern ethical review of research at
the institution, and influence the written working procedures of the on
site IRB(s).
Gayatri implies that if there is no relationship with HHS then the MPA
standards might not apply. How can an IRB permit two sets of standards to
exist to govern review of research within the same committee, depending on
sponsorship?
Secondly, I caution that evidence of HHS support of a given research
project is not always overt. Arrangements can exist between industry
sponsors and HHS deemed sufficient to amount to actual HHS support of the
study.
What you see is not always what you get.
Elisabeth Clark
Research Ethics Officer
McGill University Health Center
elisabeth clark
4/13/2000 8:05:00 AM
>
>As you allude, this particular situation will revolve around the question of
>why the treating physician chose this particular protocol to treat the
>child.
Caution. We need to be careful about use of the word protocol. It has
multiple meanings and this is a situation in which you really don't want to
mix them up.
A protocol can be a research protocol; a plan of action leading to a
scientific, quantifiable outcome.
A protocol can be a plan of action, accepted in some community, for the
treatment of an individual or similar individuals.
A protocol can also be who bows lower to whom or who sits closest to the
head table.
Erica
#################################
Erica Heath
IRC
PO Box 170 - San Anselmo CA 94979
Phone 415-485-0717
WEB www.irb-irc.com
#################################
heath
4/13/2000 11:54:00 AM
>
>As you allude, this particular situation will revolve around the question of
>why the treating physician chose this particular protocol to treat the
>child.
Caution. We need to be careful about use of the word protocol. It has
multiple meanings and this is a situation in which you really don't want to
mix them up.
A protocol can be a research protocol; a plan of action leading to a
scientific, quantifiable outcome.
A protocol can be a plan of action, accepted in some community, for the
treatment of an individual or similar individuals.
A protocol can also be who bows lower to whom or who sits closest to the
head table.
Erica
#################################
Erica Heath
IRC
PO Box 170 - San Anselmo CA 94979
Phone 415-485-0717
WEB www.irb-irc.com
#################################
heath
4/13/2000 11:56:00 AM
Lies, damned lies and statistics
Craig Weiner asked about IRBs reviewing the statistical model of a proposed
research project
We don't consider our IRB to be the primary scientific reviewers for
proposed studies. On the other hand, we are charged with evaluating all of
the risks and benefits involved. Usually, if the science is awful, then
there is no potential benefit of the study.
In actual practice, we comment on the science only if there's a real,
obvious problem. Usually, inexperienced investigators appreciate, at some
level, contructive suggestions.
Philip Low
4/13/2000 8:06:00 AM
I would like to know what policies others have adopted
Ron Low stated in a previous email:
>If companies have another reason for handing out cards, please enlighten
>me and we can continue the discussion
We have used wallet-sized diaries (for self-recorded study information such
as date/time of dosing) in some of our studies. In one case the cards were
coital diaries, and they were supposed to be small for issues related to
privacy - so the IRB was very interested in seeing the cards. Don't know if
that is what you meant by patient education.
David Borasky
Family Health International
Protection of Human Subjects Committee
Phone: (919) 405-1445
FAX: (919) 544-7261
www.fhi.org
David Borasky
4/13/2000 8:06:00 AM
I do not agree with this presumed consent! No human research can be done
without a written informed consent which is signed and dated by the patient
or a legal authorized representative of the patient. This clearly violates
the patients rights! A patients participation in a trial must be voluntary
and the patient can withdraw at any time. How can a patient volunteer or
withdraw if they are unaware that they are part of a study!?!?! Mailing a
letter to a patient is no guarantee that they have been informed! It is
also stated in the ICH guidelines that Records identifying a patient will
be kept confidential and, to the extent permitted by the applicable laws
and/or regulations, will not be made publicly available. I think this
situation should be investigated further!!!!
I also agree that the staff needs to be more aware of who they are giving
medical records to!
-----Original Message-----
From: Brian Childs [mailto:bchilds@shorehealth.org]
Sent: Thursday, April 13, 2000 9:39 AM
To: mcwirb@mcwirb.org
Subject: Presumed Consent
A physician reported the following event: One afternoon she found a person
going over one of her partner's patient charts in the medical office
kitchen.
The person was entering information on to a laptop. The physician (a two
person
IM/rheumatology practice) was told that the person with the charts was a
researcher authorized to review patient charts through a joint CDC and state
university medical school research project that got patient names from the
state registry of persons with a positive lime disease titer. The purpose of
the study was to find if there were any significant common sequelae and that
the entire chart was being examined for data. The physician asked if the
researcher had the consent of the patients and the person replied that there
were two avenues for consent: a letter was sent to each person (from public
health data since Lime Disease is a reportable disease)asking for consent.
If
there was no response to the first letter a second letter was sent informing
the patient that if they did not respond in the negative then consent to do
a
chart review was presumed. The physician was not comfortable with the
arrangment (with the research consent process and that her office staff did
not
talk to her or her partner before giving patient charts to a researcher, who
did, however, have credentials with CDC and Univesity representation)and
collected the charts and the researcher staff. A subsequent phone call to
the
university by the physician was made where the practice doctors requested
that
the research not be done with their patients without further information.
The
university researcher agreed not to send any other representatives to the
office.
What do you think of this story? Presumed consent? Need for more security
training of Primary Care Staff when confronted with 'authorizing
credentials'?
What else?
Brian H. Childs
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Heather
4/13/2000 11:59:00 AM
We have a situation which is beyond my scope as someone new to the field of IRB. I'm eager to find out the legal ramifications of the following scenario from those of you who are experienced and/or may have encountered such a situation:
A few years ago, before I was the IRB Administrator, one of our cancer PI's treated a child for cancer using commercially available treatments. His/her therapy was consistent with an arm of a research protocol for a cooperative group with whom we were not yet affiliated, with the exception of substituting dexamethazone (commercially avail) for prednisone (as recommended by the study arm). - CA docs reportedly have switched to dexamethazone because they felt it was superior to prednisone. -
The study to which the PI's therapy was similar is a study which was not open at our hospital (it could not have been, of course, because we were not yet affiliated with the cooperative group).
This case has been brought to court. The plaintiff states that there was not enough overview by IRB for this PI and that the PI should not have decided to use dexamethazone if it was not a standard therapy arm.
My feeling is that if all of the drugs were commercially available and the therapy was generally accepted as standard, then there was no research involved in this situation and it was not an IRB matter to begin with. Doesn't the doctor have the right to select the medication best suited for the patient as long as the drug is marketed for that purpose? Just because the treatment was similar to a cooperative study arm, doesn't mean that this PI was treating the patient as if he/she was a research subject, does it?
Thanks for your help!
**************************************************************************************
Leilani Price, M.S., Ph.D.
IRB Administrator
Cottage Health System
Post Office Box 689
Santa Barbara, CA 93102-0689
ph: 805-569-8323
fax: 805-569-7875
e-mail: lprice@cottagehealthsystem.org
web: http://www.cottagehealthsystem.org
*************************************************************************
Leilani Price
4/13/2000 11:56:00 AM
I would like to know what policies others have adopted
Jo Anne Bennett wrote to discuss whether wallet cards, handouts and
other items should be reviewed by the IRB.
I can think of only two reasons a company would go to the expense of
printing wallet cards, flyers, or anything else:
1) To recruit
2) Patient (and possibly, other health care workers) education
If recruitment/reward is the issue, then the IRB needs to review the
material to be sure it is not coercive, consistent with informed consent
guidelines, accurate....
If patient education and safety is an issue, then the IRB still needs to
review the document. (If your hair turns green as a result of htis
treatment, go imediately to the emergency department and tell them tao
call 800-12345678. If your hair turns purple, just apply Grecian
formula...) Does the card tell the ED personnel what kind of drug
the patient is taking and what kind of ADRs to expect? As an emergency
physician, I'm particularly interested in knowing if these information
cards include a 24/7/365 number for research projects involving
potentially serious ADRs. Many of the cards did not until we (the IRB)
required them.
If companies have another reason for handing out cards, please enlighten
me and we can continue the discussion
Ron Low
SUNY Downstate (Brooklyn)
Ronald Low
4/13/2000 8:06:00 AM
A physician reported the following event: One afternoon she found a person going over one of her partner's patient charts in the medical office kitchen. The person was entering information on to a laptop. The physician (a two person IM/rheumatology practice) was told that the person with the charts was a researcher authorized to review patient charts through a joint CDC and state university medical school research project that got patient names from the state registry of persons with a positive lyme disease titer. The purpose of the study was to find if there were any significant common sequelae and that the entire chart was being examined for data. The physician asked if the researcher had the consent of the patients and the person replied that there were two avenues for consent: a letter was sent to each person (from public health data since Lime Disease is a reportable disease)asking for consent. If there was no response to the first letter a second letter was sent informing the patient that if they did not respond in the negative then consent to do a chart review was presumed. The physician was not comfortable with the arrangment (with the research consent process and that her office staff did not talk to her or her partner before giving patient charts to a researcher, who did, however, have credentials with CDC and Univesity representation)and collected the charts and the researcher staff. A subsequent phone call to the university by the physician was made where the practice doctors requested that the research not be done with their patients without further information. The university researcher agreed not to send any other representatives to the office.
What do you think of this story? Presumed consent? Need for more security training of Primary Care Staff when confronted with 'authorizing credentials'? What else?
Brian H. Childs
Anonymous
4/13/2000 11:59:00 AM
Annual reports/block voting
We actually had a similar system in the past - however we worried that (1)we
were doing more than the regulations require, and (2) having the whole board
vote on expedited reviews could lead to a problem if the IRB decided not to
approve the already approved expedited review. We looked at 45CFR46.110(c)
which states that IRBs will adopt a method for keeping all members advised
of research proposals which have been approved under the procedure. We did
not interpret advise as vote because when they receive expedited review
they have been voted on. This is regardless of the nature of the expedited
review (continuing review, minor change, etc.).
Expedited reviews still appear in our agenda and minutes. The IRB
acknowledges them as a block, but does not vote on them. Occasionally a
member may have a comment or question about the review, but that's about it.
It helps that we're quite conservative in what we forward to the chair for
expedited review.
David Borasky
Family Health International
Protection of Human Subjects Committee
Phone: (919) 405-1445
FAX: (919) 544-7261
www.fhi.org
David Borasky
4/13/2000 8:09:00 AM
Annual reports/block voting
David Borasky stated, We looked at 45CFR46.110(c)which states that IRBs
will adopt a method for keeping all members advised of research proposals
which have been approved under the procedure.
Do most IRBs notify the members about expedited review decsions by using the
agenda and/or minutes? It appears so far that most IRBs do not require
ratification votes by the full board for expedited review. Am I correct in
this assumption?
Feel free to respond to me privately or via the list.
Evelyn Studer, IRB Administrator
Research Triangle Institute
PO Box 12194
Research Triangle Park, NC 27709-2194
919-541-6442
STUDER@rti.org
Evelyn Studer
4/13/2000 11:56:00 AM
Hindsight...It doesn't seem to have qualified as exempt?
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?
Anonymous
4/13/2000 11:25:00 AM
San Diego PRIM&R/AAMC Workshop Closed
I want to convey to list subscribers that registration for the May 12 SAN DIEGO PRIM&R/AAMC workshop on Effective IRBs: The Fundamentals is now CLOSED. We have hit our room capacity and unfortunately cannot admit any more individuals to that event.
On the other hand, the September 18 CHICAGO event is still OPEN.
For more information on registering for that event, please connect to: .
Many thanks for your understanding. If you have additional questions about registration, please direct them to Melissa Shaw at or 202-862-6103.
Allan Shipp
4/13/2000 11:56:00 AM
Documentation of IRB minutes
> It is important to indicate if the comments come from a voting member of
>the IRB, a non-voting member (e.g. the administrator of the IRB), or a
>visitor, such as a PI.
Why is it important?
Erica
#################################
Erica Heath
IRC
PO Box 170 - San Anselmo CA 94979
Phone 415-485-0717
WEB www.irb-irc.com
#################################
heath
4/13/2000 11:56:00 AM
It is not necessary to supply a copy of the protocol to the members. The
protocol itself has already been approved. The main concern when reviewing
the studies is as to whether the benefits still outweigh the risks to the
patient and as to whether the information is still needed in the study (ie.
are there still active patients or is the study still open to new patients).
Sharla Weatherall
Senior Regulatory Coordinator
US Oncology
ofc: 214-370-1810
fax: 214-370-1753
Sharla.Weatherall@USONCOLOGY.com
-----Original Message-----
From: Susie Hayes [mailto:slhayes@msuvx2.memphis.edu]
Sent: Thursday, April 13, 2000 4:06 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
Sharla D .
4/13/2000 12:32:00 PM
It is VERY common for physicians to treat patients according to drug dosing
programs that may be parts of study protocols elsewhere. It would take a very
careful look to decide if it constituted research in an individual case.
The question may well boil down to: Was the therapy given within the scope of
therapy generally accepted as reasonable for the condition the patient had? If
so, the use of a study group's protocol may have been nothing more than a handy
reference for dosing, scheduling, precautions in the use of the drugs the
physician was going to use anyway.
If the study group protocol represented a major shift from the ordinary way of
treating the patient, the issues could be more complex. That being said, the
regs (and common sense) give a practitioner a pretty broad discretion to use
licensed and approved drugs in novel ways to serve the best interests of an
individual patient. It takes more than that to meet the regulatory definition of
research.
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
4/13/2000 11:56:00 AM
Annual reports/block voting
>
>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?
>
Just curious..... Lots of other comments, I see, reached the same conclusion..
1. Why is the full board voting on them at all? Expedited review is to be
REPORTED to the full board.
2. What is the nature of the motion? Is the full board approval or
ratification of approval?
3. When is the approval effective?
Is it effective when the reviewer approves?
Is it effective when the approval letter is signed?
Is it effective when the full Board votes?
4. What is the effect of this question?
Cont review submission on June 2
Reviewer approves on June 4
Expiration date on June 5
Letter written on June 6
Full board vote on June 10.
When must the activity stop?
When can it start again?
4. Why use expedited review if a full board vote is still required?
Erica
#################################
Erica Heath
IRC
PO Box 170 - San Anselmo CA 94979
Phone 415-485-0717
WEB www.irb-irc.com
#################################
heath
4/13/2000 11:56:00 AM
|<
...
11 12 13 14 15 16 17 18 19 20
...
>|
Pages: 17 of 200