I think you are right on point here, and are not blowing this out of proportion. Our IRB had a problem with the canned language used by one of the regional oncology groups in their consent forms, saying that the tissue might be used to generate profits for the group and that the subject was consenting to that use. We asked to add language merely saying that the subject would not necessarily be given any of the profits (or explaining what part of the proceeds they WOULD be getting).
The group's lawyers objected to that added statement, saying that the subject would then be improperly waiving a right--effectively, making exactly your point! (By the way, Q. 52 on page 14 of the FDA information sheets seems to specifically resolve this issue, saying this would be an improper waiver.) So we then asked for language stating that the group, before using the tissue, would need to reach an agreement with the subject about what portion of the proceeds from the use of the tissue would go to the subject. We were never able to get the group to agree to any such language.
I don't see how, if we really buy the requirement that there cannot be a waiver, it is not always the case that any consent to use of tissue for commercial purposes clause is always conditioned by a requirement that the researchers must, before such actual commercial use, come back to the subjects and negotiate a profit sharing agreement. And that requirement should be laid out in the consent form, so that the subjects can be savvy enough to be on the lookout for such use.
It would be nice if OPRR and FDA said something about this issue that helped back up IRBs in requiring such consent form language. This is becoming a very common issue.
Jerry Menikoff
University of Kansas
Jerry Menikoff
4/25/2000 8:08:00 AM
I also agree that you are not blowing this out of proportion and should
stand your ground. I got so fed up with the legal departments of many large
research institutions trying to compel subjects in studies that came
before our board to give up their future rights and entitlements related to
tissue samples, that I took a number of evenings away from family and
friends to research the topic on my own about six months ago. My six year
old quickly figured out how guilty I felt over that and worked me for a
couple weeks because of it but that's another story. Anyway I compiled what
I found and presented it as a paper in the Bioethics Section of the American
Public Health Association meetings last November titled Commercial Aspects
of Genetic Ownership. I have it on file if you want a copy to refer to.
It's rough but has some decent references to assist you. The essence of it
was that sequential consenting is the minimal option I prefer at this time,
but that commercialization, patenting and ownership rights of genetic
materials together comprise one of the most important legal questions for
the 21st century. Equity and justice are Belmont principles that could be
used as springboards to further discussion in this area. And I also agree
that it would be nice to get some official guidance but I believe that
perhaps that would be an area the National Bioethics Advisory Commission
(NBAC) might want (or need) to tackle.
Daniel R. Vasgird, PhD
Office of Research Compliance
Research Foundation of CUNY
30 West Broadway, 11th Floor
New York, NY 10007
Ph: 212-4178485
Fax: 212-4178479
email: Daniel_Vasgird@rfcuny.org
Daniel
4/25/2000 1:02:00 PM
> That the journal did not require the details of this
> important information is quite remarkable.
Actually, it's pretty common for journals to require that authors certify
compliance with Helsinki and/or certify that IRB review has been obtained,
without requiring that the certification appear within the text of the
manuscript.
That has been our practice at J. Lab. Clin. Med. for many years. However, we're
beginning to drift toward the put-it-in-the-text camp, for a couple reasons.
First, we only retain correspondence for three years. If a question comes up
after three years, we cannot reconstruct what the author certified to us.
Second, there's the semantic guerilla warfare position: it may be a good thing
to keep before the science writing and science reading public the concept that
oversight is an ordinary and expected part of doing things right. Third, as this
particular example shows, there are circumstances where the ethical aspects of
research were particularly important or problematic, and they should then be
part of the Methods and Discussion sections of the manuscript.
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
4/25/2000 4:06:00 AM
Jon Merz wrote:
>I believe the stated language is not a waiver. It is stating a fact. The
>approach you have taken is closer to that promoted by OPRR, that is, to
>state that the institution has no intent to create any prospective
>interests in potential commercial products.
There is an underlying substantive issue here, an important one, and it appears less to do with whether or not there is a waiver (at least in terms of legal categories), or even a disclosure of the intent of the researchers, but rather whether the subject is being asked to given up a legal right, in order to participate in the study, that they should not be permitted to be required to give up as a precondition to participating. The FDA, at least, perhaps seems to be saying this is not to be permitted, and I think that is a good call, given the disparity in bargaining power. Here is part of the FDA Q & A I earlier cited:
52. Is it acceptable for the consent document to say specimens are donated?
A. It would be acceptable for the consent to say that specimens are to be used for research purposes. However, the word donation implies abandonment of rights to the property. 21 CFR 50.20 prohibits requiring subjects to waive or appear to waive any rights as a condition for participation in the study.
This Q&A might be distinguishing between merely allowing the use of the tissue in research, and being required to allow uses beyond that (e.g., use in designing a commercial product.)
We can either (a) allow researchers to make commercial use of tissues, assuming they have informed subjects of that when they entered the study, or (b) not allow researchers to acquire that property right when the subject enters the study, and is unable to bargain about such rights--instead, the researchers would have to separately acquire such rights, independent of allowing the subject to be in the study.
There would, of course, under (b), be nothing wrong with the subject altruisitically giving up any profit interest--but that would have to be done as a separate decision on their part, not tied with their ability to participate in the study. The FDA is perhaps saying that interpretation (b) is indeed the law. I think it is a reasonable rule, yet, as Otwell Timmons's comment and our own experience demonstrates, this rule seems to be ignored.
Jerry Menikoff
University of Kansas
Jerry Menikoff
4/25/2000 9:29:00 AM
> That the journal did not require the details of this
> important information is quite remarkable.
Actually, it's pretty common for journals to require that authors certify
compliance with Helsinki and/or certify that IRB review has been obtained,
without requiring that the certification appear within the text of the
manuscript.
That has been our practice at J. Lab. Clin. Med. for many years. However, we're
beginning to drift toward the put-it-in-the-text camp, for a couple reasons.
First, we only retain correspondence for three years. If a question comes up
after three years, we cannot reconstruct what the author certified to us.
Second, there's the semantic guerilla warfare position: it may be a good thing
to keep before the science writing and science reading public the concept that
oversight is an ordinary and expected part of doing things right. Third, as this
particular example shows, there are circumstances where the ethical aspects of
research were particularly important or problematic, and they should then be
part of the Methods and Discussion sections of the manuscript.
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
4/25/2000 4:09:00 AM
Funding for National Cancer Trials - IRB Compensation
We waive IRB fees for these studies, also. There are no funds for IRB fees
for NCI studies, in fact, reimbursement is minimal for these studies and
does not pay labor costs for study coordinators or data managers who do the
studies.
> ----------
> From: Ginger French[SMTP:GFFrench@aol.com]
> Reply To: mcwirb@mcwirb.org
> Sent: Friday, April 21, 2000 7:41 PM
> To: mcwirb@mcwirb.org
> Subject: Funding for National Cancer Trials - IRB Compensation
>
> We handle a large number of cooperative cancer research trials. In the
> past we
> did not charge for any of the IRBs activities. Now we have a set fee for
> study
> review, approval, and oversight. We have not, however, been charging the
> cooperative cancer groups. There has been an implication that the funds
> are
> simply not there. With new directorship at the research institute, this
> has
> been brought into question. Can you tell me if any other institutions
> charge
> for overview of cooperative cancer research trials?
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
Vickie Zimmer
4/25/2000 8:09:00 AM
This is a multi-part message in MIME format.
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charset=iso-8859-1
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I am the PI of an NIH funded multicenter study on hemolytic uremic =
syndrome (HUS). The grant was submitted as an RFA and had a very tight =
budget. The study involves an in-patient phase of variable length =
depending on the clinical severity of the HUS and a 60 day follow-up =
phase. The investigators are asked to collect blood, urine, and stool =
samples, complete forms and respond to my incessant nagging abour =
what's happening. All of the investigators now receive $500 when they =
complete the entire set of CRFs and mail in the clinical samples to a =
Core Lab. Does receipt of this money make it unlawful to submit a =
regular physician's bill for services rendered? This could amount to =
several thousands of dollars especially in sick children who may need to =
hospitalized in an ICU and be dialyzed until they recover? Appreciate =
guidance on this question.
Thanks
Howard Trachtman
------=_NextPart_000_0079_01BFAED8.BC301560
Content-Type: text/html;
charset=iso-8859-1
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<!DOCTYPE HTML PUBLIC -//W3C//DTD W3 HTML//EN> I am the PI of an NIH funded =
multicenter study=20
on hemolytic uremic syndrome (HUS). The grant was submitted as an RFA =
and had a=20
very tight budget. The study involves an in-patient phase of variable =
length=20
depending on the clinical severity of the HUS and a 60 day follow-up =
phase. The=20
investigators are asked to collect blood, urine, and stool samples, =
complete=20
forms and respond to my incessant nagging abour what's happening. =
All of=20
the investigators now receive $500 when they complete the entire set of =
CRFs and=20
mail in the clinical samples to a Core Lab. Does receipt of this money =
make it=20
unlawful to submit a regular physician's bill for services rendered? =
This could=20
amount to several thousands of dollars especially in sick children who =
may need=20
to hospitalized in an ICU and be dialyzed until they recover? Appreciate =
guidance on this question. Thanks Howard Trachtman
------=_NextPart_000_0079_01BFAED8.BC301560--
Howard Trachtman
4/25/2000 12:46:00 PM
At 10:47 AM -0400 4/25/00, Timmons, Otwell wrote:
>A commercial sponsor plans to take blood and tumor samples for unspecified
>future testing, possibly genetic. Their sample consent contains the
>statement if a commercially viable product results from use of this
>specimen, you will not have any ownership rights of proceeds. We refused
>to allow that language; no informed consent, whether oral or written, may
>include any exculpatory language to which the subject or the
>representative is made to waive or appear to waive any of the subjects
>rights...... (FDA Info Sheets). We proposed language that states that
>no current arrangement exists that would allow a subject to share in any
>profit generated from the use of his or her sample. The sponsor refuses
>the change. Our local investigator asked me to pursue other approaches.
>
>Did we blow this out of proportion? Are we correct that the sponsor is
>asking subjects to waive a right? Should we stand our ground?
I believe the stated language is not a waiver. It is stating a fact. The
approach you have taken is closer to that promoted by OPRR, that is, to
state that the institution has no intent to create any prospective
interests in potential commercial products. I took issue with the intent
approach in a private email conversation, which I copy below:
>one problem with this formulation is that subjects have an absolute right
>to give away their tissues (or anything else, for that matter), under state
>law. saying that one who donates blood is giving it away and not retaining
>any ownership interest is not, to my mind, the equivalent (legal or moral)
>of saying they have waived or appeared to waive a legal right. Black's
>defines waiver to be the intentional, voluntary relinquishment of a known
>right. by giving a sample, subjects ipso facto have waived their
>possessory right; beyond that, there arguably (absent law, and Moore -
>issued by a very influential court - holds that there is no ownership right
>to donated tissue) is no legal right here to be waived.
>
>we would not say that a volunteer in research who is not being compensated
>for the time they will spend in the research has waived their right to be
>paid, would we? clearly, we may (and even should) say in the CF: you will
>not be paid for your time. is this a waiver? arguably not, because one
>cannot demand compensation unless there were some contractual (express or
>implied, or by promissory estoppel) claim for payment. but this is because
>there is no law, statutory or otherwise, that creates a right to
>compensation. if there's no right, there's no waiver.
>
>one other legal point: i believe that most courts would be clear that,
>unless the language of waiver appears, then no waiver in law is effected.
>that is, saying i have no right to ownership would not be considered by a
>court to be an effective waiver (assuming there is a legal right to be
>waived) unless i said i expressly waive any and all rights...
>i haven't examined this issue in many years, but can make
>numerous arguments why such an attempt at creating a waiver would
>be unenforceable. Thus, if the courts were to recognize a property
>right in the future, the consent form would not be an effective
>waiver of that right.
>
>the question, then, of appearance of waiver is more problematic. this is
>an empirical question about how potential subjects interpret the
>language...
if your IRB believes the language appears to be a waiver, then that may be
determinative, and you can stick by your guns. i think it is pure
semantics, and would all be legally (which is, after all, what is driving
the sponsor) irrelevant.
jon merz
center for bioethics
university of pennsylvania
merz@mail.med.upenn.edu
Jon Merz
4/25/2000 8:12:00 AM
Our experience is that informing a potential research participant of the
requirement for abuse reporting will not eliminate all chances for
enrollment. We have reviewed several studies of kids, parents, and
families at risk, studies of incarcerated kids, studies involving the
developmentally disabled and the elderly in residential care facilities, and
studies specifically about child abuse and neglect. We require the consent
forms for adults and assent forms for kids to clearly state that
abuse/neglect will be reported (as will threats of harm, communicable
disease, and other mandated reporting, when applicable to the specific
study).
Researchers have not reported that such requirements have hindered study
enrollment, or made the study unfeasible. One longitudinal study of
families at risk has reported incidents of abuse and neglect (multiple times
for many families)--and retention remains around 95% after nine years. Our
Board requires researchers (whether mandated reporters or not) to report
suspected child abuse/neglect and abuse/neglect of dependent adults, if the
study could potentially discover such occurrences. In-home interviews are a
prime example of how observation of the home environment could lead to
concerns of abuse/neglect, even if the family is not considered at risk.
The view that abuse reporting would make a study unfeasible seems to imply
that studies of at-risk families, drug abuse, parenting skills, poverty,
persons in nursing homes, etc., etc., could never be done at all. People
participate in research for a variety of reasons--I doubt that abuse
reporting is likely to be the one and only reason an individual would refuse
participation. And if he/refuses participation for that reason alone, at
least he/she was fully informed of the limits to confidentiality.
Maggie
Maggie Frederick, MPH
Review Coordinator
DSHS Human Research Review Section
P.O. Box 45205
Olympia, WA. 98504-5205
(360) 902-8075
FAX: (360) 902-0705
Email: fredem@dshs.wa.gov
> -----Original Message-----
> From: Strause, Linda [SMTP:linda.strause@icsltd.net]
> Sent: Monday, April 24, 2000 10:31 AM
> To: mcwirb@mcwirb.org
> Subject: RE: Reporting Adult Abuse
>
> I attended a NIH forum that discussed this exact issue and depending on
> the
> laws governing that state, an IRB cannot violate a state law. Although
> each
> local IRB can make an independent decision, it must be within the state
> laws. The example discussed was child abuse within the state of Calif.
> In
> California, it is a state law that if someone believes child abuse is
> occurring they must report it to the appropriate authorities. As a result
> the study under consideration was not implemented. Only by inserting
> language into the informed consent could such a study be approved and that
> action would eliminate all chances for enrollment.
>
> Linda Strause,Ph.D
> Chair, San Diego Hospice IRB
> Linda Strause, Ph.D.
> Vice Pres. Corporate Accounts
> tel: 858-509-3689
> fax: 858-509-9107
> email: linda.strause@icsltd.net
>
Maggie
4/24/2000 12:28:00 PM
Lies, damned lies and statistics
Our institution has a committee, separate from the IRB, that reviews
projects for scientific merit, including a well-written proposal, sample
size justification and planned data analysis section. They are an
advisory committee to the IRB, but the review & approval of both
committees is required before a project may begin. A biostatistician is a
member of the research advisory committee (no lie), with physicians being
the majority of members. The IRB is grateful for this review, as it is one
less thing they have to worry about. But, as you might guess,
investigators see it as another hoop to jump through, and express
resentment when their peers question the science of the project.
Dale E. Hammerschmidt on 04/21/2000 12:55:03
PM
Please respond to Dale E. Hammerschmidt
To: craig@the-most.com
cc: mcwirb@mcwirb.org(bcc: Nancy M
Buderer/SVMC/MHP/CHP)
Subject: Re: Lies, damned lies and statistics
Craig --
An excellent question. Bad science is unethical science. Poor statistical
techniques can result in risk exposure without reliable outcomes, or it can
result in more risk exposure than is necessary to answer the question.
My thought is that scientific merit review should be done on every project
before it comes to the IRB, and the IRB should look at methodology only in
the
narrow sense of its impact on risk/benefit balance.
In the real world, lots of projects don't have scientific merit review
before
they go to the IRB. And in the real world, the statistical end of merit
review
is often shorted. So the IRB may pretty often have before it a study in
which
the question you pose is a real one.
If the risks to subjects are substantial, we'll usually look to make sure
that
some thought has been given to statistical power and design. My formal
training
in statistics is limited to an undergraduate minor and a few later courses,
so
subtleties may whizz by. But if the PIs haven't even taken the trouble to
estimate needed sample size according to some reasonable assumptions about
possible outcomes, then they haven't done their job from a human subjects'
protection point of view.
Ideally, I think the role of the IRB should be to ensure that departments
know
that they have some responsibility to make sure that junk isn't submitted
to the
IRB. The IRB can also spot the lone cowboy investigator, and ask that
person
what peer review has taken place. Beat the drums for peer review of the
science.
But don't make it a major role of the IRB, because the IRB has enough on
its
plate already. Also, expertise is likely to be spotty --- if the IRB starts
doing scientific merit review in a serious way, it's going to have the
competence to do a good job in only a subset of protocols it sees.
I think this will continue to be one of those unresolvable tensions --- a
place
where human subjects' protections could be improved, but a place where the
IRB
is probably not able to work very directly
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)
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Nancy Buderer
4/24/2000 8:35:00 AM
Approval of Minutes by Members who were not in Attendance
We have some new blood on our Board, and one of them asked yesterday if it is appropriate for them to vote to approve the minutes of the previous meeting if they were not in attendance. (There is some concern about having a quorum to vote to approve the minutes, but we could always send out an approval request for signatures to members who were at the previous meeting and are not at the present one. -- The staff thinks this may be adding too much work.) Can you give me some guidance?
Anonymous
4/24/2000 11:58:00 AM
Approval of Minutes by Members who were not in Attendance
It is possible for the members who were not at the previous meeting to vote
present. Thus they are part of the quorum but have not voted to approve
minutes whose accuracy they are not in a position to ascribe to. Abstaining,
in the view of some, leaves them out of the quorum count. But that seems
to me to be carrying the matter too far. In any case, voting present
allows them unambiguously to be part of the quorum but not take a stand on
something they may not be comfortable with. In fact, the regulations don't
say anything about the type of vote to approve minutes. I think the business
of protecting subjects is where the majority of those present and eligible (
recusals are not presumably eligible) to vote on an IRB action related to
human subjects really matters.
Voting to approve minutes is not nonsubstantive. But it is more a procedural
formality than an IRB determination of consequence on the conduct of
research.
> -----Original Message-----
> From: Ginger French [SMTP:GFFrench@aol.com]
> Sent: Friday, April 21, 2000 9:46 PM
> To: mcwirb@mcwirb.org
> Subject: Approval of Minutes by Members who were not in Attendance
>
> We have some new blood on our Board, and one of them asked yesterday if
> it is
> appropriate for them to vote to approve the minutes of the previous
> meeting if
> they were not in attendance. (There is some concern about having a quorum
> to
> vote to approve the minutes, but we could always send out an approval
> request
> for signatures to members who were at the previous meeting and are not at
> the
> present one. -- The staff thinks this may be adding too much work.) Can
> you
> give me some guidance?
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Charles Od
4/24/2000 11:58:00 AM
National Wilm's Tumor Study
Hi all -
Our IRB is involved with the National Wilm's Tumor Study #5. Because so many different stratifications of tumor are eligible for subject enrollment, the study we are reviewing has evolved into 13 consent forms (depending upon the stage, tumor histology, etc.). Our IRB questions if it is against regulations for one protocol to have more than one consent form.
They have also asked me to see how other IRB's reviewing this study have handled the subject of participant diversity (for example: stage I/favorable hist; stage III/favorable hist; stage II-IV diffuse anaplasia, etc) and provided for practical informed consent. Originally, there was one consent form, but according to the PI it was far to cumbersome to provide appropriate informed consent when so much information within the single consent form was irrelevant to their particular study therapy.
So - if anyone has info on regulations regarding multiple consent forms per study or the Wilm's Tumor Study, I'd be thankful for your insights.
**************************************************************************************
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
4/24/2000 8:38:00 AM
RE: Reporting Adult Abuse
I attended a NIH forum that discussed this exact issue and depending on the
laws governing that state, an IRB cannot violate a state law. Although each
local IRB can make an independent decision, it must be within the state
laws. The example discussed was child abuse within the state of Calif. In
California, it is a state law that if someone believes child abuse is
occurring they must report it to the appropriate authorities. As a result
the study under consideration was not implemented. Only by inserting
language into the informed consent could such a study be approved and that
action would eliminate all chances for enrollment.
Linda Strause,Ph.D
Chair, San Diego Hospice IRB
Linda Strause, Ph.D.
Vice Pres. Corporate Accounts
tel: 858-509-3689
fax: 858-509-9107
email: linda.strause@icsltd.net
Linda
4/24/2000 11:38:00 AM
Would anyone be willing to engage in the following discussion:
-the pros and cons for placing a time limit (ex. 3 years from original approval) on approvals/continuations at which time a new application must be submitted and approved
If you prefer, you can send responses to me privately at tarwood@spa.msstate.edu.
Thanks!
Tracy
Tracy Smart Arwood
Regulatory Compliance Administrator
Mississippi State University
302 Bowen Hall
Mailstop 9564
662-325-3994
662-325-8776 fax
tarwood@spa.msstate.edu
Tracy Arwood
4/24/2000 8:55:00 AM
I am trying to find out if anyone has surveyed researchers regarding their
perceptions of/opinions about IRB functioning. A Medline search only
yielded a recent british study in the J Royal College Physicians London,
and an early '90s study from australia in social sci & med.
Any references or referrals much appreciated!
jon merz
center for bioethics
university of pennsylvania
merz@mail.med.upenn.edu
Jon Merz
4/24/2000 4:52:00 PM
Lies, damned lies and statistics
One of our member as asked how much effort should be put into reviewing
the statistical methods evaluating the data obtained in a research
protocol. A recent article in the oncology literature suggests that
many of the methods currently used are inappropriate or inadequate, and
may be subjecting patients to unnecessary risk. Does this then become
part of the evaluation of risk? Since our Board does not have a
statistician member, to do an indepth evaluation of this aspect of each
study would prove onerous, time consuming, and possibly costly? I'd
appreciate your thoughts.
Craig Weiner, MD
Chair
Mercy Healthcare Sacramento Regional IRB
Craig
4/24/2000 8:44:00 AM
Lies, damned lies and statistics
Maggie asks about science of no merit, but also no risk.
This is tricky (doubtless why she asked [gg]), and the appropriate answer may
depend on the details.
We've sometimes said no in this circumstance, because of societal risk. If the
research is likely to generate unreliable information that is likely to do
societal harm, that may be a risk the IRB should think about. The example I
specifically remember was an uncontrolled study of a (wack-birds IMHO) fringe
healing practice. Visions of claims: Found effective at a major Midwestern
university... danced through our heads. Our IRB decided that this was unethical
research because of that societal risk, and was only willing to approve a
controlled study.
Another circumstance to think about is the one in which the study creates
unconsenting research participants by altering the availability of some
resource. If you're tying up needed resources to do junk science, even if the
subjects bear no substantive risk, it can be wrong.
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
4/24/2000 8:44:00 AM
National Wilm's Tumor Study
Leilani_Price_wrote_to_ask_about_mulltiple_consent_forms_for_one_project
As_you_can_tell_,I'm_having_trouble_writing--I'll_keep_this_brief
The_PI_has_the_obligation_of_insuring_that_each_enrollee_has_given_real
informed_consent.__The_IRB_is_supposed_to_approve_this_process.__
Theoretically,_there's_no_reason_a_PI_couldn't_write_a_new_informed_
consent_form_for_each_subject,_if_a_PI_had_such_an_incliniation_and_
that_much_energy--and_the_IRB_wanted_to_review_that_many_forms.__The
obligation_is_to_insure_informed+connsent.
Ron__Low
Ronald Low
4/24/2000 8:38:00 AM
Non-Discriminatory Review by Study Classification
GFFrench@aol.com wrote:
>Our IRB Chair is under the impression that studies not specifically
funded so
>that they fall under OPRR oversight nor involving drugs or devices
under the
>purview of the FDA do NOT have to be reviewed with the Common Rule
guidelines.
>I strongly disagree. He reminds members nearly every meeting if
the study
>in question does not fall into the above categories. Can you give me
some
>guidance on this?
Hi,
I presume your institution has negotiated a Multiple Project Assurance
with OPRR. Review it carefully. It generally stipulates that the
institution will adhere to the provisions of the Common Rule,
irrespective of the source of funding for research.
I'm curious. In what respect does your Committee's review process
change when the research application at hand does not involve federal
funds ? What is the practical import of this distinction at your
institution ?
Regards,
Howard Mann, M.D.
Howard Mann
4/22/2000 5:45:00 AM
> Our research provides no definitive answers. Massachusetts
> law does not name
> researchers in lists of those who must report instances of
> child, elderly
> or patient abuse.
Anyone involved in the study a physician or nurse? How about on the IRB? I do
not know Mass law, but in many states the law says health care providers, and it
does not say persons who are personally providing health care to the patients.
If health care providers have to report - and this includes communicable
diseases, child abuse, violent injuries, and other reportable conditions - then
I think your researchers who are health care providers are probably under the
law. The IRB folks would only be at issue if they see the files where
individuals are identified as abused. If it is even close, I would invite the
local district attorney (head prosecutor) to talk with you (and your lawyer,
perhaps) about what he/she things the law means. You would also have some tort
risk if you fail to report and the research subject is later injured or killed.
Ed
Edward P. Richards
Center for Public Health Law
Professor - UMKC Law School
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
4/22/2000 5:47:00 AM
Non-Discriminatory Review by Study Classification
To answer Howard's questions, we really do not deal any differently with a
study funded in one way than in another. Our CPA does read in such a manner,
as well as the SPAs we occasionally use, that all research is reviewed under
the Common Rule. Unfortunately, it is not worded that explicitly, and the
Chair either cannot or refuses to read in the implications. Unfortunately,
the CPA was just renewed or we would reword it so there would be no question.
(In our minds there is none, but when we get picky over items we think
should be in, for instance, a privately funded study's consent, there is
frequently a voice saying, But this study doesn't fall under those
guidelines. And it is the voice of our Chair.)
Ginger
Ginger French
4/22/2000 5:44:00 AM
Non-Discriminatory Review by Study Classification
I take it you are not operating under an MPA. If not, the chair is correct,
but you can be both right and wrong. It is my belief that most institutions
operating under an SPA for federal research and those who have IRB-like
bodies but do not do any federally related research do follow the federal
guidelines. The reasons include: 1) the federal guidelines are well
thought out and complete; 2) why re-invent the wheel?; 3) the federal rules
are something of a standard of care, so abiding by them does provide
liability protection.
I would ask some questions of the chair: If you are going to operate under
a different set of rules for some research, what are those rules? Moreover,
what is to be gained by using a second, assumedly lesser, standard for this
non-federal research? Finally, you can play the newspaper trump card-if
something happens in one of these studies, does he really want to read in
the newspaper about how his institution used a lesser set of standards than
most everyone else?
Usually, one of these will sway him. If not, you can try going to whoever
in administration is in charge of the IRB and attempt to get the use of the
federal guidelines for all research an institutional policy.
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.
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of
Ginger French
Sent: Friday, April 21, 2000 6:19 PM
To: mcwirb@mcwirb.org
Subject: Non-Discriminatory Review by Study Classification
Our IRB Chair is under the impression that studies not specifically funded
so
that they fall under OPRR oversight nor involving drugs or devices under the
purview of the FDA do NOT have to be reviewed with the Common Rule
guidelines.
I strongly disagree. He reminds members nearly every meeting if the
study
in question does not fall into the above categories. Can you give me some
guidance on this?
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Daniel L . Icenogle
4/22/2000 5:50:00 AM
Christy,
Get a copy of the Human Research Reports for April 2000, and read the OPRR
column on page 11. It very clearly answers your question. You cannot
approve a study more than 30 days before the previous approval date runs out
and keep that day of the year as the approval date. You either need to renew
your approval within 30 days before expiration or change the date on which
the study approval will expire.
Ginger French, Pharm.D.
Ginger French
4/22/2000 5:47:00 AM
Non-Discriminatory Review by Study Classification
Our IRB Chair is under the impression that studies not specifically funded so that they fall under OPRR oversight nor involving drugs or devices under the purview of the FDA do NOT have to be reviewed with the Common Rule guidelines. I strongly disagree. He reminds members nearly every meeting if the study in question does not fall into the above categories. Can you give me some guidance on this?
Anonymous
4/22/2000 5:50:00 AM
The actual copy of the internal memo explaining allowances can be found at
the following site:
http://grants.nih.gov/grants/oprr/humansubjects/guidance/aprvper.pdf
Ginger
Ginger French
4/22/2000 5:47:00 AM
Lies, damned lies and statistics
Craig --
An excellent question. Bad science is unethical science. Poor statistical
techniques can result in risk exposure without reliable outcomes, or it can
result in more risk exposure than is necessary to answer the question.
My thought is that scientific merit review should be done on every project
before it comes to the IRB, and the IRB should look at methodology only in the
narrow sense of its impact on risk/benefit balance.
In the real world, lots of projects don't have scientific merit review before
they go to the IRB. And in the real world, the statistical end of merit review
is often shorted. So the IRB may pretty often have before it a study in which
the question you pose is a real one.
If the risks to subjects are substantial, we'll usually look to make sure that
some thought has been given to statistical power and design. My formal training
in statistics is limited to an undergraduate minor and a few later courses, so
subtleties may whizz by. But if the PIs haven't even taken the trouble to
estimate needed sample size according to some reasonable assumptions about
possible outcomes, then they haven't done their job from a human subjects'
protection point of view.
Ideally, I think the role of the IRB should be to ensure that departments know
that they have some responsibility to make sure that junk isn't submitted to the
IRB. The IRB can also spot the lone cowboy investigator, and ask that person
what peer review has taken place. Beat the drums for peer review of the science.
But don't make it a major role of the IRB, because the IRB has enough on its
plate already. Also, expertise is likely to be spotty --- if the IRB starts
doing scientific merit review in a serious way, it's going to have the
competence to do a good job in only a subset of protocols it sees.
I think this will continue to be one of those unresolvable tensions --- a place
where human subjects' protections could be improved, but a place where the IRB
is probably not able to work very directly
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
4/21/2000 1:18:00 PM
Lies, damned lies and statistics
The benefits of virtually all research that requires the analysis
of numbers depends on the proper statistical method being employed, even
if all that is required is a pre- post- comparison.
Therefore some review of method is required to be sure there are
expected benefits. In the vast percentage of the cases I've reviewed,
that review can be cursory because either the method is obvious or the
researcher can be expected to use the appropriate method.
A simple case where a thorough review would be required is one in
which there is serious risk to subjects and the power of the test
described [or deduced] is inadequate.
Bill Birdsall birdz@umich.edu
School of Social Work (734) 763-5921 [office]
U. of Mich. (734) 936-2961 [fax]
3792 SSW Bldg.
Ann Arbor, MI, 48109-1106
HOME:
3685 Daleview Dr. (734) 769-9868 [home]
Ann Arbor, MI 48105 (734) 769-0006 [home fax]
Office Hours: Tues. 10:20 - 11:30; Wed. 12:15 - 12:45. Or by appointment.
It is always good to let me know if you are coming even during office
hours.
William Chaulk Birdsall
4/21/2000 1:21:00 PM
Advising children about risk of death in Assent document
I haven't seen enough of these to have a sense of what's usual among our
peds-heme/onc group. But it seems to me that the appropriate handling of risk of
death is something that is very maturity-dependent, and the maturity won't be
very tightly predictable from age. So I'd think it may be bad to get too
dogmatic about what's the right thing to do.
Another BIG concern for me is that the risk of death in many of these protocols
is relative, and the bulk of the risk is often study-independent. For example,
you may have a disease with a 40% cure rate with standard therapy, in which
you're doing a study in which you hope to increase the cure rate to 50% by
adding an additional drug that will modestly increase toxicity. It is true that
one possible outcome is that the additional drug won't help much and the subject
will fall victim to the increased toxicity. So death is a possible study
outcome. But death, if it occurs, is much more likely to be the result of the
fact that fewer than half of people are cured -- i.e. the limitations of
standard therapy -- than the result of study participation. That sort of
subtlety is hard to get through accurately to college-educated adults, and it's
nigh unto hopeless to get it across to a child.
So my feeling is that it's better to be pretty general, and let those who
actually know the child fill in details at a level the child can cope with. When
I once drafted a CF for a leukemia study, I used words to the effcet of: It's
possible that the new treatment won't be any better than the old 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
4/21/2000 1:21:00 PM
Research Subject-Bill of Rights
Hello,
I was wondering if anyone has a copy of the Bill of Rights for research
subjects. A copy is sometimes attached to the Consent Form, but not always. I am
part of a group that is trying to devise a consent template that will be focused
more to immigrant and/or low income families and I think that it would be a good
guidance document. One of the goals is to eventually establish educational
programs for these groups. Therefore, we want to generate a document that
encourages and facilitates discussion and understanding. Please feel free to
contact me through MCWIRB or privately.
Thank You,
Eileen M. Yates
IRB Administrator
Office of Research Affairs
Rush-Presbyterian-St. Luke's Medical Center
Chicago, IL
Phone: 312-942-5498
Fax: 312-942-2874
e-mail: Eileen_M_Yates@rush.edu
Eileen Yates
4/21/2000 12:53:00 PM
Our Hospital Administration would like for the
annual IRB review date to stay the same year
after year. Most of our studies expire every 12
months but in actuality they are reviewed every
10 months to ensure that non go delinquent. I
have always started the clock ticking again as
of the date of continuing review. Can I have the
report reviewed at 10 months but re-approval as
of the anniversary date?
If yes I thought our letters would read as
follows:
The IRB reviewed the progress report for the
above referenced study at a convened meeting
on 10 October 2000 and re-approval is granted
for 12 months as of 10 December 2000.
Thanks,
Christy Klepetko
IRB Coordinator
210-297-8892
Christy Klepetko
4/21/2000 1:15:00 PM
Advising children about risk of death in Assent document
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
Anonymous
4/21/2000 1:21:00 PM
Annual reports/block voting
Cynthia --
1) Applications for continuing review and approval (NOT annual reports)
2) If they were eligible for expedited review, they are approved as soon as the
expedited reviewer gives approval. They don't need confirmation by an assembled
quorum.
46.110(b)(2) Under an expedited review procedure, the review may be
carried out by the IRB chairperson or by one or more experienced
reviewers designated by the chairperson from among members of the IRB.
In reviewing the research, the reviewers may exercise all of the
authorities of the IRB except that the reviewers may not disapprove
the research.
The immediately following bit, (46.110(c)) provides that the IRB needs to be
kept aware of the expedited reviews, and many IRBs do this by including a list
of recent expedited actions in the agenda for a meeting. Some IRBs have a local
process whereby the members have the opportunity to call an expedited action for
examination, and this may take place as a motion to accept the report of
expedited reviews. Although that's reasonably common, all the regs say is:
(c) Each IRB which uses an expedited review procedure shall adopt a
method for keeping all members advised of research proposals which
have been approved under the procedure.
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
4/21/2000 1:24:00 PM
Donna wrote:
> Does anyone know if the father of a physician who is affiliated with
a
> hospital which has an IRB (but does not serve on the board) could be
> considered as a community member or would he be considered an
affiliated
> member? Also, I have been unable to determine from the regs if a
quorum is
>considered if there is not a community (non-affiliated) member present
at
> the meeting.
Hi,
I would not consider the father an affiliated member.
>From http://www.fda.gov/oc/oha/IRB/toc2.html :
16. Does a non-affiliated member need to attend every IRB meeting?
No. Although 21 CFR 56.108(c) does not specifically require the
presence of a member not otherwise affiliated with the institution to
constitute a quorum, FDA considers the presence of such members an
important element of the IRB's diversity. Therefore, frequent absence of
all non-affiliated members is not acceptable to FDA. Acknowledging their
important role, many IRBs have appointed more than one member who is not
otherwise affiliated with the institution. FDA encourages IRBs to
appoint members in accordance with 21 CFR 56.107(a) who will be able to
participate fully in the IRB process.
Regards,
Howard Mann, M.D.
Chairman
IRB, LDS Hospital, Salt Lake City
Howard Mann
4/20/2000 4:12:00 AM
During a recent OPRR visit a similar situation was clarified. The father of
a nurse that works within our institution is considered to be affiliated.
Therefore, he is considered a non-scientific member. We do have the parent
of a deceased patient on the committee that is considered a community
representative.
Pam Young, IRB Coordinator
St. Jude Children's Research Hospital
332 N. Lauderdale
Memphis, TN 38105
-----Original Message-----
From: Howard Mann [mailto:LDHMANN@ihc.com]
Sent: Wednesday, April 19, 2000 10:36 PM
To: SCHODS@integris-health.com; mcwirb@mcwirb.org
Subject: Re: Community members
Donna wrote:
> Does anyone know if the father of a physician who is
affiliated with
a
> hospital which has an IRB (but does not serve on the
board) could be
> considered as a community member or would he be considered
an
affiliated
> member? Also, I have been unable to determine from the
regs if a
quorum is
>considered if there is not a community (non-affiliated)
member present
at
> the meeting.
Hi,
I would not consider the father an affiliated member.
From http://www.fda.gov/oc/oha/IRB/toc2.html :
16. Does a non-affiliated member need to attend every IRB
meeting?
No. Although 21 CFR 56.108(c) does not specifically require
the
presence of a member not otherwise affiliated with the
institution to
constitute a quorum, FDA considers the presence of such
members an
important element of the IRB's diversity. Therefore,
frequent absence of
all non-affiliated members is not acceptable to FDA.
Acknowledging their
important role, many IRBs have appointed more than one
member who is not
otherwise affiliated with the institution. FDA encourages
IRBs to
appoint members in accordance with 21 CFR 56.107(a) who will
be able to
participate fully in the IRB process.
Regards,
Howard Mann, M.D.
Chairman
IRB, LDS Hospital, Salt Lake City
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Pamela Young
4/20/2000 2:15:00 PM
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.
Anonymous
4/20/2000 2:10:00 PM
I assume you are referring to an article published in the Annals of Internal
Medicine some months ago by Seeff et al. In that article, there is
absolutely no mention of informed consent issues and the journal published
this paper without any mention that there might be problems. After some
investigation on my part, it seems as though proper informed consent was
obtained and IRB oversight provided, much to the credit of the
investigators. That the journal did not require the details of this
important information is quite remarkable.
You can find more about this in a piece I wrote for the latest issue of
Research Practitioner ([formerly Research Nurse and the Journal of Clinical
Research Practice] for more information see www.ccrp.com).
Alan M. Sugar, M.D.
Professor of Medicine, Boston University School of Medicine
Chairman, New England Institutional Review Board
Co-Editor, Research Practitioner
--__--__--
Message: 3
Date: Wed, 19 Apr 2000 22:14:42 -0500
To:
From: Warren Kearney
Subject: Hepatitis C study
Seeking insight or information.
In the last week, the New York Times ran a story in the Science section on
a study done on some old blood samples drawn from military recruits in the
mid 1940's. It was essentially an exploratory study, to see if there was
evidence of Hepatitis C infection detectable in samples drawn well before
anyone knew of this type. It has provided some surprisingly confounding
information about the natural history of the disease--one man discovered
alive with apparent active viral replication and no signs of clinical
illness.
My question: The article alludes to but does not specify the inevitable
difference of opinions among ethicists about contacting those whose samples
came up positive, and indicates that it took the principal investigator a
year and a half to draft a letter that was considered acceptable. I am
wondering what ethical issue in this matter could have been that knotty as
to cause such a delay and re-drafting effort. Anyone know anything about
this?
Warren
-.,,_,.-:*'``'*:-.,,_,.-:*'``'*:-.,,_,.-:*'``'*:-.,,_,.-
Warren Kearney, M.D.
E-mail: kear0004@tc.umn.edu
2301 Minneapolis Ave
Minneapolis, MN 55406
(612) 729-1412
--__--__--
Message: 4
Date: Wed, 19 Apr 2000 21:36:28 -0600
From: Howard Mann
To: ,
Subject: Re: Community members
Donna wrote:
> Does anyone know if the father of a physician who is affiliated with
a
> hospital which has an IRB (but does not serve on the board) could be
> considered as a community member or would he be considered an
affiliated
> member? Also, I have been unable to determine from the regs if a
quorum is
>considered if there is not a community (non-affiliated) member present
at
> the meeting.
Hi,
I would not consider the father an affiliated member.
>From http://www.fda.gov/oc/oha/IRB/toc2.html :
16. Does a non-affiliated member need to attend every IRB meeting?
No. Although 21 CFR 56.108(c) does not specifically require the
presence of a member not otherwise affiliated with the institution to
constitute a quorum, FDA considers the presence of such members an
important element of the IRB's diversity. Therefore, frequent absence of
all non-affiliated members is not acceptable to FDA. Acknowledging their
important role, many IRBs have appointed more than one member who is not
otherwise affiliated with the institution. FDA encourages IRBs to
appoint members in accordance with 21 CFR 56.107(a) who will be able to
participate fully in the IRB process.
Regards,
Howard Mann, M.D.
Chairman
IRB, LDS Hospital, Salt Lake City
--__--__--
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo/mcwirb
End of MCWIRB Digest
Alan Sugar
4/20/2000 2:15:00 PM
Does anyone know if the father of a physician who is affiliated with a
hospital which has an IRB (but does not serve on the board) could be
considered as a community member or would he be considered an affiliated
member? Also, I have been unable to determine from the regs if a quorum is
considered if there is not a community (non-affiliated) member present at
the meeting.
Donna
Donna S .
4/20/2000 7:05:00 PM
I have a different take than Howard. According to the regulations (45 CFR
46.107.d):
Each IRB shall include at least one member who is not otherwise affiliated
with the institution and who is not part of the immediate family of a person
who is affiliated with the institution.
To me, clearly the physician is affiliated with the institution. The
question remains as to whether the father is an immediate family member.
I have a difficult time quantifying the father as anything BUT an immediate
family member. Clearly, prima facie, the regulations appear to be trying to
avoid conflict of interest. I cannot see how a father could not pose
conflict of interest to the institution and the IRB.
We have a situation here where the father works for our institution and the
son was considered to be the community member. We have since decided that
the situation was a conflict of interest.
Matt Westbrook
Travis Research Institute
(626) 584-5538
----- Original Message -----
From: Howard Mann
To: ;
Sent: Wednesday, April 19, 2000 10:36 PM
Subject: Re: Community members
> Donna wrote:
>
> > Does anyone know if the father of a physician who is affiliated with
> a
> > hospital which has an IRB (but does not serve on the board) could be
> > considered as a community member or would he be considered an
> affiliated
> > member? Also, I have been unable to determine from the regs if a
> quorum is
> >considered if there is not a community (non-affiliated) member present
> at
> > the meeting.
>
> Hi,
>
> I would not consider the father an affiliated member.
>
> >From http://www.fda.gov/oc/oha/IRB/toc2.html :
>
> 16. Does a non-affiliated member need to attend every IRB meeting?
>
> No. Although 21 CFR 56.108(c) does not specifically require the
> presence of a member not otherwise affiliated with the institution to
> constitute a quorum, FDA considers the presence of such members an
> important element of the IRB's diversity. Therefore, frequent absence of
> all non-affiliated members is not acceptable to FDA. Acknowledging their
> important role, many IRBs have appointed more than one member who is not
> otherwise affiliated with the institution. FDA encourages IRBs to
> appoint members in accordance with 21 CFR 56.107(a) who will be able to
> participate fully in the IRB process.
>
> Regards,
>
> Howard Mann, M.D.
> Chairman
> IRB, LDS Hospital, Salt Lake City
>
>
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
Matt Westbrook
4/20/2000 2:15:00 PM
During a recent OPRR visit a similar situation was clarified. The father of
a nurse that works within our institution is considered to be affiliated.
Therefore, he is considered a non-scientific member. We do have the parent
of a deceased patient on the committee that is considered a community
representative.
Pam Young, IRB Coordinator
St. Jude Children's Research Hospital
332 N. Lauderdale
Memphis, TN 38105
-----Original Message-----
From: Howard Mann [mailto:LDHMANN@ihc.com]
Sent: Wednesday, April 19, 2000 10:36 PM
To: SCHODS@integris-health.com; mcwirb@mcwirb.org
Subject: Re: Community members
Donna wrote:
> Does anyone know if the father of a physician who is
affiliated with
a
> hospital which has an IRB (but does not serve on the
board) could be
> considered as a community member or would he be considered
an
affiliated
> member? Also, I have been unable to determine from the
regs if a
quorum is
>considered if there is not a community (non-affiliated)
member present
at
> the meeting.
Hi,
I would not consider the father an affiliated member.
From http://www.fda.gov/oc/oha/IRB/toc2.html :
16. Does a non-affiliated member need to attend every IRB
meeting?
No. Although 21 CFR 56.108(c) does not specifically require
the
presence of a member not otherwise affiliated with the
institution to
constitute a quorum, FDA considers the presence of such
members an
important element of the IRB's diversity. Therefore,
frequent absence of
all non-affiliated members is not acceptable to FDA.
Acknowledging their
important role, many IRBs have appointed more than one
member who is not
otherwise affiliated with the institution. FDA encourages
IRBs to
appoint members in accordance with 21 CFR 56.107(a) who will
be able to
participate fully in the IRB process.
Regards,
Howard Mann, M.D.
Chairman
IRB, LDS Hospital, Salt Lake City
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Pamela Young
4/20/2000 2:13:00 PM
I assume you are referring to an article published in the Annals of Internal
Medicine some months ago by Seeff et al. In that article, there is
absolutely no mention of informed consent issues and the journal published
this paper without any mention that there might be problems. After some
investigation on my part, it seems as though proper informed consent was
obtained and IRB oversight provided, much to the credit of the
investigators. That the journal did not require the details of this
important information is quite remarkable.
You can find more about this in a piece I wrote for the latest issue of
Research Practitioner ([formerly Research Nurse and the Journal of Clinical
Research Practice] for more information see www.ccrp.com).
Alan M. Sugar, M.D.
Professor of Medicine, Boston University School of Medicine
Chairman, New England Institutional Review Board
Co-Editor, Research Practitioner
--__--__--
Message: 3
Date: Wed, 19 Apr 2000 22:14:42 -0500
To:
From: Warren Kearney
Subject: Hepatitis C study
Seeking insight or information.
In the last week, the New York Times ran a story in the Science section on
a study done on some old blood samples drawn from military recruits in the
mid 1940's. It was essentially an exploratory study, to see if there was
evidence of Hepatitis C infection detectable in samples drawn well before
anyone knew of this type. It has provided some surprisingly confounding
information about the natural history of the disease--one man discovered
alive with apparent active viral replication and no signs of clinical
illness.
My question: The article alludes to but does not specify the inevitable
difference of opinions among ethicists about contacting those whose samples
came up positive, and indicates that it took the principal investigator a
year and a half to draft a letter that was considered acceptable. I am
wondering what ethical issue in this matter could have been that knotty as
to cause such a delay and re-drafting effort. Anyone know anything about
this?
Warren
-.,,_,.-:*'``'*:-.,,_,.-:*'``'*:-.,,_,.-:*'``'*:-.,,_,.-
Warren Kearney, M.D.
E-mail: kear0004@tc.umn.edu
2301 Minneapolis Ave
Minneapolis, MN 55406
(612) 729-1412
--__--__--
Message: 4
Date: Wed, 19 Apr 2000 21:36:28 -0600
From: Howard Mann
To: ,
Subject: Re: Community members
Donna wrote:
> Does anyone know if the father of a physician who is affiliated with
a
> hospital which has an IRB (but does not serve on the board) could be
> considered as a community member or would he be considered an
affiliated
> member? Also, I have been unable to determine from the regs if a
quorum is
>considered if there is not a community (non-affiliated) member present
at
> the meeting.
Hi,
I would not consider the father an affiliated member.
>From http://www.fda.gov/oc/oha/IRB/toc2.html :
16. Does a non-affiliated member need to attend every IRB meeting?
No. Although 21 CFR 56.108(c) does not specifically require the
presence of a member not otherwise affiliated with the institution to
constitute a quorum, FDA considers the presence of such members an
important element of the IRB's diversity. Therefore, frequent absence of
all non-affiliated members is not acceptable to FDA. Acknowledging their
important role, many IRBs have appointed more than one member who is not
otherwise affiliated with the institution. FDA encourages IRBs to
appoint members in accordance with 21 CFR 56.107(a) who will be able to
participate fully in the IRB process.
Regards,
Howard Mann, M.D.
Chairman
IRB, LDS Hospital, Salt Lake City
--__--__--
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo/mcwirb
End of MCWIRB Digest
Alan Sugar
4/20/2000 2:13:00 PM
Is Informed Consent Required?
> 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?
If you are collecting information about the outcome of therapy on your patients,
i.e., if the drug is administered as treatment, I do not think you are doing
research. If you then write a paper on your clinical observations, I do not
think this is an IRB issue. There may be other issues, such as patient privacy,
which would need to be addresses, but I do not think classical clinical series
or clinical notes come under research regs at all. The key, IMHO, is the
determinate of how you chose the treatment. If it is an individualized clinical
decision, made only on the best interests of the patient, you are not doing
research. However, this cuts both ways - your data is also not research data
and is subject to the usual criticisms of clinical information: bias, control,
etc.
Ed
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
4/20/2000 2:10:00 PM
Research Subject-Bill of Rights
The Experimental Subjects' Bill of Rights, required in California, is
appended.
Thomas G. Keens, M.D.
Chair. Committee on Clinical Investigations (IRB)
Childrens Hospital Los Angeles
Experimental Subject's Bill of Rights
Any person who is requested to consent to participate as a subject
in a research study involving a medical experiment, or who is requested to
consent on behalf of another, has the right to:
1. Be informed of the nature and purpose of the experiment.
2. Be given an explanation of the procedures to be followed in the
medical experiment, and any drug or device to be utilized.
3. Be given a description of any attendant discomforts and risks
reasonably to be expected from your/your child's participation in the
experiment.
4. Be given an explanation of any benefits reasonably to be expected
from your/your child's participation in the experiment.
5. Be given a disclosure of any appropriate alternative procedures,
drugs, or devices that might be advantageous to you/your child, their
relative risks and benefits.
6. Be informed of avenues for medical treatment, if any, available to
you/your child after the experimental procedure if complications should
arise.
7. Be given an opportunity to ask any questions concerning the medical
experiment or the procedures involved.
8. Be instructed that consent to participate in the experimental
procedure may be withdrawn at any time and that you/your child may
discontinue participation in the medical experiment without prejudice.
9. Be given a copy of this form and the signed and dated written
consent form.
10. Be given the opportunity to decide to consent or not to consent to
the medical experiment without the intervention of any element of force,
fraud, deceit, duress, coercion or undue influence on your decision.
You have carefully read the information contained above in the Experimental
Subject's Bill of Rights and you understand fully the rights of a potential
subject in a medical experiment involving people as subjects.
Date: __________ Subject:
__________________________________________
Time: __________ Parent:
__________________________________________
Witness:
__________________________________________
Tom
4/19/2000 11:34:00 AM
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
Anonymous
4/19/2000 4:27:00 AM
Is Informed Consent Required?
I think if you were prospectively collecting data, the opportunity exists to
get consent for access to patient records for research purposes. The
scenario you present sounds like research, therefore my view is that consent
of patients is required, not for prescribing the medication, but for using
confidential information in medical records to evaluate the treatment for
the group of patients.
Publication doesn't have anything to do with whether consent should be
obtained, either ethically or legally. Nor does publication really have
anything to do with whether or not an activity is research: lots of research
never gets published (I'm sure we can all relate to that....), and many
activities that are published in professional/scientific/peer-reviewed
journals are not research.
If I were a patient in this (I assume fictional) scenario, I would be more
than a bit peeved that my physician was using confidential information in my
medical records for research, when he/she had an opportunity to request my
consent. The common response that we do it all the time just doesn't hold
up as a justification.
Maggie
Maggie Frederick, MPH
Review Coordinator
DSHS Human Research Review Section
P.O. Box 45205
Olympia, WA. 98504-5205
(360) 902-8075
FAX: (360) 902-0705
Email: fredem@dshs.wa.gov
Maggie
4/19/2000 11:34:00 AM
The following is OPRR's longstanding guidance on continuing review:
Continuing IRB review of research must be substantive and
meaningful.
In conducting continuing review of research not eligible for
expedited review, all IRB members should at least receive and review a
protocol summary and a status report on the progress of the research,
including (i) the number of subjects accrued; (ii) a description of any
adverse events or unanticipated problems involving risks to subjects or
others and of any withdrawal of subjects from the research or complaints
about the research; (iii) a summary of any recent literature, findings
obtained thus far, amendments or modifications to the research since the
last review, reports on multi-center trials and any other relevant
information, especially information about risks associated with the
research; and (iv) a copy of the current informed consent document. Primary
reviewer systems may be employed, so long as the full IRB receives the above
information. Primary reviewers should also receive a copy of the complete
protocol including any modifications previously approved by the IRB (see
OPRR Reports 95-01 at
http://grants.nih.gov/grants/oprr/humansubjects/guidance/hsdc95-01.htm).
When conducting research under an expedited review procedure, the
IRB Chair or designated IRB member conducting the review should receive and
review all of the above referenced documentation.
Please note that OPRR considers the above guidelines to represent the
minimum standards for conducting adequate continuing review of research.
Michael A. Carome, M.D.
Chief, Compliance Oversight Branch
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health (MSC 7507)
6100 Executive Blvd, Suite 3B01
Rockville, MD 20892-7507
Tel: 301-402-5567
Fax: 301-402-2071
E-mail: mc2a@nih.gov
Michael Od
4/19/2000 4:27:00 AM
This is not an unusual situation, in my experience.
One scenario is to approve part 1 of a protocol, and then have the
investigator come back to the Board with additional information, revised
protocol, or whatever is needed, before parts 2 -x are approved. The
approval date is the date of approval of part 1. The review of
additional groups would be handled as an amendment, keeping the initial
approval dates constant. For example, if the protocol for the first group
of patients is approved at a meeting on April 18th, the approval dates
would be (assuming a 12-month approval) April 18, 2000-April 17, 2001. If
the investigator comes back with the additional data to allow groups 2
through x to be approved, and that protocol is approved on June 15th, you
would note in the Minutes that the amendment was approved as of June 15th,
but the approval dates would stay April 18,2000-April 17,2001. Not to
confuse you further, but an exception to this would be when the amended
protocol is so different from the first that it should be treated as a new
protocol: then I would probably terminate the first protocol and start
anew with the second, with the approval dates of the second, revised,
protocol as the applicable dates.
Jon Hart
At 03:35 PM 4/18/00 -0500, you 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
Jon Hart, Director, Sponsored Programs Administration
The Rockefeller University
1230 York Ave.-Box 82, NY, NY 10021-6399
tel: (212) 327-8054; fax: (212) 327-8400
Jon Hart
4/18/2000 12:26:00 PM
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
Anonymous
4/18/2000 5:41:00 PM
I agree with Jon Hart throughout but would add one aside.
Occasionally, when the members review the major modificaation mid-year,
they will also be given all of the information that would normally come in
for a continuing review. When that happens, they can extend the approval
period for up to one year from that approval date.
For example, if group 2 approval is dependent on positive results from the
first x subjects from group 1, we would receive the group 1 data. At that
point, it would be reviewed and could be granted - by full board - another
period/year.
Erica
Erica Heath
President, IRC
415-485-0717
heath
4/18/2000 5:41:00 PM
Presumed Consent - statutory access?
It is hard to tell from the recited facts what is really going on. In most
states, the health department has the right to review patient charts and extract
information that can aid in the control of communicable diseases. If the study
was being done under that police power, then it is not subject to IRB review or
the federal regulations, and, probably, is not research in the sense used by
IRBs. If, however, it is not being done under the police power but is a just a
traditional research study that happens to be cooperating with the health
department, then I think the concerns expressed below are entirely proper. My
own bet is that the health department did not set it up properly to fall under
their police power and it probably should have been considered reviewable
research.
A related issue is access to records of workers who have been exposed to toxic
chemicals - which covers a LOT of people because of the long list of things
NIOSH (National Institute of Occupational Safety and Health) considers toxic.
The government and the unions have the right to come in and see the records for
whatever purpose, they do not need consent, and the health care providers have
to provide all necessary support to get the charts. Throwing them out can get
you in serious trouble.
Just to keep everyone on their toes, as many have found to their dismay,
Medicare, Medicaid, auditors, and sometimes even private insurance company
auditors, depending on the policy terms, also have unfettered access to the
charts.
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
> -----Original Message-----
> From: Robert Nelson [mailto:rmnelson@mcw.edu]
> Sent: Thursday, April 13, 2000 4:30 PM
> To: mcwirb@mcwirb.org
> Subject: re: Presumed Consent
>
>
> Presumed consent is not appropriate. The issue is whether
> this investigation
> meets the standard for the waiver of informed consent. Since
> there is no
> documentation of whether the participants received the
> letter, or consented to
> the review, one could not appeal to a waiver of written
> documentation. I would
> have thrown out the researcher as well.
>
> Robert Skip Nelson, MD, PhD
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
Edward Richards
4/18/2000 12:12:00 PM
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