Tiered consent options for genetic research
Hi All,
We are all familiar with the concept of the acquisition and storage of tissue samples for research, particularly genetic research.
Associated with this is an inescapable tension between the desire of researchers to establish tissue repositories for future research and the necessity of obtaining the sample-donor's specific consent for research.
Two core issues associated with this are :
1. Respect for the donor's privacy and confidentiality interests. Thus,we distinguish between unidentified and identified/coded use of tissue samples.
2. Respect for the donor's right (as a moral agent) to decide what research to support. As an expression of moral, religious or cultural values, a donor may decline to participate in certain kinds of research.
Consent Documents contain variations of the options enumerated in the report of the National Bioethics Advisory Commission concerning this issue :
* refusing use of their biological materials in research.
* permitting only unidentified or unlinked use of their biological materials in [including future, unspecified] research.
( This option does promotes 1., but not 2. )
* permitting coded or identified use of their biological materials for one particular study only, with no further contact permitted to ask for permission to do further studies.
( This strongly promotes 2.,but is not consistent with the aims of a repository)
* permitting coded or identified use of their biological materials for one particular study only, with further contact permitted to ask for permission to do further studies.
( Investigators do not like this -- donors may have relocated, may not respond, or may have died in the interim.)
* permitting coded or identified use of their biological materials for any study relating to the original condition for which the sample was originally collected, with further contact permitted to seek permission for other types of studies.
* permitting coded use of their biological materials for any kind of future study.
(Not unexpectedly, some Commissioners objected to the last two options. I share their concern with the last option, in particular. These two options do not promote 2.)
Interestingly, the Commission did not consider options that specified future studies *reviewed and approved by an IRB*. Some donors may consider permitting a form of proxy consent whereby an IRB may determine whether a proposed study is still encompassed within the aims of the originally- approved research.
How do you deal with these options in the context of IRB review and approval ?
How do you balance the needs of a tissue repository and recipient-investigators with the IRB's duty to promote the interests of the sample-donor as explicated above ?
Regards,
Howard
Anonymous
7/14/2000 6:23:00 AM
> ----------
> From: Clark, Elisabeth[SMTP:clarke@muhchem.mcgill.ca]
> ... and finally why does the DeGette, Mica and Waxman Bill need to bring
> all human research under the Common Rule, if as an agency of HHS the FDA
> must function in accord with 45 CFR 46? Will the Common Rule require
> amending to accommodate the differing provisions in 21 CFR 50 & 56?
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
I wonder if the DeGette bill would make the Common Rule truly common
across agencies. Currently, some agencies do not entirely agree with OHRP
interpretations of the Common Rule. Would DeGette make OHRP the prime
interpreter of the Code?
David Borasky
Protection of Human Subjects Committee
Family Health International
P.O. Box 13950
Research Triangle Park, NC 27709
Tel. 919/405-1445
Fax 919/544-7261
E-mail: dborasky@fhi.org
David Borasky
7/14/2000 3:33:00 AM
community representatives
IRBs request that review services be paid for by companies or investigators
that are not their staff or employees or otherewise affiliated. So the
service is a real value added in their eyes. I believe the same is true
for the unaffiliated member, particularly those who are not doing this as
collateral responsibility for their own employer or organization.
Also, no one is constrained to accept payment if they wish to make an in
kind donation of their time and contributions. They can decline or donate
the money to charity. That is altruistic.
I repeat that it is inequitable to expect individuals to give of their time
and valuable view points without fair remuneration. Abe Lincoln used to have
the motto up that A lawyer is only paid for his time and advice. Sounds
fair to me. Not to compensate such members is exploitation, pure and
simple.
When the organization is a shoe string or store front type of operation, it
may be appropriate for the unaffiliated member(s) to be uncompensated. We
have all done such volunteer work. But the altruism is willing not forced by
the failure to acknowledge the value added of the unaffiliated ( community?)
member.
> -----Original Message-----
> From: David Borasky [SMTP:DBorasky@fhi.org]
> Sent: Friday, July 14, 2000 8:22 AM
> To: mcwirb@mcwirb.org
> Cc: MacKay, Charles (OD)
> Subject: RE: community representatives
>
> > ----------
> > From: MacKay, Charles (OD)[SMTP:MACKAYC@odrockm1.od.nih.gov]
> > Maybe in the last analysis, you get what you pay for and if you don't
> pay,
> > maybe you aren't getting all that you can. Why should unaffiliated
> members
> > make such personal sacrifices?
> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
>
> I work with two very different IRBs. One IRB (FHI) is made up entirely of
> people from outside our organization. They are all compensated as
> consultants based on the time they spend preparing for and attending the
> meeting. I don't know how that would change if we couldn't compensate
> them
> (and thankfully, I don't have to worry about that).
>
> On the other IRB (UNC School of Dentistry) I am the Community Rep. and
> currently the Chairperson. Our Community Reps. receive $50/meeting as a
> token honorarium, but we've only been doing this for a year. Previously,
> community representatives were true volunteers, receiving only a dinner
> for
> their efforts each month.
>
> Why would they serve our board for free? (Why do subjects volunteer for
> studies where there is no payment or direct benefit?) Talking with past
> and
> present community members it was clear that their reasons were entirely
> altruistic. They simply wanted to give something back to the community or
> the institution (maybe they should have talked to Roy Williams) and this
> was
> an interesting way of doing so.
>
> David Borasky
> Chairperson / Community Rep.
> UNC-Chapel Hill Dental IRB
>
>
> David Borasky
> Protection of Human Subjects Committee
> Family Health International
> E-mail: dborasky@fhi.org
>
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Charles Od
7/14/2000 7:24:00 AM
community representatives
Commendable civic virtue. A fine list. But to force the position on someone
by not offering adequate remuneration blunts their civic zeal. It is really
a greater contribution if you are shown how much value the organization
places on your effort and you decline it or donate the payment to charity.
> -----Original Message-----
> From: Phillip Michaels [SMTP:wmicha36@aloha.net]
> Sent: Friday, July 14, 2000 1:30 AM
> To: mcwirb@mcwirb.org
> Subject: RE: community representatives
>
> At 04:56 PM 7/13/2000 -0400, you wrote:
>
> >It seems to me that nonaffiliated IRB members, who are not compensated
> for
> >their services. . . . Why should unaffiliated members
> >make such personal sacrifices?
>
>
> Some reasons that have occurred to me:
> 1. to strive to become a better person;
> 2. to try to make the world a better place;
> 3. to promote a better social ethic
> 4. to promote a better work ethic;
> 5. to protect subjects, patients, the mentally ill, and just the unknowing
>
> and unsuspecting from those who have the power and potential to cause them
>
> harm;
> 6. to counter the perspective in society that people do not do anything
> unless they will personally reap financial gain from it;
> 7. to set an example for children, students, and adults;
> 8. to achieve a small sense of what it was that motivated people like
> Albert Schweitzer and others who have similarly devoted themselves to
> their
> fellow human beings;
> 9. to bring to the table knowledge, experience, ability, and perspective
> that would not otherwise be represented;
> 10. to grow, learning and experiencing what would not otherwise be learned
>
> and experienced;
> 11. to teach/inform;
> 12. to lead;
> 13. to actualize what the ancient Greeks understood when they invented
> democracy--that freedom cannot exist without those who unselfishly accept
> responsibility;
> 14. to fulfill one's civic duty;
> 15. to partially compensate for having so much while so many in the world
> have so little;
> 16. to demonstrate that more expensive resources are not necessarily
> better
> resources;
> 17. to meet others who are interested in protecting others; and
> 18. to gain a sense of personal satisfaction and accomplishment.
>
> Phillip Michaels
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Charles Od
7/14/2000 8:26:00 AM
community representatives (fwd)
This is a very interesting list, but does not include the reasons why our
community members are serving (they are not financially compensated). One
of our community members is a retired MD (80+) who just loves the
intellectual stimulation, collegiality, and opportunity that the IRB
affords to remain up to date on the latest biomedical research. He has
just about the best attendance record on the IRB. My other community
member is a part-time middle school teacher who is between undergrad and
graduate school. She is interested in going to law school and perhaps
pursuing medical ethics as a career - what better way to explore this
career than serving on an IRB?! (It also looks great on a CV.)
Erica C. Jonlin, Ph.D.
Human Subjects Review Coordinator
Human Subjects Division
Box 355752
(206)543-4798 phone; (206)685-9502 fax
---------- Forwarded message ----------
Date: Thu, 13 Jul 2000 19:29:53 -1000
From: Phillip Michaels
To: mcwirb@mcwirb.org
Subject: RE: community representatives
At 04:56 PM 7/13/2000 -0400, you wrote:
>It seems to me that nonaffiliated IRB members, who are not compensated for
>their services. . . . Why should unaffiliated members
>make such personal sacrifices?
Some reasons that have occurred to me:
1. to strive to become a better person;
2. to try to make the world a better place;
3. to promote a better social ethic
4. to promote a better work ethic;
5. to protect subjects, patients, the mentally ill, and just the unknowing
and unsuspecting from those who have the power and potential to cause them
harm;
6. to counter the perspective in society that people do not do anything
unless they will personally reap financial gain from it;
7. to set an example for children, students, and adults;
8. to achieve a small sense of what it was that motivated people like
Albert Schweitzer and others who have similarly devoted themselves to their
fellow human beings;
9. to bring to the table knowledge, experience, ability, and perspective
that would not otherwise be represented;
10. to grow, learning and experiencing what would not otherwise be learned
and experienced;
11. to teach/inform;
12. to lead;
13. to actualize what the ancient Greeks understood when they invented
democracy--that freedom cannot exist without those who unselfishly accept
responsibility;
14. to fulfill one's civic duty;
15. to partially compensate for having so much while so many in the world
have so little;
16. to demonstrate that more expensive resources are not necessarily better
resources;
17. to meet others who are interested in protecting others; and
18. to gain a sense of personal satisfaction and accomplishment.
Phillip Michaels
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Erica Jonlin
7/14/2000 8:35:00 AM
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For comparison, I wanted to share our policy on payment of IRB members. It
is the policy of Copernicus Group Independent Review Board to pay each
member for each meeting they attend.... Scientific,
non-scientific--physician, clergy, housewife receive the same amount per
meeting attended. Each member spends a number of hours in both preparation
for and participation in the meeting. This payment is made irregardless of
the number of studies for which the member serves as primary reviewer. The
payment is $250 per meeting, equal across the board and has been the same
since I began the organization in 1996.
Sharon Hill Price
President
Copernicus Group IRB
www.copernicusgroup.com
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 4.0 Transitional//EN> For comparison,=20
I wanted to share our policy on payment of IRB members. It is the =
policy=20
of Copernicus Group Independent Review Board to pay each member for each =
meeting=20
they attend.... Scientific, non-scientific--physician, clergy, =
housewife=20
receive the same amount per meeting attended. Each member spends a =
number=20
of hours in both preparation for and participation in the meeting. =
This=20
payment is made irregardless of the number of studies for which the =
member=20
serves as primary reviewer. The payment is $250 per =
meeting,=20
equal across the board and has been the same since I began the =
organization in=20
1996. Sharon =
Hill=20
Price President Copernicus Group=20
IRB www.copernicusgroup.com
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Sharon Hill Price
7/14/2000 9:56:00 AM
community representatives
> ----------
> From: MacKay, Charles (OD)[SMTP:MACKAYC@odrockm1.od.nih.gov]
> Maybe in the last analysis, you get what you pay for and if you don't pay,
> maybe you aren't getting all that you can. Why should unaffiliated members
> make such personal sacrifices?
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
I work with two very different IRBs. One IRB (FHI) is made up entirely of
people from outside our organization. They are all compensated as
consultants based on the time they spend preparing for and attending the
meeting. I don't know how that would change if we couldn't compensate them
(and thankfully, I don't have to worry about that).
On the other IRB (UNC School of Dentistry) I am the Community Rep. and
currently the Chairperson. Our Community Reps. receive $50/meeting as a
token honorarium, but we've only been doing this for a year. Previously,
community representatives were true volunteers, receiving only a dinner for
their efforts each month.
Why would they serve our board for free? (Why do subjects volunteer for
studies where there is no payment or direct benefit?) Talking with past and
present community members it was clear that their reasons were entirely
altruistic. They simply wanted to give something back to the community or
the institution (maybe they should have talked to Roy Williams) and this was
an interesting way of doing so.
David Borasky
Chairperson / Community Rep.
UNC-Chapel Hill Dental IRB
David Borasky
Protection of Human Subjects Committee
Family Health International
E-mail: dborasky@fhi.org
David Borasky
7/14/2000 3:33:00 AM
community representatives
At 04:56 PM 7/13/2000 -0400, you wrote:
>It seems to me that nonaffiliated IRB members, who are not compensated for
>their services. . . . Why should unaffiliated members
>make such personal sacrifices?
Some reasons that have occurred to me:
1. to strive to become a better person;
2. to try to make the world a better place;
3. to promote a better social ethic
4. to promote a better work ethic;
5. to protect subjects, patients, the mentally ill, and just the unknowing
and unsuspecting from those who have the power and potential to cause them
harm;
6. to counter the perspective in society that people do not do anything
unless they will personally reap financial gain from it;
7. to set an example for children, students, and adults;
8. to achieve a small sense of what it was that motivated people like
Albert Schweitzer and others who have similarly devoted themselves to their
fellow human beings;
9. to bring to the table knowledge, experience, ability, and perspective
that would not otherwise be represented;
10. to grow, learning and experiencing what would not otherwise be learned
and experienced;
11. to teach/inform;
12. to lead;
13. to actualize what the ancient Greeks understood when they invented
democracy--that freedom cannot exist without those who unselfishly accept
responsibility;
14. to fulfill one's civic duty;
15. to partially compensate for having so much while so many in the world
have so little;
16. to demonstrate that more expensive resources are not necessarily better
resources;
17. to meet others who are interested in protecting others; and
18. to gain a sense of personal satisfaction and accomplishment.
Phillip Michaels
Phillip Michaels
7/14/2000 2:06:00 AM
We have a graduate student representative on our IRB and have had for at
least 7-8 years. She is a voting member of the committee. Many of the
applications we receive are from graduate students and we have found that
having that point of view represented has been very helpful. The down side
is that it tends to take a little longer to train this person. With
faculty, they generally have some exposure to the research arena and ethical
conduct of research with human subjects. A graduate student (if they are
early in their graduate career) may not have a minimum background to start
with.
I have never had any trouble appointing a student - most tend to enjoy the
experience.
Debbie Comeaux, Compliance Specialist
Committee for the Protection of Human Subjects
Division of Research
University of Houston
(713) 743-9215
dcomeaux@uh.edu
-----Original Message-----
From: Susie Hayes [mailto:slhayes@msuvx2.memphis.edu]
Sent: Friday, July 14, 2000 11:48 AM
To: mcwirb@mcwirb.org
Subject: student representative
We are currently filling vacancies on our IRB. Since many
of the subjects tend
to be students, we are looking at the possibility of having
a student serve on
the board.
Do any institutions have a student representative on the
IRB? If so, in what
capacity (voting or non-voting). What are some of the pros
and cons of having a
student serve?
Thanks in advance.
Susie Hayes
Compliance Coordinator
University of Memphis
slhayes@cc.memphis.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Debra Comeaux
7/14/2000 10:06:00 AM
We have also included a graduate student as a full voting member of our IRB
for many years. Over the last 5 or 6 years, this student has come from
either Physical Therapy or Psychology, as these are the departments on our
campus whose graduate students produce the greatest volume of research
involving human subjects. We often try to recruit students who are early in
their graduate programs so they will be able to serve for at least a couple
of years. Service on the IRB is a valuable learning experience for the
students (as it would be for any researcher) by sensitizing them first-hand
to the human subjects issues they should consider when designing their
research projects.
Timothy P. Stratton, Ph.D., R.Ph.
Associate Professor of Pharmacy Administration
School of Pharmacy and Allied Health Sciences
The University of Montana-Missoula
Member, UM IRB
ph: (406) 243-2339
fax: (406) 243-4353
e-mail: timstrat@selway.umt.edu
snail mail: Pharmacy Practice
32 Campus Drive #1522
Missoula, MT 59812-1522
-----Original Message-----
From: Susie Hayes [mailto:slhayes@msuvx2.memphis.edu]
Sent: Friday, July 14, 2000 11:48 AM
To: mcwirb@mcwirb.org
Subject: student representative
We are currently filling vacancies on our IRB. Since many
of the subjects tend
to be students, we are looking at the possibility of having
a student serve on
the board.
Do any institutions have a student representative on the
IRB? If so, in what
capacity (voting or non-voting). What are some of the pros
and cons of having a
student serve?
Thanks in advance.
Susie Hayes
Compliance Coordinator
University of Memphis
slhayes@cc.memphis.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
timstrat@selway.umt.edu
7/14/2000 2:09:00 PM
To the List
With respect to the mcwirb law of *no question too simple*, I seek answers
to the following:
If a non-MPA constituted IRB established working procedures consistent with
21 CFR 50 & 56 would situations arise where committee functioning would not
be consistent with 45 CFR 46?
Could a request for waiver of documented informed consent simply be refused
to remain compliant with FDA regs, assuming the refusal was accounted for
by institutional SOPs?
Apart from FDA's comparison does another document exist to simplify
comparison of 45 CFR 46 with 21 CFR 50 and 56? Something similar to the
comparison prepared by Paul Goebel of 21 CFR 50 and 56 with ICG E6 would be
nice.
... and finally why does the DeGette, Mica and Waxman Bill need to bring
all human research under the Common Rule, if as an agency of HHS the FDA
must function in accord with 45 CFR 46? Will the Common Rule require
amending to accommodate the differing provisions in 21 CFR 50 & 56?
Thanks ... remember I'm Canadian ...
Elisabeth Clark
elisabeth clark
7/14/2000 3:33:00 AM
I would like to think that Phillip Michaels list of reasons to make personal
sacrifices is a bit tongue in cheek. They may be reasons someone may want to
volunteer, but they also seem like many of reasons given over the years to
underpay teachers.
We are asking community members to learn a great deal, and to put a lot of time
into reading, reviewing and preparing, most of which we may not pay them for.
The least we can do is pay some kind of reimbursement for mileage, and
inconvenience.
Meg McClaskey
Director Ethics Consutlation
Rush North Shore Medical Center
Meg McClaskey
7/14/2000 10:03:00 AM
community representatives
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Monte,
This is an interesting query. We currently do not compensate our Community
Member(s) with the exception of covering parking and providing lunch at the
IRB meetings. If IRBs were to compensate (monetarily or, perhaps,
otherwise) community representatives, are they still community
representatives or do they become employees/consultants and are therefore
now associated with the institution?
I'd be interested in others opinions on this.
As an additional discussion item...how do you/fellow mcwirb participants
recruit community members? To date we have done it, for the most part, by
word of mouth, contacting local churches/groups or press release. We are
especially interested in targeting minority groups for representation. Any
thoughts/comments would be appreciated.
Thank you.
Betty
Betty L. Dunger
Coordinator, Institutional Review Board Activities
MetroHealth Medical Center
Cleveland, OH 44109-1998
email: bdunger@research.metrohealth.org
(216) 778-5459 (IRB office)
(216) 778-3884 (direct)
(216) 778-8720 (fax)
> -----Original Message-----
> From: Monte Maney [SMTP:fitp@aol.com]
> Sent: Wednesday, July 12, 2000 9:41 PM
> To: mcwirb@mcwirb.org
> Subject: community representatives
>
> ,Our IRB is seeking advice on how much to pay our community
> representatives.
> They provide an invaluable service and are a necessary and insightful
> component
> of the Board. I have spoken with administrators of several Boards and the
> honorarium ranges from $100/meeting to $50/hour including several hours of
> preparation time. Any advice would be appreciated.
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: community representatives Monte, This is an =
interesting query. We currently do not compensate our Community =
Member(s) with the exception of covering parking and providing lunch at =
the IRB meetings. If IRBs were to compensate (monetarily or, =
perhaps, otherwise) community representatives, are they still community =
representatives or do they become employees/consultants and are =
therefore now associated with the institution? I'd be interested in =
others opinions on this. As an additional =
discussion item...how do you/fellow mcwirb participants recruit =
community members? To date we have done it, for the most part, by =
word of mouth, contacting local churches/groups or press release. =
We are especially interested in targeting minority groups for =
representation. Any thoughts/comments would be =
appreciated. Thank you. Betty Betty L. Dunger Coordinator, Institutional Review =
Board Activities MetroHealth Medical Center Cleveland, OH =
44109-1998 email: =
bdunger@research.metrohealth.org (216) 778-5459 (IRB office) (216) 778-3884 (direct) (216) 778-8720 (fax) -----Original Message----- From: Monte Maney [SMTP:fitp@aol.com] Sent: Wednesday, July 12, 2000 9:41 PM To: mcwirb@mcwirb.org Subject: =
community representatives ,Our IRB is seeking advice on how much =
to pay our community representatives. They provide an invaluable service =
and are a necessary and insightful component of the Board. I have spoken =
with administrators of several Boards and the honorarium ranges from $100/meeting =
to $50/hour including several hours of preparation time. Any advice =
would be appreciated. _______________________________________________ MCWIRB maillist - =
MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <=
/FONT>
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Betty Dunger
7/13/2000 6:52:00 AM
community representatives
MY view: somethings are priceless. For everything else there is Master
Charge.
It seems to me that nonaffiliated IRB members, who are not compensated for
their services from their own source of employment as a collateral duty (
e.g., staff from a health voluntary, a lawyer doing pro bono, etc) ought to
be compensated for their contributions. Anything else is simply inequitable.
Maybe in the last analysis, you get what you pay for and if you don't pay,
maybe you aren't getting all that you can. Why should unaffiliated members
make such personal sacrifices?
> -----Original Message-----
> From: LaRusso, Sandra ARMC-Prof Svcs
> [SMTP:LaRussoS@armc.co.san-bernardino.ca.us]
> Sent: Thursday, July 13, 2000 12:32 PM
> To: 'mcwirb@mcwirb.org'
> Subject: RE: community representatives
>
> All of our IRB members volunteer their time and talent. I rotate
> assignments and keep things organized as much as possible to maximize the
> benefit of their time. I have been firm about investigators meeting
> deadlines, etc. so we are not having to constantly convene extra meetings
> or
> try to do business by telephone.
>
> > -----Original Message-----
> > From: Monte Maney [SMTP:fitp@aol.com]
> > Sent: Wednesday, July 12, 2000 6:41 PM
> > To: mcwirb@mcwirb.org
> > Subject: community representatives
> >
> > ,Our IRB is seeking advice on how much to pay our community
> > representatives.
> > They provide an invaluable service and are a necessary and insightful
> > component
> > of the Board. I have spoken with administrators of several Boards and
> the
> > honorarium ranges from $100/meeting to $50/hour including several hours
> of
> > preparation time. Any advice would be appreciated.
> >
> >
> > _______________________________________________
> > MCWIRB maillist - MCWIRB@mcwirb.org
> > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Charles Od
7/13/2000 12:45:00 PM
community representatives
Mary,
You stated:
> We are a public agency, and the community member has indicated that, if we
were unable to pay him, he would serve on our board on a volunteer basis.
However, if we were a private for-profit corporation, I doubt that he or
other potential community members would be as willing to serve free gratis.
>
>
We are a private non-profit IRB however, we operate in the same manner as a
for-profit IRB would. We maintain our non-profit status by donating
additional revenues generated back into our community through student
scholarships and other non-profit corporations who promote science and
education in elementary through high school aged students. That said... All
of our IRB members donate their time. We provide only food which is served
during our meetings. We do not pay our members for their attendance nor do
we provide them with travel reimbursement. We have not had any trouble
recruiting members for the IRB. Most members do it for the experience and
the community service. We meet weekly and have had some members as long as
10+ years.
Michele Baptista, IRB Administrator
Biomed IRB, San Diego
(619) 282-9997
fax (619) 282-9998
email: mbaptista@biomedirb.com
Michele
7/13/2000 12:34:00 PM
I have been asked to sign a waiver to allow staff members of our Hospital
to use hospital laboratory & X-ray for studies which have not been reviewed
by he Hospital IRB. I am not quite clear on whether this creates liability
on the part of the Hospital, our IRB members or myself. Since the subjects
are not hospitalized, and the medications are not dispensed in the hospital,
the investigator argues that there is no need to use the hospital IRB. So
why do they need a waiver?
There is no sentiment in the Hospital toward reviewing all of the protocols
done in the community, but it is certainly possible (and has happened) that
subjects are admitted for unrelated problems and need to continue with their
study medication while in the hospital. It would require a two-thirds vote
of the medical staff to approve a bylaw change requiring the Hospital IRB to
review all outpatient studies or lose staff privileges. I doubt if it
would pass. We already review some of the outpatient studies (for free) and
it seems inconsistent to waive our responsibility.
How many of you have run into this problem? Any thoughts on how to handle
it?
The solicitor says, just sign it.
--James A. Wilson, M.D.
Chairman, LGH IRB
Jawx
7/13/2000 5:43:00 AM
community representatives
At our institution, community members are given a $50 stipend per meeting to
cover mileage, etc.
---Original Message-----
From: Monte Maney [mailto:fitp@aol.com]
Sent: Wednesday, July 12, 2000 9:41 PM
To: mcwirb@mcwirb.org
Subject: community representatives
,Our IRB is seeking advice on how much to pay our community representatives.
They provide an invaluable service and are a necessary and insightful
component
of the Board. I have spoken with administrators of several Boards and the
honorarium ranges from $100/meeting to $50/hour including several hours of
preparation time. Any advice would be appreciated.
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Brenda Merritt
7/13/2000 6:21:00 AM
community representatives
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We don't pay our board members. We do see them as extremely valuable but we
also see it as them doing a service to the entire community, not just to us.
Most of our members enjoy serving just for the satisfaction that they may be
lending a hand in discovering a new drug, device.....etc to improve the
future of our less fortunate community members.....those who have been
stricken with life-threatening and/or serious illnesses and injuries.
Erin J. Morgan
IRB Coordinator
Spartanburg Regional Medical Center
Phone: (864) 560-6892
Fax: (864) 560-6016
emorgan@srhs.com
> -----Original Message-----
> From: Monte Maney [SMTP:fitp@aol.com]
> Sent: Wednesday, July 12, 2000 9:41 PM
> To: mcwirb@mcwirb.org
> Subject: community representatives
>
> ,Our IRB is seeking advice on how much to pay our community
> representatives.
> They provide an invaluable service and are a necessary and insightful
> component
> of the Board. I have spoken with administrators of several Boards and the
> honorarium ranges from $100/meeting to $50/hour including several hours of
> preparation time. Any advice would be appreciated.
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: community representatives We don't pay our =
board members. We do see them as extremely valuable but we also =
see it as them doing a service to the entire community, not just to =
us. Most of our members enjoy serving just for the satisfaction =
that they may be lending a hand in discovering a new drug, =
device.....etc to improve the future of our less fortunate community =
members.....those who have been stricken with life-threatening and/or =
serious illnesses and injuries. Erin J. =
Morgan IRB Coordinator =
Spartanburg =
Regional Medical Center Phone: (864) =
560-6892 Fax: (864) =
560-6016 emorgan@srhs.com -----Original Message----- From: Monte Maney [SMTP:fitp@aol.com] Sent: Wednesday, July 12, 2000 9:41 PM To: mcwirb@mcwirb.org Subject: =
community representatives ,Our IRB is seeking advice on how much =
to pay our community representatives. They provide an invaluable service =
and are a necessary and insightful component of the Board. I have spoken =
with administrators of several Boards and the honorarium ranges from $100/meeting =
to $50/hour including several hours of preparation time. Any advice =
would be appreciated. _______________________________________________ MCWIRB maillist - =
MCWIRB@mcwirb.org http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb <=
/FONT>
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Erin
7/13/2000 6:24:00 AM
community representatives
We pay IRB members not employeed by our institution $150 per meeting.
Jeff Parks
IRB Manager
Palmetto Health Alliance Research Administration
Palmetto Richland Memorial Hospital
Med Park 5, Columbia, South Carolina 29203
tel: 803-434-4899; fax: 803-434-2885
email: jeff.parks@palmettohealth.org
>>> Monte Maney 07/12/00 09:41PM >>>
,Our IRB is seeking advice on how much to pay our community representatives.
They provide an invaluable service and are a necessary and insightful component
of the Board. I have spoken with administrators of several Boards and the
honorarium ranges from $100/meeting to $50/hour including several hours of
preparation time. Any advice would be appreciated.
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Jeffrey M. Parks, CIP
7/13/2000 6:46:00 AM
community representatives
All of our IRB members volunteer their time and talent. I rotate
assignments and keep things organized as much as possible to maximize the
benefit of their time. I have been firm about investigators meeting
deadlines, etc. so we are not having to constantly convene extra meetings or
try to do business by telephone.
> -----Original Message-----
> From: Monte Maney [SMTP:fitp@aol.com]
> Sent: Wednesday, July 12, 2000 6:41 PM
> To: mcwirb@mcwirb.org
> Subject: community representatives
>
> ,Our IRB is seeking advice on how much to pay our community
> representatives.
> They provide an invaluable service and are a necessary and insightful
> component
> of the Board. I have spoken with administrators of several Boards and the
> honorarium ranges from $100/meeting to $50/hour including several hours of
> preparation time. Any advice would be appreciated.
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sandra Armc-Prof Svcs
7/13/2000 11:18:00 AM
September 18, 2000 AAMC/PRIM&R Workshop
By way of this e-mail, I wanted to alert list members that the Sept. 18
PRIM&R/AAMC workshop Effective IRBs: The Fundamentals in Chicago is now
fully subscribed; no more registrations can be accepted at this time. The
limited enrollment is part of our effort to preserve a workshop-like
atmosphere at these events.
Please know that it is likely that we will have at least two more workshops
sometime in the future, and details will be announced as soon as they are
available.
Many thanks for your interest.
Allan Shipp, AAMC and Joan Rachlin, PRIM&R
rachlinj@aol.com
7/13/2000 6:43:00 AM
The following is a comparison of Title 21 vs. 45, regarding regulations
pertaining to IRBs and informed consent, as issued by FDA in an October 1995
Guidance document.
SIGNIFICANT DIFFERENCES IN HHS AND FDA REGULATIONS FOR IRBs AND INFORMED
CONSENT
The HHS regulations (45 CFR 46) apply to research involving human subjects,
conducted by the HHS or supported in whole or in part by the HHS. The FDA
regulations (21 CFR 50 and 56) apply to research involving products
regulated by the FDA-federal funds do not need to be involved. When research
involving products regulated by the FDA is funded by HHS, both the HHS and
FDA regulations apply.
IRB REGULATIONS WHICH DIFFER (FDA VS. HHS)
§56.102 (FDA) and §46.102 (HHS)
FDA definitions are included for terms specific to the type of research
covered by the FDA regulations (test article, application for research or
marketing permit, clinical investigation). A definition for emergency use is
provided.
§56.104 (FDA) and §46.116(HHS)
FDA provides exemption from the prospective IRB review requirement for
emergency use of test article in specific situations. HHS regulations
state that they are not intended to limit the provisions of emergency
medical care.
§56.105 (FDA) and §46.101 (HHS)
FDA provides for sponsors and sponsor-investigators to request a waiver of
IRB review requirements (not informed consent requirements). HHS exempts
certain categories or research and provides for a Secretarial waiver.
§56.109 (FDA), §46.109 (HHS) and §46.117(c) (HHS)
Unlike HHS, FDA does not provide that an IRB may waive the requirement for
signed consent when the principal risk is a breach of confidentiality
because FDA does not regulate studies which would fall into that category of
research. (Both regulations allow for IRB waiver of documentation of
informed consent in instances of minimal risk.)
§56.110 (FDA) and §46.110 (HHS)
The FDA list of investigations eligible for expedited review (published in
the federal register) does not include HHS criteria #9, because the types of
studies described are not regulated by FDA.
§56.114 (FDA) and §46.114 (HHS)
FDA does not discuss administrative matters dealing with grants and
contracts because they are irrelevant to the scope of the Agency's
regulation. (Both regulations make allowances for review of
multi-institutional studies.)
§56.115 (FDA) and §46.115 (HHS)
FDA has neither an assurance mechanism nor files of IRB membership.
Therefore, FDA does not require the IRB or institution to report changes in
membership whereas HHS does make that requirement. Because FDA has neither
an assurance mechanism nor files of IRB membership, there is no reason for
FDA to be informed about changes in membership.
§56.115(c) (FDA)
FDA may refuse to consider a study in support of a research or marketing
permit if the IRB or the institution refuses to allow FDA to inspect IRB
records. HHS has no such provision because it does not issue research or
marketing permits.
§56.120 - §56.124 (FDA)
FDA regulations provide sanctions for non-compliance with regulations.
INFORMED CONSENT REGULATIONS
§50.23 (FDA)
FDA, but not HHS, provides explicit guidance for an exemption from the
informed consent requirements in emergency situations. The provision is
based on a statutory requirement in the Medical Device Amendments of 1976
and may be used in investigations involving drugs, devices, and other FDA
regulated products in situations described in §50.23.
§46.116(c)and(d)(HHS)
HHS provides for waiving or altering elements of informed consent under
certain conditions. FDA has no such provision because the types of studies
which would qualify for this section are either not regulated by FDA or are
covered by the emergency treatment provisions (§50.23).
§50.25(a) (5) (FDA) and §46.116(a)(5) (HHS)
FDA explicitly requires that subjects be informed that FDA may inspect the
records of the study because FDA may occasionally examine a subject's
medical records as they pertain to the study. While HHS has the right to
inspect records of studies it funds, it does not impose that same informed
consent requirement.
-----Original Message-----
From: Clark, Elisabeth [SMTP:clarke@muhchem.mcgill.ca]
Sent: Thursday, July 13, 2000 4:38 PM
To: mcwirb@mcwirb.org
Subject: CFR anyone?
To the List
With respect to the mcwirb law of *no question too simple*, I seek
answers
to the following:
If a non-MPA constituted IRB established working procedures
consistent with
21 CFR 50 & 56 would situations arise where committee functioning
would not
be consistent with 45 CFR 46?
Could a request for waiver of documented informed consent simply be
refused
to remain compliant with FDA regs, assuming the refusal was
accounted for
by institutional SOPs?
Apart from FDA's comparison does another document exist to simplify
comparison of 45 CFR 46 with 21 CFR 50 and 56? Something similar to
the
comparison prepared by Paul Goebel of 21 CFR 50 and 56 with ICG E6
would be
nice.
... and finally why does the DeGette, Mica and Waxman Bill need to
bring
all human research under the Common Rule, if as an agency of HHS the
FDA
must function in accord with 45 CFR 46? Will the Common Rule
require
amending to accommodate the differing provisions in 21 CFR 50 & 56?
Thanks ... remember I'm Canadian ...
Elisabeth Clark
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Robert Catalano
7/13/2000 12:43:00 PM
A scenario for your consideration:
A protocol proposes to examine communication processing in aphasic
patients. The study would involve three different sessions, each on a
different day, in which the patient (or an age matched control recruited
from local nursing homes) met with a speech pathologist for a battery of
word and sound association tests. The total time involved will be 3-5 hrs.
The inclusion criteria for the protocol means that only a few patients
(<15) will be available for the study. The data collected for the aphasic
group will be compared to the age-matched and control group.
The local IRB raised the question as to whether the number of research and
control subjects in the study would allow the investigators to make
meaningful statistical comparisons between the groups. The PI responded
that aphasic patients who meet the inclusion criteria are hard to come by
and the standard practice in the field is to study whatever patients the
investigator can recruit, regardless of considerations of statistical validity.
The issue is whether this research should be done as proposed.
One argument holds that if there are not sufficient numbers of research
subjects to make meaningful conclusions, then the research should not be
done. Even though the study is minimally invasive, it involves time and
effort of (usually) elderly individuals who have significant problems
communicating, and perhaps other problems associated with their CVA. Also,
if diagnostic, prognostic and therapeutic conclusions are drawn from this
sort of research in which the study population may not be representative of
aphasic patients in general, then these clinical decisions may not be made
on the basis of adequate information.
On the other hand, this is the sort of problem that arises when
investigating rare diseases and pathologies. Should we not investigate
such diseases/pathologies and lose the chance to obtain important insight
into them simply because you may not be able to run powerful statistical
analysis on the results?
How should an IRB handle this scenario?
Thanks for your input.
Steven S. Clark, Ph.D.
Associate Professor of Human Oncology and
Member, UW Comprehensive Cancer Center
University of Wisconsin School of Medicine
600 Highland Ave, K4/432
Madison, WI 53792
Office: (608) 263-9137
FAX: (608) 263-4226
ssclark@facstaff.wisc.edu
http://www.humonc.wisc.edu/clark/
Steve Clark
7/13/2000 3:52:00 AM
community representatives
Interesting question. Over the years, our community reps have volunteered their time and compensation has never been considered apart from their receiving courtesy parking for meetings and eating the same luncheon buffet as other members.
bjr
>>> Monte Maney 07/12 9:41 PM >>>
,Our IRB is seeking advice on how much to pay our community representatives.
They provide an invaluable service and are a necessary and insightful component
of the Board. I have spoken with administrators of several Boards and the
honorarium ranges from $100/meeting to $50/hour including several hours of
preparation time. Any advice would be appreciated.
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Barbara Riter
7/13/2000 6:18:00 AM
community representatives
Monte,
We pay our community member a relatively small stipend of approximately $60/meeting and mileage of $0.31/mile to and from the convened IRB meetings (approximately 16-20 miles roundtrip). We are a relatively small organization, and only meet once during each month for approximately 2+ hours. On rare occasions we might hold convened meetings twice during the month. Our community member is not paid for his time spent to review protocols in preparation for the IRB meetings.
We are a public agency, and the community member has indicated that, if we were unable to pay him, he would serve on our board on a volunteer basis. However, if we were a private for-profit corporation, I doubt that he or other potential community members would be as willing to serve free gratis.
Hope this helps.
Mary
>>> Monte Maney 07/12/00 07:41PM >>>
,Our IRB is seeking advice on how much to pay our community representatives.
They provide an invaluable service and are a necessary and insightful component
of the Board. I have spoken with administrators of several Boards and the
honorarium ranges from $100/meeting to $50/hour including several hours of
preparation time. Any advice would be appreciated.
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Mary M. Caputo
Bureau of Internal Review & Audit
Utah State Department of Human Services
120 North 200 West, Rm. 221
Salt Lake City, UT 84103
(801) 538-4295
(801) 538-9881 FAX
Mary Caputo
7/13/2000 11:24:00 AM
I can't claim as many yrs on an IRB (only 3-1/2) but I've had 15 yrs
experience analyzing medical research data, much of it working with the
kinds of tests that are the measures in this study. Performance tests can
be quite different from other data seen in medical research. If well
designed and administered, they can be more reliable than, say, laboratory
tests. Also, the difference between normal and aphasic responding could
easily exceed the interocular trauma test for significance. I hardly
think it is fair apriori to assume that a small sample is not sufficient to
detect a clinically meaningful difference in performance. I do think the
burden rests on the investigators to suggest what sort of effect they expect
to see, and to produce evidence of the reliability of their measures as
tests of aphasia. Unless of course they are trying to validate a new set of
measures--which is a different situation altogether.
I agree that using nonparametrics worsens the situation.
Chris
> -----Original Message-----
> From: Richard Goldstein [SMTP:richgold@ix.netcom.com]
> Sent: Monday, July 10, 2000 2:22 PM
> To: Steve Clark
> Cc: mcwirb@mcwirb.org
> Subject: Re: The power of statistics
>
> As a statistician who served for 9 years on 2 IRB's, I have the
> following points to make:
>
> 1. Although people (i.e., researcher's) claim that they will not
> interpret a failure to reject the null hypothesis as an acceptance of
> the null, this is generally not true -- it is a very easy trap to fall
> into.
>
> 2. There are many ways to increase the power of a study without
> increasing the sample size: note that power depends on variability and
> that some research designs result in less variability than to other
> research designs; insufficient information is provided in the question
> to determine whether a re-design would help here.
>
> 3. There are ways to increase the sample size:
> a. loosen the inclusion/exclusion criteria; this may be desirable
> for
> of generalizability anyway; it may also be desirable for reasons
> of
> justice (a more fair sharing of the research burden).
>
> b. increase the length of the study (e.g., if now set for 6 months,
> make it
> for one year).
>
> c. add other sites.
>
> 4. I note that one of your comments said that the researcher's plan to
> use non-parametric statistical analysis techniques. This is sometimes
> done under the mistaken impression that these techniques involve no
> distributional assumptions; they do not involve assumptions about
> parameters (e.g., the mean or the standard deviation), but many, if not
> all, do involve assumptions about the distribution of the data; e.g.,
> many assume the data are symmetrically distributed. If these
> assumptions are false, then power is reduced and since the power of
> non-parametric techniques is generally lower than the power of
> parametric techniques (when the parametric assumptions are met), this
> just makes the situation worse.
>
> Based on your question and the information supplied, I would vote to
> reject the study on the grounds that a higher power study is possible
> with additional work.
>
> Rich Goldstein
>
> Steve Clark wrote:
> >
> > A scenario for your consideration:
> >
> > A protocol proposes to examine communication processing in aphasic
> > patients. The study would involve three different sessions, each on a
> > different day, in which the patient (or an age matched control recruited
> > from local nursing homes) met with a speech pathologist for a battery of
> > word and sound association tests. The total time involved will be 3-5
> hrs.
> >
> > The inclusion criteria for the protocol means that only a few patients
> > ( aphasic
> > group will be compared to the age-matched and control group.
> >
> > The local IRB raised the question as to whether the number of research
> and
> > control subjects in the study would allow the investigators to make
> > meaningful statistical comparisons between the groups. The PI responded
> > that aphasic patients who meet the inclusion criteria are hard to come
> by
> > and the standard practice in the field is to study whatever patients
> the
> > investigator can recruit, regardless of considerations of statistical
> validity.
> >
> > The issue is whether this research should be done as proposed.
> >
> > One argument holds that if there are not sufficient numbers of research
> > subjects to make meaningful conclusions, then the research should not be
> > done. Even though the study is minimally invasive, it involves time and
> > effort of (usually) elderly individuals who have significant problems
> > communicating, and perhaps other problems associated with their CVA.
> Also,
> > if diagnostic, prognostic and therapeutic conclusions are drawn from
> this
> > sort of research in which the study population may not be representative
> of
> > aphasic patients in general, then these clinical decisions may not be
> made
> > on the basis of adequate information.
> >
> > On the other hand, this is the sort of problem that arises when
> > investigating rare diseases and pathologies. Should we not investigate
> > such diseases/pathologies and lose the chance to obtain important
> insight
> > into them simply because you may not be able to run powerful statistical
> > analysis on the results?
> >
> > How should an IRB handle this scenario?
> >
> > Thanks for your input.
> > Steven S. Clark, Ph.D.
> > Associate Professor of Human Oncology and
> > Member, UW Comprehensive Cancer Center
> > University of Wisconsin School of Medicine
> > 600 Highland Ave, K4/432
> > Madison, WI 53792
> >
> > Office: (608) 263-9137
> > FAX: (608) 263-4226
> >
> > ssclark@facstaff.wisc.edu
> > http://www.humonc.wisc.edu/clark/
> >
> > _______________________________________________
> > MCWIRB maillist - MCWIRB@mcwirb.org
> > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Gullion Christina M
7/13/2000 3:52:00 AM
The following question was posed to me at our recent IRB meeting:
>How are IRB's covered by liability insurance?
>Being the first time that this has come up for our institution, I don't
>know the answer to this question. I would appreciate any information from >McWIRBer's on this topic.
>Respectfully,
>Janette E. Rangel
>IRB Coordinator
>Texas Cancer Center
>at Brackenridge Hospital
>Austin, Texas
>jrangel@seton.org
Anonymous
7/12/2000 11:11:00 AM
Janette,
All four of my IRB's are hospital committees, either Medical Staff Committees
or Administrative committees. As such, we are all covered by the hospitals
insurance, since we are working for the hospital.
Rebecca M. Clark
Scripps Health/Children's Hospital IRBs
San Diego, CA
(858) 576-4008
rebcaclark@aol.com
Rebecca M. Clark
7/12/2000 11:11:00 AM
Ann,
I am inclined to think that there are three issues here, on one of which I
agree with you!
1. If you object to being addressed in a particular way, it is simple
good manners for your colleagues to refrain from so addressing you. If you
are known to object to being referred to as chairman, then it is rude and
disrespectful of someone knowing your objection deliberately so to address
you.
2. Are you affording the same respect that you demand for your views to
the views (based on sound etymology) of those who regard the word chairman
as gender non-specific? How do you address a person (of either sex) who
prefers to be referred to as chairman?
3. I find very disturbing your desire for a legal ruling. This strikes me
as verging on the orwellian, and contrary to the principle of freedom of
expression.
Regards
Richard Doehring
Member: Taranaki Ethics Committee
New Plymouth, New Zealand
Doehring
7/12/2000 4:48:00 AM
Pharmacy Costs for Research
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Our hospital is also developing a research program so I, too, am
interested in any current fee structures for pharmacy services related to
hospital-based clinical research. I have two articles that are 9-12 years
old that provide some fee structure information (I'll fax these to anyone
who would like them) but would really like to have more up-to-date
information. Thanks.
Robert Middleton, Pharm.D.
Beebe Medical Center
Department of Pharmacy
424 Savannah Road
Lewes, DE 19958
Phone: 302-645-3779
Fax: 302-645-3624
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> Pharmacy Costs for Research Our hospital is also developing a research program so I, =
too, am interested in any current fee structures for pharmacy services =
related to hospital-based clinical research. I have two articles =
that are 9-12 years old that provide some fee structure information =
(I'll fax these to anyone who would like them) but would really like to =
have more up-to-date information. Thanks. Robert Middleton, Pharm.D. Beebe Medical Center Department of Pharmacy 424 Savannah Road Lewes, DE 19958 Phone: 302-645-3779 Fax: 302-645-3624
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Bob
7/12/2000 11:11:00 AM
Friends:
I know there are more important bioethical issues to grapple with, so I apologize for beating an old feminist horse to death, but I'm sooooo tired of being called ChairMAN that I think I'm gonna scream! I am very clear about what I believe the morally and politically correct nomenclature is, but I don't know if I have a legal leg to stand on. Can anyone help me out with the legally acceptable terminology?
I am concerned with investigators who, in spite of numerous requests to call me Chair, or if you must, call me Sofa, but please don't call me Chairman continue (over and over and over again) to call me ChairMAN. How can I feel comfortable that they are recognizing study participants humanity when they cannot acknowledge mine? Do I have any recourse (three strikes and you're out) regarding their protocols? Chapter and verse citations would be gratefully appreciated.
Ann Danoff,MD
IRB Chairgirl
Bronx-Lebanon Hospital Center, NY
Anonymous
7/12/2000 6:31:00 AM
Dear Janette:
There was a discussion of this issue just recently about the first or second
week of June that you might want to access. Unless you're a free-standing
IRB, separately incorporated, which I doubt you are, the most practical
answer to your question can probably be obtained from your institution's
risk manager or general counsel or the center/hospital administrator. My
guess is that whatever coverage your IRB and its members have is provided by
the general policy held by your parent institution and that there is no
exclusion for the IRB.
Good luck.
Tom Dalglish J.D., Ph.D.
Community Representative, Committee C
University of Washington
(206) 543-0098 (University)
(206) 706-1000 (Office)
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
Of Janette Rangel
Sent: Wednesday, July 12, 2000 9:13 AM
To: mcwirb@mcwirb.org
Subject: Liability
The following question was posed to me at our recent IRB meeting,
how are IRB's covered by liability insurance?
Being the first time that this has come up for our institution, I don't
know the answer to this question. I would appreciate any information from
McWirber's on this topic.
Respectfully,
Janette E. Rangel
IRB Coordinator
Texas Cancer Center
at Brackenridge Hospital
Austin, Texas
jrangel@seton.org
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
thomas k. dalglish
7/12/2000 11:11:00 AM
Hello,
There are terms and tones other than chairman which convey authority and
focus,chair, or madame chair among them. Using chairman for a woman
could, in the opinion of many, remind both the speaker and the addressee
that the locus of historical authority has rested almost exclusively with
men, a fact which is gratefully - but slowly - changing. Our language should
correspondingly change to match this belated trend. As Dr. Danoff suggests,
for some the language used is an explicit reminder of gender inequality,
while for others it is sub or unconscious.
In a sense, the issue raised by Dr. Danoff is a microcosm of the problems
faced by investigators and IRBs when drafting consent forms, or other
materials designed for research participants or patients. It is important in
those cases to set aside OUR conventional ways of talking and even thinking,
in favor of trying to find ways of communicating that are more respectful,
inclusive, and appropriate for the intended party. This is not easy, but it
is important to try. Language is powerful, and words can support or undermine.
Joan Rachlin
In a message dated 7/12/2000 9:57:05 AM Eastern Daylight Time,
Konopkv@mail.amc.edu writes:
<<
Dear Dr. Danoff,
I suppose in the age of Political Correctness I should come to
the same conclusion that you have regarding the word Chairman
not recognizing your female gender. On the other hand, Chairman
to me is a respectable title with authority and focus. It is a word
that denotes Leader (whether male or female). I do not view this
as a gender issue. It would not be important to me that someone recognizes
my
gender as long as they recognized my intellect, capabilities and treated me
with equal respect. If you are being treated with the respect and dignity you
deserve then you may want to rethink your position.
Having said that however, it is obvious this is a sore point for you. Since
all investigators and IRB Members would be subject to the title change, you
would need to send something in written form letting everyone know you prefer
the word Chairperson or Chairwomen or whatever you decide. You will also
need to review your SOP's and other documents to make sure no other wording
changes will need to be clarified.
I hope you can resolve this issue in a way that will bring closure to
the gender issue for you and your IRB. Good Luck!
These comments are strickly my own opinion and in no way a reflection
of the instituion with which I am affiliated.
Valerie Konopka, MA
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb. >>
rachlinj@aol.com
7/12/2000 6:31:00 AM
No question this is a sensitive and prickly issue. The chair, as I understand, goes back to ancient times when the most authoritative posture for a teacher or religious or political figure was to sit down while others stood (hence the throne.) Since patriarchy ruled, chairMAN simply rolled off the tongue. In my circles, people use the terms chairperson rather than chairwoman. That way, no gender reference is made. Or, one can say The chair--I do think that every effort should be made to avoid patriarchal language. It is not egalitarian and it is often patronizing and demeaning. Thanks for raising the issue.
James Londis
Director of Ethics and Corporate Integrity
Kettering Medical Center Network
Dayton, Ohio
james.londis@kmcnetwork.org
>>> danoffann@aol.com 07/11/00 10:48AM >>>
Friends:
I know there are more important bioethical issues to grapple with, so I
apologize for beating an old feminist horse to death, but I'm sooooo tired of
being called ChairMAN that I think I'm gonna scream! I am very clear about
what I believe the morally and politically correct nomenclature is, but I
don't know if I have a legal leg to stand on. Can anyone help me out with the
legally acceptable terminology?
I am concerned with investigators who, in spite of numerous requests to call
me Chair, or if you must, call me Sofa, but please don't call me Chairman
continue (over and over and over again) to call me ChairMAN. How can I feel
comfortable that they are recognizing study participants humanity when they
cannot acknowledge mine? Do I have any recourse (three strikes and you're out)
regarding their protocols? Chapter and verse citations would be gratefully
appreciated.
Ann Danoff,MD
IRB Chairgirl
Bronx-Lebanon Hospital Center, NY
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
James Londis
7/12/2000 5:12:00 AM
I doubt that there are many legal precedents that can be cited. I
think this is more of an institutional policy issue. It sounds to
me like the head of your institution needs to put out a message to
all staff urging them to eliminate sexist language in all official
businss and providing them with guidelines for doing so. Your
organization cannot be a top-notch organization and cannot compete in the
job market for top-notch people if it permits sexism to persist.
Unfortunately there are still quite a few "old boys" around who
do not appreciate the fact that these kinds of things matter.
There are a number of organizations that have issued guidelines on
avoiding sexist language. Two particularly good ones that I use
are:
1. "Guidelines for Equal Treatment of the Sexes in McGraw-Hill
Book Company Publications"
2. "Guidelines for Avoiding Sexist Language" (from the
Unitarian-Universalist Assoc.)
(But I am sure that there are others available from other organizations,
too.)
The second one is particularly good because it is an easy to use little
brochure that can be purchased in quantity for very reasonable
prices. It is available from:
The Unitarian Universalist Association
25 Beacon Street
Boston, MA 02108
Perhaps your director would be willing to purchase a box of these and
send them to all staff members along with a note asking people to follow
them.
I have always referred to myself as "Chair" of the IRB and that
seems to work.
Brian Belanger
IRB Chair National Institute of Standards and Technology
Brian Belanger
7/12/2000 5:28:00 AM
Pharmacy Costs for Research
Our institution is creating a fee schedule for pharmacy involvement in
hospital-based clinical research projects. Would you please share your
existing institutional charges with me and break out individual items if
possible? I would appreciate any information you have available.
Edwin V. Gaffney, Ph.D.
Executive Director
Clinical Research Center
Baptist Health System, Inc.
860 Montclair Road, Suite 764
Birmingham, AL 35213
Phone: 205/599-3017
Fax: 205/599-3060
Edwin
7/12/2000 11:11:00 AM
I fully realize your problem. I looked into Webster's Dictionary - Chair is
defined as an office seat or seat of authority; an office or position of authority
or dignity. Professorship is included and unfortunately the Chairman comes
here.... Webster's needs updating. Now, the other term I've heard used is Chief
such as service Chiefs in hospitals. Again, Webster's definition of chief is leader
or the head of a body or persons. We've at our University just use only Chair
Now, I know this doesn't really help you. I also knowof no regulations. But, in
the last few months I had this tremendous discussion with a journal editor of
pharmacy (I won't identify the person or journal) about the use of the word sex vs
gender in scientific publications. I talked to several journal editors in medicine
who are women about this issue and most feel that it is extremely difficult to
change the cannons of scientific terminology (worse than the Ten Commandments?!).
So, what I can say....except do what you think is right and what you can live
with....
Ann Danoff wrote:
> Friends:
>
> I know there are more important bioethical issues to grapple with, so I
> apologize for beating an old feminist horse to death, but I'm sooooo tired of
> being called ChairMAN that I think I'm gonna scream! I am very clear about
> what I believe the morally and politically correct nomenclature is, but I
> don't know if I have a legal leg to stand on. Can anyone help me out with the
> legally acceptable terminology?
>
> I am concerned with investigators who, in spite of numerous requests to call
> me Chair, or if you must, call me Sofa, but please don't call me Chairman
> continue (over and over and over again) to call me ChairMAN. How can I feel
> comfortable that they are recognizing study participants humanity when they
> cannot acknowledge mine? Do I have any recourse (three strikes and you're out)
> regarding their protocols? Chapter and verse citations would be gratefully
> appreciated.
>
> Ann Danoff,MD
> IRB Chairgirl
> Bronx-Lebanon Hospital Center, NY
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Michael Jann
7/12/2000 5:25:00 AM
U.S. Halts Cancer Tests In Oklahoma
By Rick Weiss and Deborah Nelson
Washington Post Staff Writers
Tuesday, July 11, 2000; Page A01
Federal regulators have shut down all government-funded human medical
experiments at the University of Oklahoma Health Sciences Center in Tulsa
amid evidence that researchers there broke multiple rules designed to
protect patients and then tried to cover up their lapses by withholding
information from university overseers and patients.
Among the concerns that led to the unusually severe disciplinary action were
that dozens of cancer patients may have been injected with experimental
cancer-fighting vaccines contaminated with dangerous bacteria or viruses;
that 11 of the first 18 patients to get the vaccines were not eligible for
the study; and that the informed-consent form given to volunteers overstated
the possible benefits of the experiment and understated the risks.
University officials said yesterday they were looking into the lapses but
had found no evidence that any patients had been harmed.
The research suspension, which affects about 75 studies on campus,
represents the first major disciplinary action by the newly constituted
federal Office for Human Research Protections (OHRP). Health and Human
Services Secretary Donna E. Shalala created the office in the past month in
response to a growing recognition of the need for enhanced federal oversight
of human clinical studies.
Michael Carome, OHRP's chief of compliance, sent a 17-page letter to
University of Oklahoma officials on June 29, outlining a plethora of patient
protection failings. Most were related to a study of the experimental cancer
vaccine, which had been approved for use in 40 patients with advanced
melanoma--a deadly form of skin cancer--but which was actually injected into
at least 90 patients. The study was led by Michael McGee, who was vice
chairman of the university's department of surgery until recently, when he
was relieved of that status.
According to OHRP's letter, first described yesterday in USA Today and
obtained by The Washington Post, McGee's department asked a private
consulting group to conduct an independent audit of the work early this
year.
Among that group's March findings: The university researchers making the
cancer vaccine were not qualified to do so; the techniques used could not
ensure that the vaccine doses were produced free of contamination; the
vaccines were being shipped to remote locations for injection into patients
without proper assurance that they remained cold enough and were
administered properly; and there was no reliable system for determining
whether illnesses experienced by vaccine recipients--indeed, whether any of
the 26 deaths that occurred among those patients--were due to the vaccine.
The auditors recommended that the experiment, which they said suffered from
egregious lapses, be discontinued immediately, since adequate precautions
to protect the safety of patients have not been taken. The auditors also
noted that liability and public relations issues could surface as a result
of this trial, according to a subsequent memo from McGee's boss, the
chairman of surgery, to the university's dean.
But certain key details of that report, including the possibility that
patients may have been harmed by the vaccine, were not immediately forwarded
to the university's Institutional Review Board (IRB), which is responsible
for ensuring patient safety in clinical studies, or to surviving patients,
as is required by federal regulations and international principles of human
medical research.
Instead, in an April 10 letter to participating researchers and surviving
patients, and in a May 17 report to the IRB, McGee wrote that the study had
been suspended because so many patients had expressed interest in the study
that they had run out of vaccine. McGee also wrote that there are no
significant safety issues.
In a telephone interview yesterday, Ken Lackey, president of the
university's Tulsa campus, said the school had recently hired consultants to
review each patient's medical chart and look for evidence that any may have
been harmed by the vaccine. It certainly appears from that review that all
the deaths were from the natural consequences of their diseases, he said.
As for the vaccine samples themselves, he said, they were all tested and
found to be free of contamination.
This past weekend, fulfilling one of OHRP's required corrective actions,
the university sent out new letters to doctors involved in the study, the
surviving participants' primary care physicians and the closest known
relatives of deceased patients, explaining the truth about why the study was
suspended.
Lackey said he had disbanded the university's IRB and relieved two
high-ranking research oversight officials of their administrative duties
while the university completes its own internal investigation and prepares
to come back into compliance with federal regulations.
Staff researcher Alice Crites contributed to this report.
http://washingtonpost.com/wp-dyn/articles/A16527-2000Jul10.html
Imre
7/11/2000 1:58:00 PM
Steve Clark wrote:
> They seemed to imply that studies that didn't have strong statistical power
> are,
> therefore, qualitative studies. I think that this is wrong thinking.
I am also concerned that qualitative research is getting a bad name in these
discussions. Although my knowledge of this field is limited, I feel the need to
stop lurking and throw in my thoughts.
Qualitative research refers to a group of research methods, including
phenomenology, grounded theory, discourse analysis, etc., that have in common an
emphasis on rich description rather than quantitative analysis. The data
collection goes deep rather than broad, i.e. lots of information about a few
subjects instead of a bit of information about a lot of subjects. A case history
illustrates the kind of information that might be sought in a qualitative study
(although on its own it does not make for a qualitative study). Each type of
qualitative method is supported by its own theoretical framework and is
associated with specific study design including the type of research question
that can be asked, rationale for selection of subject population and methods for
analysis of the results. Thus you would not take a quantitative study design and
call if qualitative if you do not have enough subjects.
If I have made any errors I apologize to the qualitative experts out there.
Nancy Ondrusek
Nancy Ondrusek
7/11/2000 1:58:00 PM
FYI
Table of contents
MONASH BIOETHICS REVIEW - a peer reviewed bioethics journal
VOL.19 NO.3 JULY 2000
Complementary medicine, evidence based medicine and informed consent
by John Gruner
Breaching confidentiality in the public interest: Guidance from
Canada? by Bernadette McSherry
Who killed Jesse Gelsinger? Ethical issues in human gene therapy by
Satya Shreenivas
Ethics and trials in developing countries: Researchers and
responsibility by Daniel Reidpath, Pascale Allotey, and Joe Thomas
Plus: News in Brief * At the Centre *
Ethics Committee Supplement * Notes *
To order copies and for subscription details contact Heather Mahamooth
email: Heather.Mahamooth@arts.monash.edu.au
All the best
Merle Spriggs
--
Co-Editor Monash Bioethics Review
Centre for Human Bioethics
P.O. Box 11A, Monash University
Victoria 3800, Australia
Phone +61 3 9905 5163
Fax +61 3 9905 3279
Merle.Spriggs@arts.monash.edu.au
http://www.arts.monash.edu.au/bioethics/index.htm
Merle Spriggs
7/10/2000 2:39:00 AM
My two cents:
There seems to be some confusion regarding the notion that inferential
statistical analysis is the sine qua non of experimental research. BF
Skinner, and his progeny who use Functional Analysis of Behavior
technologies, have generated a rich literature leading to a full
understanding of the general laws of human and animal learning by using
single case designs (studying one organism at a time) that are clearly
experimental in nature. Statistical analyses are rarely used (those used are
akin to time-series designs due to the autocorrelated error problem), and
data are usually interpreted graphically without benefit of inferential
statistics. My friends who use this experimental technology (as compared to
those of us who use between-group/within-group/or cross-over large-N
methodologies) would bristle at the notion that this research approach is
either qualitative or not rigorous science. Also, behavioral
pharmacologists examining the characteristics of drugs in pre-clinical
experiments often present experimental data in graphical form without
benefit of inferential statistics--many such studies get into top-flight
science journals. My point is that use of inferential statistics is not a
defining characteristic of the experimental approach.
Best wishes,
Mitchell Berman, Ph.D.
Co-chair, IRB
USM
Mitchell Berman
7/10/2000 2:39:00 AM
paying traveling expenses forstudy participants
>>> Mick, Deborah 07/06/00 09:44AM >>>
wrote :
one of our PI's would like to pay a study patient 32 cents/mile for
travel
expenses. THis is currently not outlined in the consent form and he
only
wants to offer this to one patient. Does this offer not have to be in
the
consent form and available to all participants?
..............................................................................................................................
Hi,
This is an unusual request, to say the least. What motivates it ?
You may want to consider an extension of the notion of Justice as
explicated in the Belmont Report.
With respect to this particular group of research subjects, should one
subject only be targeted as the beneficiary
of a proposal that is intended to diminish the burden associated with
participation in the investigational study ?
I cannot readily conceive of a situation that would justify this.
Depending on the actual circumstances, one could even
suggest that this represents inappropriate inducement to
participation.
Regards,
Howard
Howard Mann
7/10/2000 2:33:00 AM
Thanks for the input. I agree that qualitative studies are valuable, but
the study I am concerned about is a between-group comparison in which
statistical power should be a concern (in my opinion). I am concerned by
some of the responses I received to my original inquiry. They seemed to
imply that studies that didn't have strong statistical power are,
therefore, qualitative studies. I think that this is wrong thinking.
At 07:56 PM 07/07/2000 -0500, Mitchell Berman wrote:
>My two cents:
>There seems to be some confusion regarding the notion that inferential
>statistical analysis is the sine qua non of experimental research. BF
>Skinner, and his progeny who use Functional Analysis of Behavior
>technologies, have generated a rich literature leading to a full
>understanding of the general laws of human and animal learning by using
>single case designs (studying one organism at a time) that are clearly
>experimental in nature. Statistical analyses are rarely used (those used are
>akin to time-series designs due to the autocorrelated error problem), and
>data are usually interpreted graphically without benefit of inferential
>statistics. My friends who use this experimental technology (as compared to
>those of us who use between-group/within-group/or cross-over large-N
>methodologies) would bristle at the notion that this research approach is
>either qualitative or not rigorous science. Also, behavioral
>pharmacologists examining the characteristics of drugs in pre-clinical
>experiments often present experimental data in graphical form without
>benefit of inferential statistics--many such studies get into top-flight
>science journals. My point is that use of inferential statistics is not a
>defining characteristic of the experimental approach.
>
>Best wishes,
>Mitchell Berman, Ph.D.
>Co-chair, IRB
>USM
Steve Clark
7/10/2000 9:03:00 AM
As a statistician who served for 9 years on 2 IRB's, I have the
following points to make:
1. Although people (i.e., researcher's) claim that they will not
interpret a failure to reject the null hypothesis as an acceptance of
the null, this is generally not true -- it is a very easy trap to fall
into.
2. There are many ways to increase the power of a study without
increasing the sample size: note that power depends on variability and
that some research designs result in less variability than to other
research designs; insufficient information is provided in the question
to determine whether a re-design would help here.
3. There are ways to increase the sample size:
a. loosen the inclusion/exclusion criteria; this may be desirable for
of generalizability anyway; it may also be desirable for reasons of
justice (a more fair sharing of the research burden).
b. increase the length of the study (e.g., if now set for 6 months,
make it
for one year).
c. add other sites.
4. I note that one of your comments said that the researcher's plan to
use non-parametric statistical analysis techniques. This is sometimes
done under the mistaken impression that these techniques involve no
distributional assumptions; they do not involve assumptions about
parameters (e.g., the mean or the standard deviation), but many, if not
all, do involve assumptions about the distribution of the data; e.g.,
many assume the data are symmetrically distributed. If these
assumptions are false, then power is reduced and since the power of
non-parametric techniques is generally lower than the power of
parametric techniques (when the parametric assumptions are met), this
just makes the situation worse.
Based on your question and the information supplied, I would vote to
reject the study on the grounds that a higher power study is possible
with additional work.
Rich Goldstein
Steve Clark wrote:
>
> A scenario for your consideration:
>
> A protocol proposes to examine communication processing in aphasic
> patients. The study would involve three different sessions, each on a
> different day, in which the patient (or an age matched control recruited
> from local nursing homes) met with a speech pathologist for a battery of
> word and sound association tests. The total time involved will be 3-5 hrs.
>
> The inclusion criteria for the protocol means that only a few patients
> ( group will be compared to the age-matched and control group.
>
> The local IRB raised the question as to whether the number of research and
> control subjects in the study would allow the investigators to make
> meaningful statistical comparisons between the groups. The PI responded
> that aphasic patients who meet the inclusion criteria are hard to come by
> and the standard practice in the field is to study whatever patients the
> investigator can recruit, regardless of considerations of statistical validity.
>
> The issue is whether this research should be done as proposed.
>
> One argument holds that if there are not sufficient numbers of research
> subjects to make meaningful conclusions, then the research should not be
> done. Even though the study is minimally invasive, it involves time and
> effort of (usually) elderly individuals who have significant problems
> communicating, and perhaps other problems associated with their CVA. Also,
> if diagnostic, prognostic and therapeutic conclusions are drawn from this
> sort of research in which the study population may not be representative of
> aphasic patients in general, then these clinical decisions may not be made
> on the basis of adequate information.
>
> On the other hand, this is the sort of problem that arises when
> investigating rare diseases and pathologies. Should we not investigate
> such diseases/pathologies and lose the chance to obtain important insight
> into them simply because you may not be able to run powerful statistical
> analysis on the results?
>
> How should an IRB handle this scenario?
>
> Thanks for your input.
> Steven S. Clark, Ph.D.
> Associate Professor of Human Oncology and
> Member, UW Comprehensive Cancer Center
> University of Wisconsin School of Medicine
> 600 Highland Ave, K4/432
> Madison, WI 53792
>
> Office: (608) 263-9137
> FAX: (608) 263-4226
>
> ssclark@facstaff.wisc.edu
> http://www.humonc.wisc.edu/clark/
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Richard Goldstein
7/10/2000 11:23:00 AM
paying traveling expenses forstudy participants
one of our PI's would like to pay a study patient 32 cents/mile for travel
expenses. THis is currently not outlined in the consent form and he only
wants to offer this to one patient. Does this offer not have to be in the
consent form and available to all participants?
Deborah Mick
IRB Specialist-MGH/Sutter
415/925-7965
email: mickd@sutterhealth.org
Deborah Mick
7/10/2000 2:33:00 AM
NEJM article on Chinese herbs
>>> Howard Trachtman 07/03/00 03:09PM >>> wrote:
I was just reading the article in the 6/8/00 issue of the NEJM in which
the authors described the occurrence of uroepithelial cancer in 18/39
kidneys removed prophylactically from patients who had been treated with
Chinese herbs. Is this research? Is IRB approval needed? None is
recorded in the Methods section. How does one go about getting IRB
approval for a surgical procedure (removal of native kidneys) of unknown
value in the absence of any data? Doesn't this paper suggest that much
critical work of undetermined risk and benefit is being carried out all
the time without IRB oversight and later surfaces as research?
............................................................................................................................................................
Hi,
In the methods section of the article, it states :
After informing the patients about the risk of cancer in the native
urinary tract, we suggested the prophylactic removal of their
nonfunctioning atrophic native kidneys, including the ureters.
Thus, the surgical procedure involved patients and was not
investigational. Their recommendation was based on existent evidence
associating the herb with the development of cancer ( as described and
referenced in the article).
Regards,
Howard
Howard Mann
7/7/2000 9:54:00 AM
NEJM article on Chinese herbs
>>> Howard Trachtman 07/03/00 03:09PM >>> wrote:
I was just reading the article in the 6/8/00 issue of the NEJM in which
the authors described the occurrence of uroepithelial cancer in 18/39
kidneys removed prophylactically from patients who had been treated with
Chinese herbs. Is this research? Is IRB approval needed? None is
recorded in the Methods section. How does one go about getting IRB
approval for a surgical procedure (removal of native kidneys) of unknown
value in the absence of any data? Doesn't this paper suggest that much
critical work of undetermined risk and benefit is being carried out all
the time without IRB oversight and later surfaces as research?
............................................................................................................................................................
Hi,
In the methods section of the article, it states :
After informing the patients about the risk of cancer in the native
urinary tract, we suggested the prophylactic removal of their
nonfunctioning atrophic native kidneys, including the ureters.
Thus, the surgical procedure involved patients and was not
investigational. Their recommendation was based on existent evidence
associating the herb with the development of cancer ( as described and
referenced in the article).
Regards,
Howard
Howard Mann
7/7/2000 9:56:00 AM
NEJM article on Chinese herbs
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Howard Trachtman
7/7/2000 9:56:00 AM
Survey of College Freshmen
IMO, the inclusion of questions about alcohol use and political views would
exclude the possibility of exemption because the federal regulations do not
allow such sensitive issues to be included in exemptions. Also, data
collected during the conduct of exempt research must be anonymous...meaning
that even the researcher CANNOT identify the subjects. there can be no
identifiers whatsoever. Adding the element of coercion...well, nothing more
needs to be said.
(Although no longer employed there, I have several years of experience as
the IRB Administrator for a socio-behavioral IRB at a Midwestern
University.)
Our IRB just received a protocol for this year's survey and again have
serious problems with it. (At our IRB's direction, students under 18 are
now excluded from the survey here.) The survey is still claimed to be
exempt. CIRP still claims that there are no sensitive questions -- yet it
asks students about their alcohol consumption (a crime), whether they
suffer from depression (a health problem that could affect future
employability and insurability), their political and moral views, and
family history. They must provide their full name and social security
number to allow followup.
At our insistence, the survey forms given to Georgia Tech freshmen must
emphasize that completion of any or all questions is voluntary. Yet,
proctors are told to convince the reluctant students to complete the
forms. It's hard to imagine a group more vulnerable to coercion than
college freshmen on their first day away from home.
Loreene Broker
johnandrain@voyager.net
Loreene Kempmerman
7/7/2000 1:42:00 AM
Survey of College Freshmen
Mike and Fellow McWirbers:
Questions and concerns raised in this forum about this survey certainly seem
on first impression to be legitimate, but what exactly are the facts
regarding this whole matter? IRB approval(s), if any, ever, at UCLA? When
and how often and how recently? What about elsewhere? Should each
cooperating institution review the survey before it is administered locally,
and has UCLA got documentation for whatever is the case? What is the
content of the protocol, of the survey, and what actually is the sensitivity
and identifiability of the data gathered? And so on and so on. I'm sure we
all have key questions that might concern us. If there are violations of
some sort, after all the facts are ascertained, what then might be the
remedy?
Perhaps someone at an institution currently about to administer the survey
could contact Dr. Alexander Astin at the Higher Education Research Institute
at UCLA [(310) 825-1925] to find out more about the IRB review history of
this roughly thirty year endeavor. I for one would be very interested in
learning more.
Regards,
Tom Dalglish J.D., Ph.D.
Community Representative, Committee C
University of Washington
(206) 543-0098 ((University)
(206) 706-1000 (Office)
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
Of Mike Kelly
Sent: Wednesday, July 05, 2000 12:09 PM
To: mcwirb@mcwirb.org
Subject: Survey of College Freshmen
This question is directed at university IRBs. It involves the Cooperative
Institutional Research Program survey that is given to all incoming
university freshmen at (we are told) over 200 universities. Results are
tabulated at UCLA and published for the academic community. The survey was
exempted by UCLA's IRB several years ago although the questions change from
year-to-year. We at Georgia Tech began examining this survey a year ago
after a parent complained that her 17 year-old daughter was required to
take the survey in order to register for college, that parental permission
was not sought, and that it contained sensitive questions. Our IRB had
never been sent an application because the survey was declared exempt at
its source and our local PI thought that eliminated need for local review.
Our IRB just received a protocol for this year's survey and again have
serious problems with it. (At our IRB's direction, students under 18 are
now excluded from the survey here.) The survey is still claimed to be
exempt. CIRP still claims that there are no sensitive questions -- yet it
asks students about their alcohol consumption (a crime), whether they
suffer from depression (a health problem that could affect future
employability and insurability), their political and moral views, and
family history. They must provide their full name and social security
number to allow followup.
At our insistence, the survey forms given to Georgia Tech freshmen must
emphasize that completion of any or all questions is voluntary. Yet,
proctors are told to convince the reluctant students to complete the
forms. It's hard to imagine a group more vulnerable to coercion than
college freshmen on their first day away from home.
I'd like to hear from other university IRBs about their knowledge and
handling of this national survey. I'm told that we're the only IRB that
has voiced any concerns about the survey. Thanks for your comments.
Mike Kelly
IRB Chair
Georgia Tech
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
thomas k. dalglish
7/7/2000 1:38:00 AM
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