Establishment of a system for an effective IRB-Response Review Co mmittee
Our IRB has a Response Review Committee that is almost non-active at this
point, due to the following reasons:
1. some of the members (esp., the physicians) are very busy and can't meet
frequently.
2. It takes longer for the committee to review 6-10 patients per protocol.
3. Lack of commitment on the side of some members.
Therefore, our institutional internal audit system would like some
suggestions from someone on how to set up a standard system within the audit
process/quality control
center, to make this committee an effective workable group, as well as
making it mandatory for doctors to be part of the process. Thank you for
your help.
Haddy Jallow,MSc., MPH
Internal Audit Manager
Dana Farber/Partners Cancer Care
Quality Control Center
454 Brookline Avenue
Suite #132
Boston MA 02115
Phone: 617-632-3762
Fax: 617-632-3768
E-mail: Haddy_Jallow@dfci.harvard.edu
Haddy
6/8/2000 12:05:00 PM
IRB Review by Consultants
I've noticed a few requests for outside review of IRB's. Goodroe Healthcare Solutions, LLC is a healthcare consulting company that has extensive experience in strategic planning and re-engineering in hospitals. We've got experience in assisting hospitals to evaluate current IRB operations and process's.
If anyone is looking to have our consultants work with your IRB's, please contact us for further details, references and support staff education and experience at :
770/621-8540
Julie Moss, CPCS
Goodroe Healthcare Solutions, LLC
Atlanta, Georgia 30084
Julie Moss
6/8/2000 12:05:00 PM
Financial disclosure in the informed consent
We use a CIRB (Conflict of Interest Review board). They review the
financial conflict of interest, give investigator instructions on how to
elimiate or minimize the conflict of interest and notify the IRB if the
conflict is not resolved.
The down side it is a voluntary disclosure
-----Original Message-----
From: Jeffrey Cooper [mailto:cooperj@mail.amc.edu]
Sent: Wednesday, June 07, 2000 2:25 PM
To: mcwirb@mcwirb.org
Subject: re: Financial disclosure in the informed consent
Dan Somers said:
I do believe that it is appropriate to let subjects know that the people
enrolling them in research studies have motives other than the subject's
best
interests guiding their actions or at least influencing them.
and
...who do we protect by allowing investigators/sponsors to hide the
capitalistic nature of their endeavors from the subjects?
If you have an investigator who will be influenced by motives that he or she
will place ahead of the subject's best interests, then he or she has NO
BUSINESS BEING AN INVESTIGATOR and the IRB should disapprove or withdraw
approval of the investigator's research. This could occur in two situations.
First, the investigator is morally bankrupt and cannot prevent small
conflicts
(like $100, authorship on a paper, or getting to a ball game on time) from
disabling his or her moral fiduciary responsibility to the subject. Second,
the
investigator is morally intact, but has a conflict so huge it will make
reasonable people act become ethically disabled (like making $10 million
dollars in stock options if the study drug works as expected with few side
effects). The IRB should conduct an examination of these possibilities with
each review.
Again, I don't have a problem with telling a subject about financial
considerations. It is hard to argue against and it may, in a small number of
cases, influence a decision not to participate. I don't think such a
decision
will be rational, but subjects are free to make irrational decisions not to
participate.
However, the ability of the IRB to detect, understand and quantify conflicts
of
interest is far greater than that of the subject. The IRB must use its
superior
knowledge and experience to protect subjects. It is very unlikely (maybe
close
to impossible) that the informed consent process will allow subjects to
avoid
investigators who will not place the interest of subjects first. Informed
consent does not equalize knowledge.
Again I have no problem supporting a subject's autonomy with information
about
financial relationships. But please do not use informed consent to protect
subjects from harm. It will not work. Informed consent exists to protect
subject autonomy, not to protect the subject's right to be treated with
beneficence.
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Penny Jester
6/8/2000 12:03:00 PM
Financial disclosure in the informed consent
Cynthia Mendoza wrote:
> Our IRB is developing a policy that will require investigators to disclose to
> the IRB all compensation for subject recruitment. In the process of developing
> this policy, members are considering the idea of requiring the disclosure of
> this information not only to the IRB but also to the patient in the informed
> consent.
at a conceptual level, the more disclosure you have, the better chance
you have of controlling conflicts of interest. i think it's very
reasonable that subjects know the investigator is being compensated for
conduct of the study, and who is sponsoring the study... then they have
the chance to determine if that adds a layer of conflict with which they
are uncomfortable.
at a more practical level, i have stopped short of advocating disclosure
of actual dollars and cents in consent forms. as soon as you tell
someone that dr. x is receiving $10,000 for enrolling you in this
study, then you need to go on to explain that from that amount, $3000
pays for the extra scans done for research purposes only, $2000 pays for
the study nurse, $1000 pays for investigational drug service, $2000 for
institutional overhead, etc, etc. and yes, an undetermined amount
may/may not be left over after all the bills are paid. point being, it
would be misleading if subjects are left thinking that the entire amount
goes into the investigator's pocket. it becomes a tricky thing to put
into proper perspective, in a way that creates meaningful information
for potential subjects.
so my personal view is that letting some light shine on the situation by
way of disclosure is an important concept but that, as always, the devil
is in the details. a separate but related mechanism that may have just
as much to do with controlling COI... is how an institution handles
clinical trial payments, and what it does with any residuals.
> Any thoughts on whether regulators are headed in this direction or are we way off?>
i won't pretend to know where the regulators are headed, but clearly
recent events have brought COI onto everyone's radar screens. just this
week NIH released some points to consider in this area, and i will
paste part of the notice below. you can find the full notice at the NIH
website.
dan
Daniel K. Nelson, Director, Human Research Studies
Research Associate Professor of Pediatrics and Social Medicine
University of North Carolina-Chapel Hill
Chapel Hill, NC 27599-7097
Phone: 919-966-1344
fax: 919-966-7879
e-mail: dnelson@med.unc.edu
-----------------------------------------------------------------
>
> NIH on Monday issued a notice providing points to consider related to
> investigator financial conflicts of interest and the review of their
> research proposals by IRBs. The notice also announces that NIH will
> hold a meeting on August 15 and 16 on real and apparent financial
> conflicts of interest. According to the notice, This forum will
> afford an opportunity to discuss sharing of information on the conduct
> of clinical trials between IRBs and compliance offices that deal with
> institutional policies and procedures on investigators' conflict of
> interest. Other topics for discussion will include conflicts of
> interest pertaining to institutions, individual investigators, and IRB
> members. The following notice will be published in an upcoming NIH
> Guide to Grants and Contracts.
> >
> FINANCIAL CONFLICTS OF INTEREST AND RESEARCH OBJECTIVITY: ISSUES FOR
> INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS
>
> Release Date: June 5, 2000
>
> NOTICE: OD-00-040
>
> National Institutes of Health [TRUNCATED]
-----------------------------------------------------------------
Daniel Nelson
6/7/2000 6:31:00 AM
Several of our protocols involve determination of HIV status as a part of the screening process. We would appreciate your response to the following question: Does your institution require a Certificate of Confidentiality when protocol screening procedures include HIV testing?
Responses may be forwarded to beersc@msnotes.wustl.edu. Thank you.
Courtney Beers
Human Studies Committee
Washington University School of Medicine
Anonymous
6/7/2000 8:10:00 AM
Patient Remuneration in Europe
I'm doing some research on paying patients for participating in clinical trials in Europe. I know that, unlike the US, it is often considered unethical to pay patients - even for time and travel -- to participate in a clinical trial in Europe. Does anyone have either articles or personal experience with patient recruiting in Europe? Are there regulations that prohibit payment to patients?
Thank you.
Cheryl Miller, Pharm.D,
Executive Direction, CSO
SCIREX Corporation
25 Main Street
Hartford, CT 06106
860.724.0091 x143
Anonymous
6/7/2000 12:10:00 PM
Financial disclosure in the informed consent
Folks:
We are beginning to react to this issue.
Seems that the crucial question that the IRB needs to adjudicate on behalf of the human subject is whether or not the inducement has interfered with the risk to the subject from the intended research, by potentially increasing this risk.
Just knowing that the researcher received benefit from the study may not be enough. How the researcher reacts to that benefit is the question that will need to be ultimately answered. We presume that individual investigators will have different responses to different levels of inducement/support.
I think that it is important for the IRB to know that there is monetary or other gain which accrues to the researcher, but the beneficence/risk ratio seems to be almost a completely different matter. The real and tangible ethics of the study should be embodied in the protocol, the informed consent process.
We are considering:
All investigators who receive any benefit from commercial entities report to the University in a yearly disclosure, and the process includes a report to our Compliance Officer.
This information is reduced to a yes/no statement in the IRB processing form.
Consideration for a statement in the consent form indicating that the investigator is receiving monetary benefit from the research (not indicating the quantity or quality of such support).
I am not sure that we have the correct answer for this, but this is some of the thought process to date.
Thanks.
Paul R. G. Cunningham, MD
Chair, University and Medical Center IRB.
East Carolina University,
Greenville,
North Carolina 27858
252-816-2914
pcunningham@pcmh.com
>>> Dan Somers 06/07/00 11:53AM >>>
Cynthia,
I do believe that it is appropriate to let subjects know that the people enrolling
them in research studies have motives other than the subject's best interest
guiding their actions (or at least influencing them). This becomes especially
important to me in instances where the investigator is also the patient/subject's
personal physician, and the therapeutic misconception may play a large role in the
patient/subject's decision to enroll.
I'm not arguing that consent forms should quote the study budget verbatim, but I do
think it is appropriate to let subjects know that researchers make money from
enrolling them in studies (and I don't think that statements such as this research
is sponsored by company X adequately convey that message). Withholding this
information seems to me contrary to the notion of informed consent (insofar as
informed consent comes from informed subjects). Investigator financial conflict of
interest is a very real, very important issue, and we don't do the subjects we're
supposed to protect any favors by keeping them in the dark. After all, who do we
protect by allowing researchers/sponsors to hide the capitalistic nature of their
endeavors from subjects?
I'd be very interested to hear arguments from the opposing viewpoint.
-Dan
Cynthia Mendoza wrote:
> Our IRB is developing a policy that will require investigators to disclose to
> the IRB all compensation for subject recruitment. In the process of developing
> this policy, members are considering the idea of requiring the disclosure of
> this information not only to the IRB but also to the patient in the informed
> consent. Any thoughts on whether regulators are headed in this direction or
> are we way off?
>
> Cynthia Mendoza
> Covenant Health System
> cmendoza@covhs.org
> 806/725-0571
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
--
Dan S. Somers
IRB Coordinator
School of Medicine IRB
UNC Chapel Hill
(919) 966-1344
dsomers@med.unc.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul Cunningham
6/7/2000 12:09:00 PM
Patient Remuneration in Europe
The policy of our EC is that volunteers in e.g. phase I clinical trials are
payed their travel costs and for the time they spend; the amount of money
comparable to the legal minimum salary. Patients get compensation for the
travel costs they have. They will not receive any money for participation,
because they benefit as a patient or as a member of a patient group in the
future when the medicine is tried out.
Anjo Strik,
Member of the Medical Ethics Committee, Universitity Medical Center Utrecht
Holland.
----- Original Message -----
From: Nancy J Stark
To:
Sent: Wednesday, June 07, 2000 2:08 AM
Subject: Re: Patient Remuneration in Europe
> Cheryl,
>
> EN 540--Clinical Investigation of Medical Devices for Human Subjects,
allows
> for compensation to subjects for their inconvenience. Section 5.6.9
states:
> Payment or any other form of inducement to subjects who cannot be
expected
> to derive any direct thera-peutic benefit, shall only be for expense, time
> and inconvenience.
>
> Nancy Stark
> Clinical Design Group
>
>
> ----- Original Message -----
> From: Cheryl Miller
> To:
> Sent: Tuesday, June 06, 2000 1:39 PM
> Subject: Patient Remuneration in Europe
>
>
> > I'm doing some research on paying patients for participating in clinical
> trials
> > in Europe. I know that, unlike the US, it is often considered unethical
> to pay
> > patients - even for time and travel -- to participate in a clinical
trial
> in
> > Europe. Does anyone have either articles or personal experience with
> patient
> > recruiting in Europe? Are there regulations that prohibit payment to
> patients?
> >
> > Thank you.
> >
> > Cheryl Miller, Pharm.D,
> > Executive Direction, CSO
> > SCIREX Corporation
> > 25 Main Street
> > Hartford, CT 06106
> > 860.724.0091 x143
> >
> >
> > _______________________________________________
> > 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
Anjo Strik
6/7/2000 12:10:00 PM
Financial disclosure in the informed consent
Cynthia Mendoza wrote:
> Our IRB is developing a policy that will require investigators to disclose to
> the IRB all compensation for subject recruitment. In the process of developing
> this policy, members are considering the idea of requiring the disclosure of
> this information not only to the IRB but also to the patient in the informed
> consent.
at a conceptual level, the more disclosure you have, the better chance
you have of controlling conflicts of interest. i think it's very
reasonable that subjects know the investigator is being compensated for
conduct of the study, and who is sponsoring the study... then they have
the chance to determine if that adds a layer of conflict with which they
are uncomfortable.
at a more practical level, i have stopped short of advocating disclosure
of actual dollars and cents in consent forms. as soon as you tell
someone that dr. x is receiving $10,000 for enrolling you in this
study, then you need to go on to explain that from that amount, $3000
pays for the extra scans done for research purposes only, $2000 pays for
the study nurse, $1000 pays for investigational drug service, $2000 for
institutional overhead, etc, etc. and yes, an undetermined amount
may/may not be left over after all the bills are paid. point being, it
would be misleading if subjects are left thinking that the entire amount
goes into the investigator's pocket. it becomes a tricky thing to put
into proper perspective, in a way that creates meaningful information
for potential subjects.
so my personal view is that letting some light shine on the situation by
way of disclosure is an important concept but that, as always, the devil
is in the details. a separate but related mechanism that may have just
as much to do with controlling COI... is how an institution handles
clinical trial payments, and what it does with any residuals.
> Any thoughts on whether regulators are headed in this direction or are we way off?>
i won't pretend to know where the regulators are headed, but clearly
recent events have brought COI onto everyone's radar screens. just this
week NIH released some points to consider in this area, and i will
paste part of the notice below. you can find the full notice at the NIH
website.
dan
Daniel K. Nelson, Director, Human Research Studies
Research Associate Professor of Pediatrics and Social Medicine
University of North Carolina-Chapel Hill
Chapel Hill, NC 27599-7097
Phone: 919-966-1344
fax: 919-966-7879
e-mail: dnelson@med.unc.edu
-----------------------------------------------------------------
>
> NIH on Monday issued a notice providing points to consider related to
> investigator financial conflicts of interest and the review of their
> research proposals by IRBs. The notice also announces that NIH will
> hold a meeting on August 15 and 16 on real and apparent financial
> conflicts of interest. According to the notice, This forum will
> afford an opportunity to discuss sharing of information on the conduct
> of clinical trials between IRBs and compliance offices that deal with
> institutional policies and procedures on investigators' conflict of
> interest. Other topics for discussion will include conflicts of
> interest pertaining to institutions, individual investigators, and IRB
> members. The following notice will be published in an upcoming NIH
> Guide to Grants and Contracts.
> >
> FINANCIAL CONFLICTS OF INTEREST AND RESEARCH OBJECTIVITY: ISSUES FOR
> INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS
>
> Release Date: June 5, 2000
>
> NOTICE: OD-00-040
>
> National Institutes of Health [TRUNCATED]
-----------------------------------------------------------------
Daniel Nelson
6/7/2000 6:33:00 AM
MCWIRB digest, Vol 1 #249 - 8 msgs
Laying aside the question of not including women who are pregnant at the
time of enrollment, it seems to me that vaccine trials have an advantage
over drug trials in enrolling women who could become pregnant. Unlike drug
trials, in which the exposure to the test article occurs consistently over
time, in vaccine trials the exposure occurs at known times. Investigators
can avoid giving vaccine to pregnant women by doing a pregnancy test at the
start of the study visit at which the vaccine will be administered. If the
woman is pregnant, the vaccine isn't given.
______________________________________
Sherry A. Marts, Ph.D.
Scientific Director
Society for Women's Health Research
1828 L Street NW, Suite 625
Washington, DC 20036
www.womens-health.org
202-496-5019 vox
202-833-3472 fax
-----Original Message-----
To: , , ,
Cc: , ,
Subject: Pregnant women--the never ending story--vaccines
Once again, we find ourself accused of idealism. We have held up
approval of a Lyme Vaccine study because the PI and his sponsors refuse
to include pregnant women or any woman who might be pregnant.
According to the PI, Smith Kine Beecham has assured me that EVERY OTHER
IRB has approved this study without worrying about the pregnancy issue.
Do any McWIRB readers know of any case where a Lyme Vaccine study was
held up because it excluded some women, anywhere else in this big
country?? Has anyone else read the Belmont Report? Is there a
consensus anywhere that vaccines are different and that the Belmont
report does not apply to them?
Sherry Marts
6/7/2000 6:27:00 AM
Patient Remuneration in Europe
In my experience on a UK ethics committee the re-imbursement of travel
expenses and other reasonable expenses such as refreshments, where these are
incurred as the result of additional visits to a clinic over and above the
patient's normal routine visits, is expected and if it is not offered we
will strongly recommend that it should be. However we are very wary of
allowing inducements, so such re-imbursement would usually be against
receipts for expenditure incurred or set at a modest level. We did see one
proposal that suggested that, rather than cause subjects the inconvenience
of providing receipts, a fixed sum would be paid for each visit, but the
amount suggested was clearly going to be considerably more than the likely
actual expenses and was in our view an inducement to help recruitment to a
trial which we suspected would have difficulties recruiting. We required
the investigators to adopt the usual approach of re-imbursing actual
expenses.
Hope that helps,
Paul
Dr Paul Wainwright
School of Health Science
University of Wales Swansea
Singleton Park
Swansea SA2 8PP
Tel: +44 1792 518599
Fax: +44 1792 295769
email: p.wainwright@swansea.ac.uk
> -----Original Message-----
> From: Cheryl Miller [SMTP:cmiller@scirex.com]
> Sent: Tuesday, June 06, 2000 9:39 PM
> To: mcwirb@mcwirb.org
> Subject: Patient Remuneration in Europe
>
> I'm doing some research on paying patients for participating in clinical
> trials
> in Europe. I know that, unlike the US, it is often considered unethical
> to pay
> patients - even for time and travel -- to participate in a clinical trial
> in
> Europe. Does anyone have either articles or personal experience with
> patient
> recruiting in Europe? Are there regulations that prohibit payment to
> patients?
>
> Thank you.
>
> Cheryl Miller, Pharm.D,
> Executive Direction, CSO
> SCIREX Corporation
> 25 Main Street
> Hartford, CT 06106
> 860.724.0091 x143
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul
6/7/2000 6:33:00 AM
Courtney Beers wrote:
> Several of our protocols involve determination of HIV status as a part of the
> screening process. We would appreciate your response to the following
> question: Does your institution require a Certificate of Confidentiality when
> protocol screening procedures include HIV testing?>
no to the Certificate of Confidentiality. to my understanding, that
starts to get afield from the intended purposes of COC, though that
seems to be broadening. more to the point, i'm not sure it would
actually protect you or the subject from reporting obligations.
but we do make certain that subjects are aware there ARE reporting
obligations under state law, and that positive tests will be reported to
state health authorities.
dan
Daniel K. Nelson, Director, Human Research Studies
Research Associate Professor of Pediatrics and Social Medicine
University of North Carolina-Chapel Hill
Chapel Hill, NC 27599-7097
Phone: 919-966-1344
fax: 919-966-7879
e-mail: dnelson@med.unc.edu
Daniel Nelson
6/7/2000 6:27:00 AM
Patient Remuneration in Europe
In my experience on a UK ethics committee the re-imbursement of travel
expenses and other reasonable expenses such as refreshments, where these are
incurred as the result of additional visits to a clinic over and above the
patient's normal routine visits, is expected and if it is not offered we
will strongly recommend that it should be. However we are very wary of
allowing inducements, so such re-imbursement would usually be against
receipts for expenditure incurred or set at a modest level. We did see one
proposal that suggested that, rather than cause subjects the inconvenience
of providing receipts, a fixed sum would be paid for each visit, but the
amount suggested was clearly going to be considerably more than the likely
actual expenses and was in our view an inducement to help recruitment to a
trial which we suspected would have difficulties recruiting. We required
the investigators to adopt the usual approach of re-imbursing actual
expenses.
Hope that helps,
Paul
Dr Paul Wainwright
School of Health Science
University of Wales Swansea
Singleton Park
Swansea SA2 8PP
Tel: +44 1792 518599
Fax: +44 1792 295769
email: p.wainwright@swansea.ac.uk
> -----Original Message-----
> From: Cheryl Miller [SMTP:cmiller@scirex.com]
> Sent: Tuesday, June 06, 2000 9:39 PM
> To: mcwirb@mcwirb.org
> Subject: Patient Remuneration in Europe
>
> I'm doing some research on paying patients for participating in clinical
> trials
> in Europe. I know that, unlike the US, it is often considered unethical
> to pay
> patients - even for time and travel -- to participate in a clinical trial
> in
> Europe. Does anyone have either articles or personal experience with
> patient
> recruiting in Europe? Are there regulations that prohibit payment to
> patients?
>
> Thank you.
>
> Cheryl Miller, Pharm.D,
> Executive Direction, CSO
> SCIREX Corporation
> 25 Main Street
> Hartford, CT 06106
> 860.724.0091 x143
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul
6/7/2000 6:31:00 AM
A simple question of length
One aspect of the consent process that seems to have been lost, especially
as it relates to oncology trials, is discerning the risks associated with
participation in the trial vs. the risks associated with the cancer
treatment. Many oncology-related trials are Phase III trials comparing the
standard of care to a second arm involving a promising new combination or
agent.
46.111(a)(2) states: In evaluating risks and benefits, the IRB should
consider only those risks and benefits that may result from the research (as
distinguished from risks and benefits of therapies subjects would receive
even if not participating in the research). The IRB should not consider
possible long-range effects of applying knowledge gained in the research
(for example, the possible effects of the research on public policy) as
among those research risks that fall within the purview of its
responsibility.
While the need to inform patients of the risks associated with cancer
treatment is essential, these risks are not unique to participation in the
trial and should be addressed separately from the actual risks the patient
would not otherwise be subjected to were they not to agree to participate in
the clinical trial.
This concept alone would reduce the complexity of the form used to document
the consent process.
-----Original Message-----
From: Gullion Christina [SMTP:Christina.Gullion@HCAHealthcare.com]
Sent: Tuesday, June 06, 2000 10:59 AM
To: 'mcwirb@mcwirb.org'
Subject: RE: A simple question of length
Related to this question, I have seen consent forms that are quite
lengthy
because they go into great detail about all the possible adverse
effects of
consenting to a procedure as a whole, when only a minuscule aspect
is
experimental--e.g., CABG where a variant in, say, a filter on the
bypass
machine is being tried. The consent reads as though CABG were an
experimental procedure, even though the person has already agreed to
undergo
CABG and what is at issue is the use of this filter vs. that filter.
What is the thinking about including detailed description of the
non-experimental aspects of a research study in a consent form--is
this a
good place to apply the less is more concept?
Chris
Christina M. Gullion, Ph.D.
Biostatistician/Senior Scientist
Department of Clinical Research
Medical City Dallas Hospital
7777 Forest Lane, Suite C-740
Dallas TX 75230
phone: 972-566-4718, fax: 972-566-4715
NOTE NEW EMAIL ADDRESS: christina.gullion@lonestarhealth.com
*** NOT NOT NOT christina.gullion@hcahealthcare.com ********
> -----Original Message-----
> From: Jeffrey Cooper [SMTP:cooperj@mail.amc.edu]
> Sent: Saturday, June 03, 2000 11:04 AM
> To: mcwirb@mcwirb.org
> Subject: re: A simple question of length
>
> Craig,
>
> I share your concerns with a long consent documents. The consent
document
> must
> be well written, logical and understandable.
>
> That said some research studies have well written consent
documents that
> need
> to be 13 pages or longer. To me a well written 13 page consent
document
> means
> that the investigator should spend about 2 hours explaining the
trial to
> the
> subject. I would be more interested in how the researcher will
approach
> obtaining consent.
>
> Even a well-written consent document does not substitute for
consent.
>
> Jeff Cooper
>
>
> _______________________________________________
> 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
Robert Catalano
6/7/2000 6:33:00 AM
Some of my faculty are interested in exploring the possibilities
of doing clinical trials and are in the process of talking with
CROs.
I am only vaguely aware of what CROs are and what they do. I
would appreciate it if someone who is familiar with the administrative
aspects of clinical trials would contact me directly (as my questions at
this point are not really IRB related) and help educated me.
Thank you.
Vicki Zerby Frew
IRB/Research Coordinator
University of Illinois
College of Medicine at Rockford
Vicki Frew
6/7/2000 12:15:00 PM
Financial disclosure in the informed consent
Cynthia,
I do believe that it is appropriate to let subjects know that the people enrolling
them in research studies have motives other than the subject's best interest
guiding their actions (or at least influencing them). This becomes especially
important to me in instances where the investigator is also the patient/subject's
personal physician, and the therapeutic misconception may play a large role in the
patient/subject's decision to enroll.
I'm not arguing that consent forms should quote the study budget verbatim, but I do
think it is appropriate to let subjects know that researchers make money from
enrolling them in studies (and I don't think that statements such as this research
is sponsored by company X adequately convey that message). Withholding this
information seems to me contrary to the notion of informed consent (insofar as
informed consent comes from informed subjects). Investigator financial conflict of
interest is a very real, very important issue, and we don't do the subjects we're
supposed to protect any favors by keeping them in the dark. After all, who do we
protect by allowing researchers/sponsors to hide the capitalistic nature of their
endeavors from subjects?
I'd be very interested to hear arguments from the opposing viewpoint.
-Dan
Cynthia Mendoza wrote:
> Our IRB is developing a policy that will require investigators to disclose to
> the IRB all compensation for subject recruitment. In the process of developing
> this policy, members are considering the idea of requiring the disclosure of
> this information not only to the IRB but also to the patient in the informed
> consent. Any thoughts on whether regulators are headed in this direction or
> are we way off?
>
> Cynthia Mendoza
> Covenant Health System
> cmendoza@covhs.org
> 806/725-0571
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
--
Dan S. Somers
IRB Coordinator
School of Medicine IRB
UNC Chapel Hill
(919) 966-1344
dsomers@med.unc.edu
Dan Somers
6/7/2000 6:27:00 AM
It is, and always has been, the official recommendation of CDC, that all
personnel dealing with blood or other potentially infectious material use
universal precautions all the time. This is not due to ADA or other
discriminatory concerns, but because these personnel cannot expect to know
when the precautions should be used; i.e., when the source is potentially
infectious. The concern is not limited to HIV; indeed, the far greater risk
is the transmission of hepatitis B or C. Moreover, it is an OSHA
requirement that any and all medical personnel who may come into contact
with blood and other potentially infectious fluids must be trained in
universal precautions and should use them at all times. I do not think that
a study that involves HIV positive patients requires any special
documentation of lab personnel training.
Dan
Daniel L. Icenogle, MD, JD
Icenogle & Associates
1858 Sand Ridge Ct.
Verona, WI 53593-8814
608.832.0549 (voice and fax)
Electronic mail from Daniel L. Icenogle, MD, c/o Icenogle & Associates at
Dan_Icenogle@icenogle.net. This communication is intended for the use of
the addressee. It may contain information which is privileged or
confidential under applicable law. If you are not the intended recipient or
the agent of the recipient, you are hereby notified that any dissemination,
copy or disclosure of this communication is strictly prohibited. If you
have received this communication in error, please notify Icenogle &
Associates at (608) 832-0549 or via return Internet electronic mail at
Dan_Icenogle@icenogle.net and expunge this communication without making any
copies. Thank you for your cooperation.
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf Of
Richards, Edward P.
Sent: Tuesday, June 06, 2000 4:29 PM
To: mcwirb@mcwirb.org
Subject: RE: HIV testing
The Bragdon v. Abbott, 118 S.Ct. 2196, 141 L.Ed.2d 540 (1998) has generally
be
read to mean that any differential treatment of an HIV infected person by
health
care provider is a violation of the ADA unless it is medically indicated.
The
case involved a dentist who wanted to do dental work on an HIV infected
patient
in the hospital rather than his office because he was concerned about
infection
control. The testimony was basically that the official position in the US
is
for health care providers to use universal precautions for every patient,
every
time, and that you do not do anything different for HIV infected patients.
Since universal precautions are the rule, it is assumed by many health care
lawyers that extra precautions violate the ADA.
Ed
> Furthermore, considering regs on biosafety, what does any IRB
> (should)do on
> protocols that involve blood drawing from HIV positive
> patients. Is a
> certification that involves training on bloodborne
> pathogens mandatory for
> approving protocols that involve researchers or research
> personnel drawing
> blood from HIV postive or positive for other bloodborne
> pathogens? Should
> the individual's (person drawing the blood) name be included
> in the IRB
> application?
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Dan Icenogle
6/7/2000 6:36:00 AM
Thank you to those of you who responded to my initial inquiry. I had not
intended to imply the use of the telephone conversation in place of written
documentation, but as a replacement for face to face conversation in the
informed consent process.
Thanks Paul for the FDA reference which clearly supports the use of
facsimile with phone conversation. My question is whether this reasonably
extends to the use of the mail to deliver the documentation (2 copies--one
to sign, one to keep), and then a phone call for the live dialogue component
of the informed consent process. It would seem prudent to require a witness
to the phone conversation like is typically done for consents in clinical
situations.
Finally, I would presume that FDA, OPRR, and maybe JCAHO would all want to
see a policy and procedure that outlines these steps for the investigators.
Does anyone out there have a written policy they are willing to share?
Any further comments from the group?
Don E. Workman, Ph.D.
IRB Administrator
St. Jude Children's Research Hospital
332 N. Lauderdale
Memphis, TN 38101
901-495-4359
-----Original Message-----
From: Goebel, Paul (OD) [mailto:GoebelP@OD.NIH.GOV]
Sent: Monday, June 05, 2000 1:23 PM
To: 'Workman, Don'; 'mcwirb@mcwirb.org'
Subject: RE: Telephone Consent
FDA guidance for faxing the consent to the legally authorized
representative, conducting the consent interview by telephone and faxing
back the signed consent is contained in Question and Answer # 35, page 11 of
the 1998 update to the FDA Information Sheets for IRBs and Clinical
Investigators. The information sheets are on the FDA website at
http://www.fda.gov/oc/oha/irb/toc.html.
Paul W. Goebel, Jr.
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
6100 Executive Boulevard, suite 3B01, MSC-7507
Rockville, MD 20892-7507
Phone: 301-402-4372
email: pg122v@nih.gov
Fax: 301-402-4256
OPRR url: http://grants.nih.gov/grants/oprr/oprr.htm
> -----Original Message-----
> From: Workman, Don [SMTP:Don.Workman@stjude.org]
> Sent: Wednesday, May 31, 2000 3:36 PM
> To: 'mcwirb@mcwirb.org'
> Subject: Telephone Consent
>
> I have an Investigator asking about procedures for obtaining informed
> consent via the telephone. Written guidelines for this would be
> advantageous in our Institution for two situations: One possible scenario
> would be the use of previously collected blood or tissue samples for a new
> research protocol. Another would involve obtaining the consent from the
> other parent for a study involving more than minimal risk with no likely
> benefit to the subject (many of our subjects travel here accompanied by
> only
> one parent). Would anyone be willing to share (on or off-line) written
> procedures or other guidelines for obtaining and witnessing informed
> consent
> over the telephone?
>
> Don E. Workman, Ph.D.
> IRB Administrator
>
> St. Jude Children's Research Hospital
> 332 N. Lauderdale
> Memphis, TN 38101
> 901-495-4359
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Don Workman
6/6/2000 8:29:00 AM
Hi,
What is a Certificate of Confidentiality? Is that a special creation of
Washington law?
Thanks, Ed
Edward P. Richards
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
> -----Original Message-----
> From: Courtney Beers [mailto:beersc@msnotes.wustl.edu]
> Sent: Tuesday, June 06, 2000 11:47 AM
> To: mcwirb@mcwirb.org
> Subject: HIV testing
>
>
> Several of our protocols involve determination of HIV status
> as a part of the
> screening process. We would appreciate your response to the following
> question: Does your institution require a Certificate of
> Confidentiality when
> protocol screening procedures include HIV testing?
>
> Responses may be forwarded to beersc@msnotes.wustl.edu. Thank you.
>
> Courtney Beers
> Human Studies Committee
> Washington University School of Medicine
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
Edward Richards
6/6/2000 11:30:00 AM
A simple question of length
Related to this question, I have seen consent forms that are quite lengthy
because they go into great detail about all the possible adverse effects of
consenting to a procedure as a whole, when only a minuscule aspect is
experimental--e.g., CABG where a variant in, say, a filter on the bypass
machine is being tried. The consent reads as though CABG were an
experimental procedure, even though the person has already agreed to undergo
CABG and what is at issue is the use of this filter vs. that filter.
What is the thinking about including detailed description of the
non-experimental aspects of a research study in a consent form--is this a
good place to apply the less is more concept?
Chris
Christina M. Gullion, Ph.D.
Biostatistician/Senior Scientist
Department of Clinical Research
Medical City Dallas Hospital
7777 Forest Lane, Suite C-740
Dallas TX 75230
phone: 972-566-4718, fax: 972-566-4715
NOTE NEW EMAIL ADDRESS: christina.gullion@lonestarhealth.com
*** NOT NOT NOT christina.gullion@hcahealthcare.com ********
> -----Original Message-----
> From: Jeffrey Cooper [SMTP:cooperj@mail.amc.edu]
> Sent: Saturday, June 03, 2000 11:04 AM
> To: mcwirb@mcwirb.org
> Subject: re: A simple question of length
>
> Craig,
>
> I share your concerns with a long consent documents. The consent document
> must
> be well written, logical and understandable.
>
> That said some research studies have well written consent documents that
> need
> to be 13 pages or longer. To me a well written 13 page consent document
> means
> that the investigator should spend about 2 hours explaining the trial to
> the
> subject. I would be more interested in how the researcher will approach
> obtaining consent.
>
> Even a well-written consent document does not substitute for consent.
>
> Jeff Cooper
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Gullion Christina
6/6/2000 8:30:00 AM
Human Subject Protections Bill
Reps. DeGette, Waxman, Mica, Stark, Towns and Kucinich are preparing to
introduce the attached legislation on the morning of Thursday, June 8th. The Human Research Subject Protections Act of 2000 proposes to extend provisions of the common rule to include forms of research presently not included under its regulation because of source of funding or other conditions that enable its exclusion. It also addresses several issues that have become evident through the findings of several commissions and investigations.
Please read the attached pdf file and determine for yourselves whether this document enhances the capacity of IRBs to protect human research subjects. Please address any comments or concerns to your legislators in the house of representatives so they may be aware of your opinions by Thursday 8 June 2000.
Anonymous
6/6/2000 2:57:00 AM
This is an important question. I am also looking for answers.
Furthermore, considering regs on biosafety, what does any IRB (should)do on
protocols that involve blood drawing from HIV positive patients. Is a
certification that involves training on bloodborne pathogens mandatory for
approving protocols that involve researchers or research personnel drawing
blood from HIV postive or positive for other bloodborne pathogens? Should
the individual's (person drawing the blood) name be included in the IRB
application?
I would appreciate some discussion on the above topic as well.
Sree Murthy.
s.murthy@drexel.edu
AVP for Research Complaince
Drexel and MCP Hahnemann Universities
-----Original Message-----
From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
Of Courtney Beers
Sent: Tuesday, June 06, 2000 12:47 PM
To: mcwirb@mcwirb.org
Subject: HIV testing
Several of our protocols involve determination of HIV status as a part of
the
screening process. We would appreciate your response to the following
question: Does your institution require a Certificate of Confidentiality
when
protocol screening procedures include HIV testing?
Responses may be forwarded to beersc@msnotes.wustl.edu. Thank you.
Courtney Beers
Human Studies Committee
Washington University School of Medicine
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sreekant Murthy
6/6/2000 11:30:00 AM
If your state has HIV reporting (by name or otherwise) a federal Certificate
of Confidentiality would not relieve the researcher of the obligation to
report HIV infection to health authorities. The Certificate does not
override the duty to report child/dependent adult abuse/neglect,
communicable diseases, etc. You need to check your local statutes regarding
what is reportable (and the form of mandated reporting) in terms of HIV
infection and/or AIDS.
Maggie
Maggie Frederick, MPH
Review Coordinator
DSHS Human Research Review Section
P.O. Box 45205
Olympia, WA. 98504-5205
(360) 902-8075
FAX: (360) 902-0705
Email: fredem@dshs.wa.gov
> -----Original Message-----
> From: Courtney Beers [SMTP:beersc@msnotes.wustl.edu]
> Sent: Tuesday, June 06, 2000 9:47 AM
> To: mcwirb@mcwirb.org
> Subject: HIV testing
>
> Several of our protocols involve determination of HIV status as a part of
> the
> screening process. We would appreciate your response to the following
> question: Does your institution require a Certificate of Confidentiality
> when
> protocol screening procedures include HIV testing?
>
> Responses may be forwarded to beersc@msnotes.wustl.edu. Thank you.
>
> Courtney Beers
> Human Studies Committee
> Washington University School of Medicine
Maggie
6/6/2000 1:00:00 PM
A simple question of length
> What is the thinking about including detailed description of the
> non-experimental aspects of a research study in a consent
> form--is this a
> good place to apply the less is more concept?
There is no law on this point, as far as I know. However, it might be a
problem:
First, the physician ordering/doing the non-experimental part has the
responsibility for getting consent for that part. By doing a second consent
document covering the same stuff, you may undermine the legal effectiveness of
that consent by giving additional/different information. You needlessly dilute
the information about the experimental part, which reduces the effectiveness of
that consent as well. Worst, you may inadvertently set an unrealistic standard
for consent for folks undergoing the non-experimental procedure in your
institution - Why did Patient A get all this information and all I got was this
little bit?
Edward P. Richards
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
6/6/2000 11:36:00 AM
If your institution has experience with an IRB software program called PRO_IRB, developed by Richard C. Fluegel at Compliance Concepts, of Florida, could you comment on your assessment of the system? Off-line works fine, too. Thanks in advance.
Celia Walker
Regulatory Compliance
Colorado State University
cwalker@research.colostate.edu
970-491-1563 (voice) 491-2293 (fax)
Anonymous
6/6/2000 11:30:00 AM
Hi Celia:
We are a Mac-based office and apparently there is currently no Mac version
of PRO_IRB. Otherwise, I'd be very anxious to try the demo. Would you
happen to know about any similar software that is available for the Mac?
Lorrie Clark
Grants Administrator
Office of Sponsored Programs
Phone: 6-2121 Fax: 6-2123
>If your institution has experience with an IRB software program called
>PRO_IRB,
>developed by Richard C. Fluegel at Compliance Concepts, of Florida, could you
>comment on your assessment of the system? Off-line works fine, too.
>Thanks in
>advance.
>
>Celia Walker
>Regulatory Compliance
>Colorado State University
>cwalker@research.colostate.edu
>970-491-1563 (voice) 491-2293 (fax)
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
mclark@brandeis.edu
6/6/2000 11:30:00 AM
The Bragdon v. Abbott, 118 S.Ct. 2196, 141 L.Ed.2d 540 (1998) has generally be
read to mean that any differential treatment of an HIV infected person by health
care provider is a violation of the ADA unless it is medically indicated. The
case involved a dentist who wanted to do dental work on an HIV infected patient
in the hospital rather than his office because he was concerned about infection
control. The testimony was basically that the official position in the US is
for health care providers to use universal precautions for every patient, every
time, and that you do not do anything different for HIV infected patients.
Since universal precautions are the rule, it is assumed by many health care
lawyers that extra precautions violate the ADA.
Ed
> Furthermore, considering regs on biosafety, what does any IRB
> (should)do on
> protocols that involve blood drawing from HIV positive
> patients. Is a
> certification that involves training on bloodborne
> pathogens mandatory for
> approving protocols that involve researchers or research
> personnel drawing
> blood from HIV postive or positive for other bloodborne
> pathogens? Should
> the individual's (person drawing the blood) name be included
> in the IRB
> application?
Edward Richards
6/6/2000 1:00:00 PM
New Office for Human Research Protections Created, Dr. Greg Koski Named Director
Date: June 6, 2000
For Release: Immediately
Contact: OPHS Press Office (202) 205-1842
Headline: New Office for Human Research Protections Created, Dr. Greg Koski Named Director
Edward Greg Koski, Ph.D., M.D., will serve as the first director of the Office for Human Research Protections (OHRP), a new office at the Department of Health and Human Services to lead efforts for protecting human subjects in biomedical and behavioral research, HHS announced today.
As recommended last year by the Advisory Committee to the Director of NIH, the new office will be located at the HHS department level, in the office of the Assistant Secretary for Health. It replaces the Office for Protection from Research Risks (OPRR), which was part of the National Institutes of Health (NIH) and had authority over NIH-funded research.
Koski, 50, is currently director of human research affairs at Partners
HealthCare System, Inc., in Boston, and Associate Professor of Anesthesia at Harvard Medical School. At Partners HealthCare, he oversees patient
protection for research conducted at a consortium of institutions including
Massachusetts General Hospital, Brigham and Women's Hospital, and their joint venture with the Dana Farber Cancer Institute, as well as several
Partners-affiliated community hospitals and physician practices.
Dr. Koski is a national leader in today's renewed efforts to assure that
patients taking part in research are better protected and fully informed,
said HHS Assistant Secretary for Health and Surgeon General David Satcher in announcing the appointment. The new office will have increased resources and broader responsibility, and we will look to it for leadership in articulating our goals for protecting individuals who volunteer to participate in research.
Greg Koski is the right person with the right experience at the right time to take on this challenge, said HHS Secretary Donna E. Shalala. He understands that everyone in the research community must share the responsibility for protecting research subjects, and he knows how to make institutions and investigators sit up and respond fully to the needs of patients in research.
Medical research today is exploding with opportunity, she said. But to
achieve the benefits of that research, we need a solid foundation of
thoughtfully-designed and thoroughly-executed research patient protections.
The new OHRP will work with HHS agencies and with research institutions and
sponsors to ensure that this foundation is in place and working productively.
The new office will also provide leadership for all 17 federal agencies which carry out research involving human subjects under a regulation known as the Common Rule.
The OHRP will officially come into existence this month. At the same time,
HHS will also charter a new National Human Research Protections Advisory
Committee, to provide broad-based counsel on patient protection and research needs. A Federal Register notice will solicit nominations for the new 12-member committee, which was also a recommendation made last year by the Advisory Committee to the Director of NIH.
The new OHRP will focus entirely on protection for human subjects, while
treatment for animal subjects will be overseen separately by a new Office of Laboratory Animal Welfare at NIH. The OPRR had been responsible for both human and animal subjects.
Taking over from OPRR, the new OHRP will monitor programs for the protections of human subjects at more than 4,000 HHS-funded universities, hospitals and other medical and behavioral research institutions in the United States and abroad. These programs must meet the requirements of HHS regulations for the protection of human research subjects and comply with the assurances that the institutions must have approved by HHS as a prerequisite for funding.
The OHRP will also work with NIH and the Food and Drug Administration (FDA) to carry out new patient protection initiatives announced by Secretary Shalala last month. These include:
· new efforts to educate and train clinical investigators and members and
staff of the Institutional Review Boards (IRB) that carry out patient
protection at research institutions;
· new guidance and procedures on informed consent for patients and volunteers in research;
· improved monitoring by researchers, sponsors and the FDA to ensure safety
and quickly detect any problems; and
· clarification of existing policies on potential conflicts of interest
affecting researchers, and development of updated policies.
As an immediate action, NIH today released two new guidelines and a set of
issues for investigators and IRBs to consider on financial conflict of
interest and research objectivity. One of the new guidelines requires that
clinical researchers seeking NIH funding certify that they have taken special training in the ethical conduct of clinical research, and the other requires researchers applying for grants to conduct Phase I and Phase II clinical trials to send their clinical trials monitoring plans to the NIH. Each of the documents is available at the NIH website
(http://grants.nih.gov/grants/oer.htm)
In the longer term, Dr. Satcher said, HHS will look to the new OHRP to develop new, stronger and clearer patient protection policies, with an expanded focus on performance and prevention as well as enforcement. The overall policies will apply to research funded or regulated by all HHS agencies, and will provide a model for other federally- and privately-sponsored research.
Under the new OHRP structure, FDA retains its enforcement authority to ensure that researchers carrying out FDA-authorized drug and medical device clinical trials are complying with HHS patient protection and consent requirements. The new organizational structure will enable more effective coordination of HHS-wide policies and actions, Dr. Satcher said.
With strong leadership and coherent policy guidance for all HHS agencies,
researchers will get a single set of messages, they will understand their
responsibilities better, and they will understand they are being held more
closely accountable, he said.
In addition, Secretary Shalala announced last week that she will seek new
authority for FDA to levy civil monetary penalties of up to $250,000 per
clinical investigator and up to $1 million per research institution in the
event of violations of patient protection agreements. No money penalties are currently available to FDA for such violations, although the agency can issue warning letters and take action to halt research until problems are rectified.
Dr. Koski comes to the new position with a background not only in research
management and patient protection, but also in basic and clinical research.
His research experience includes clinical investigation over a range of
disciplines, including human and animal physiology, biochemical pharmacology, neurosciences and regulatory biology.
In 1991 he was appointed to serve on the Subcommittee on Human Studies, the
IRB for Massachusetts General Hospital, which was one of the first such
committees in the country created to protect human subjects in research. In 1993 he became chair of the Subcommittee. In 1995, as director of Clinical Research and Development for Massachusetts General Hospital, he helped lead an effort to integrate and improve the IRB processes of that hospital and the Brigham and Women's Hospital when they joined to form the Partners HealthCare System.
Dr. Koski lives in Holliston, Mass., with his wife Linda and their three
children, Jessica, Hannah and Jared. He will begin work and planning with the new office immediately as a consultant, and take over as director in
September.
Anonymous
6/6/2000 11:12:00 AM
I have an Investigator asking about procedures for obtaining informed
consent via the telephone. Written guidelines for this would be
advantageous in our Institution for two situations: One possible scenario
would be the use of previously collected blood or tissue samples for a new
research protocol. Another would involve obtaining the consent from the
other parent for a study involving more than minimal risk with no likely
benefit to the subject (many of our subjects travel here accompanied by only
one parent). Would anyone be willing to share (on or off-line) written
procedures or other guidelines for obtaining and witnessing informed consent
over the telephone?
Don E. Workman, Ph.D.
IRB Administrator
St. Jude Children's Research Hospital
332 N. Lauderdale
Memphis, TN 38101
901-495-4359
Don Workman
6/6/2000 8:29:00 AM
Patient Remuneration in Europe
Cheryl,
EN 540--Clinical Investigation of Medical Devices for Human Subjects, allows
for compensation to subjects for their inconvenience. Section 5.6.9 states:
Payment or any other form of inducement to subjects who cannot be expected
to derive any direct thera-peutic benefit, shall only be for expense, time
and inconvenience.
Nancy Stark
Clinical Design Group
----- Original Message -----
From: Cheryl Miller
To:
Sent: Tuesday, June 06, 2000 1:39 PM
Subject: Patient Remuneration in Europe
> I'm doing some research on paying patients for participating in clinical
trials
> in Europe. I know that, unlike the US, it is often considered unethical
to pay
> patients - even for time and travel -- to participate in a clinical trial
in
> Europe. Does anyone have either articles or personal experience with
patient
> recruiting in Europe? Are there regulations that prohibit payment to
patients?
>
> Thank you.
>
> Cheryl Miller, Pharm.D,
> Executive Direction, CSO
> SCIREX Corporation
> 25 Main Street
> Hartford, CT 06106
> 860.724.0091 x143
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Nancy J Stark
6/6/2000 1:06:00 PM
Our institution is giving consideration to the formation of a second IRB.
Our IRB is a medical staff committee which receives input from the Research
Committee when protocols have not been reviewed elsewhere for scientific
merit. We hold a Multiple Project Assurance. We have a large IRB with a
heavy workload, especially for our volunteer members, and hope to form two
smaller IRB's to share the workload.
Would participants be willing to share experiences in setting up, problems
encountered, policies developed, processes in place, etc. with a second +
IRB? Personal replies would be welcomed.
Thanks,
Cindy
Cindy Clukey
IRB and QI Committees Coordinator
(cclukey@emh.org)
(207) 973-7906
Cindy Peterson
6/5/2000 9:24:00 AM
Is the larger question that we need to be asking ro what extent does a
patient recruited by a physician have a right to know the nature of the
financial relationship between the physician and the sponsor? Secondly, when
we speak of double-dipping, are we also including the trip for the PI paid
for from the proceeds of a clinical trial or the computer purchased from those
proceeds?
John M. Cavendish, Ed.D., J.D., CRA
Executive Director, LLVARE
2094 W. Redlands Blvd.
Redlands, CA 92373-6267
Ph. 909-633-7675(Cell)
800-741-8387 Ext. 2510(Work)
____________________________________________________________________
Get your own FREE, personal Netscape WebMail account today at http://webmail.netscape.com.
John Cavendish
6/5/2000 10:44:00 AM
FDA guidance for faxing the consent to the legally authorized
representative, conducting the consent interview by telephone and faxing
back the signed consent is contained in Question and Answer # 35, page 11 of
the 1998 update to the FDA Information Sheets for IRBs and Clinical
Investigators. The information sheets are on the FDA website at
http://www.fda.gov/oc/oha/irb/toc.html.
Paul W. Goebel, Jr.
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
6100 Executive Boulevard, suite 3B01, MSC-7507
Rockville, MD 20892-7507
Phone: 301-402-4372
email: pg122v@nih.gov
Fax: 301-402-4256
OPRR url: http://grants.nih.gov/grants/oprr/oprr.htm
> -----Original Message-----
> From: Workman, Don [SMTP:Don.Workman@stjude.org]
> Sent: Wednesday, May 31, 2000 3:36 PM
> To: 'mcwirb@mcwirb.org'
> Subject: Telephone Consent
>
> I have an Investigator asking about procedures for obtaining informed
> consent via the telephone. Written guidelines for this would be
> advantageous in our Institution for two situations: One possible scenario
> would be the use of previously collected blood or tissue samples for a new
> research protocol. Another would involve obtaining the consent from the
> other parent for a study involving more than minimal risk with no likely
> benefit to the subject (many of our subjects travel here accompanied by
> only
> one parent). Would anyone be willing to share (on or off-line) written
> procedures or other guidelines for obtaining and witnessing informed
> consent
> over the telephone?
>
> Don E. Workman, Ph.D.
> IRB Administrator
>
> St. Jude Children's Research Hospital
> 332 N. Lauderdale
> Memphis, TN 38101
> 901-495-4359
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul Od
6/5/2000 9:29:00 AM
PriceWaterhouse IRB Training
Here is the information about the training we held with Pricewaterhouse a
few weeks ago. As I mentioned before, it was originally planned as training
for IRB members and staff only, but as people heard about it and contacted
us, we opened it to faculty, clinical staff, and central compliance staff
(Biosafety, Animals, Rad Safety etc.)
The contact at PWC is Vikki Jenkins from the LA office. Her phone number is
213-236-3004. Her email is vikki.e.Jenkins@pwcglobal.com.
Topics covered in 3 hour presentation and discussion:
I. Historical Overview, Principles of Ethics, Belmont Report, Definitions
II. Summary of Federal Regulations
III. University of Arizona's MPA
IV. IRB
a. IRB Composition and Responsibilities
b. IRB Review Process
c. Current Issues
d. Value of a Compliance Review
e. IRB Composition and Responsibilities
Due to the diverse audience, the discussion was particularly interesting. A
total of 45 attended.
Alice C. Langen
Coordinator, Research Services
Office of the VP for Research
U of Arizona
520-621-5196
Alice C Langen
6/4/2000 3:10:00 AM
A simple question of length
Use your power. Cut, Chop, Organize, Beautify.
Check out my paper in the Applied Clinical Trial of June 1999. The point I
made is that the best crafted language will never be read if the document
looks like a mortgage or lease form. It is useless and protects only the
PI against the subject. The other point is that poorer readers don't track
across long lines so lots of white space please.
It is your DUTY to withhold approval until the consent form is informative.
Erica
(Boy, on Friday she doesn't mince words!)
_____________________
>I've been presented a consent for a trial utilizing a new pacemaker
>device. The consent is somewhat disjointed, and difficult to
>understand, even for someone with a
>background in medicine. That represents one problem. The other is that
>this
>consent form runs 13 (thirteen) pages in length (and with rather small
>font size as well).
>
>If we are really going to do justice to the PROCESS of consent, does
>anyone agree
>with me that 13 pages is a significant hinderance to proper disclosure,
>and that merely by its length, most potential subjects will either
>refuse the trial, or sign it
>merely on the basis that they trust their doctor.
>
>Even a great consent is just words on paper if no one reads it.
>
>Thanks for your thoughts.
>
>Craig Weiner, MD
>Chair
>Mercy Healthcare Sacramento Regional IRB
>craig@the-most.com
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Erica Heath
President, IRC
415-485-0717
heath
6/3/2000 3:03:00 AM
A simple question of length
Combining a couple of posts, we have routine consent forms running 7-8 pages,
and questions about a 13 page consent form being perhaps too long.
Have there been careful studies about comprehension on these forms, i.e., what
happens when you go back even an hour later and give the patient a quiz? Having
studied consent from the context of regular medical practice, and from the
general problem of getting effective waivers, I find it very difficult to
believe that the patients are carefully studying and retaining the information
from these forms. I would love to be proved wrong and await to be buried in
citations.
I can say with some assurance that you will be in trouble in a court room with a
consent form that runs 7-8 pages, much less 13. There is a well developed
doctrine in law about diluting warnings: the courts recognize that after a
certain point more is less and overly comprehensive forms defeat informed
consent.
Edward P. Richards, J.D., M.P.H.
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
6/3/2000 3:03:00 AM
IRB Review of Applications/Proposals for HHS support
Posted on OPRR's website is a clarification of OPRR's expectations regarding
IRB review of applications or proposals for HHS support:
http://grants.nih.gov/grants/oprr/humansubjects/guidance/aplrev.htm
Tom Od
6/2/2000 11:40:00 AM
IRB Review of Applications/Proposals for HHS support
Posted on OPRR's website is a clarification of OPRR's expectations regarding
IRB review of applications or proposals for HHS support:
http://grants.nih.gov/grants/oprr/humansubjects/guidance/aplrev.htm
Tom Od
6/2/2000 11:40:00 AM
COF for Physicians Fee from a Drug Company
I would be less concerned about double-dipping than the PI shuffling
unsuspecting private patients into research studies for his/her own personal
financial gain. In some GI research, for instance, drug companies and CROs will
pay PI's three times (or more) what insurance companies routinely pay for
endoscopy. Given that kind of incentive to forge patients into subjects, I think
it is prudent for IRBs to question the PI's financial interests. I fear that the
therapeutic misconception sometimes becomes a recruitment and retention strategy
in cases where patients' doctors suddenly morph into subjects' PIs.
My (Goebel-esque?) disclaimer: these are my own extreme views and they are not
necessarily shared by anyone.
-Dan
Jeff Parks wrote:
> I would appreciate information from others on what is considered to be a
> reasonable range for an average physicians (PI) fee for a study sponsored by a
> drug company.
>
> Does this fee need to be reported to the IRB as a potential conflict of
> interest? Should the IRB be concerned with the possibility of the PI double
> dipping?
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
--
Dan S. Somers
IRB Coordinator
School of Medicine IRB
UNC Chapel Hill
(919) 966-1344
dsomers@med.unc.edu
Dan Somers
6/2/2000 8:46:00 AM
Pregnant women--the never ending story--vaccines
The issue, as I will present it at the IRB, is that the Industry is not going to
do research involving the Lyme vaccine in women who are pregnant because of
liability issues. Perhaps, if the feds were to set up some form of
indemnification such as the vaccine compensation system, then industry might go
ahead. I would like to know if my information is correct about the
willingingness of the major vaccine manufactures to study vaccines in pregnant
women. Women who could biologically become pregnant are not exclused. When
someone does become pregnant (it happenes), the subject is followed for any
outcome.
kbromberg@netmail.hscbklyn.edu
6/2/2000 6:49:00 AM
Pregnant women--the never ending story--vaccines
> Once again, we find ourself accused of idealism. We have held up
> approval of a Lyme Vaccine study because the PI and his
> sponsors refuse
> to include pregnant women or any woman who might be pregnant.
Given the potential problems with teratogenesis, it seems a very reasonable
exclusion until there is clear evidence that the vaccine is safe for pregnant
women. (Which is a very different study than just including them in a general
trial.) I would be more worried about the flip side - how do you get effective
consent from a potentially pregnant woman for something that may be teratogenic,
but you do not know? Do we know if Lyme disease causes congenital infections -
it is very possible, give the type of organism. If so, then this makes the
problem even worse as to sorting out the risk from the vaccine and the disease.
Ed
Edward P. Richards
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
6/2/2000 6:52:00 AM
COF for Physicians Fee from a Drug Company
I would appreciate information from others on what is considered to be a reasonable range for an average physicians (PI) fee for a study sponsored by a drug company.
Does this fee need to be reported to the IRB as a potential conflict of interest? Should the IRB be concerned with the possibility of the PI double dipping?
Anonymous
6/2/2000 11:40:00 AM
Standard tests within the consent
--=====================_175861415==_.ALT
Content-Type: text/plain; charset=us-ascii; format=flowed
Forgive me if this has been discussed recently, but I am relatively new to
this forum.
I work for a CRO and am currently working on a consent for a drug
company-sponsored oncology study. It has generally been our policy to
briefly mention routine tests that the patient can expect during his or her
participation. In this case, as part of the patients standard testing, he
or she will have MRIs of the abdomen and pelvis done. For this reason, I
mentioned it in the consent - briefly describing it as using magnetic
waves and radio waves to produce images...
Our IRB has now come back asking that we always use a standard
IRB-generated descriptive module. This 6-paragraph module runs an entire
page long (an average cancer study consent here usually runs about 5 - 7
pages). In addition, it includes information that I believe to confusing if
not inaccurate:
...The MRI pictures obtained in this study will not be in a form readable
by either you or your physician. Therefore a copy of the MRI pictures or
the results of your individual study will not be given either to you or
your physician. While the MRI pictures in this study are not formally
reviewed by a radiologist, if in the course of processing the images we
notice any abnormality that would be potentially relevant to your health we
will notify you and a physician you designate.
How have others handled similar issues? I feel this is going too far and
takes the focus off of the research being done. If our IRB is comes out
with similar such modules, our consents could easily double in length. Any
thoughts or suggestions?
Jeff Atkinson
Regulatory Affairs and IRB Coordinator
Robert H. Lurie Comprehensive Cancer Center of
Northwestern University
(312) 908-0475
--=====================_175861415==_.ALT
Content-Type: text/html; charset=us-ascii
Forgive me if this has been discussed recently, but I am relatively new
to this forum.
I work for a CRO and am currently working on a consent for a drug
company-sponsored oncology study. It has generally been our policy
to briefly mention routine tests that the patient can expect during his
or her participation. In this case, as part of the patients
standard testing, he or she will have MRIs of the abdomen and pelvis
done. For this reason, I mentioned it in the consent - briefly
describing it as "using magnetic waves and radio waves to produce
images..."
Our IRB has now come back asking that we always use a standard
IRB-generated descriptive module. This 6-paragraph module runs an
entire page long (an average cancer study consent here usually runs about
5 - 7 pages). In addition, it includes information that I believe to
confusing if not inaccurate: "...The MRI pictures obtained in this
study will not be in a form readable by either you or your physician.
Therefore a copy of the MRI pictures or the results of your individual
study will not be given either to you or your physician. While the MRI
pictures in this study are not formally reviewed by a radiologist, if in
the course of processing the images we notice any abnormality that would
be potentially relevant to your health we will notify you and a physician
you designate."
How have others handled similar issues? I feel this is going too
far and takes the focus off of the research being done. If our IRB
is comes out with similar such modules, our consents could easily double
in length. Any thoughts or suggestions? Jeff Atkinson Regulatory Affairs and IRB Coordinator Robert H. Lurie Comprehensive Cancer Center of Northwestern University (312) 908-0475
--=====================_175861415==_.ALT--
Jeff Atkinson
6/2/2000 11:40:00 AM
Pregnant women--the never ending story--vaccines
Once again, we find ourself accused of idealism. We have held up
approval of a Lyme Vaccine study because the PI and his sponsors refuse
to include pregnant women or any woman who might be pregnant.
According to the PI, Smith Kine Beecham has assured me that EVERY OTHER
IRB has approved this study without worrying about the pregnancy issue.
Do any McWIRB readers know of any case where a Lyme Vaccine study was
held up because it excluded some women, anywhere else in this big
country?? Has anyone else read the Belmont Report? Is there a
consensus anywhere that vaccines are different and that the Belmont
report does not apply to them?
Ronald Low
6/2/2000 6:52:00 AM
COF for Physicians Fee from a Drug Company
>From an Institutional perspective, I would be VERY concerned about double
dipping. Medicare, for one, considers this fraud.
Cindy Dunn
----------
From: Dan Somers [SMTP:dsomers@med.unc.edu]
Sent: Friday, June 02, 2000 1:15 PM
To: mcwirb@mcwirb.org
Subject: Re: COF for Physicians Fee from a Drug Company
I would be less concerned about double-dipping than the PI
shuffling
unsuspecting private patients into research studies for his/her own
personal
financial gain. In some GI research, for instance, drug companies
and CROs will
pay PI's three times (or more) what insurance companies routinely
pay for
endoscopy. Given that kind of incentive to forge patients into
subjects, I think
it is prudent for IRBs to question the PI's financial interests. I
fear that the
therapeutic misconception sometimes becomes a recruitment and
retention strategy
in cases where patients' doctors suddenly morph into subjects'
PIs.
My (Goebel-esque?) disclaimer: these are my own extreme views and
they are not
necessarily shared by anyone.
-Dan
Jeff Parks wrote:
> I would appreciate information from others on what is considered
to be a
> reasonable range for an average physicians (PI) fee for a study
sponsored by a
> drug company.
>
> Does this fee need to be reported to the IRB as a potential
conflict of
> interest? Should the IRB be concerned with the possibility of the
PI double
> dipping?
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
--
Dan S. Somers
IRB Coordinator
School of Medicine IRB
UNC Chapel Hill
(919) 966-1344
dsomers@med.unc.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Cindy
6/2/2000 11:40:00 AM
At Childrens Hospital Los Angeles, we have had treatment protocols involving
experimental therapy for newborn infants being transported to our NICU.
Often, the parents are at a distance from our hospital, and the mother may
be confined to her hospital for some days (i.e., after Caesarian birth), and
thus would not be able to come to our hospital for face to face informed
consent. We have used the following procedure. Transport physicians or
nurses would take a copy of the study consent with them (or it could be
FAX'd) to give to the mother. The investigator at our institution then
discusses the protocol over the telephone, with the transport personnel
available to help provide information, and with the written study consent in
front of the mother. If agreeable, the mother can then consent, witnessed
by the Transport doc or nurse. I believe this does meet the spirit of the
regulations in terms of obtaining informed consent with the written document
available and the investigator available to explain the study and answer
questions. When the parent is finally able to come to our hospital, the
informed consent process is repeated (verified) to be sure they understood
everything, have additional questions answered, and still agree to
participation of their infant in the study.
Thomas G. Keens, M.D.
Chair, Committee on Clinical Investigations (IRB)
Childrens Hospital Los Angeles
-----Original Message-----
From: Robert Nelson [SMTP:rmnelson@mcw.edu]
Sent: Thursday, June 01, 2000 5:52 AM
To: mcwirb@mcwirb.org
Subject: re: Telephone Consent
When I first started as Chair of the Children's Hospital IRB in
1994, I
approved a verbal consent procedure for a study in the Pediatric ICU
(as I was
used to this approach for clinical treatment, especially when a
child is
transported from a distance and the parents are not on site as yet).
The FDA
came along within the next six months on their scheduled inspection
tour, found
the approval (as it was for an IND investigation) and issue a
citation. Oops!
The argument based on the regulations was that a verbal consent
procedure over
the telephone can only be used if it meets the criteria for waiver
of written
documentation (45CFR46.117; I do not recall the 21CFR50,56
citation). In this
case, it did not. So one must resort to FAX machines, or to the
Transport team
delivering a package of consent forms to the parent(s) when the
child is picked
up (hardly a moment for voluntary and informed consent). The
assumption behind
the use of telephone consent procedures in the clinical setting is
the need for
the timely use of efficacious treatments. However, the view that a
research
protocol involves the timely use of an efficacious treatment may
undercut the
assumption of clinical equipoise that serves to justify the research
in the
first place. Bottom line: no telephone consent unless a waiver of
written
documentation applies, or the parent(s) are able to FAX the
signature page back
to the investigator.
Robert Skip Nelson, MD, PhD
Coordinator, The IRB Discussion Forum
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Tom
6/1/2000 8:45:00 AM
Release of records to government agencies in other countries
Thanks, Howard, for the websites. This is an interesting global regulatory
problem.
How does one balance the benefit of using fewer subjects worldwide and the
privacy rights of subjects? There are some logistical changes coming I am
sure.
Erica
Erica Heath
President, IRC
415-485-0717
heath
6/1/2000 5:20:00 PM
Possible Requirement for Both MPA and SPA?
My community based hospital has, on occasion, reviewed survey-style studies to be performed at our institution by professors from our nearby university. These studies received approval by the university IRB (which has an MPA for nonmedical research). Subsequently, the IRB at our hospital also reviewed these studies. The research usually entailed interview-style interactions with patients or parents of patients in very minimal-risk-type studies.
Do these expedited reviews required the PI to file an SPA at our facility because it is a medical institution (and the university MPA doesn't cover medical research) - or - by the nature of these studies merely being survey-style research, does the university MPA cover these studies? It was my belief that our institution was merely approving the research because it was taking place at our facility and did not require an additional assurance to be filed.
Feedback would be greatly appreciated. Thanks!
Leilani Price, Ph.D.
IRB Administrator
Cottage Health System
Leilani Price
6/1/2000 11:09:00 AM
Possible Requirement for Both MPA and SPA?
My community based hospital has, on occasion, reviewed survey-style studies to be performed at our institution by professors from our nearby university. These studies received approval by the university IRB (which has an MPA for nonmedical research). Subsequently, the IRB at our hospital also reviewed these studies. The research usually entailed interview-style interactions with patients or parents of patients in very minimal-risk-type studies.
Do these expedited reviews required the PI to file an SPA at our facility because it is a medical institution (and the university MPA doesn't cover medical research) - or - by the nature of these studies merely being survey-style research, does the university MPA cover these studies? It was my belief that our institution was merely approving the research because it was taking place at our facility and did not require an additional assurance to be filed.
Feedback would be greatly appreciated. Thanks!
Leilani Price, Ph.D.
IRB Administrator
Cottage Health System
Leilani Price
6/1/2000 11:09:00 AM
While telphone consent can be used for clinical emergencies I don't think
that it should ever be appropriate for research projects.
-----Original Message-----
From: Workman, Don [mailto:Don.Workman@stjude.org]
Sent: Wednesday, May 31, 2000 12:36 PM
To: 'mcwirb@mcwirb.org'
Subject: Telephone Consent
I have an Investigator asking about procedures for obtaining informed
consent via the telephone. Written guidelines for this would be
advantageous in our Institution for two situations: One possible scenario
would be the use of previously collected blood or tissue samples for a new
research protocol. Another would involve obtaining the consent from the
other parent for a study involving more than minimal risk with no likely
benefit to the subject (many of our subjects travel here accompanied by only
one parent). Would anyone be willing to share (on or off-line) written
procedures or other guidelines for obtaining and witnessing informed consent
over the telephone?
Don E. Workman, Ph.D.
IRB Administrator
St. Jude Children's Research Hospital
332 N. Lauderdale
Memphis, TN 38101
901-495-4359
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
John
6/1/2000 3:00:00 AM
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