At my previous institution, we discussed this issue at length with
attorneys, insurance companies and the like. Since the community
members of the IRB have to be unaffiliated with the institution, we
could not cover them under the corporate policy. We, therefore, had
them sign up as volunteers at the hospital. This covered them and
kept them coporately unaffiliated.
Diane C. Gilbert, CRA
Director, Research and Service Grants Administration
Boston Medical Center
Howard Mann wrote:
>
> Gullion Christina M 06/09/00
> 08:41AM wrote:
>
> >>The question has come up here of whether IRB members need to worry
> about
> personal liability. Two possible situations come to mind--one is if a
> fine
> is levied by OHRP/HHS against an institution because of its IRB's
> failings.
> The second is a lawsuit that determines an IRB was negligent in
> protecting a
> human subject--which doesn't seem totally farfetched to us, with the
> major
> advances in tort law that we've seen in this country.
>
> >>While hospital and university employees would probably be covered by
> their
> institution's liability insurance, what is the status of physicians in
> private practice and community members who served on an IRB?
>
> ................................................................................................................................................................................
>
> Christina,
>
> Your institution should have an identifiable indemnification policy
> that covers the members of the IRB.
>
> At my institution, IRB members act as Officers of the Corporation with
> respect to their IRB duties.
>
> Here is a relevant excerpt from my Institution's bylaws :
>
> ARTICLE VII
>
> INDEMNIFICATION
>
> Section 7.01. Indemnification. To the maximum extent
> permitted by law, no Trustee or officer of the Corporation shall be
> personally liable for any obligations of the Corporation or for any
> duties or obligations arising out of any acts or conduct of any such
> Trustee or officer performed for or on behalf of the Corporation. The
> Corporation shall and does hereby indemnify and hold harmless each
> person and his or her heirs and administrators who shall serve at any
> time hereafter as a Trustee or officer of the Corporation...
>
> Regards,
>
> Howard
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Diane Gilbert
6/13/2000 9:58:00 AM
Financial disclosure in the informed consent
Jeff --
I may have to ruminate a bit before I decide if I agree with you down the line,
but I certainly agree with you on the pragmatism issue. IRBs are simply no good
at detecting many of the medium-sized financial conflicts, and it's
extraordinarily hard to come up with a coherent plan for when and how to
disclose them. My oft-cited favorite example (more endoscopies, paid at a
non-discounted rate, in study subjects than in off-study patients) was in fact
called to my attention by the investigator -- not picked up by the IRB.
(And of course, if the investigator was concerned enough to wonder if he should
disclose it, he probably wasn't the guy whose judgement was going to be warped
by a couple thousand extra bucks.)
A bigger concern is probably subtle skewing of judgement rather than conscious
decisions adverse to patient/subject welfare --- but there the practical
problems of detection and implementation become enormous.
So I'm not sure you can do this well even if you think it's the right thing to
do.
Dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
6/13/2000 12:05:00 PM
IRB approval letters -Reply
The answer can be found in FDA IRB Information sheets under FAQ: Does the FDA expect the IRB chair to sign the approval letters? FDA does not specify the procedure that IRBs must use regarding signature of IRB approval letter. The written operating procedures fir the IRB should outline the procedure that is followed. At our institution, per our written policy, I sign all letters issued as the IRB coordinator. To backup my actions, the IRB chairperson signs the final approved version of the meeting minutes which reflects the basis for the approval letter.
Renee LeBoeuf, Rph, CCRC
IRB Coordinator
Mother Frances Hospital
Tyler, TX Leboeur@trimofran.org
Renee Leboeuf
6/13/2000 7:58:00 AM
Informed Consent Signature Lines
Actually I would add a line for an additional signature, if your state allows
for Durable Power of Attorney for Health Care or Surrogates to sign research
consents. If so there should be a line which says :
Printed and signed name of legaly designated decison maker i.e. DPAHC,
Surrogate, or Guardian.
Meg McClaskey
Director, Ethics Consultation
Rush North Shore Medcial Center.
GFFrench@aol.com on 06/12/2000 01:09:23 PM
To: mcwirb@mcwirb.org
cc: (bcc: Meg McClaskey/RNS/RSH)
Subject: Informed Consent Signature Lines
It has been our practice to request the following labeled signature lines for
informed consent:
1)Printed and signed name of subject
2)Printed and signed name of parent/guardian
3)Printed and signed name of witness
4)Printed and signed name of investigator
5)If appropriate, child's assent
I am wondering if this is reasonable or if it's overkill. I'd appreciate
your comments.
Ginger French, Pharm.D.
Wichita, Kansas
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Meg McClaskey
6/13/2000 8:08:00 AM
Compassionate use does not have a strict regulatory definition, and is
entitled to no special IRB handling. Confusion arises because compassionate
use has overlap with emergency use, and the terms get muddled.
Compassionate use typically describes access to a test substance for the sake
of individual patient/subject benefit rather than for the sake of research data.
It may or may not be in an emergency situation, and thus may or may not be
eligible for special considerations under the regs.
Typical examples:
I have a patient who would probably benefit from New Drug X,
now in phase 3 trials. No trial is active here, and I'd like to
get the drug for the patient.
I have a patient who would probably benefit from New Drug X,
now in phase 3 trials. The trial is active here, but the patient is
ineligible for the protocol because his disease is a bit different
from the entry criteria.
This sort of use may be allowable if it is within the provisions of the IND (or
if the FDA grants permission for the individual patient), if it's OK with the
sponsor, and if the IRB approves it.
For the issue at hand, the IRB deciding not to charge for compassionate-use
needs to define compassionate use well enough that they can be consistent in
their calls, and they need to decide whether an ongoing protocol for
compassionate-use access would enjoy the same waiver of fee that is accorded a
protocol for a single patient's benefit.
dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
6/13/2000 12:15:00 PM
In my previous life with FDA, I would have said the following.
The written procedures for the IRB should state who is authorized to sign
IRB approval letters. The FDA and HHS regulations do not specify who that
should be. If the written procedures authorize only the chair to sign, then
it must be the chair, the administrator cannot sign/initial for the chair.
If the written procedures authorize the administrator, then the
administrator's typed name should be under his/her signature.
The above message is not an official FDA or OPRR statement. And yes, it is
still OPRR. The office is scheduled to change to OHRP on June 18, 2000.
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
Paul Od
6/13/2000 4:58:00 AM
Informed Consent Signature Lines (fwd)
Ginger: I'm more concerned that it's ambiguous than that it's overkill.
Witness to what? This could be interpreted as a witness to the signature (a la
notary) or as a witness attesting to the adequacy of process. The circumstances
in which a witness signature is actually required by USA federal regs are
circumstances in which the whole process is being witnessed, rather than just
the signature -- so that may be the default understanding. We advise PIs to
label such a line functionally (e.g. witness to signature) if their intent is
anything less broad than witness to concent process.
And the investigator's signature means what? Again, this could have several
meanings, from I am the person who did his best to inform this potential
subject to This looks OK to me; I'm logging it in as completed. A line
identified functionally would be better. This actually became an issue in one
criminal case --- a PI's signature on a form was used as evidence of fraud
because he was out of town on the date the form was actually completed; he
maintained that his signature was approving and taking responsibility for the
information in the form, rather than attesting that he had personally done all
the gathering (he got convicted, but I don't now remember if the counts on which
he lost included any where this was an issue).
#2 should also be if appropriate, of course.
> 1)Printed and signed name of subject
> 2)Printed and signed name of parent/guardian
> 3)Printed and signed name of witness
> 4)Printed and signed name of investigator
> 5)If appropriate, child's assent
> I am wondering if this is reasonable or if it's overkill.
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
6/13/2000 12:10:00 PM
The question has come up here of whether IRB members need to worry about
personal liability. Two possible situations come to mind--one is if a fine
is levied by OHRP/HHS against an institution because of its IRB's failings.
The second is a lawsuit that determines an IRB was negligent in protecting a
human subject--which doesn't seem totally farfetched to us, with the major
advances in tort law that we've seen in this country.
While hospital and university employees would probably be covered by their
institution's liability insurance, what is the status of physicians in
private practice and community members who served on an IRB?
Is this a reasonable concern?
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 ********
Gullion Christina M
6/13/2000 11:34:00 AM
IRB approval letters -Reply
The Chair does not need to sign all letters. I
would recommend Documenting that your
director has signature authority under specific
circumstances.
In my opinion these circumstances should be
limited to the actions of the Board that are
documented in the minutes or general
correspondence. Your signed/Board approved
minutes is your supporting documentation.
Hope this helps.
Christy Klepetko
IRB Coordinator
Christy Klepetko
6/13/2000 7:58:00 AM
Christina:
I wouldn't worry a bit, as I suspect your own counsel, whom you should
consult for reassurance, will probably tell you. Anyone, whether employee or
outside or community member, serving on an IRB was presumably appointed to
membership by an official of the parent institution with authority to make
such appointments. Decisions by members of the IRB acting in their capacity
as members, would be decisions made in the course of their official duties
and on behalf of the parent institution. Members of whatever type (e.g.
physicians in private practice, community members) would probably be viewed
as agents, if not employees, of the institution. If some IRB-approved
research project went bad and suit were brought, I have no doubt the
institution (or its insurer if any), and not the individual IRB member(s),
would be on the hook if the claimant were able to prove liability. That
said, anyone with the money to pay a court filing fee (probably in the range
of two hundred dollars or so, plus or minus) could sue anyone naming anyone,
and you cannot prevent such things from happening. It would be up to the
courts to dismiss frivolous claims, with perhaps (depending on state law)
discretionary authority to impose sanctions on anyone who filed a really
frivolous claim in bad faith for improper (e.g. harassment) purposes.
Don't fear what you call advances in tort law (e.g. think of asbestos and
tobacco litigation), or a system of civil fines. There are two ways to
regulate an activity. One is by writing an increasing number of more and
more detailed rules, to anticipate nuance, and to try to control and monitor
very sophisticated human activities in advance, in order to prevent any harm
from ever occurring. This is what we have done thusfar in attempting to
protect human subjects. We may have reached a saturation point, however, in
which there are now, or soon will be, more rules than anyone can be expected
to remember, understand, or apply. The second way is to develop some
general principles that define a duty, which we expect people to adhere to.
Presumably people will try to meet their duty, and act reasonably and free
of negligence, if for no other reason than fear that if they fail to do so
they might be held liable (through a dreaded lawsuit), or fined. I favor a
mix of both approaches. The first tends to rely upon legislative and
administrative power, the second upon judicial power, for enforcement of
principles.
In my view, IRB members, individually, will never in a million years be held
personally liable for research gone bad, or be required personally to pay
money damages or civil fines (assuming a system of fines ever gets
established in the first place). They or the IRB itself might get named
as defendants in a lawsuit, a possibility that cannot really be prevented as
noted above, but they should not be afraid, as their actions are likely
considered to be taken or not taken as agents of the institution. I
strongly suspect the parent institution would step forward, provide IRB
members a defense, pay for legal expenses, and pay any damages that might be
assessed for research gone wrong. Check with your own counsel on this,
however. Finally, for what it may be worth, as a community member of an IRB
I am not in the slightest bit concerned about personal liability, and never
expect to be.
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 Gullion Christina M
Sent: Friday, June 09, 2000 7:41 AM
To: 'mcwirb@mcwirb.org'
Subject: Liability of IRB members
thomas k. dalglish
6/13/2000 4:58:00 AM
Financial disclosure in the informed consent
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
Anonymous
6/13/2000 12:05:00 PM
I think IRB members should be concerned about liability and should not assume
that the institution will cover them. First, there are two different costs to
worry about, the cost of a judgment/settlement, and the cost of a lawyer. The
risk to institutional employees is that the institution may decide to blame you
as part of a settlement deal, and may even refuse to pay for your defense or
share of the settlement. There is nothing in an employment relationship that
obliges the employer to protect the employers or even extend their insurance
umbrella over them. Court decisions have made it clear that the institution's
lawyer is not your lawyer and that you cannot even expect attorney client
privilege for information you provide to the institution's lawyer, if the
institution chooses to divulge it. (Non-employees are even more likely to be on
their own, and this may not be covered by your medical malpractice insurance and
is definitely not covered by your home owner's policy.)
These are not idle fears - in the parallel realm of government investigations of
scientific misconduct, institutions have cut employees adrift, to face
multi-hundred thousand dollar legal bills on their own. The key is whether the
institution decides you did wrong - if it does, expect to on your own.
IRB members should have contracts of indemnification from their institutions
that provide that the IRB member will be defended, that they institution will
pay for a lawyer to represent the IRB member's interests, and that the IRB
member will be reimbursed for all expenses - which could include months of trial
time in a bad case.
I do not know how many institutions offer to protect IRB members, but I doubt it
is very many. If the institution itself is shaky financially, or if there are
state law reasons why a state institution cannot offer to indemnify an IRB
member, then the institution should buy some type of insurance for the IRB
member, that the IRB member controls, rather than the institution.
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
> The question has come up here of whether IRB members need to
> worry about
> personal liability. Two possible situations come to
> mind--one is if a fine
> is levied by OHRP/HHS against an institution because of its
> IRB's failings.
> The second is a lawsuit that determines an IRB was negligent
> in protecting a
> human subject--which doesn't seem totally farfetched to us,
> with the major
> advances in tort law that we've seen in this country.
>
> While hospital and university employees would probably be
> covered by their
> institution's liability insurance, what is the status of physicians in
> private practice and community members who served on an IRB?
Edward Richards
6/13/2000 4:58:00 AM
A simple question of length
Bob --
You're on target, here. This speaks to muddling the role of caregiver with the
role of researcher, as it speaks to confusing the treatment or disease context
with that which is being studied.
We have a PI handout called The Study vs. The Therapy that tries to make this
clearer for physician/investigators; sometimes it works (gg). The basic story
line is that a patient should, after reading the CF, find it easy to answer the
question: What will actually be different if I enter this study rather than be
treated without being in the study?
Sometimes the protocol committees don't get it, either, and absolutely demand
quite inappropriate consent documents in group trials. To their credit, the NCI
(who used to be prime offenders on this score) has put stress on making this
distinction in their recent materials for improving the consent process and
documents.
dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
6/13/2000 10:43:00 AM
In my previous life with FDA, I would have said the following.
The written procedures for the IRB should state who is authorized to sign
IRB approval letters. The FDA and HHS regulations do not specify who that
should be. If the written procedures authorize only the chair to sign, then
it must be the chair, the administrator cannot sign/initial for the chair.
If the written procedures authorize the administrator, then the
administrator's typed name should be under his/her signature.
The above message is not an official FDA or OPRR statement. And yes, it is
still OPRR. The office is scheduled to change to OHRP on June 18, 2000.
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
Paul Od
6/13/2000 4:55:00 AM
Christina:
One additional thought beyond what I posted yesterday in response to your
concerns. It's this. Even if an IRB or one of its members blew a call,
that resulted in harm to a subject, that lapse in all likelihood would
become the responsibility of the parent institution under what is known as
the doctrine of respondeat superior. The parent institution would have to
bear (and pay) the consequences, if (a big if)the claimant were able to
meet his/her burden of proof in establishing fault/blame/liability by
showing that the actions or omissions of the IRB or one of its members
breached a duty or fell below acceptable standards or was intentional and
caused the harm. (Sorry for the legalese here. Which reminds me, do check
with your own counsel on these issues.) I assume, by the way, that when you
refer to an individual member you mean one capable of acting alone or
authorized to.
This relationship between the IRB and the parent institution has one
interesting implication easily and often overlooked. Sometimes IRBs or
members are made to feel that they are betraying the interests of the
institution or its research community by being overly zealous in protecting
subjects. In actuality the opposite is likely to be the case. The best way
to protect the interests of the parent institution and its researchers is
for an IRB to act in good faith, adhere to the spirit and letter of the
rules, and conscientiously protect the subject. The interests of the
institution and the researcher are protected when the subject is.
Finally, I have tended to emphasize the legal frame of reference in my
comments here. I do not mean to ignore ethical considerations which bring
poetry and aesthetics into the equation.
Regards,
Tom Dalglish J.D., Ph.D.
Community Member, 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 Gullion Christina M
Sent: Friday, June 09, 2000 7:41 AM
To: 'mcwirb@mcwirb.org'
Subject: Liability of IRB members
The question has come up here of whether IRB members need to worry about
personal liability. Two possible situations come to mind--one is if a fine
is levied by OHRP/HHS against an institution because of its IRB's failings.
The second is a lawsuit that determines an IRB was negligent in protecting a
human subject--which doesn't seem totally farfetched to us, with the major
advances in tort law that we've seen in this country.
While hospital and university employees would probably be covered by their
institution's liability insurance, what is the status of physicians in
private practice and community members who served on an IRB?
Is this a reasonable concern?
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 ********
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
thomas k. dalglish
6/13/2000 7:55:00 AM
> Even if an IRB or one of its members
> blew a call,
> that resulted in harm to a subject, that lapse in all likelihood would
> become the responsibility of the parent institution under
> what is known as
> the doctrine of respondeat superior.
Yes and no. As we say in torts class, liability spreads, but seldom shifts.
The individual is always personally liable - even if the institution is also
liable - and attorneys like to sue individuals to put pressure on them and the
institution. (In some state systems, the individual may have more liability than
the institution.) Again, the big risk is that the plaintiff's attorney will
claim personal wrongdoing by the IRB member, such as a hidden conflict of
interest, which will force the institution to back away from the IRB member. If
the feds go to a personal sanctions system that includes IRB members, that
automatically drives a wedge between the IRB member and the institution.
I do not want to indulge in potential horror stories, but look at it this way:
IRB members are the pressure point in a multi-billion dollar research
enterprise, caught between two institutional players - sponsors and
hospitals/medical schools/universities - who can only be loyal to their
corporate interests. If it is no problem, they should not hesitate in adopting
an indemnification plan, such as the one posted by Howard Mann. If they baulk
at indemnifying you, they are telling you that there might be a problem and they
are reserving the option to sacrifice your interests to the institutional good.
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
6/13/2000 9:58:00 AM
Chris,
As administrator of our IRB, I have been signing approval letters and have
had no negative feedback from any sponsors, federal, state, or private.
David Hann
Coordinator
Advisory Committee on Human Experimentation
University of Kansas
-----Original Message-----
From: Chris Samek [mailto:CFSamek@aol.com]
Sent: Monday, June 12, 2000 2:19 PM
To: mcwirb@mcwirb.org
Subject: IRB approval letters
Is there a rule anywhere that states that IRB approval letters are required
to
be signed by the IRB Chairperson? A study sponsor has questioned my IRB
director's signature on an approval letter. The director has always been
the
signitory person for all IRB corrospondence as far back as my records go.
Your
help would be greatly appreciated.
Chris Samek
Roger Williams Medical Center
Providence, RI 02908
CFSamek@aol.com
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
David
6/12/2000 11:03:00 AM
Need Info on setting up Office of Research Integrity
Gang,
I'm looking for info on setting up an Office of Research Integrity at one of my hospitals. This would be separate from our IRB functions and focus on COI, audits, things like that.
Do any of you know of good links or have info of your own? I'm setting thhis up for someone who doesn't really understand the scope of the issues we deal with and I need to be very completein my outline and plan.
Any help would be deeply appreciated. Please respond off list.
Thanks!
Rebecca Clark
Children's Hosptial
San Diego
858-576-4008
rebcaclark@aol.com
Anonymous
6/12/2000 5:33:00 PM
Office for Human Research Protections
Hi All...A bit confusing, yes! The bill recently introduced by
Representatives DeGette, Mica and Waxman has been in the pipeline for some
time, as I understand it, and does not reflect the recent initiatives of the
Secretary to create the new office and strengthen protections for human
subjects. One of the key features of the legislation is to bring all human
research under the Common Rule, a step that I believe would be very
valuable....stay tuned! Greg
> -----Original Message-----
> From: Tom Tollison [SMTP:Tom.Tollison@bannerhealth.com]
> Sent: Monday, June 12, 2000 2:35 PM
> To: mcwirb@mcwirb.org
> Subject: Office for Human Research Protections
>
> Is the new Office for Human Research Protections, where Dr. Koski is the
> new
> director, meant to be THE NEW Office for Protection of Research Subjects
> in
> the office of the Secretary of Health and Human Services as promulgated by
> Section 401, Title IV - (Federal Oversight) of the proposed Human Research
> Subject Protection Act 2000? Or is the OHRP an entirely different office
> in
> addition to what is promulgated in Section 401 as referenced above?
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Greg
6/12/2000 11:00:00 AM
Chris,
As administrator of our IRB, I have been signing approval letters and have
had no negative feedback from any sponsors, federal, state, or private.
David Hann
Coordinator
Advisory Committee on Human Experimentation
University of Kansas
-----Original Message-----
From: Chris Samek [mailto:CFSamek@aol.com]
Sent: Monday, June 12, 2000 2:19 PM
To: mcwirb@mcwirb.org
Subject: IRB approval letters
Is there a rule anywhere that states that IRB approval letters are required
to
be signed by the IRB Chairperson? A study sponsor has questioned my IRB
director's signature on an approval letter. The director has always been
the
signitory person for all IRB corrospondence as far back as my records go.
Your
help would be greatly appreciated.
Chris Samek
Roger Williams Medical Center
Providence, RI 02908
CFSamek@aol.com
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
David
6/12/2000 11:06:00 AM
Office for Human Research Protections
OPRR became OHRP when it moved, so it is the NEW office.
-----Original Message-----
From: Tom Tollison [mailto:Tom.Tollison@bannerhealth.com]
Sent: Monday, June 12, 2000 11:35 AM
To: mcwirb@mcwirb.org
Subject: Office for Human Research Protections
Is the new Office for Human Research Protections, where Dr. Koski is the new
director, meant to be THE NEW Office for Protection of Research Subjects
in
the office of the Secretary of Health and Human Services as promulgated by
Section 401, Title IV - (Federal Oversight) of the proposed Human Research
Subject Protection Act 2000? Or is the OHRP an entirely different office in
addition to what is promulgated in Section 401 as referenced above?
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Joan
6/12/2000 9:57:00 AM
Informed Consent Signature Lines
>From a recent conference I attended of IRB Managers, it was also pointed out
that the consent document contain the time the document was signed.
-----Original Message-----
From: GFFrench@aol.com [mailto:GFFrench@aol.com]
Sent: Monday, June 12, 2000 2:09 PM
To: mcwirb@mcwirb.org
Subject: Informed Consent Signature Lines
It has been our practice to request the following labeled signature lines
for
informed consent:
1)Printed and signed name of subject
2)Printed and signed name of parent/guardian
3)Printed and signed name of witness
4)Printed and signed name of investigator
5)If appropriate, child's assent
I am wondering if this is reasonable or if it's overkill. I'd appreciate
your comments.
Ginger French, Pharm.D.
Wichita, Kansas
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Anonymous User
6/12/2000 11:06:00 AM
Informed Consent Signature Lines
>From a recent conference I attended of IRB Managers, it was also pointed out
that the consent document contain the time the document was signed.
-----Original Message-----
From: GFFrench@aol.com [mailto:GFFrench@aol.com]
Sent: Monday, June 12, 2000 2:09 PM
To: mcwirb@mcwirb.org
Subject: Informed Consent Signature Lines
It has been our practice to request the following labeled signature lines
for
informed consent:
1)Printed and signed name of subject
2)Printed and signed name of parent/guardian
3)Printed and signed name of witness
4)Printed and signed name of investigator
5)If appropriate, child's assent
I am wondering if this is reasonable or if it's overkill. I'd appreciate
your comments.
Ginger French, Pharm.D.
Wichita, Kansas
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Anonymous User
6/12/2000 11:06:00 AM
in response to bob short, i wrote:
> it is my understanding that institutions are not allowed to levy
> additional fees like this on federally funded research, even if we were
> so inclined, because this would constitute double-dipping on top of the
> federal indirect cost rates.>>
a postscript of sorts: the above remains true for the moment, but the
degette-waxman-mica bill now winding its way through congress (and
relayed to mcwirb last friday by deb barnard, via the installment
plan...) includes the following provision:
Section 306 - Cost Recovery: Authorizes institutions to recover the
costs of compliance with human subject protections from government
research sponsors as direct costs.
i can see deans and chancellors across the country, smiling in their
sleep....
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
6/12/2000 3:02:00 AM
in response to bob short, i wrote:
> it is my understanding that institutions are not allowed to levy
> additional fees like this on federally funded research, even if we were
> so inclined, because this would constitute double-dipping on top of the
> federal indirect cost rates.>>
a postscript of sorts: the above remains true for the moment, but the
degette-waxman-mica bill now winding its way through congress (and
relayed to mcwirb last friday by deb barnard, via the installment
plan...) includes the following provision:
Section 306 - Cost Recovery: Authorizes institutions to recover the
costs of compliance with human subject protections from government
research sponsors as direct costs.
i can see deans and chancellors across the country, smiling in their
sleep....
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
6/12/2000 3:05:00 AM
When I was IRB coordinator, I was challenged with the chairperson's signature
issue. I wrote his name and added a slash and my initials to the right of
his name on the letter. When challenged and one wanted the chairperson's
actual signature, I made it available for that one letter and continued my
practice with other communication. There is probably a reason why this
investigator wants or must have the chair's signature.
I understand your procedure, but if the investigator wants to have the
chair's real signature before initiating the study, I do not understand your
issue. If the investigator has a need to go beyond your local procedure to
add a level of assurance, I do not understand your issue with it. It seems
to me that the chair's signature is needed. If not needed, it is highly
desired.
Thomas E. Ball, M.Div, CIM
The National Association of IRB Managers, Inc.
Ballthomas@aol.com
ballthomas@aol.com
6/12/2000 11:06:00 AM
I am our IRB Manager as well as the Risk and Contract Manager. We draft all
of the IRB correspondence but send it out under the Chair's signature just
as we would for the Chairperson of any other entity or committee. The only
time I sign approval letters is when the study involves the Chair's
department or he/she is also the principal investigator.(another whole
discussion) Since I am also a voting member of the IRB, I am acting as the
Chair's designee. I hope to solve this in the future by having a Vice
Chair. Our policy and procedures do not specify a signator. They globally
refer to the IRB responsibilities rather than specific Chair
responsibilities. I am in the process of developing a job description for
the IRB Chairperson as well as for members of the IRB and roll it all
together in an educational module and resource manual for the Chair and IRB
members.
> -----Original Message-----
> From: Chris Samek [SMTP:CFSamek@aol.com]
> Sent: Monday, June 12, 2000 12:19 PM
> To: mcwirb@mcwirb.org
> Subject: IRB approval letters
>
> Is there a rule anywhere that states that IRB approval letters are
> required to
> be signed by the IRB Chairperson? A study sponsor has questioned my IRB
> director's signature on an approval letter. The director has always been
> the
> signitory person for all IRB corrospondence as far back as my records go.
> Your
> help would be greatly appreciated.
>
> Chris Samek
> Roger Williams Medical Center
> Providence, RI 02908
> CFSamek@aol.com
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sandra Armc-Prof Svcs
6/12/2000 11:04:00 AM
I am our IRB Manager as well as the Risk and Contract Manager. We draft all
of the IRB correspondence but send it out under the Chair's signature just
as we would for the Chairperson of any other entity or committee. The only
time I sign approval letters is when the study involves the Chair's
department or he/she is also the principal investigator.(another whole
discussion) Since I am also a voting member of the IRB, I am acting as the
Chair's designee. I hope to solve this in the future by having a Vice
Chair. Our policy and procedures do not specify a signator. They globally
refer to the IRB responsibilities rather than specific Chair
responsibilities. I am in the process of developing a job description for
the IRB Chairperson as well as for members of the IRB and roll it all
together in an educational module and resource manual for the Chair and IRB
members.
> -----Original Message-----
> From: Chris Samek [SMTP:CFSamek@aol.com]
> Sent: Monday, June 12, 2000 12:19 PM
> To: mcwirb@mcwirb.org
> Subject: IRB approval letters
>
> Is there a rule anywhere that states that IRB approval letters are
> required to
> be signed by the IRB Chairperson? A study sponsor has questioned my IRB
> director's signature on an approval letter. The director has always been
> the
> signitory person for all IRB corrospondence as far back as my records go.
> Your
> help would be greatly appreciated.
>
> Chris Samek
> Roger Williams Medical Center
> Providence, RI 02908
> CFSamek@aol.com
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sandra Armc-Prof Svcs
6/12/2000 11:06:00 AM
I am our IRB Manager as well as the Risk and Contract Manager. We draft all
of the IRB correspondence but send it out under the Chair's signature just
as we would for the Chairperson of any other entity or committee. The only
time I sign approval letters is when the study involves the Chair's
department or he/she is also the principal investigator.(another whole
discussion) Since I am also a voting member of the IRB, I am acting as the
Chair's designee. I hope to solve this in the future by having a Vice
Chair. Our policy and procedures do not specify a signator. They globally
refer to the IRB responsibilities rather than specific Chair
responsibilities. I am in the process of developing a job description for
the IRB Chairperson as well as for members of the IRB and roll it all
together in an educational module and resource manual for the Chair and IRB
members.
> -----Original Message-----
> From: Chris Samek [SMTP:CFSamek@aol.com]
> Sent: Monday, June 12, 2000 12:19 PM
> To: mcwirb@mcwirb.org
> Subject: IRB approval letters
>
> Is there a rule anywhere that states that IRB approval letters are
> required to
> be signed by the IRB Chairperson? A study sponsor has questioned my IRB
> director's signature on an approval letter. The director has always been
> the
> signitory person for all IRB corrospondence as far back as my records go.
> Your
> help would be greatly appreciated.
>
> Chris Samek
> Roger Williams Medical Center
> Providence, RI 02908
> CFSamek@aol.com
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Sandra Armc-Prof Svcs
6/12/2000 11:06:00 AM
I am a sponsor, and cringe every time I see an IRB charging for a review. I
don't think it is wrong, but it is another budget item for me. While $1,000
is not a large fee, try multiplying that times 30, the number of sites in one
of my multicenter trials.
Also I continue to use commercial IRBs, and they are less than a $1,000 per
site they review. So please think before you raise your fees.
Sincerely,
Cliff R. Kline, II
Director, Clinical Programs
Mentor
cliffk2@aol.com
6/9/2000 5:11:00 AM
need list of recognized medical ethicists
Would anybody be willing to provide me with a list of medical ethicists who are
well recognized in their field that might be available for consultation?
You may respond publically or to me privately at:
springer.st@pg.com
thank you
Steve Springer
Steve Springer-St
6/9/2000 11:41:00 AM
I am a sponsor, and cringe every time I see an IRB charging for a review. I
don't think it is wrong, but it is another budget item for me. While $1,000
is not a large fee, try multiplying that times 30, the number of sites in one
of my multicenter trials.
Also I continue to use commercial IRBs, and they are less than a $1,000 per
site they review. So please think before you raise your fees.
Sincerely,
Cliff R. Kline, II
Director, Clinical Programs
Mentor
cliffk2@aol.com
6/9/2000 5:09:00 AM
Bob Short wrote:
>> Because of our stong support of cancer research, cooperative group studies such as SWOG, ECOG, and RTOG were exempted from the fee....>>
just a cautionary note, to you or anyone else implementing review fees.
it is my understanding that institutions are not allowed to levy
additional fees like this on federally funded research, even if we were
so inclined, because this would constitute double-dipping on top of the
federal indirect cost rates. not sure what kind of institution you're
at, but it shouldn't matter in this regard.
federally sponsored studies should be exempted, but for reasons less
noble (but no less real...) than the desire to support cancer research.
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
6/9/2000 11:41:00 AM
Propulsid Limited Access Program
The drug cisapride (Propulsid) is being taken off the market by the manufacturer Janssen Pharmceutica, L.P. due to a number of sudden deaths possibly related to cardiac dysrhythmia. My understanding is that the people at risk for sudden death developed a prolonged QT interval that can be readily detected by serial ECGs.
The drug is used for gastroesophageal reflux disease. Unfortunately, some people require cisapride and do not get any relief from other substitutes. Janssen is making the drug available through a limited access program. Howver, to be in the program physicians must use a protocol provided by the company and obtain IRB review and approval and IRB approved informed consent.
I called the FDA. Lila Talarico, MD at CDER (301) 827-7310. She said the drug is not investigational. It remains FDA approved. The drug is being voluntarily withdrawn from the market by Janssen. FDA has no plans to withdraw approval of the drug.
I have some concerns about this approach. We have an approved drug. The drug company wants to limit liability and believes that they can do so through the IRB process and calling a limited access program research.
From what I can see this project involves neither an FDA regulated drug, nor a systematic investigation into new knowledge. My physicians are doing this because they want their patients who truly need this approved drug can have access to this approved drug. The drug company is doing this so that patients who truly need this approved drug can be supplied with the drug in a way that is safe.
Is anyone else having problems with this study? What will be the next clinical approved drug or procedure that will required IRB review? Coronary artery bypass grafting, adriamycin therapy, ... all of which have much poorer risk benefit ratios than cisapride.
Also, the FDA admitted that this was not research. I asked the company what regulatory authority they had to force the IRB to review a clinical protocol and clinical consent to make an approved drug available. They are getting back to me.
Any other comments....
Jeff Cooper
Chair, IRB
Albany Medical Center
Anonymous
6/9/2000 6:59:00 AM
Compassionate use has been adopted to mean things like expanded access and on
a case by case basis
near as I can tell.
Deb Barnard
Robert Nelson on 06/07/2000 04:53:55 PM
Please respond to mcwirb@mcwirb.org
To: mcwirb@mcwirb.org
cc: (bcc: Deborah L Barnard/Rush/RSH)
Subject: Compassionate Use?
Message posted for Jeanne Gaffney
Lynne Moffitt's posting regarding Charging for IRB Review caught my eye, not
for the obvious, but because she made reference to waiving the fee for
compassionate use protocols. Recently, I had a conversation with Paul Goebel
regarding this topic. He simply stated that the FDA does not recognize this
term. But it seems to continue to surface on this site. What does it mean
when someone states, The drug has been approved for compassionate use?
Jeanne Gaffney
Human Research Review Board
Baptist Health System, Inc.
Birmingham, AL
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Deborah L Barnard
6/9/2000 11:41:00 AM
>-----Original Message-----
>Recently, I had a conversation
>with Paul Goebel
>regarding this topic. He simply stated that the FDA does not
>recognize this
>term.
It's true that the term Compassionate Use does not appear anywhere in 21
CFR 50 or 56, but you can find a reference to applicable federal regulations
on the CDRH site: http://www.fda.gov/cdrh/ode/idepolcy.html. Scroll to the
table at the end of the document.
Roger Bertholf
Chair, IRB-03
University of Florida
Health Science Center/Jax
Roger
6/9/2000 5:14:00 AM
Paul,
In the UK Multi-Centre Research Ethics Committee system, industry sponsored
research is charged a £1000 fee. Other applicants are not charged.
Paul
> -----Original Message-----
> From: Paul Sesin [SMTP:sesinp@southcoast.org]
> Sent: Friday, May 19, 2000 7:39 PM
> To: mcwirb@mcwirb.org
> Subject: Charging for IRB Review
>
> Our Institutional IRB has made the decision to begin charging for
> IRB Review. If anyone would be willing to share with us your policy
> and/or
> procedure for IRB review fees, it would be greatly appreciated. Thank you
> for
> your time and efforts regarding our request.
> Paul Sesin, Pharm.D.
> IRB Coordinator, Charlton Memorial Hospital, Fall River, MA 02720
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul
6/9/2000 5:11:00 AM
I agree that education both on this issue and as a general matter for
IRB members, invcestigators et. al. is a good idea. If the regs are
complicated enough to cause confusion, however, should we not also look
at ways to simplify or clarify the regs so as to minimize the difficulty
people are having?
Steve
Greg Koski wrote:
This issue comes up very often, and the regs are sufficiently
complicated to
lead to confusion....this is an area where education, both for the IRB
members and staff, and for investigators, would be very valuable.
--
Stephen Erickson
Director, Office of Research Administration
Boston College
McGuinn Hall 600
Chestnut Hill, MA 02467
Telephone: 617-552-3344
On-Campus Fax: 617-552-0747
Fax to My Computer: 413-895-8328
Stephen Erickson
6/9/2000 5:11:00 AM
AAMC Endorses Bill to Protect Patients In Clinical Research
Jordan J. Cohen, M.D., President
Association of American Medical Colleges
June 8, 2000
The AAMC endorses the legislation introduced today by Reps. Diana
DeGette (D-Colo.), Henry Waxman (D-Calif.), John Mica (R-Fla.) and their
colleagues designed to significantly enhance the protections provided to
patients involved in clinical research. The Human Research Subject
Protections Act of 2000 includes a number of provisions long advocated
by the AAMC as important steps toward ensuring the safety and welfare of
all patients.
In particular, the AAMC supports the application of the Common Rule and
vulnerable-population protections to all human research subjects
independent of setting and funding source and agrees that the HHS
Secretary should have the authority to modify these safeguards when
necessary.
The AAMC also agrees with the legislation's requirement to educate
investigators and institutional review board (IRB) members about human
research subject protections. This provision dovetails nicely with the
Association's ongoing efforts to educate and inform the research
community about existing federal oversight regulations for clinical
research.
Finally, the AAMC is very pleased that the bill calls for the
accreditation of all IRBs by a nonprofit private entity effective two
years after the enactment of the legislation. For the past several
months, the AAMC, along with several other organizations, has been
assessing the feasibility of creating such a mechanism. We look forward
to working with the Congress and HHS to see that this concept becomes a
reality.
The legislation introduced today, coupled with the HHS recommendations
announced recently and the ongoing efforts on the part of the academic
medical community, underscore the need to be diligent in ensuring human
subjects protections. At a time of unparalleled promise in clinical
research, we must redouble our efforts to create a safe environment for
all individuals willing to advance the scientific process through their
voluntary participation
HUMAN RESEARCH SUBJECT PROTECTIONS ACT OF 2000
SECTION BY SECTION SUMMARY
SHORT TITLE, FINDINGS AND PURPOSES
Section 1 - Short Title
This Act may be cited as the Human Research Subjects Protections Act
of 2000.
Section 2 - Findings and Purposes
The purposes of this Act are -
1. To apply Common Rule and vulnerable-population protections to all
human research subjects independent of setting and funding
source.
2. Require classified research be approved by an Institutional Review
Board (IRB) and compliant with other human research subject
protections.
3. Establish an Office for Protection of Research Subjects in the HHS
Office of the Secretary.
TITLE I - HUMAN SUBJECT PROTECTIONS
Section 101 - Protection of Human Subjects in Research; Uniform
National Applicability of Common Rule and Provisions Protecting
Vulnerable Populations
Applies Common Rule and vulnerable-population protections to all human
research subjects independent of setting and funding source.
Section 102 - Scope of Authority of Secretary
Establishes the Secretary's authority to modify the Common Rule and
vulnerable-population protections. Permits Federal agencies to
establish protections above and in addition to the Common Rule and
vulnerable-population protections.
Authorizes the Secretary to suspend or revoke the registration, impose
restrictions on, or withhold Federal funding from an IRB.
Section 103 - Enhanced Human Subject Protections
Instructs the Secretary to promulgate new standards to protect research
subjects with diminished decision-making capacity within 180 days of the
date of enactment.
TITLE II - INFORMED CONSENT
Section 201 - Right of Informed Consent
Establishes a research subject's legal right of informed consent.
Requires the provision of full and complete information to research
s
Anonymous
6/9/2000 10:24:00 AM
TITLE IV - FEDERAL OVERSIGHT
Section 401 - Establishment of Office for Protection of Research
Subjects
Establishes an Office for Protection of Research Subjects in the Office
of the Secretary of Health and Human Services. Calls for an Office
Director to be appointed by the Secretary.
Section 402 - Authorization of Appropriations
Authorizes $20,000,000 for the Office in fiscal year 2001 and such sums
as may be necessary in subsequent years.
Section 403 - Institutional Programs for Providing Education on
Protection of Human Subjects in Research
Requires a comprehensive and ongoing program to educate investigators
and IRB members on human research subject protections as a condition of
Federal grants, cooperative agreements or contracts with public or
private entities for the conduct of research.
Section 404 - Certain Classified Human Subject Research
Prohibits Federal funding of secret, classified research if an IRB has
waived the requirement of informed consent or the research is exempt
under the Common Rule from IRB review. Fulfills the recommendations of
the 1995 Report of the National Advisory Committee on Human Radiation
Experiments.
Section 405 - Rule of Construction Regarding Individual Agency Offices
Provides for transferring duties from any existing office, such as the
HHS Office of Human Research Protections, to the newly authorized
Office for Protection of Research Subjects.
Section 406 - National Bioethics Advisory Commission
Authorizes the National Bioethics Advisory Commission as the successor
body to the President's Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research (1979-1986).
Anonymous
6/9/2000 10:26:00 AM
TITLE I - HUMAN SUBJECT PROTECTIONS
Section 101 - Protection of Human Subjects in Research; Uniform
National Applicability of Common Rule and Provisions Protecting
Vulnerable Populations
Applies Common Rule and vulnerable-population protections to all human
research subjects independent of setting and funding source.
Section 102 - Scope of Authority of Secretary
Establishes the Secretary's authority to modify the Common Rule and
vulnerable-population protections. Permits Federal agencies to
establish protections above and in addition to the Common Rule and
vulnerable-population protections.
Authorizes the Secretary to suspend or revoke the registration, impose
restrictions on, or withhold Federal funding from an IRB.
Section 103 - Enhanced Human Subject Protections
Instructs the Secretary to promulgate new standards to protect research
subjects with diminished decision-making capacity within 180 days of the
date of enactment.
TITLE II - INFORMED CONSENT
Section 201 - Right of Informed Consent
Establishes a research subject's legal right of informed consent.
Requires the provision of full and complete information to research
subjects necessary to make an informed decision, free of coercion,
regarding their participation in research. Also specifies the minimum
elements of an informed consent form.
Section 202 - Written Attestation and Disclosure
Requires investigators to file a written attestation of familiarity and
agreement to comply with human subject research protections. Requires
investigators to disclose to research subjects their financial interests
in the research and any other conflicts of interest deemed necessary by
the IRB.
TITLE III - INSTITUTIONAL REVIEW BOARDS
Section 301 - Requirements for Board
Requires IRB approval before human subject research can proceed.
Establishes IRB membership requirements consistent with current Common
Rule regulations. Establishes procedural requirements, including
adequate funding, quorums for decision-making, orientation and
continuing education programs, and registration with the Secretary.
Section 302 - Notification of Institutional Review Board
Requires sponsors and investigators to notify IRBs of prior IRB review
and findings on a research proposal, as well as the regulatory
disqualification or restriction of the sponsor, investigator or research
institution by a Federal agency.
Section 303 - Activities
Requires IRBs to compile and report summary annual data on the number
of proposals reviewed, number of human subjects involved, and other
subjects. Requires the Secretary to promulgate regulations on improved
clinical trial monitoring and the conduct of research at multiple
research sites.
Section 304 - Disclosure of Interests
Requires investigators to disclose to IRBs their financial interests
and conflicts of interest in the research. Requires all IRB members to
disclose their conflicts of interest in the research, including
ownership or financial relationships with the sponsors. Prohibits
participation of IRB members in decisions on research in which they have
conflicts of interest.
Section 305 - Accreditation
Effective two years after the date of enactment, IRBs shall be
accredited by a nonprofit private entity approved by the Secretary.
Specifies that accreditation shall be to standards established by the
Secretary.
Section 306 - Cost Recovery
Authorizes institutions to recover the costs of compliance with human
subject protections from government research sponsors as direct costs.
Section 307 - Applicability of Requirements
Requirements of the Act shall apply on the date of enactment.
Anonymous
6/9/2000 10:25:00 AM
Compassionate use has been adopted to mean things like expanded access and on
a case by case basis
near as I can tell.
Deb Barnard
Robert Nelson on 06/07/2000 04:53:55 PM
Please respond to mcwirb@mcwirb.org
To: mcwirb@mcwirb.org
cc: (bcc: Deborah L Barnard/Rush/RSH)
Subject: Compassionate Use?
Message posted for Jeanne Gaffney
Lynne Moffitt's posting regarding Charging for IRB Review caught my eye, not
for the obvious, but because she made reference to waiving the fee for
compassionate use protocols. Recently, I had a conversation with Paul Goebel
regarding this topic. He simply stated that the FDA does not recognize this
term. But it seems to continue to surface on this site. What does it mean
when someone states, The drug has been approved for compassionate use?
Jeanne Gaffney
Human Research Review Board
Baptist Health System, Inc.
Birmingham, AL
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Deborah L Barnard
6/9/2000 11:39:00 AM
I agree that education both on this issue and as a general matter for
IRB members, invcestigators et. al. is a good idea. If the regs are
complicated enough to cause confusion, however, should we not also look
at ways to simplify or clarify the regs so as to minimize the difficulty
people are having?
Steve
Greg Koski wrote:
This issue comes up very often, and the regs are sufficiently
complicated to
lead to confusion....this is an area where education, both for the IRB
members and staff, and for investigators, would be very valuable.
--
Stephen Erickson
Director, Office of Research Administration
Boston College
McGuinn Hall 600
Chestnut Hill, MA 02467
Telephone: 617-552-3344
On-Campus Fax: 617-552-0747
Fax to My Computer: 413-895-8328
Stephen Erickson
6/9/2000 5:11:00 AM
In Canada we used the term compassionate use and emergency drug release
for drugs that were currently not approved
(i.e. experimental medications) but required for patients who were
refractory to currently available medications. The regs in Canada have
changed and the program is not called Special Access Program. However the
term compassionate release is still widely used. Additionally, where I have
been involved in multi-country trials (especially Canada & USA),
compassionate use protocol was used for continuing to supply patients who
participated in clinical trials but could not afford the new therapies once
the phase III program was complete. Basically the patients who could not
afford the medications to optimally treat their underlying condition, but
who were controlled on the new medication were supplied with the test
article for about one year post NDA submission under a compassionate use
protocol.
Hope this helps
Rodney Butt
Director, Clinical Research
Boehringer Ingelheim Canada
> -----Original Message-----
> From: Robert Nelson [SMTP:rmnelson@mcw.edu]
> Sent: Wednesday, June 07, 2000 5:54 PM
> To: mcwirb@mcwirb.org
> Subject: Compassionate Use?
>
> Message posted for Jeanne Gaffney
>
> Lynne Moffitt's posting regarding Charging for IRB Review caught my eye,
> not
> for the obvious, but because she made reference to waiving the fee for
> compassionate use protocols. Recently, I had a conversation with Paul
> Goebel
> regarding this topic. He simply stated that the FDA does not recognize
> this
> term. But it seems to continue to surface on this site. What does it
> mean
> when someone states, The drug has been approved for compassionate use?
>
> Jeanne Gaffney
> Human Research Review Board
> Baptist Health System, Inc.
> Birmingham, AL
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
rbutt@bur.boehringer-ingelheim.com
6/8/2000 12:03:00 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 12:05:00 PM
I don't know what others mean when they use the term compassionate use
protocols but in our policy what we are referring to by the short-hand use
of the term is our pharmaceutical research protocols for which our facility
or investigators do not receive any grant funds but do receive the study
drug at no cost. Because there is no funding from the sponsor, the
investigators involved in such trials were afraid that if we charged a fee
for the protocol submission the sponsor might not want to use us an
investigative site and as a consequent patients would not have any other
access to the study drug. To date the only protocols I know of at our
facility which fall under our usage of this term have been for patients who
are HIV positive.
> ----------
> From: Robert Nelson[SMTP:rmnelson@mcw.edu]
> Reply To: mcwirb@mcwirb.org
> Sent: Wednesday, June 07, 2000 5:53 PM
> To: mcwirb@mcwirb.org
> Subject: Compassionate Use?
>
> Message posted for Jeanne Gaffney
>
> Lynne Moffitt's posting regarding Charging for IRB Review caught my eye,
> not
> for the obvious, but because she made reference to waiving the fee for
> compassionate use protocols. Recently, I had a conversation with Paul
> Goebel
> regarding this topic. He simply stated that the FDA does not recognize
> this
> term. But it seems to continue to surface on this site. What does it
> mean
> when someone states, The drug has been approved for compassionate use?
>
> Jeanne Gaffney
> Human Research Review Board
> Baptist Health System, Inc.
> Birmingham, AL
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
Lynne Moffitt
6/8/2000 12:05:00 PM
In Canada we used the term compassionate use and emergency drug release
for drugs that were currently not approved
(i.e. experimental medications) but required for patients who were
refractory to currently available medications. The regs in Canada have
changed and the program is not called Special Access Program. However the
term compassionate release is still widely used. Additionally, where I have
been involved in multi-country trials (especially Canada & USA),
compassionate use protocol was used for continuing to supply patients who
participated in clinical trials but could not afford the new therapies once
the phase III program was complete. Basically the patients who could not
afford the medications to optimally treat their underlying condition, but
who were controlled on the new medication were supplied with the test
article for about one year post NDA submission under a compassionate use
protocol.
Hope this helps
Rodney Butt
Director, Clinical Research
Boehringer Ingelheim Canada
> -----Original Message-----
> From: Robert Nelson [SMTP:rmnelson@mcw.edu]
> Sent: Wednesday, June 07, 2000 5:54 PM
> To: mcwirb@mcwirb.org
> Subject: Compassionate Use?
>
> Message posted for Jeanne Gaffney
>
> Lynne Moffitt's posting regarding Charging for IRB Review caught my eye,
> not
> for the obvious, but because she made reference to waiving the fee for
> compassionate use protocols. Recently, I had a conversation with Paul
> Goebel
> regarding this topic. He simply stated that the FDA does not recognize
> this
> term. But it seems to continue to surface on this site. What does it
> mean
> when someone states, The drug has been approved for compassionate use?
>
> Jeanne Gaffney
> Human Research Review Board
> Baptist Health System, Inc.
> Birmingham, AL
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
rbutt@bur.boehringer-ingelheim.com
6/8/2000 12:05:00 PM
The FDA Information sheets explain this pretty well. The often used term
'compassionate use' has been abandoned and replaced with more specific
terminology to distinguish between those uses that require prospective IRB
approval and those that do not.
What used to be called 'compassionate' uses are essentially treatment uses
of investigational drugs, devices or biologics outside of IRB approved
protocols. Emergency Use is permitted only in case of a true life
threatening emergency, and must be reported to, but does not require
approval by the IRB, unless stipulated by local institutional rules. The
specific criteria are detailed in the information sheets. An institution is
generally permitted only one such use; others, at least for the same
indication, should be anticipated and a protocol should be submitted to the
IRB for review and approval.
When a life/limb-threatening emergency situation does not exist, and there
is time for IRB review, treatment use may be requested, but full IRB
approval is required. One should carefully review the Information Sheets
and the OPRR Guidebook for specifics. Note that requirements for informed
consent are not automatically waived even in emergency situations!
Neither OPRR nor FDA regulate the practice of medicine....emergency uses for
treatment purposes do not produce research data.
This issue comes up very often, and the regs are sufficiently complicated to
lead to confusion....this is an area where education, both for the IRB
members and staff, and for investigators, would be very valuable.
Greg
-----Original Message-----
From: Robert Nelson [SMTP:rmnelson@mcw.edu]
Sent: Wednesday, June 07, 2000 5:54 PM
To: mcwirb@mcwirb.org
Subject: Compassionate Use?
Message posted for Jeanne Gaffney
Lynne Moffitt's posting regarding Charging for IRB Review caught
my eye, not
for the obvious, but because she made reference to waiving the fee
for
compassionate use protocols. Recently, I had a conversation with
Paul Goebel
regarding this topic. He simply stated that the FDA does not
recognize this
term. But it seems to continue to surface on this site. What does
it mean
when someone states, The drug has been approved for compassionate
use?
Jeanne Gaffney
Human Research Review Board
Baptist Health System, Inc.
Birmingham, AL
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Greg
6/8/2000 12:09:00 PM
Financial Disclosure in the Informed Consent
Our practice is to inform subjects, as part of the consent that the
physician may receive compensation from the sponsor, but not do into
further details. We do
require that the PI detail the renumeration if asked by the subject.
Also, as part of our review process, we query the PI's as to the
reunmeration, including monetar or non-monetary compensation. We do not
ask for a study
budget, but often receive less than satisfactory answers such as
Investigators are only compensated for their time required for extra
testing and for data collection.
We struggle with how much detailed information is required in the
consent.
A question:
Many IRB's and institutions have a policy on Conflicts of Interest or
is that Conflict of Interests? Either way, does anyone have the PI's
sign a letter or memorandum of understanding divulging any real or
potential COI's, including guidelines for what the institution considers
COI?
Thanks.
Oh, and this just in...
Oncology Research Coordinator
Mercy Healthcare Sacramento has a unique opportunity for a Regional
Oncology Research Coordinator. Strong research background required with
planning, implementing and coordinating clinical research trials, IRB,
data management, pt enrollment, audit experience and strong
interpersonal skills required. Oncology experience and RN a plus. For
more information, call (916)733-6888.
Md
6/8/2000 12:05:00 PM
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
1 2 3 4 5 6 7 8 9 10
...
>|
Pages: 8 of 200