Use of international cDNA library
Bree Klotter wrote :
A researcher at my site has been offered use of a fetal tissue cDNA
library
created by researchers in Italy. Our researcher has been told the
library was
created with completely anonymous/unidentified samples and that the
women were
informed that samples might be used for research, but no consent form
was
required (per Italian law). No Italian IRB was involved in this
process.
Anyone familiar with Italian IRBs/ethical review boards? Would you
consider
research uses of this library to be exempt from human subjects
regulations?
Any feedback would be appreciated.
.....................................................................................................................................................................
Bree,
Here are two items that address your question:
Is a human subject involved ?
http://grants.nih.gov/grants/oprr/humansubjects/45cfr46.htm#46.102
(f) (2)
Private information must be individually identifiable (i.e., the
identity of the subject is or may readily be ascertained by the
investigator or associated with the information) in order for obtaining
the information to constitute research involving human subjects.
(An unidentified sample is supplied to the researcher from a repository
that has a collection of unidentified human specimens.Research using
such material is typically exempt from the requirement for IRB review.
For additional definitions, see :
http://www.ihc.com/ldsh/irb/hbm/fedregs.html )
This is a summary you may find useful:
http://www.ihc.com/ldsh/irb/hbm/research1.gif
Regards,
Howard
Howard Mann
5/24/2000 2:55:00 AM
Removal from Phase 1 Trial
Kenneth Kipnis 05/22/00 09:39PM queried :
A question:
>>It is not uncommon for a P1 cancer trial to select patients who have
already (excuse the expression) failed standard treatment.
Investigational drugs are administered to cohorts of these patients
with the primary intention of identifying toxicity.
The intent is generally to identify a maximum tolerated dose (
MTD). As dosage is increased, clinical
efficacy and toxicity increase. Of course, the latter eventually
precludes potential gains in the former.
>>It is common to remove patients from these trials if their tumors
progress, increasing in size by some amount.
I do not quite understand this point. It is known that the
statistical likelihood of a subject experiencing a meaningful,
long-lasting response is very low. Thus, the oft-stated concern with the
so-called therapeutic misconception in Phase 1( cancer) trials.
>>Patients early in the trial will, presumably, receive doses that are,
at
least theoretically, sub-therapeutic. Later cohorts will receive
larger
doses if safety -- the absence of toxicity -- permits.
Correct. Thus, there are those that have proposed alternative
approaches to Phase 1 studies.
The late Dr. Benjamin Freedman has written a lot about this.
(http://www.mcgill.ca/CTRG/)
>>My understanding is that the reason why patients are removed from
the
study if their tumors progress is because it is, by that time, clear
that
the treatment is not benefitting them and, accordingly, they should be
on
something else.
I do not really agree with this sentiment-- there generally is
*not* any other satisfactory therapy, as you allude next.
>>But these patients were initially selected in part because there were
no
other effective options remaining. It seems disingenuous to say We
have
to take you off this experimental drug because, for your own sake, you
should be on some more effective course of treatment if, in fact,
those
other treatments had already been tried and had failed, and especially
since those failures were the reason they were allowed onto the P1
study
in the first place.
I believe subjects are often removed because of the advent of
unacceptable toxicity. One's tolerance of toxicity may be expected to
diminish in the absence of evidence of tumor regression.
>>And since the early patients in a P1 trial receive, for obvious
reasons,
theoretically sub-therapeutic doses, it is not clear to me why these
patients shouldn't be kept on the study and receive escalated doses,
especially if toxicity had failed to appear at those higher levels.
Thus, commentators have proposed alternative methods of conducting
these trials.
>>Finding toxic effects at high and therapeutic-level doses is, after
all,
the main point of a P1 study. Wouldn't that purpose be furthered by
retention?
>>Moreover it seems investigators would not be doing all they can do
to
provide subjects with treatment that is at least as good as the
alternatives. They could, it seems, administer to patients with
progressing tumors doses closer to theoretically efficacious ones
provided that contraindicating adverse reactions have failed to appear
at
those higher levels and certainly provided that low levels have proved
to
be ineffective, as predicted.
>>And certainly retention should occur if the higher level proves to be
both
safe *and effective.*
>>This is not a rhetorical question. I am simply baffled by the
presence of
the requirement that patients with progressing tumors be removed from
P1
trials.
Is this indeed the case ? Would anyone else care to comment ?
Regards,
Howard
Howard Mann
5/24/2000 4:03:00 PM
Clinical Trial Sanctions Urged
Clinical Trial Sanctions Urged
By Marc Kaufman
Washington Post Staff Writer
Wednesday, May 24, 2000 ; A2
The Clinton administration wants the authority to fine scientists as much as $250,000 if they violate patient research guidelines during human clinical trials. Under the proposal, research institutions could face $1 million in similar fines.
The request was announced yesterday as part of a larger effort to tighten controls on scientists who test medical treatments on people and comes after recent revelations that doctors failed to properly protect volunteers in gene therapy and other experiments.
We need to stop and say to everyone, 'Take notice,' said Health and Human Services Secretary Donna E. Shalala. Investigators and institutions need to know that when they deviate from accepted practices, there are consequences.
In addition to telling researchers that they and their research centers will face increased scrutiny of their human clinical trials, Shalala announced several immediate efforts to increase patient protections. They include improved training for the review boards that oversee patient safety at research institutions, greater assurances that patients fully understand the risks they will be facing, and increased monitoring of patients' welfare in the earlier stages of the clinical trial process.
FDA Commissioner Jane E. Henney said yesterday that agency inspectors have also begun unprecedented examinations of 30 gene therapy trials that are still in their early phases. And National Institutes of Health Acting Director Ruth Kirschstein said her agency will conduct 10 site visits to research institutions to see how they are handling patient protection issues.
What's at stake is the integrity of research, public confidence in that research and the integrity of the institutions as well as researchers all around the country, Shalala said.
Since September, gene therapy and human trials in general have come under intense public scrutiny and criticism after teenager Jesse Gelsinger died in a University of Pennsylvania gene therapy experiment that federal regulators concluded was badly managed. Congressional and governmental inquiries later revealed hundreds of lapses in similar studies being conducted around the country.
The HHS inspector general also reported last month that the institutional review boards that oversee human clinical trials at research universities are often overworked and undertrained. The inspector general criticized HHS for making minimal progress in implementing suitable protections for people enrolled in medical experiments, although the office had detailed widespread problems with the procedures two years before.
Sen. Bill Frist (R-Tenn.), who has scheduled a hearing for Thursday on patient safety during research trials, called yesterday's announcements by the administration a step in the right direction.
But he raised doubts about the proposed civil penalties, saying it strikes me as somewhat premature to create civil monetary penalties before fully assessing the current federal guidelines and regulations, which have not been thoroughly examined since 1981.
However, the proposal to enable the FDA to fine researchers and their institutions won support yesterday from Nils Hasselmo, president of the Association of American Universities, which represents large research universities. He said that under current statutes, federal authorities can only criticize research practices or withdraw federal funds from an entire research enterprise, and do little in between.
It is a positive proposal because it provides for something between an admonition and the death penalty, Hasselmo said of the civil penalties. His organization appointed a task force in March to examine the issues of patient consent and potential institutional conflicts of interest involving clinical trials.
There will be strong action coming from inside the research university community itself, Hasselmo said. Our recommendations will likely go very much in the same directions as Secretary Shalala.
The federal proposal was not as well received by Vera Hassner Sharav, an activist with the New York-based Citizens for Responsible Care and Research. She believes that research institutions have been left with too much of the responsibility for policing themselves.
Public confidence in clinical trials has been shaken by revelations that human beings have been put at high risks without those risks being disclosed to them, she said. This directive hardly tackles that major, fundamental issue.
While the administration's proposal focuses on improving patient safety during human trials and clarifying who is responsible for ensuring it, the increasingly complex question of researcher conflicts of interest is also addressed.
Shalala said that new guidelines will be drawn up regarding potential conflicts when researchers, or research institutions, have financial relationships with biotech or other medical firms. The agency will hold public meetings this summer to explore ways of managing the conflicts and making sure that research subjects are aware of them.
We need to clarify and reassert oversight and responsibility, and if we need additional tools, we will get additional tools, Shalala said. This cannot be business as usual because the business has changed fundamentally.
Anonymous
5/24/2000 7:20:00 AM
use of international cDNA libarary
Howard Mann wrote:
Private information must be individually identifiable
(i.e., the identity of the subject is or may readily be ascertained by the
investigator or associated with the information) in order for obtaining the
information to constitute research involving human subjects.
(An unidentified sample is supplied to the researcher from a
repository that has a collection of unidentified human specimens.Research
using such material is typically exempt from the requirement for IRB review.
Interestingly enough though, we've received assurance documents from
cell-line repositiories (private, but undoubtedly established with
NIH-funding) that have required us to certify that we will apply 45 CFR 46
to the use of the (anonymous) human cell lines. This seems to fly in the
face of the above definitions? Or is it certifying that we will apply 45
CFR 46 to document that those regulations don't apply??
_________________________________________________
Celia Walker, Regulatory Compliance
Colorado State University
970-491-1563 (v) 970-491-2293 (fax)
cwalker@research.colostate.edu
Celia
5/24/2000 8:06:00 AM
Use of international cDNA library
Hi, all! I am most thankful for folks who put out this list and its
contributors as the discussions have been extremely helpful in my job. I
face a problem similar to Bree's. One of the researcher that we are funding
will be using pathological specimens from Switzerland. These were obtained
during patients' surgery there by his counterpart. The PI tells us that the
local IRB there did not require any consent forms from the patients. My
questions are identical to that of Bree's: Is there anybody familiar with
Swiss IRB rules/ethical review boards? Should we consider this use as exempt
from human subjects regulation? Your advice is most appreciated. Thanks in
advance
> -----Original Message-----
> From: Bree Klotter [SMTP:klotter1@llnl.gov]
> Sent: Tuesday, May 23, 2000 12:37 PM
> To: mcwirb@mcwirb.org
> Subject: Use of international cDNA library
>
> A researcher at my site has been offered use of a fetal tissue cDNA
> library
> created by researchers in Italy. Our researcher has been told the library
> was
> created with completely anonymous/unidentified samples and that the women
> were
> informed that samples might be used for research, but no consent form was
> required (per Italian law). No Italian IRB was involved in this process.
> Anyone familiar with Italian IRBs/ethical review boards? Would you
> consider
> research uses of this library to be exempt from human subjects
> regulations?
> Any feedback would be appreciated.
>
> Bree Klotter, IRB Administrator, Lawrence Livermore National Lab
> klotter1@llnl.gov, 925-422-9782
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Pradeep Dhs-Cdic
5/23/2000 12:59:00 PM
whole board and expeditited review
I concur with Joan Sieber on the example provided. But I am also interested
in your thoughts on reversals in general, not just those of an expedited
review. It seems to me that even if a full board meets and approves a
research proposal, and then later has misgivings, that there is an
obligation for additional review, and if that additional review finds
problems with the research that may have been overlooked, or not attended
to with sufficient rigor/diligence for whatever reason, then approval
should be retracted for the sake of the subjects--whether that is one week,
one month, or one year after the original approval.
There is, after all, an annual review obligation anyway which would seem to
have been incorporated into the rules for the reason that reversals were
anticipated as a possibility, and perhaps even as recognition of the need
for on-going reconsideration of past events. As this field evolves, so do
(and should) the rules governing its functioning. If there is not the
possibility of recognizing that we have also erred in approving something
and that we need to correct our own action--well that seems to me to be
dangerous and a failure to fulfill the mission of IRBs--protection of the
subjects.
I have heard an argument that such an approach is not fair to the
researchers because the researchers have an investment in the research,
thus it would have to be something of really serious harm before a board
should reverse itself. I find such an approach to be just too excessively
conservative--both for the adequate protection of patients, and for an
evolving field. Where would IRB members draw that line for serious harm
to subjects? It would seem to me that IRBs do not have the right to assume
that less than serious harm (or even risk) to subjects is ever okay,
whether we recognized it before or after we approved it.
Thoughts please.
Phillip Michaels
At 12:46 PM 5/17/2000 -0700, Joan E. Sieber wrote:
>I don't think this problem is necessarily preventable. There simply are
>times when a reviewer (e.g., the chair) sees a protocol as acceptable,
>when others can raise issues that everyone sees as significant (even the
>initial reviewer). What then? I think the solution is to humbly notify
>the PI that while the IRB wanted to provide expedited review and did so,
>upon reflection the board recognizes that there are some serious
>problems to be addressed.....
>
>Joan Sieber
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Phillip Michaels
5/23/2000 7:29:00 AM
OPRR has issued guidance clarifying (i) requirements for HHS-supported
research involving prisoners, and (ii) continuing IRB review of research
overseen by a Data and Safety Monitoring Board (DSMB). This guidance is
available at
http://grants.nih.gov/grants/oprr/humansubjects/guidance/prison.htm and
http://grants.nih.gov/grants/oprr/humansubjects/guidance/dsmb.htm
Tom Od
5/23/2000 3:00:00 AM
Below is the text of a Department of HHS press release issued today concerning protection of human subjects of research.
Date: May 23, 2000
For Release: Immediately
Contact: HHS Press Office (202) 690-6343
Headline: SECRETARY SHALALA BOLSTERS PROTECTIONS FOR HUMAN RESEARCH
SUBJECTS
HHS Secretary Donna E. Shalala today announced several new initiatives to further strengthen protections of human research subjects in clinical trials, including those involving gene transfer. The department’s actions are designed to heighten government oversight of biomedical research and to reinforce to research institutions their responsibility to oversee their clinical researchers and institutional review boards (IRBs).
“In the last few years, we’ve seen dramatic advances in the effort to find new therapies for cancer and other diseases, and we’ve taken new steps to protect the safety of patients in clinical trials,” Secretary Shalala said. “But the explosion in biomedical research has also brought new challenges, as more researchers are becoming involved in commercial ventures that may create new ethical dilemmas. Today’s actions are designed to further strengthen government oversight of all biomedical research, including gene transfer research, and to reinforce institutions’ and researchers’ responsibility to follow internationally accepted ethical standards and federal guidelines.”
The actions taken by HHS today focus on expanding education and training for all clinical investigators and IRB members and staff; enhancing the informed consent process and ensuring more vigilant monitoring and oversight; ensuring that researchers understand and comply with federal conflict of interest regulations; and pursuing efforts to provide the Food and Drug Administration (FDA) with additional enforcement tools to enhance its oversight role. They also respond to a request from President Clinton to examine ways to ensure patient safety and increase public confidence in clinical trials.
Secretary Shalala also stressed the responsibility of the leaders of universities and academic medical centers to oversee IRBs.
“Recent reports of problems in gene transfer trials have highlighted the new pressures facing researchers, IRBs, and research institutions themselves,” she said. “Protecting patient safety, and ensuring informed consent, is a shared responsibility. I want to urge university presidents, leaders of our academic medical centers, and others involved in biomedical research to take a hard look at oversight of clinical trials, their partnerships with the private sector, their own ethical guidelines, and the support and guidance they give their IRBs. Public confidence in clinical trials is essential to the continued advances in medicine we all hope to see in the next century.”
“We must ensure that patients are well protected and properly informed when they choose to enroll in a clinical trial,” said FDA Commissioner Jane E. Henney, M.D. “By maintaining high standards and requiring that all investigators adhere to them, we can be sure that the nation’s biomedical research enterprise will continue to earn the trust of research subjects.”
“We are constantly exploring new and effective ways to enhance systems to strngthen protections for human research subjects without unduly burdening IRBs,” added Ruth Kirschstein, M.D., acting director of the National Institutes of Health (NIH). “These new initiatives should significantly improve communication among researchers, patients and the IRBs.”
Today’s announcements address the following issues:
Education and Training. HHS will undertake an aggressive effort to improve the education and training of clinical investigators, IRB members, and associated IRB and institutional staff. NIH, FDA and the Office for Protection from Research Risks (OPRR) will work closely together to ensure that all clinical investigators, research administrators, IRB members and IRB staff receive appropriate resear
Anonymous
5/23/2000 6:20:00 AM
Norman:
Perhaps I misunderstand regarding your statement, Outpatient studies
usually have outside IRBs so we never see those protocols. Do you mean
that as long as there has been an outside IRB review for your
institution's outpatients, that there is no other internal review to ensure
the protection and welfare of your institution's patients who are research
subjects? If so, do the hospital's attorneys find that to be acceptable
practice? Do they not see that as a liability and a major financial risk to
the institution?
At our hospital after much soul-searching and inquiries to JCAHO, we opted
to avoid having our own internal IRB, but we still have a committee that
reviews all research that PIs want to conduct at the hospital with our
patients and/or staff. We have found problems with IRB approved research
that in our opinion did not measure up to acceptable standards of research
subject protection--some even approved (we were told) by NIH and then
on-going in other hospitals.
It seems to me that each institution has ethical and legal responsibilities
to protect its own patients (and the institution)--responsibilities that
are arguably not avoided by placing one's complete reliance for physical
and legal protections on the review of an outside IRB. So, with perhaps
over 3000 IRBs out there, and the well-known propensity for them to come to
differing conclusions, I find it hard to believe that a well-managed,
risk-managed institution would rely solely on an outside IRB for protection
of the institution and its patients.
Phillip Michaels
At 02:16 PM 5/20/2000 -0400, Norman Leopold wrote:
>Paul,
>This is a ticklish problem that we have tried to deal with. First, As
>chair of our IRB, I felt that our role was to review protocols and
>ensure that research was done correctly. If the hospital
>administration wished to pursue a separate policy that charged for
>that review, that was their business. I only asked that the fees not
>be onerous so as to discourage research and that there be a policy to
>permit those with little funding so ask for a waiver of fees. Our
>hospital administration agreed with this approach. I believe a charge
>of $1000 is required for the intial review and $500 for yearly
>reviews. For the m ost part, fees are paid by drug companies doing
>in-hospital research. Outpatient studies usually have outside IRBs
>so we never see those protocols. If you need more details, I can get
>them for you. I ahve tried to stay out of this arena.
>Norm
>
>
>
>------------------ Reply Separator --------------------
>Originally From: Paul Sesin
>Subject: Charging for IRB Review
>Date: 05/19/2000 01:38pm
>
>
>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
>
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Phillip Michaels
5/23/2000 7:23:00 AM
whole board and expeditited review
I don't know if this has ever happened to anyone--
Suppose the chair gives a project expedited review then the whole board
reviews the approval and is unhappy. Can the whole board withdraw the
approval that's already been given? (It really is a hypothetical
question)
Ron Low
SUNY Downstate
Ronald Low
5/23/2000 7:29:00 AM
Dear All:
I am wondering if anyone has a format (template) for minutes that they
would share. Specifically, we are attempting to develop a tool for IRB
Coordinators to use while taking minutes during the board meeting.
Your help will be greatly appreciated!
With my sincere regards,
Lisa Ballance
Virginia Commonwealth University's
Medical College of Virginia
lballanc@hsc.vcu.edu
804-225-4991 804-827-0087 fax
Lisa Ballance
5/23/2000 11:04:00 AM
Informed consent of cognatively impaired
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The question is what is legal informed consent from a cognitively =
impaired patient to participate in an investigational protocol? While =
it is obvious that unconscious patients or stroke patients fall in this =
category, do patients who have received narcotics as part of their =
initial treatment fall in the category of cognitively impaired?=20
Would appreciate hearing what other think.
Wm. T. Huskison, M.D.
St Edward Mercy Med Center
Ft Smith, AR
billhusk@prodigy.net
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 4.0 Transitional//EN> The question is what is legal informed consent =
from a=20
cognitively impaired patient to participate in an investigational=20
protocol? While it is obvious that unconscious patients or stroke =
patients=20
fall in this category, do patients who have received narcotics as part =
of their=20
initial treatment fall in the category of cognitively impaired? =
Would appreciate hearing what other =
think. Wm. T. Huskison,=20
M.D. St Edward Mercy Med=20
Center Ft Smith, =
AR billhusk@prodigy.net
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Billhusk
5/22/2000 5:49:00 AM
Informed consent of cognatively impaired
Bill,
All persons who are approached to participate in research should be evaluated for their capacity to consent. For most potential research subjects this evaluation is done as part of the consent interview. The person who is obtaining consent should evaluate whether the person appears capable of consenting (and whether they are fully informed and are agreeing to participate without being coerced).
For some subjects, their physical or mental state, or the circumstances may raise a doubt about their capacity to consent. In this case the IRB may want to request that a person with special qualifications, e.g. a clinical psychologist, psychiatrist or clinical social worker, and/or a person independent of the research team, should assess capacity.
You asked about who should be considered cognitively impaired. Subjects may be impaired due to stroke, drug or alcohol abuse, brain injury, delirium secondary to renal failure or diabetes, or due to mental illness such as schizophrenia and depression. Decisional impairment may also be associated with specific situations such as the stress of being given a diagnosis of a life threatening condition. With all such populations, however, care should be taken to distinguish between persons who are impaired and persons who have a condition that may cause impairment.
The additional protections appropriate for decisionally impaired subjects should be applied to all decisionally impaired persons, regardless of the source of their impairment.
You question whether patients who have received narcotics as part of their initial treatment fall in the category of cognitively impaired? I believe the answer is that individual assessments of capacity are essential and that the timing of the consent process is also an important factor. For example, in studies involving interventions during labor and delivery, consideration should be given to obtaining consent in advance of the woman being admitted to the hospital. Capacity is not an all or none phenomenon. It is usually possible to tailor a consent process, including the method and timing, to maximize the potential subject's capacity to consent.
The other part of your question related to legal informed consent. If the potential subject lacks the capacity to consent, then consent should be obtained from a legally authorized representative. You should consult with your attorney about the laws in your state, as the legally authorized representative is determined by state law. The subjects should also be informed about the study to the extent that they are capable of understanding.
Earlier discussions in MCWIRB have addressed the issue of legally authorized representatives.
I hope that this is helpful.
Susan
Susan J. Delano
Director of Clinical Research Administration
Research Foundation for Mental Hygiene, Inc.
44 Holland Ave.
Albany, N.Y. 12229
(518) 486 4244
(518) 474 6995 Fax
>>> BillHusk 05/20 2:46 PM >>>
The question is what is legal informed consent from a cognitively impaired patient to participate in an investigational protocol? While it is obvious that unconscious patients or stroke patients fall in this category, do patients who have received narcotics as part of their initial treatment fall in the category of cognitively impaired?
Would appreciate hearing what other think.
Wm. T. Huskison, M.D.
St Edward Mercy Med Center
Ft Smith, AR
billhusk@prodigy.net
Susan Delano
5/22/2000 5:49:00 AM
Compassionate care revisited
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The question arises , under what circumstances the use of Compassionate =
Care is used. My understanding is that it may be used for individual =
patients, who may not meet protocol requirements, but may, in the =
opinion of the PI or their physician receive benefit from the drug or =
device. Can this be used in leiu of a protocol and how do your IRB's =
handle these cases? I would appreciate feedback.
Wm. T. Huskison
St. Edward Mercy Medical Center
Ft. Smith, AR =20
billhusk@prodigy.net
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<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 4.0 Transitional//EN> The question arises , under what circumstances the =
use of=20
Compassionate Care is used. My understanding is that it may be used for=20
individual patients, who may not meet protocol requirements, but may, in =
the=20
opinion of the PI or their physician receive benefit from the drug or =
device.=20
Can this be used in leiu of a protocol and how do your IRB's handle =
these cases?=20
I would appreciate feedback. &nbs=
p; =20
Wm. T. Huskison &nbs=
p; =20
St. Edward Mercy Medical Center &nbs=
p; =20
Ft. Smith, AR &nbs=
p; =20
billhusk@prodigy.net
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Billhusk
5/22/2000 5:52:00 AM
Greetings again from New Zealand!
There is one worrying issue left over from this discussion and it is this:
It seems from here that any procedure that requires subjects to resort to
the expense and anxiety of legal action to enforce their rights to
compensation will raise the level of risk in almost all cases so that the
balance of benefit and risk will make the proposed research unethical.
We have an arrangement here which involves an agreement by major drug
companies as to exactly what they will pay by way of compensation.
Any research proposal which does not protect subjects from the possibility
of involvement with the courts seems doomed!
What do others think?
Frank Gaze
Chair
Taranaki Ethics Committee
Frank And Margaret Gaze
5/22/2000 5:52:00 AM
Compassionate care revisited
Bill Husk wrote:
The question arises , under what circumstances the use of
Compassionate Care is used. My understanding is that it may be used for
individual patients, who may not meet protocol requirements, but may, in
the opinion of the PI or their physician receive benefit from the drug
or device. Can this be used in leiu of a protocol and how do your IRB's
handle these cases? I would appreciate feedback.
Bill ,
Here are two items that address your question :
1. http://ctep.info.nih.gov/Policies/TRCException.htm#NRC
2. http://www.fda.gov/oc/oha/IRB/toc7.html
Note that IRB does not review and approve the use of the drug , per se
. There is a notification requirement that is explicated in the
document.
Regards,
Howard
Howard Mann
5/22/2000 5:52:00 AM
How many IRBs are out there in the US? -Reply
The U.S. Office of Inspector General estimated that there are 3,000-4,000 not-for-profit RBs in the United States. At last count there are approximately 19 for-profit IRBs. See the Office of Inspector General Report Institutional Review Boards: A Time for Reform. June 1998. Publication Number OEI-O1-97-00193 .
OPRR has a mailing list (which is out-of-date) of IRB chairs that can be obtained by filing a request under the Freedom of Information Act.
Karen Maschke
5/22/2000 9:09:00 AM
Paul,
This is a ticklish problem that we have tried to deal with. First, As
chair of our IRB, I felt that our role was to review protocols and
ensure that research was done correctly. If the hospital
administration wished to pursue a separate policy that charged for
that review, that was their business. I only asked that the fees not
be onerous so as to discourage research and that there be a policy to
permit those with little funding so ask for a waiver of fees. Our
hospital administration agreed with this approach. I believe a charge
of $1000 is required for the intial review and $500 for yearly
reviews. For the m ost part, fees are paid by drug companies doing
in-hospital research. Outpatient studies usually have outside IRBs
so we never see those protocols. If you need more details, I can get
them for you. I ahve tried to stay out of this arena.
Norm
------------------ Reply Separator --------------------
Originally From: Paul Sesin
Subject: Charging for IRB Review
Date: 05/19/2000 01:38pm
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
Norman Leopold
5/21/2000 8:10:00 AM
One IRB's approach to genetic research
Hi All,
In this posting I describe the manner in which my IRB reviews applications for genetic research -- more precisely, research using human biological materials.
In formulating the components of this approach, I was informed primarily by the report of the National Bioethics Advisory Commission concerning this issue. (http://bioethics.gov/nbac.html)
The approach essentially is comprised of three elements:
1. A guidance document that explicates the nature of research using human biological materials, describes our Committee's review process, and proposes a means whereby a study may be eligible for expedited review
( minimal risk is defined in this context).
http://www.ihc.com/ldsh/irb/hbm/hbm.html
2. A template for the formulation of a Consent Document. This is patterned after our template for clinical research that, in turn, is patterned after that provided by the NCI :
(http://cancertrials.nci.nih.gov/researchers/safeguards/consent/template.html )
http://www.ihc.com/ldsh/irb/hbmtemplate.html
3. A separate Application for Research using Human Biological Materials.
http://www.ihc.com/ldsh/irb/forms/application1.wpd ( Wordperfect document)
In essence, we require that consent for the use of human tissue for research be obtained separately from that for clinical research.
I would appreciate your critical appraisal of these documents -- you may send comments to me at ldhmann@ihc.com or howardm@xmission.com . I hope you find them useful.
The next difficult task concerns the oversight of research involving tissue repositories, tissue-collectors and investigator-recipients. I'd appreciate any practical ideas. I anticipate formulating an analogous set of documents for this matter.
Regards,
Howard
Anonymous
5/20/2000 5:19:00 AM
How many IRBs are out there in the US?
I had heard that range also and I recently was checking it out with OPRR. They
said the same (3000 to 5000). For the number of commercial or non-affiliated
IRBs, I checked the HIMA website, which as I recall listed 21 with a note that
the list may not be complete.
Lee
Lee L. Zwanziger, Ph.D.
Senior Program Officer
Division of Health Care Services
Institute of Medicine
Mailing: 2101 Constitution Ave NW, Suite FO3117
Washington, DC 20418
phone: 202/334-3042
fax: 202/334-1463
email: lzwanzig@nas.edu
Lee Zwanziger
5/19/2000 6:20:00 AM
Release of records to government agencies in other countries
Howard et al
I am not sure that I like it but it is symbolic of our global community.
Now that FDA can consider data generated under ICH, sponsors are doing not
only multi-center but multi-national studies. If they submit the data to
FDA then FDA can audit the source documents at each site -- including sites
in France, Germany, Italy, Japan, etc. But, should they submit the same
data to France and France wants to audit the source data, France believes
they should have the same audit rights.
Seems pretty fair when I think about it. I just want the same safeguards.
I would want my PI to refuse to let the sponsor or the regulatory agency
(US or France) have any information or pages that are identifiable. It
might mean hours of redaction.
Erica
>Hi,
>
>In the context of a particular study, the industrial sponsor has requested the
>addition of the quoted language to the list of enumerated entities that require
>access to the study-related records.
>
>To what extent have you seen this request before ? I presume it relates to the
>regulatory process in these other countries involved in the evaluation and
>approval of drugs for marketing.
>
>I am concerned about the propriety of the quoted language, and its conceivable
>implications with respect to a subject's privacy and confidentiality interests.
>
>I'd appreciate any thoughts from those who've encountered this kind of request
>before.
>
>Thanks,
>
>Howard
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Erica Heath
President, IRC
415-485-0717
heath
5/19/2000 6:17:00 AM
National Registries - IRB role?
Roles of IRB in various national registries explored
Anonymous
5/19/2000 6:11:00 AM
How many IRBs are out there in the US?
>Does anyone know where to find the number of IRBs operating within the US?
No
>Isthere an educated guess?
MPA = (look on OPRR website)
+
SPA = (look on OPRR website)
+
FDA = (look at FDA website for inspected sites)
+
Other = unknown (State IRBs, private foundation IRBs, etc)
+
Independents = look at HIMANET.org
-
all the duplicates
=
Total
Erica
Erica Heath
President, IRC
415-485-0717
heath
5/19/2000 6:20:00 AM
Exculpatory Language - Revisited
Dear Discussion Forum Members,
I hate to beat a topic to death, but this issue has resurfaced within our committee just this week, and we would like to ask for input concerning the specific language in the IC document that we find questionable. Please let us know: a) if you believe the following clause contains exculpatory language. If not, please explain the reasoning behind why it is not exculpatory; b) your experience in successfully negotiating placing the drug company in first payee position for research-related injuries; and c) is there any organized or concerted effort to pressure drug companies to change such language?
Here's the clause in its entirety (with the company and PI name changed):
In the event of any physical and/or mental injury resulting from your participation in this research project, Panacea Drug Company will pay medical expenses due to any medical problems caused by the study procedures, or by the study medication if it is taken as directed by Dr. Researcher, or the study doctor assigned to you, to the extent that such costs are not covered by your medical or hospital insurance or by third party or govermental programs providing such coverage. No additional financial compensation will be offered. Any claims beyond the compensation offered above would have to be pursued through channels outside Panacea Drug Company's reimbursement commitment.
Specifically, we would like to remove the language that I've highlighted, but have been unsuccessful in negotiating this. Any thoughts and/or suggestions?
I apologize for bringing this up again, and beg your indulgence and assistance.
Mary
Mary M. Caputo
Bureau of Internal Review and Audit (BIRA)
Utah State Department of Human Services
120 North 200 West, Rm. 221
Salt Lake City, UT 84103
(801) 538-4295
Mary Caputo
5/19/2000 6:55:00 PM
National Registries - IRB role?
I think the situation with respect to QA may change for most registries in
the near future. For instance, the organ transplant registry database is
now accessible online by registered transplant data coordinators. Those
involved in data management at the centers are now asked to (and able to)
verify their own past data, as well as do direct entry of current data.
Local control doesn't necessarily mean better data quality, but it does
allow centers to put QA procedures in place that were not possible before.
> -----Original Message-----
> From: Kathy Schulz [SMTP:kschulz@buckcenter.org]
> Sent: Wednesday, May 17, 2000 2:51 PM
> To: mcwirb@mcwirb.org
> Subject: re: National Registries - IRB role?
>
> Eric,
>
> Bravo to the bone marrow registry for taking the high ground and
> soliciting
> consent.
>
> You pushed one of my favorite buttons. Most of these registries fall
> under
> quality assurance (and I use the term loosely), and are not reviewed by an
> IRB
> here, there or anywhere. What I see as especially problematic, is that
> while
> cancer registries are mandated by state law, the MI registries, PTCA,
> registries, labor and neonate regiatries and goodness knows how many
> others,
> are not regulated and many physicians forward them extensive patient data
> in
> the name of QA and benchmarking without any patient permission (or even
> knowledge). These registries collect such data as home address and phone,
> dob,
> ssn, marital status, and generally an extensive prior medical history.
> While
> they generally promise to hold this confidential and to release
> information
> only in the aggregate, it seems only a matter of time until they are
> bought out
> by the insurance sector, or some other organization for whom
> confidentiality
> means something entirely different.
>
> Then there is the fact that there is generally no QA on what is
> transmitted--data is often collected by one individual (and manybe many on
> different shifts) entered into a local computer by others, and uploaded to
> the
> registry site, where it is accepted--not reviewed, not checked, just
> compiled
> and regurgitated.
>
> As for your mother, if she is treated for and AMI or has a cath lab
> procedure
> all of her personal data will doubtless be forwarded to one of these
> registries
> without her knowledge or permission.
>
> Despite the workload on IRBs I, for one, would like to see this sector
> controlled. Ideally a patient would be allowed to choose whether or not
> to
> participate.
>
> You could always choose to review this locally--but the static level will
> be
> very high, because no one else has to . . .
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Gullion Christina
5/19/2000 6:11:00 AM
Our Ethics Committee reviews protocols for investigators conducting the =
clinical research within the University Hospital. From some designated =
regional hospitals hospital protocls are reviewed too. The fee for a =
multicenter protocol from the industry is about USD 2000,--. The fee for =
an in house developed protocol, the investigator is affiliated within =
the Universtity hospital is about USD 350,--.
Dr. Anjo Strik
University Medical Center Utrecht
Holland
Anjo Strik
5/19/2000 5:31:00 PM
How many IRBs are out there in the US?
Does anyone know where to find the number of IRBs operating within the US? Is there an educated guess? I am looking for independent IRB + organization-affiliated IRB = XXXXX.
thanks! Lisa
Anonymous
5/19/2000 6:20:00 AM
Exculpatory Language - Revisited
Mary and Fellow Forum Members:
I believe the language Mary Caputo quotes is objectionable on two grounds,
1) as a partial (not complete) release from liability for negligence or
fault, and 2)as a partial waiver of the subject's legal rights, in that it
seeks to limit the damages Panacea might have to pay for any injuries.
Both 45 CFR 46.116 and 21 CFR 50.20 prohibit four types of clauses: 1)those
that waive a subject's legal rights, 2) those that appear to waive such
rights, 3)those that release an investigator, sponsor, institution or its
agents from negligence, and 4) those that appear to accomplish such a
release. A waiver or release can be partial to be objectionable; it need
not be complete to be so. We have been terming these clauses exculpatory.
An injured subject must make two basic showings in order to be compensated
for his/her injuries. First, the subject must show that the research
activity is to blame for the injury. In other words, the subject must prove
fault or negligence on the part of the investigator, sponsor, institution,
or its agents. Second, the subject must prove that he/she suffered damages.
Normally, and in most states, these damages will include past and future
medical expenses, past and future lost earnings, pain and suffering, and
loss of ability to enjoy life, to identify just the basic elements of
damages. There are others, which could include, in certain situations,
losses of family members, such as loss of consortium. Causation is a key
question with respect to both fault and damages, and the burden is one the
subject to make the proof.
The clause in question that Mary has quoted (see below) attempts a partial
release of Panacea from liability for its own negligence or fault. It is
therefore objectionable. It contains qualifiers regarding which of
Panacea's acts Panacea is ready to accept responsibility for. By implication
it attempts to exclude all other acts not identified in the clause. The
qualifiers include a reference to study procedures and study medication
if it is taken as directed by the Dr. Researcher or the study doctor
assigned to the subject. I respectfully submit that once a subject is
enrolled in a study, is consented in, there is potential (emphasize
potential) liability on the part of the investigator or sponsor or
institution or their agents for any of their acts of negligence that occur
in the research activity, not just those that derive from study procedures
or that result from study medication if it taken as directed, or where the
direction comes from Dr. Researcher or the assigned study doctor. In
other words, the clause attempts to narrow the range of activities for which
Panacea might otherwise be liable. The clause may not be a complete release
from liability for negligence, but it is a partial release. Or appears to
be.
The clause in question that Mary quotes also attempts to limit damages by
confining compensation to medical expenses only, and by implicitly excluding
other elements of damages to which a subject might have a legal right. On
the second ground, therefore, the clause is objectionable, as an attempt to
waive, by limiting, the subject's legal rights. It certainly appears to
limit legal rights. That Panacea says no additional financial compensation
will be offered scarcely clarifies things. What is meant by the word
offered after such extensive qualifiers? And the last sentence?
Channels outside Panacea's reimbursement? What channels? And what's
this about reimbursement? Does this mean that the subject must first pay
medical expenses out of his/her own pocket, or his/her insurer must do so,
then seek reimbursement from Panacea?
The clause goes even further in attempting to waive the subject's legal
rights, however. It attempts to subordinate Panacea's so-called commitment
to the payment of medical expenses, by requiring the subject first to
exhaust personal health insurance coverage, and then to exhaust third party
or governmental programs. Finally, and only after these first two or three
coverages are exhausted, would Panacea step forward and pay the subject's
medical expenses. Panacea, in short, is putting its interests first, ahead
of the subject's. These third party or governmental programs, by the way,
presumably could include, say, an employer's compensation program or a
government program such as medicare or some form of state or local health or
mental health protection that might be available, if any. If the subject
has a legal right to claim against Panacea, why must the subject first chase
down, then claim against, and then exhaust these other coverages or program
benefits, all as a precondition to collecting from Panacea?
In short, the clause Mary has quoted is exculpatory in two respects (as a
partial release and as a waiver of rights), or appears to be, and is
objectionable.
There are a few other random concerns here that deserve comment. One is
that health insurance typically contains exclusions for procedures that are
not medically necessary. A subject's participation in a clinical trial may
not be deemed medically necessary. Exclusions also exist for services or
supplies that are experimental, that are provided by a non-participating
provider, or for certain excluded conditions. The clause Mary quotes would
impose upon the subject the legal, emotional and financial risk of
attempting to coordinate his/her coverage under a personal health insurance
plan, a third party's (employer's) plan, or a governmental plan, with the
protection(?) or compensation(?) that Panacea is allegedly offering through
the clause in question. That's unfair to the subject.
Another concern is: why should the subject pay, through the premiums he/she
is paying for health insurance, for the medical expenses required as a
result of participating in Panacea's research? Why should the third party
pay? Or the government? Or the taxpayers? If it's Panacea's fault, these
other possible coverages shouldn't be on the loss. Panacea is obviously
trying to avoid paying compensation for damages. Could it be that Panacea
does not have liability insurance coverage itself, or is self-insured up to
certain limits, or that the underwriters won't provide coverage for Panacea?
Yet another concern arises. Investigators and institutions (universities,
clinics, hospitals, non-profits etc.) and their agents may be on the hook
for paying compensation for injuries if Panacea is successful in laying off
its own liability for damages. Note that the language in the disputed
clause in question only refers to Panacea. It does not refer to, say, the
clinic or hospital in which the research takes place. Panacea is attempting
to cut its own deal with the subject and is arguably leaving the other
entities out of the loop. What interests, if any, do these other entities
have in accepting or sharing responsibility for liability and damages? This
may be covered in agreements between the sponsor and the institution, but if
so, all the more reason for not including them in the consent-for-research
document the unsophisticated subject is asked to sign.
Another concern is whether Mary's IRB, or any IRB, should get into the
business of approving detailed language that disposes of or appears to deal
with the legal rights of subjects. It is one thing for an IRB to evaluate
whether the subject is adequately protected in the research according to the
usual methods by which an IRB assesses such matters. It is quite another
for an IRB to review and approve detailed language in a consent form that
deals with a subject's legal rights and partial release from liability. Who
on the IRB is qualified to provide legal advice to the subject in this
connection, or should?
Finally, and not so incidentally, if the institution's counsel sits on the
IRB and votes, or attends its meetings and advises the IRB, or reviews the
contested language here in question, that attorney may have a conflict when
it comes to saying whether the subject's rights are protected adequately by
the clause you quote. That conflict may raise ethical questions. Counsel
for the institution should not be in the position of advising whether the
subject's legal rights are protected by the clause you quote.
All of which leads to the conclusion that such a clause has no business in a
consent-for-research document. It is entirely self-serving on the part of
Panacea, it confuses the subject, it is at least a partial release of
Panacea,or appears to be, it may impair or prejudice the respective
positions of the institution and/or the investigator, it waives legal rights
of the subject, or appears to, and it thrusts the IRB evaluating the
clause into the perfectly untenable posture of passing on the effect of
something it probably isn't equipped to evaluate.
I apologize for the length of this, and hope it helps. It would be nice if
this issue could be resolved.
Tom Dalglish J.D., Ph.D.
Community Member, Committee C
University of Washington
(206) 543-0098 (University)
(206) 706-1000 (Office)
thomas k. dalglish
5/19/2000 6:16:00 AM
Non-common rule federal research
As I look more into the federal regulation of human subjects research, it
appears that several agencies, such as Department of Defense and FDA, have their
own standards for review of research, some of which do not seem to require the
usual common rule IRB review.
Am I understanding this correctly? Assume we are talking about research done
outside of an institution that has agree to use the common rule IRB review for
all human subjects research, are there other systems of review and is there some
federally funded human subjects research that does not require IRB review? Is
this summarized anywhere on the WWW?
Thanks, Ed
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
5/19/2000 5:29:00 PM
Non-common rule federal research
The Department of Defense does abide by the common rule. 32 CFR 219
outlines the Protection of Human Subjects Regulations for the Department of
Defense, which mirror those of 45 CFR 46. In addition, the DOD has its own
regulations, policies and procedures which must be adhered to in addition to
the common rule, and this is where the process becomes more confusing. All
submissions to the DOD involving the use of human subjects are required to
undergo a secondary level of review IN ADDITION TO the local IRB. DOD -
sponsored research, development, test and evaluation (RDT&E) studies
conducted or managed by the United States Army Medical Research and Materiel
Command are subject to Army regulations. Army regulations require that all
protocols and consent forms are approved by the Army Surgeon General's Human
Subjects Research Review Board (HSRRB). Additional information is located
on the U.S. Army Medical Research and Materiel Command Website:
http://MRMC-www.army.mil under Regulatory Compliance and Quality, Human
Subjects Protection Division. Consult this website for updated information
and regulations. Regulations and laws to pay particular attention to are AR
70-25 - Use of Volunteers as Subjects of Research, AR 40-7 - Use of
Investigational Drugs and Devices in Humans and the Use of Schedule I
Controlled Drug Substances (this one is on the same site under Regulatory
Affairs), OTSG 15-2- Human Subjects Research Review Board, and Title 10 USC
980. A more reader friendly guidance is the Guidelines for Research
Involving Human Subjects and/or Anatomical Substances, which outlines the
requirements.
I hope this information is helpful!
Caryn L. Duchesneau
Human Subjects Protection Specialist
U.S. Army Medical Research and Materiel Command
Phone: (301) 619-7801
Fax: (301) 619-7803
Caryn L Ms Usamrmc
5/19/2000 1:06:00 PM
Department of Health and Human Services action plan for addressing human protections shortcomings due out soon
--------------------------------------------------------------------------
WASHINGTON FAX May 17, 2000
Department of Health and Human Services action plan for addressing human protections shortcomings due out soon
A plan being develop by the Department of Health and Human Services (HHS) to address deficiencies in government oversight of clinical trials will include both administrative and statutory remedies, Food and Drug Administration (FDA) Commissioner Jane Henney told a group of teaching hospital CEOs last week.
Henney also made it clear during her May 11 remarks to the Association of American Medical Colleges (AAMC) Council of Teaching Hospitals that investigator awareness of the current regulations would improve the system more than enhanced policing and adopting new policies. She emphasized the importance of ensuring investigators and lab personnel are well-trained in good clinical practices (GCPs).
Daniel Michels, director of FDA's Office of Regulatory Affairs Enforcement, told the House Government Reform Committee's Human Resources Subcommittee during a hearing May 3 FDA may ask Congress for intermediate enforcement authority for GCP violations, short of shutting down a clinical site.
The only action available to NIH and FDA is an extreme one--that is, the authority to shut down and operation in its entirety, Michels said. The strength of that causes, most frequently, a voluntary shutdown before we get to deal with it, he noted.
One of the things that we are exploring is the possibility of asking the Congress for intermediate remedies that are less than throwing the atom bomb, if you will, for dealing with these situations, Michel explained.
If we can find something that is more prescriptive, that is more targeted to the particular problems that institution has, rather than shutting down the whole engine, we would be possibly better off than we are right now, Michels suggested.
Henney cautioned the AAMC group that because academic researchers have increasing conflicts of interest as they take on roles as sponsors of the IND (Investigational New Drug) investigations, patent holders and product manufacturers, adequate protections should be in place to guard against improper behavior caused by conflicted loyalties on the part of researchers. She indicated institutions and individuals serving as sponsors will be held to the same standard as any pharmaceutical company.
She emphasized that patients should be protected so they are not exploited by those driven to find the next blockbuster miracle drug.
Clinical investigators are not following standards for good clinical practices, Henney said. I fear the world of clinical research is evolving in ways that portend continued problems....Clearly some researchers at prestigious institutions have failed to follow basic good clinical practices.
Additionally, investigators often do not report appropriate information to institutional review boards (IRBs), and, in turn, clinical trial oversight by IRBs lacks overall vigor and quality, Henney said.
These practices are taking place in your clinical facilities--you along with other responsible institutional officers need to ensure your hospital is not the next one with a public health crisis on its hands, she implored the group.
Henney spoke in particular about recent GCP lapses in academic gene therapy research. Gene therapy has been tarnished because of failure to report adverse events and non-compliance to clinical trial standards, she said, noting investigators often fail to incorporate agreed-upon protocol changes or implement changes without notifying their IRB or FDA.
Henney noted the government has been criticized for the inadequate amount of resources that have been devoted to this issue; the limited range of enforcement options that can be implemented swiftly and effectively; as well as allegations of insufficient coordination and overlapping jurisdictions among federal agencies, particularly FDA and NIH.
HHS is developing a plan of action that will soon be announced...which will include both administrative and statutory changes that will be implemented or requested to address some of these critical issues, she said.
In another context, HHS Secretary Donna Shalala recently warned academic centers that future research funding could be tied to compliance with good clinical practice standards. Shalala told a May 4 gathering of the National Health Council that, while she is sympathetic to the strain on research funds at academic centers, continued publicity regarding failures in human subject protection could lead to reduced funding from the federal government.
I am well aware that the institutions don't believe that the overhead [reimbursed for academic research] is good enough, but the fact is that the vast expansion of research money is based on the assumption that we have the highest standards and the highest integrity, Shalala said.
Every institution in this country has to look again at what they're doing, reinforce the importance of this, and every principle investigator in this country has to keep their future, the future of the research and the future of their students, tied to their willingness to make sure that every disclosure and every permission is done very carefully, she continued.
Shalala acknowledged that most researchers meet the standards for ethical research subject protections, but warned that in Washington, DC, anecdote become data, and when almost every week we find a new institution in which a researcher did not pay attention to the subjects protection the image of the entire system suffers.
The role of the IRB and the relationship between academic researchers and private industry are becoming increasingly visible issue, Shalala said, particularly as the line between public and private research become more blurred.
--Shirley Haley
Information in this story comes from reports by Rebecca Spieler, managing editor of The Blue Sheet, a publication affiliated with Washington Fax, and Tom Hogan, a reporter for The Blue Sheet. To subscribe to The Blue Sheet, view a sample, or sign up for a free trial go to [http://www.fdcreports.com/bluewfax.html].
For more on this topic, see our Protecting human research subjects roundup of related stories and documents.
(C) 1998 WASHINGTON FAX, an established news and information service
specializing in science policy [http://www.washingtonfax.com]. Apply for a
free trial subscription at [http://www.washingtonfax.com/auto-trial.htm], or e-mail [trial@washingtonfax.com].
Anonymous
5/19/2000 6:01:00 AM
whole board and expeditited review
I don't think this problem is necessarily preventable. There simply are
times when a reviewer (e.g., the chair) sees a protocol as acceptable,
when others can raise issues that everyone sees as significant (even the
initial reviewer). What then? I think the solution is to humbly notify
the PI that while the IRB wanted to provide expedited review and did so,
upon reflection the board recognizes that there are some serious
problems to be addressed.....
Joan Sieber
Joan E . Sieber
5/18/2000 2:42:00 AM
National Registries - IRB role?
There are several issues.
One is that some registries are legally mandated, which makes the authority
lines complex.
Another is that registries that are NOT legally mandated often have simply
operated in the same manner as the legally-mandated ones, and have never
examined the confidentiality issues in any depth.
Yet another is that many of the SOPs for registries have simply been carried
forward from the first tumor registries in the 50s and early 60s, with a
1950s-type level of concern for confidentiality.
Then, the confidentiality requirements of the public law establishing cancer
databases are largely ignored.
Then, even if the registry is legally mandated, many of the registries operate
in a patently unethical manner because either (a) they've never given it a
moment's thought or (b) they take their legal mandate as carte blanche.
A week never goes by without a registry asking me for follow-up information on a
patient. Less often than twice a year does the request provide any evidence that
the patient has consented, that the patient has even been told, or that the
registry has a statutory mandate. Over half of the time, the request includes
asking MY PERMISSION (as though it were mine to give) to contact the patient
directly, or to contact a patient's family. Most of those requests, in turn,
include a statement that my consent will be inferred in the absence of a
response.
My stock response is to send a memo that says:
-- It is unethical to provide the requested information without the patient's
consent;
-- Please provide evidence of patient consent and IRB approval;
-- I have no moral or legal or ethical authority to give you permission to
approach anyone with whom I share or have shared a confidential relationship;
I'm shocked that you would ask that;
-- The absence of voiced dissent is not the same as consent; even if the
permission were mine to give, it would be improper to infer it from the lack of
a response.
I have sent this memo out perhaps 150 times. I have yet to receive my first
reply.
So yeah, your concerns are on target.
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
5/18/2000 2:42:00 AM
How many IRBs are out there in the US?
In the September-October issue of Duke magazine, they estimated between
3,000 to 5,000 IRBs in the US. They stated that no one has a more precise
number. The article is called Managing a Medical Makeover, Research Under
Scrutiny, by Robert J. Bliwise.
Evelyn Studer, IRB Administrator
Research Triangle Institute
PO Box 12194
Research Triangle Park, NC 27709-2194
919-541-6442
STUDER@rti.org
-----Original Message-----
From: Reed, Lynda J CIV [mailto:LJReed@nmcsd.med.navy.mil]
Sent: Wednesday, May 17, 2000 4:03 PM
To: mcwirb@mcwirb.org
Subject: RE: How many IRBs are out there in the US?
I would check with OPRR for information on the number of IRBs. They have a
web site where you can ask questions.
OPRR Electronic Access
Web site: http://grants.nih.gov/grants/oprr/oprr.htm
-----Original Message-----
From: Lisa Ballance [mailto:lballanc@hsc.vcu.edu]
Sent: Wednesday, May 17, 2000 11:42 AM
To: mcwirb@mcwirb.org
Subject: How many IRBs are out there in the US?
Does anyone know where to find the number of IRBs operating within the US?
Is
there an educated guess? I am looking for independent IRB +
organization-affiliated IRB = XXXXX.
thanks! Lisa
_______________________________________________
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
Evelyn Studer
5/18/2000 5:48:00 AM
How many IRBs are out there in the US?
I would check with OPRR for information on the number of IRBs. They have a
web site where you can ask questions.
OPRR Electronic Access
Web site: http://grants.nih.gov/grants/oprr/oprr.htm
-----Original Message-----
From: Lisa Ballance [mailto:lballanc@hsc.vcu.edu]
Sent: Wednesday, May 17, 2000 11:42 AM
To: mcwirb@mcwirb.org
Subject: How many IRBs are out there in the US?
Does anyone know where to find the number of IRBs operating within the US?
Is
there an educated guess? I am looking for independent IRB +
organization-affiliated IRB = XXXXX.
thanks! Lisa
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Lynda J Civ
5/18/2000 2:42:00 AM
Exculpatory Language - Revisited
Ms. Caputo:
Your highlighting did not come through in my copy, so I do not know which
wording you find problematic.
My read of the wording does not raise concerns. The statement clearly
outlines the conditions under which the company is prepared to pay. The
clause ... to the extent such costs are not covered by your medical or
hospital insurance or by third party or governmental programs providing such
coverage may cause delay and hassle receiving payment, but the prohibition
in the regulations is against release from liability, not absence of hassle.
The wording No additional financial compensation will be offered seems
appropriate. It does not release or appear to release [anyone] from
liability for negligence. The last sentence seems to inform subjects not to
waste their time with Panacea's reimbursement commitment, but to pursue
other channels. Again, it does not release or appear to release anyone from
liability for negligence.
The above is not an official OPRR statement.
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
OPRR url: http://grants.nih.gov/grants/oprr/oprr.htm
Paul Od
5/18/2000 5:46:00 AM
Thanks, Marilyn and Thanks, Paul.
I agree that it's better to be clear and straightforward in the first place,
rather than say something that sounds like a waiver of rights, then deny that it
is one.
I actually have a slide that I use in an introductory course on how to give a
reasearch talk ... It says, roughly, Valuable obfuscatory tools should be saved
for when you really need them. It's a tongue-in-cheek way to say that simple is
often better. It's true in CFs, too.
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
5/17/2000 9:40:00 AM
Responsibility to Report Abuse?
The Children's Bureau (DHHS) Office of Child Abuse and Neglect (OCAN) funds
a clearinghouse of state laws and other related information, which is kept
by Caliber Associates. (Of course, this information is not a substitute for
the advice of a qualified attorney.)
The URL is:
http://www.calib.com/nccanch/services/statutes.htm#Vol_I
Evelyn Studer, IRB Administrator
Research Triangle Institute
PO Box 12194
Research Triangle Park, NC 27709-2194
919-541-6442
STUDER@rti.org
Evelyn Studer
5/17/2000 5:34:00 AM
Ruth,
HIPAA stands for the Health Information Portability and Accountability Act
that was enacted by congress on August 21, 1996. It has two main goals:
1. To improve access to individual insurance policies for those who lose
group insurance coverage by introducing a guaranteed-issue policy
that would limit exclusions based on pre-existing conditions.
2. To improve access to employer group health plans by limiting exclusions
for pre-existing conditions, providing credit for prior health coverage,
guaranteeing availability of health insurance coverage(s), etc...
Although these are examples of the Specific goals of HIPAA, please keep in
mind that HIPAA standards and requirements cover a broad range of health
information topics including, but not limited to the electronic exhange of
patient data and the confidentiality requirements thereof, and HIPAA
standards are designed to standardize the information coding sets and
tranaction formats used for the general exchange of electronic data between
entities, define national identifiers, and set standards for electronic
security and standards.
If your organization has not already done so, be prepared to put a
significant amount of money and time to bring your system(s) and procedures
into compliance with HIPAA dictates. It is my understanding that our
organization has already spent more money on HIPAA then it did on Y2K
compliance expenditures. Please refer to your Compliance Department for more
detailed info.
Tom Tollison
Assistant Director of Compliance/Research Contracts Attorney
Banner Health Research Institute
Banner Health System
-----Original Message-----
From: Ruth Tallman [mailto:rt01@lehigh.edu]
Sent: Wednesday, May 17, 2000 8:05 AM
To: mcwirb@mcwirb.org
Subject: HIPPA regulations
Hello folks,
Here's a question: One of my colleagues asked me about HIPPA
regulations in regard to human subjects. What is HIPPA?
Ruth
Ruth Tallman
Office of Research and Sponsored Programs
Lehigh University
526 Brodhead Avenue
Bethlehem, PA 18015
Phone: (610)758-3024
FAX: (610)758-5994
E-mail: rt01@lehigh.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Tom
5/17/2000 7:00:00 AM
I am very confused by the guidelines on exculpatory language.
I understand that the guidelines state this is not something that can be in a consent document, however, can this language be in the consent document if it is immediately followed by You are not giving up any of your legal rights by signing this document??
I have had several investigators at our institution request this to be added so that their sponsor can keep their liability statement in the consent document.
I would appreciate anyone's input on this matter.
Thank you
Cheri J. Rieben
Protocol Administrator
University of Utah
801-581-8236
cheri.rieben@hsc.utah.edu
Anonymous
5/17/2000 9:40:00 AM
Hello folks,
Here's a question: One of my colleagues asked me about HIPPA
regulations in regard to human subjects. What is HIPPA?
Ruth
Ruth Tallman
Office of Research and Sponsored Programs
Lehigh University
526 Brodhead Avenue
Bethlehem, PA 18015
Phone: (610)758-3024
FAX: (610)758-5994
E-mail: rt01@lehigh.edu
Ruth Tallman
5/17/2000 9:09:00 AM
(Fwd) Re: Withholding Info from the PI
As an investigator, I agree with your argument re not doing placebo studies
in adults. The FDA has all the cards - I'm sure
The drug companies would be more than happy to do active
Comparator studies for Phase III trials. Given that in the real world,
even within clinical systems, many people wait eight weeks
Just to get a psych eval, and given that the suicide rate is not
Increased in placebo group in current mdd studies, is boycotting
The research pipeline more ethical than continuing to bring to the
FDAs attention that their standards for psychotropics re placebo
Trials are another case of stigmatization of psychiatric disorders.
In comparable general medical illnesses with comparable morbidity
And mortality AND comparable drug effects, placebo trials are
NOT required.
Also, in children and adolescents, where there are no approved meds
for depression, how does one select an active
Comparator.? TCAs failed the placebo test. For years. Emslies
Fluoxetine study passed, the Paxil study was marred in my opinion. SSRIs,
if they DO treat MDD in child. And adol., and my
Clinical belief is they do, and that they are superior to TCAs, need to show
superiority to placebo to establish that any class of drugs
Is effective in child. And adol. In this disorder. Comments?
Finally. I want to thank you for doing the kind of analysis that
Provides data for the argument against placebo controls in mdd
In adults. I find it hard to believe that the FDA continues to
Insist on placebo controls in schizophrenia research!!! I think
That the FDA does not appreciate the extent to which psychotropic
Drugs in the same class are NOT me-too drugs, and that the CNS may be
the organ system where pt - specific variability
In response to specific agents (due prob. In part to the existence
Of several alleles for each receptor protein) is most prominent, and the
existence of more agents within a class is a good thing
Generally. Mike Stevens, Dir. Psychopharm. Research ,
Valley Mental Health
PS: Denny, could you forward this to rest of IRB and Meredith?
Thanks, MIke
-----Original Message-----
From: Dr. Donald Kornfeld [SMTP:kornfel@cuadmin.cis.columbia.edu]
Sent: Tuesday, January 18, 2000 12:40 PM
To: mcwirb@mcwirb.org
Subject: (Fwd) Re: Withholding Info from the PI
------- Forwarded Message Follows -------
From: Self
To: hamme001@maroon.tc.umn.edu
Subject: Re: Withholding Info from the PI
Date: Tue, 18 Jan 2000 12:34:18 EST
I don 't mean to overdo this issue of the use of placebo in the drug
trials of Major Depression, but unfortunately there is this common
belief that placebo controls are required because of the statistical
problems created by a high placebo response and the inability to do
adequate trials with a proven effective drug.
A member of our faculty did a literature review in 1998 of all
randomized clinical trials of anti depressants and placebo done
betwen 1980 and 1997.(N=71).
The mean placebo rate was 29.2%
In 53 trials , where week by week comparison was possible, a drug
placebo differrence was detected in 65% of patients 2.5+/-1.5 (SD)
weeks after randomization and in 92.5% there was a significant
difference by week four.
Re variability of response, in only 13% of the RCT's was the
response
rate greater than 40%.
Established agents failed to demonstrate superiority over placebo in
only 12.6% of studies.
My statistical consultant here and two nationally known
statisticians
working with psychiatric data agree that there are statistical
methods available which would allow studies of new drugs to be
done with an active drug, instead of placebo, as the control using a
reasonable number of patients.
I am hoping that if enough IRB's refuse to do such placebo
controlled
studies that the drug companies and the FDA will realize that this
is an unethical practice and alter their protocols accordingly.
Donald S. Kornfeld, M.D.
Chairman, IRB
Professor of Psychiatry
Columbia Presbyterian Medical Center
New York, N.Y.
x7-5883
dsk3@columbia.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Michael Stevens
5/17/2000 7:22:00 AM
whole board and expeditited review
Glad for your sake that it's a hypothetical.
If your SOPs require full board _ratification_ of expedited reviews, then one
can argue that there was no approval until the board has voted. The regs just
require that the full board be kept apprised of expedited reviews, so such a
vote is usually an acceptance of report rather than a ratification.
We have listed the expedited actions as FYI items on the agenda; any member
may call one for special examination. This has happened perhaps twice in the
past decade. I don't think we've ever written out an SOP for the scenario, but
our informal one was that, if a member called an expedited action for full board
review, it would be presented to the full board at its next meeting, with a
primary reviewer assigned. The board could then decide to change the approval
status ... but I don't remember that outcome ever happening.
Rather, I think we would have done the same thing we do with a problematic
renewal ... if the problem is small, give a shorter than usual approval, with a
statement of what will need to be brought up to speed in order to get a more
durable OK.
So I think we would have, for example, sent the PI a letter:
Your IRB application #xyzab, which was approved by expedited review
on x/xx/yy, was selected for further review by the full IRB, at the
request of a member who feared it might not qualify under the
federal rules for expedited review. Full board review took place on
y/y/xx. Although the board found that the application was approvable,
it was marginal in its eligibility for expedited review, and the
full board found additional concerns. Accordingly, the following
additional stipulations are made and suggestions are offered:
(List)
The problems are not so great that the research need be suspended.
Rather, the IRB elected to adjust the expiry date of your approval to
z/zz/xx, to afford you time to address the concerns without having
to suspend the study.
Of course, it's a more painful letter to write if you find something that is bad
enough that the study has to be suspended while a fix is pending.
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
5/17/2000 9:40:00 AM
Ruth:
HIPAA is the Health Insurance Portability and Accountability Act of 1996,
Pub. L. No. 104-191, 42 U.S.C. Secs. 1320d-1320d-8, 45 CFR 160-164. In
November 1999 DHHS proposed rules under this Act that would establish
comprehensive privacy standards for health care information. The comment
period for these proposed rules expired February 17, 2000. Final rules may
not be issued for a long time, possibly not until next year. Check Vol. 64
Federal Register No. 212, p.59,917 and following (Wednesday, 11/3/99)for the
text of the proposed rules.
Technically the rules cover health care providers (individuals and
institutions), health plans and billing service entities. It also appears
that they pertain only to patient health care information in electronic
format. The scope of the Act and the rules is at this point unclear, but
don't be surprised if it is quite broad. First, because of provisions that
in effect amount to a kind of reach through to entities (that could
include researchers, see p.59924 of the 11/3/99 64 Fed.Reg. No. 212) that do
business with covered entities. Second, because the privacy/confidentiality
standards under the act will be so broad that there will be pressure on
others to conform to these requirements just to keep compliance simple and
more uniform. Penalties for violation of this very detailed and complex set
of requirements could potentially include civil and criminal fines and even
imprisonment. The Act and proposed rules contemplate the conduct of human
research (see page 59925 of the Federal Register referred to above), but a
detailed analysis of the impact of this Act and the (still only proposed)
new rules on human research processes, IRB reviews and so forth will have to
come later. Others surely have more up-to-date information, citations, etc.
than I on this, and references would be of great interest. You might be
advised to contact your local counsel, as local institutional policy or
state law may affect implementation.
A hint at federal intent is found in the following language at page 59926 of
the 11/3/99 64 Fed.Reg. No. 212:
[beginning of quote]: The uses and disclosures that would be permitted
under proposed rule [sic] would be just that -- permissible. Thus, for
disclosures that are not compelled by other law, providers and payers would
be free to disclose or not, according to their own policies and ethical
principles. We propose these rules as a basic set of legal controls, but
ethics and professional practice may dictate more guarded disclosure
policies. At the same time, nothing in this rule would provide authority
for a covered entitiy to restrict or refuse to make a disclosure mandated by
other law.[end of quote].
I hope this helps.
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 Ruth Tallman
Sent: Wednesday, May 17, 2000 8:05 AM
To: mcwirb@mcwirb.org
Subject: HIPPA regulations
Hello folks,
Here's a question: One of my colleagues asked me about HIPPA
regulations in regard to human subjects. What is HIPPA?
Ruth
Ruth Tallman
Office of Research and Sponsored Programs
Lehigh University
526 Brodhead Avenue
Bethlehem, PA 18015
Phone: (610)758-3024
FAX: (610)758-5994
E-mail: rt01@lehigh.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
thomas k. dalglish
5/17/2000 9:09:00 AM
Howard Trachtman queried :
I am the principal investigator for a multicenter clinical trial
involving a potential new therapy for hemolytic uremic syndrome (HUS). A
question regarding reporting of SAEs has arisen that I would like advice
on. Specifically, does dialysis need to be reported as an SAE in this
randomized, placebo-controlled study? I would appreciate it if responses
could be sent to me as well as to Dr. A Cnaan (see e-mail address in the
cc), who is the PI of the Data Coordinating Center.
...................................................................................................................................................................................
Hi,
I presume the study involves a test article that falls under the
purview of the FDA.
If so, then the regulations provide the following defintional guidance
:
For this pupose, a serious adverse experience is :
...any experience that suggests a significant hazard,
contraindication, side effect, or precaution. With respect to human
clinical experience, a serious adverse drug experience includes any
experience that is fatal or life-threatening, is permanently disabling,
requires inpatient hospitalization, or results in a congenital anomaly
or cancer, or represents an overdose.
An unexpected adverse experience is defined as :
...any adverse experience that is not identified in nature, severity
or frequency in the current investigator brochure; or, if an
investigator brochure is not required, that it is not identified in
nature, severity or frequency in the risk information described in the
general Investigational Plan or elsewhere in the current research
application.
Note that the requirement for reporting includes both notions --
serious and unanticipated -- and an experience that is related or
likely related to the investigational article.
I presume that the requirement for dialysis in a proportion of patients
is anticipated, described in the Investigator's Brochure, and also
disclosed in the Consent Document. Therefore, its occurrence will not ,
per se, represent a reportable event.
( The frequency of the need for dialysis in the experimental group
should be monitored. If it is higher than reasonably anticipated, it
*may* indicate a problem with the experimental therapy. I presume the
study has a Data and Safety Monitoring Board that will identify and deal
with observations of this sort )
Regards,
Howard
Howard Mann
5/17/2000 7:00:00 AM
HIPAA is the (proposed) Health Insurance Portability and Accountability Act
of 1996. Its primary purpose is to improve access to health insurance, its
secondary purpose is to protect the privacy of personally identifiable
health information. The deadline of August, 1999 was missed by Congress.
These proposed regulations favor research, but interpretation of certain
language could be a problem. The final regs may differ.
For more information, visit the Academy for Health Services Research and
Health Policy website (look under Government Relations) at
http://www.ahsr.org
Evelyn Studer, IRB Administrator
Research Triangle Institute
PO Box 12194
Research Triangle Park, NC 27709-2194
919-541-6442
STUDER@rti.org
-----Original Message-----
From: Ruth Tallman [mailto:rt01@lehigh.edu]
Sent: Wednesday, May 17, 2000 11:05 AM
To: mcwirb@mcwirb.org
Subject: HIPPA regulations
Hello folks,
Here's a question: One of my colleagues asked me about HIPPA
regulations in regard to human subjects. What is HIPPA?
Ruth
Ruth Tallman
Office of Research and Sponsored Programs
Lehigh University
526 Brodhead Avenue
Bethlehem, PA 18015
Phone: (610)758-3024
FAX: (610)758-5994
E-mail: rt01@lehigh.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Evelyn Studer
5/17/2000 6:55:00 AM
This is a multi-part message in MIME format.
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I am the principal investigator for a multicenter clinical trial =
involving a potential new therapy for hemolytic uremic syndrome (HUS). A =
question regarding reporting of SAEs has arisen that I would like advice =
on. Specifically, does dialysis need to be reported as an SAE in this =
randomized, placebo-controlled study? I would appreciate it if responses =
could be sent to me as well as to Dr. A Cnaan (see e-mail address in the =
cc), who is the PI of the Data Coordinating Center.
Thanks in advance
Howard Trachtman
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charset=iso-8859-1
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<!DOCTYPE HTML PUBLIC -//W3C//DTD W3 HTML//EN> I am the principal investigator for =
a=20
multicenter clinical trial involving a potential new therapy for =
hemolytic=20
uremic syndrome (HUS). A question regarding reporting of SAEs has arisen =
that I=20
would like advice on. Specifically, does dialysis need to be reported as =
an SAE=20
in this randomized, placebo-controlled study? I would appreciate it if =
responses=20
could be sent to me as well as to Dr. A Cnaan (see e-mail address in the =
cc),=20
who is the PI of the Data Coordinating Center. Thanks in advance Howard =
Trachtman
------=_NextPart_000_0010_01BFBF6B.160E3920--
Howard Trachtman
5/17/2000 7:00:00 AM
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this format, some or all of this message may not be legible.
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Dr. Trachtman,
The answer depends on whether the treatment has an impact on the need for
dialysis.
If such an impact is inconceivable, dialysis would not need to be reported
as an SAE. Certainly, HUS often requires dialysis in the absence of any
research treatments. The need for dialysis might even be viewed as an
outcome rather than as an SAE.
If the treatment could conceivably increase the need for dialysis, dialysis
would need to be reported. This should be the default approach for most
drugs and invasive devices. In other words, I would assume that a drug or
indwelling device could increase the incidence of renal failure, and SAE
reporting of dialysis would be needed.
Otwell Timmons, M.D.
Chair, IRB B
Pediatric Intensivist
Carolinas Healthcare System
> -----Original Message-----
> From: Howard Trachtman [SMTP:trachtma@lij.edu]
> Sent: Tuesday, May 16, 2000 7:15 PM
> To: MCWIRB
> Cc: Avital Cnaan
> Subject: SAEs
>
> I am the principal investigator for a multicenter clinical trial involving
> a potential new therapy for hemolytic uremic syndrome (HUS). A question
> regarding reporting of SAEs has arisen that I would like advice on.
> Specifically, does dialysis need to be reported as an SAE in this
> randomized, placebo-controlled study? I would appreciate it if responses
> could be sent to me as well as to Dr. A Cnaan (see e-mail address in the
> cc), who is the PI of the Data Coordinating Center.
> Thanks in advance
> Howard Trachtman
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Content-Transfer-Encoding: quoted-printable
<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 3.2//EN> RE: SAEs Dr. =
Trachtman, The answer depends =
on whether the treatment has an impact on the need for dialysis. If such an impact is =
inconceivable, dialysis would not need to be reported as an SAE. =
Certainly, HUS often requires dialysis in the absence of any research =
treatments. The need for dialysis might even be viewed as an =
outcome rather than as an SAE. If the treatment =
could conceivably increase the need for dialysis, dialysis would need =
to be reported. This should be the default approach for most =
drugs and invasive devices. In other words, I would assume that a =
drug or indwelling device could increase the incidence of renal =
failure, and SAE reporting of dialysis would be needed. Otwell Timmons, =
M.D. Chair, IRB B Pediatric =
Intensivist Carolinas =
Healthcare System -----Original Message----- From: Howard Trachtman [SMTP:trachtma@lij.edu] Sent: Tuesday, May 16, 2000 7:15 PM To: MCWIRB Cc: Avital Cnaan Subject: =
SAEs I am the principal =
investigator for a multicenter clinical trial involving a potential new =
therapy for hemolytic uremic syndrome (HUS). A question regarding =
reporting of SAEs has arisen that I would like advice on. Specifically, =
does dialysis need to be reported as an SAE in this randomized, =
placebo-controlled study? I would appreciate it if responses could be =
sent to me as well as to Dr. A Cnaan (see e-mail address in the cc), =
who is the PI of the Data Coordinating Center. Thanks in =
advance Howard =
Trachtman
------_=_NextPart_001_01BFC00A.AB22BE10--
Otwell
5/17/2000 4:58:00 AM
whole board and expeditited review
I agree with the overall sentiment of Dale's posting. My philosophy of
expedited review (and the authority of the IRB Chair) is that the IRB
delegates to the Chair (or another person) the authority to perform
expedited reviews as authorized by the regulations. 45CFR46 refers to the
IRB as having the authority to review research, which is then delegated to a
member of the IRB in the case of expedited reviews. Although these expedited
approvals do not need to be reviewed at an IRB meeting in a formal sense,
a listing of the protocols approved as expedited should be provided to the
full IRB (with the category under which the protocol was approved). The full
IRB should be comfortable that the Chair is making these decisions in a
manner consistent with the regulations AND the majority views of the full
IRB.
Robert M. (Skip) Nelson, M.D., Ph.D.
Coordinator: The MCWIRB Discussion Forum
http://www.mcwirb.org
Phd
5/17/2000 9:49:00 AM
Responsibility to Report Abuse?
Need a little help here everyone.
This question has to do with liability in research with children and adolescents in the social sciences. A solicitation of information on the methodological and ethical issues confronting researchers working with this population is in order.
While researchers are obligated to maintain confidentiality of information provided by human participants (particularly those responding to open-ended interview questions addressing adolescent moral identity), there is additional concern with the safety and protection of these participants. Reporting abuse, neglect and mental illness in a research setting may be an issue if such material is presented in the interviewing process.
Here are the questions:
1. Under these circumstances, would researchers be mandated to report?
2. Should this potential breech of confidentiality be included in the Informed Consent document?
3. Are there other issues concerning mandatory reporting of abuse in this type of research setting?
In addition, it would be of assistance to receive feedback on whether or not researchers must expand their protocols to include more in-depth investigation of potential abuse.
Whew! Have any of you had experience with this issue in a similar context?
Anonymous
5/17/2000 5:34:00 AM
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