Securing permission to access medical records
Hi All,
I've previously mentioned the troublesome inclusion of other government entities or foreign government entities in the enumerated list of those requiring access to the subject's medical records. ( These are in the model Consent Documents provided by the study's sponsors)The requirement is never explicated.
I've also stated that we will not permit language that requires the subject to grant unfettered access to the subject's medical record -- the latter containing information unrelated to the clinical investigation.
Thus, I've formulated my own model language for this portion of the Consent Document :
http://www.ihc.com/ldsh/irb/consent_template.html#CONFIDENTIALITY
What do you think ? ( It's cumbersome to explicate in a comprehensible and succinct manner)
( Sponsors : Please take notice )
Regards,
Howard
Anonymous
7/7/2000 12:33:00 PM
At 02:14 PM 07/07/2000 -0400, you wrote:
>I THINK that when you do research that doesnt expect to use statistics,
>either because of numbers or because the sort of data being collected
>doesnt yield itself to statistical analysis, you use qualitative research
>designs- which, as I understand them, allow you to investigate and
>describe a population or/and an intervention, and report on it without the
>use of standard statistical analyses. I believe that social science
>research and nursing research are the biggest proponents and users of
>these techniques. Does that make any sense??
I understand your point. Thank you for the feedback.
I guess that, even though what you describe for nursing and social sciences
may be the norms for those fields, this doesn't necessarily make it
acceptable science. I have a hard time understanding what precisely can be
qualitatively gleaned from the study I described in my original post on
this topic. In fact, the investigators of the study propose to analyze the
data they obtain using nonparametric statistics. However, they failed to
include in their protocol any discussion regarding the power of their
analysis given the expected small numbers of subjects.
Steven S. Clark, Ph.D.
Associate Professor of Human Oncology and
Member, UW Comprehensive Cancer Center
University of Wisconsin School of Medicine
600 Highland Ave, K4/432
Madison, WI 53792
Office: (608) 263-9137
FAX: (608) 263-4226
ssclark@facstaff.wisc.edu
http://www.humonc.wisc.edu/clark/
Steve Clark
7/7/2000 9:56:00 AM
It should be kept in mind that tests of the kind they propose to use are
probably routinely used to diagnose and prescribe treatment for individuals,
and should already have been evaluated for reliability and validity in a
relevant population. Neuropsychologists, audiologists, and speech
pathologists routinely work under these conditions.
The power of a study of this kind needs to be large enough to detect a
clinically meaningful difference. Even a small study may have adequate
power if the effect size (the difference between groups adjusted for the
within-group variability) is large. Diagnostic tests are designed to be
quite sensitive, so it would not surprise me if a small sample was adequate
to obtain useful information.
If the study sample is drawn from a small population, it may be
representative of the aphasic population. The control group is a concern
for me--are all aphasic patients nursing home residents? Nursing home
residents have a higher rate of serious illness, disability, and depression
than the general population of elders, so they are not representative of the
same age population.
Is no information preferable to small sample information which may be a
biased estimate of population parameters? Much medical and psychological
research has had to cope with this situation--one hopes that the
investigators use the information responsibly, keeping in mind its
limitations. Over time, accumulating data will tell whether any single
study is an accurate representation of the population. Unfortunately, even
very large studies have sometimes produced irreproducible results, so larger
sample size offers not a guarantee, only a better probability of a
representative result.
Chris
> -----Original Message-----
> From: Steve Clark [SMTP:ssclark@facstaff.wisc.edu]
> Sent: Wednesday, July 05, 2000 2:44 PM
> To: mcwirb@mcwirb.org
> Subject: The power of statistics
>
> A scenario for your consideration:
>
> A protocol proposes to examine communication processing in aphasic
> patients. The study would involve three different sessions, each on a
> different day, in which the patient (or an age matched control recruited
> from local nursing homes) met with a speech pathologist for a battery of
> word and sound association tests. The total time involved will be 3-5
> hrs.
>
> The inclusion criteria for the protocol means that only a few patients
> (
> group will be compared to the age-matched and control group.
>
> The local IRB raised the question as to whether the number of research and
>
> control subjects in the study would allow the investigators to make
> meaningful statistical comparisons between the groups. The PI responded
> that aphasic patients who meet the inclusion criteria are hard to come by
> and the standard practice in the field is to study whatever patients the
> investigator can recruit, regardless of considerations of statistical
> validity.
>
> The issue is whether this research should be done as proposed.
>
> One argument holds that if there are not sufficient numbers of research
> subjects to make meaningful conclusions, then the research should not be
> done. Even though the study is minimally invasive, it involves time and
> effort of (usually) elderly individuals who have significant problems
> communicating, and perhaps other problems associated with their CVA.
> Also,
> if diagnostic, prognostic and therapeutic conclusions are drawn from this
> sort of research in which the study population may not be representative
> of
> aphasic patients in general, then these clinical decisions may not be made
>
> on the basis of adequate information.
>
> On the other hand, this is the sort of problem that arises when
> investigating rare diseases and pathologies. Should we not investigate
> such diseases/pathologies and lose the chance to obtain important insight
> into them simply because you may not be able to run powerful statistical
> analysis on the results?
>
> How should an IRB handle this scenario?
>
> Thanks for your input.
> Steven S. Clark, Ph.D.
> Associate Professor of Human Oncology and
> Member, UW Comprehensive Cancer Center
> University of Wisconsin School of Medicine
> 600 Highland Ave, K4/432
> Madison, WI 53792
>
> Office: (608) 263-9137
> FAX: (608) 263-4226
>
> ssclark@facstaff.wisc.edu
> http://www.humonc.wisc.edu/clark/
>
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Gullion Christina M
7/6/2000 9:07:00 AM
Survey of College Freshmen
Mike:
This is a question we have had to deal with also, not specific to CIRP but
related to other general data gathering and survey requests for
accreditation, evaluation, etc. I believe that if it asks for identifiers
and there is personal information being requested or gathered, it needs to
go to the IRB office for initial determination by the IRB chair on whether
it is exempt, eligible for expedited review or needs full review. It very
well could be decided by the IRB that it is exempt but the point is your IRB
needs to look at it carefully and make the call - not any other person,
institution or IRB. We have a standing policy within our institution that
all first step human subjects protection decisions have to be made by the
IRB chairs (more than one campus in our system) with requested input from
designated advisors as needed. This is something which needs to be
emphasized at every opportunity within the institution so that it becomes
second nature over time.
Also I don't know how you found out that UCLA had exempted the CIRP years
ago (how many years ago?) although I realize it is your responsibility to
ask and theirs of course to tell you. However I would be very hesitant from
a COI perspective to look for precedent from the institution that is
responsible for ultimate compilation and publication of a report. I also
wonder if the UCLA IRB has been consulted at each step as the original
protocol has changed over the years (I believe that CIRP has been around for
3 decdes or so). It very well could have been that originally the survey did
qualify for exemption but has evolved into a higher than minimal risk
proposition. In any event as it stands CIRP is not exempt from what I can
see.
Another point is that the only exemption category that could possibly be
utilized to support exemption would be 45CFR46.101 (b) 5 and I inquired from
OPRR about this category a few years ago and was told its original intent
was to deal with social security evaluation. It should not in any case be
used as an end run around IRB review. Category 1 doesn't apply since it is
not normal educational practice to ask for identified highly sensitive and
personal information. And CIRP's assertion that it needs identifiers to
allow followup is a reason for IRB review, not exemption.
All this being said evaluations need to be done. And it makes sense that
student verification is needed. If that is CIRP's reason for doing
followup, then one way to address the issue in our institution has been to
have an in-house committee or team do the cross match to verify student
status and/or other demographic info if that's the stated reason for wanting
ID's and then delink before sending the info on to the institution doing the
evaluation/research. The desire to do followback (directly contacting the
responders) of course would make this a moot point and should serve to make
the decision easier as to whether to have the IRB review it.
Daniel R. Vasgird, PhD
Office of Research Compliance
Research Foundation of CUNY
30 West Broadway, 11th Floor
New York, NY 10007
Ph: 212-4178485
Fax: 212-4178479
email: Daniel_Vasgird@rfcuny.org
-----Original Message-----
From: Mike Kelly [mailto:mike.kelly@gtri.gatech.edu]
Sent: Wednesday, July 05, 2000 3:09 PM
To: mcwirb@mcwirb.org
Subject: Survey of College Freshmen
This question is directed at university IRBs. It involves the Cooperative
Institutional Research Program survey that is given to all incoming
university freshmen at (we are told) over 200 universities. Results are
tabulated at UCLA and published for the academic community. The survey was
exempted by UCLA's IRB several years ago although the questions change from
year-to-year. We at Georgia Tech began examining this survey a year ago
after a parent complained that her 17 year-old daughter was required to
take the survey in order to register for college, that parental permission
was not sought, and that it contained sensitive questions. Our IRB had
never been sent an application because the survey was declared exempt at
its source and our local PI thought that eliminated need for local review.
Our IRB just received a protocol for this year's survey and again have
serious problems with it. (At our IRB's direction, students under 18 are
now excluded from the survey here.) The survey is still claimed to be
exempt. CIRP still claims that there are no sensitive questions -- yet it
asks students about their alcohol consumption (a crime), whether they
suffer from depression (a health problem that could affect future
employability and insurability), their political and moral views, and
family history. They must provide their full name and social security
number to allow followup.
At our insistence, the survey forms given to Georgia Tech freshmen must
emphasize that completion of any or all questions is voluntary. Yet,
proctors are told to convince the reluctant students to complete the
forms. It's hard to imagine a group more vulnerable to coercion than
college freshmen on their first day away from home.
I'd like to hear from other university IRBs about their knowledge and
handling of this national survey. I'm told that we're the only IRB that
has voiced any concerns about the survey. Thanks for your comments.
Mike Kelly
IRB Chair
Georgia Tech
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Daniel
7/6/2000 9:04:00 AM
Survey of College Freshmen
If the data is collected and stored with any personal identifiers then the
study requires IRB approval and may require informed consent. Only anonomous
survey data is exempt. If your particular institution accepts outside IRB
(national or commercial) and the survey was approved by one of those IRBs
then it might not have to be reviewed in toto locally but should still have
expedited/administrative review.
John Jennings MD
Chairman, IRB
Jerry L Pettis VAMC
Loma Linda, CA
-----Original Message-----
From: Andrew Cockburn [mailto:acockbur@wvu.edu]
Sent: Wednesday, July 05, 2000 1:25 PM
To: mcwirb@mcwirb.org
Subject: RE: Survey of College Freshmen
I would also like to know the answer.
According to their website, the questionnaire was given last year to 350,000
students at 700 institutions.
If anyone wants more info, the CIRT website is at
http://www.gseis.ucla.edu/heri/heri.html
Andrew Cockburn, PhD
Director of Institutional Research Compliance/Biological Safety
West Virginia University
Morgantown, WV 26506-9006
Telephone: 304-293-7157
FAX: 304-293-4529
Email: acockbur@wvu.edu
> -----Original Message-----
> From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
> Of Mike Kelly
> Sent: Wednesday, July 05, 2000 3:09 PM
> To: mcwirb@mcwirb.org
> Subject: Survey of College Freshmen
>
>
> This question is directed at university IRBs. It involves the Cooperative
> Institutional Research Program survey that is given to all incoming
> university freshmen at (we are told) over 200 universities. Results are
> tabulated at UCLA and published for the academic community. The
> survey was
> exempted by UCLA's IRB several years ago although the questions
> change from
> year-to-year. We at Georgia Tech began examining this survey a year ago
> after a parent complained that her 17 year-old daughter was required to
> take the survey in order to register for college, that parental permission
> was not sought, and that it contained sensitive questions. Our IRB had
> never been sent an application because the survey was declared exempt at
> its source and our local PI thought that eliminated need for local review.
>
> Our IRB just received a protocol for this year's survey and again have
> serious problems with it. (At our IRB's direction, students under 18 are
> now excluded from the survey here.) The survey is still claimed to be
> exempt. CIRP still claims that there are no sensitive questions -- yet it
> asks students about their alcohol consumption (a crime), whether they
> suffer from depression (a health problem that could affect future
> employability and insurability), their political and moral views, and
> family history. They must provide their full name and social security
> number to allow followup.
>
> At our insistence, the survey forms given to Georgia Tech freshmen must
> emphasize that completion of any or all questions is voluntary. Yet,
> proctors are told to convince the reluctant students to complete the
> forms. It's hard to imagine a group more vulnerable to coercion than
> college freshmen on their first day away from home.
>
> I'd like to hear from other university IRBs about their knowledge and
> handling of this national survey. I'm told that we're the only IRB that
> has voiced any concerns about the survey. Thanks for your comments.
>
> Mike Kelly
> IRB Chair
> Georgia Tech
>
>
>
>
>
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
John
7/6/2000 9:01:00 AM
Survey of College Freshmen and coercion.
Dear Folks (Regular MCWIRB Participants),
Would anyone like to take on the issue of explicit coercion vis-à-vis
implicit coercion?
In the VA we have some situations where the implicit coercion might be a
veteran patient who is a frequent user of a VA hospital for a chronic
medical condition(s) (e.g. diabetes, hypertension and arthritis) fears a
loss of access to health care if he/she refuses to participate in a research
study or believes it is an extension of a patriotic duty to enroll?
We seem to think of the possibility of intimidation (children are
vulnerable) and secondary benefits (sometimes pecuniary) as tending to
undermine a full and free voluntary consent to participation in a research
protocol.
Does anyone have a good paper they could refer me to on a discussion of
various 'situations' where implicit coercion is well discussed ('situations'
needing to be thoughtfully reviewed by the IRB and carefully handled by the
investigator)?
Thank you
-----Original Message-----
From: Howard Mann [mailto:ldhmann@ihc.com]
Sent: Wednesday, July 05, 2000 9:53 PM
To: mcwirb@mcwirb.org
Subject: re: Survey of College Freshmen
I would like to make several comments :
Participation should, of course, be voluntary. Allegations of coercion
should be taken seriously.
M . D . Orca
7/6/2000 9:46:00 AM
Could anyone provide information about how oral histories are handled at your University?
Our library has an oral history program collecting histories on a wide range of topics daily: university history, state history, anything relating to the special collections held by the library. The topics are endless. They are audio taped, identifiable and placed in the library for use by researchers.
Reviewing each one specifically would be a monumental task. Can anyone suggest a process for such a project?
Thanks in advance-
Tracy
Tracy Smart Arwood
Regulatory Compliance Administrator
Mississippi State University
304 Bowen Hall
Mailstop 9564
662-325-3994
662-325-3803 fax
tarwood@spa.msstate.edu
www.msstate.edu/dept/spa/regcompliance/irb.html
Tracy Arwood
7/6/2000 9:40:00 AM
Survey of College Freshmen
This is an excellent question. At a college where I previously taught I
raised this issue. Not only was the CIRT being administered but also a
college generated survey that purported to measure a student's moral
growth over 4 years. Neither survey had applied for nor received local
IRB approval, students were not given any informed consent and were in fact
told to complete these Q's as part of their orientation program. In
addition, names were on the Q's and used to track the student's
progress. While I understand why a college would like this kind of data, I
believe that the whole process is ethically flawed.
Kelly Carroll
7/6/2000 9:04:00 AM
Survey of College Freshmen
Mike,
We recently dealt with the CIRP at our institution as well (Illinois State
University). Like many schools our institutional research office had been
giving the CIRP to our students without having gone through the IRB. The
IRB caught wind of it when a copy of one year's CIRP data, complete
(unfortunately) with student ID's, ended up in the hands of our IRB
Chairperson (me, in this case). An investigation resulted, and lots of
changes were made.
Our IRB reviewed the survey and decided, despite the potential good intents
of the instruments, that we could not classify it as exempt. Data were not
being collected anonymously, sensitive data (from both the questions on the
instrument and from student records data merged via SSNs) were being made
available, and students really had no clue (from the cover form or
administration protocol) that they could refuse to do this. Our review
determined that the effort required an expedited review process, for which
we give it an annual re-review (so we get to look at the latest revision of
the instrument) and a three-year complete resubmission. We also required a
more detailed cover sheet and verbal instructions that clearly laid out the
student's rights, including their right to respond to the instrument
without providing any identifying information (their SSN, in this case).
Finally, we also talked with out institutional research office about
establishing protocols regarding the release of student info (to conform
with both the IRB rules and the university and federal rules regarding
student information privacy). With all those conditions the IRB approved
the administration of the instrument to students 18 years of age or older.
I would be interested in hearing of anyone else's interactions with this
survey. It did raise more than a few eyebrows on our campus!
- Jeff Hecht
Chair, ISU IRB
----------
This question is directed at university IRBs. It involves the Cooperative
Institutional Research Program survey that is given to all incoming
university freshmen at (we are told) over 200 universities. Results are
tabulated at UCLA and published for the academic community. The survey was
exempted by UCLA's IRB several years ago although the questions change from
year-to-year. We at Georgia Tech began examining this survey a year ago
after a parent complained that her 17 year-old daughter was required to
take the survey in order to register for college, that parental permission
was not sought, and that it contained sensitive questions. Our IRB had
never been sent an application because the survey was declared exempt at
its source and our local PI thought that eliminated need for local review.
Our IRB just received a protocol for this year's survey and again have
serious problems with it. (At our IRB's direction, students under 18 are
now excluded from the survey here.) The survey is still claimed to be
exempt. CIRP still claims that there are no sensitive questions -- yet it
asks students about their alcohol consumption (a crime), whether they
suffer from depression (a health problem that could affect future
employability and insurability), their political and moral views, and
family history. They must provide their full name and social security
number to allow followup.
At our insistence, the survey forms given to Georgia Tech freshmen must
emphasize that completion of any or all questions is voluntary. Yet,
proctors are told to convince the reluctant students to complete the
forms. It's hard to imagine a group more vulnerable to coercion than
college freshmen on their first day away from home.
I'd like to hear from other university IRBs about their knowledge and
handling of this national survey. I'm told that we're the only IRB that
has voiced any concerns about the survey. Thanks for your comments.
Mike Kelly
IRB Chair
Georgia Tech
----------------------------------------------------------------------------
------------------
Dr. Jeffrey B. Hecht Office: (309) 438-5585
Campus Box 5900 FAX: (309) 438-8683
Illinois State University E-mail: jbhecht@tierlab.ilstu.edu
Normal, IL 61790-5900 http://tierlab.ilstu.edu
----------------------------------------------------------------------------
------------------
Dr . Jeffrey B . Hecht
7/6/2000 9:00:00 AM
Survey of College Freshmen
John Jennings wrote:
> If the data is collected and stored with any personal identifiers then the
> study requires IRB approval and may require informed consent. Only anonomous
> survey data is exempt....>>
just as a general point of order, this is not entirely accurate.
identifiable surveys may still be exempt, *UNLESS* disclosure of
responses could also reasonably place subjects at risk [note the
...and... in 45 CFR 46.101(b)(2)].
however, i agree with all that's been said about this particular
circumstance. the CIRP survey walks and talks like a duck (i.e. human
subjects research), and doesn't appear to qualify for exemption,
precisely because of that ...and... clause discussed above. i intend
to circulate this discussion on campus, by way of finding out if we are
participating, and what kind of review CIRP received.
thanks MCWIRB!
Daniel K. Nelson, Director, Human Research Studies
Research Associate Professor of Pediatrics and Social Medicine
University of North Carolina-Chapel Hill
Chapel Hill, NC 27599-7097
Phone: 919-966-1344
fax: 919-966-7879
e-mail: dnelson@med.unc.edu
Daniel Nelson
7/6/2000 10:28:00 AM
Ed-
My train of thought regarding oral histories follows:
The information in the oral history program here is placed in the library for public use and is completely identifiable. The interviews are identifiable interventions and the information adds to generalizable knowledge. Also, #7 of the expedited review list effective November 1998 lists oral histories specifically.
I, too, would be interested in arguments contending oral histories are not research.
Tracy
Tracy Smart Arwood
Regulatory Compliance Administrator
Mississippi State University
304 Bowen Hall
Mailstop 9564
662-325-3994
662-325-3803 fax
tarwood@spa.msstate.edu
www.msstate.edu/dept/spa/regcompliance/irb.html
>>> Richards, Edward P. 07/05/00 05:28PM >>>
> Could anyone provide information about how oral histories are
> handled at your University?
This gets into that tricky area of what is research? These do not seem to be
research under any definition I am familiar with, but I am curious what others
think. If they are not research, I do not see why they are an IRB issue.
(There are other issues such as ownership rights to the material that should be
reviewed, and whether the subject understands that they will be made available
to the public. These would be for the University Counsel and copyright office,
however.)
Ed
Edward P. Richards
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Tracy Arwood
7/6/2000 9:40:00 AM
Survey of College Freshmen
I am told that West Virginia University abolished its relationship with CIRP
in 1983 (long before I arrived).
The administration objected to the requirement for SSN#s, and perhaps some
of the behavior questions.
Andrew Cockburn, PhD
Director of Institutional Research Compliance/Biological Safety
West Virginia University
Morgantown, WV 26506-9006
Telephone: 304-293-7157
FAX: 304-293-4529
Email: acockbur@wvu.edu
Andrew Cockburn
7/6/2000 11:58:00 AM
Steve Clark raises a good point about the ethics of conducting even minimal
risk research when the inferential (i.e., statistical) power of a study is
low -- that is, the proposed sample size is expected to be too small for
strong inferences to be drawn. He also raises a point about the
generalizability of results (from non-random samples), but that is a
somewhat different issue.
If statistical power is weak, investigators are prevented from knowing why
null hypotheses are sustained (i.e., not rejected). Say, for example, that
no statistically significant difference is found between Treatment and
Control groups on some factor X. This may mean that (1) there is no
relationship between X and treatment or (2) that there was insufficient
power to detect the relationship that does exist. Clearly a troubling
position and one that suggests any risk/burden borne by subjects may not be
justifiable.
However, if a significant relationship is found between X and Treatment,
things are okay. Yes, there may be cases where effects are large enough to
be detected even in low powered studies. Even a study of n = 2 can be useful
if no other information is available and the rest of the design is
satisfactory. Descriptive statistics are critically important here. The
point is that there may be cases where relationships are detected in low
powered studies -- the probability of not finding a relationship when one
exists (Type II error) can overwhelmed by large differences. I
parenthetically note that many advances in medical research have been made
by further testing of woefully underpowered secondary analyses.
I know nothing of research on aphasia, but it seems to me that if a study
poses minimal risk then the fact that it is (must be?) underpowered, in and
of itself, should not prevent it from passing IRB review. Such studies may
generate hypotheses critical to the advance of science and the treatment and
prevention of disease. Scientific Review Committees will take the
investigator to task on the power issue if they think she/he is on shaky
ground. I rarely see underpowered studies funded.
More generally, I think the issue of research design merits more attention
and debate in the IRB community. We need to be careful, though, to (1) not
assume the role of scientific review committees, (2) not to prevent the
generation of hypotheses to be tested in more expensive studies, and (3) not
to underemphasize the role of risk in risk/benefit discussions.
----------------------------------------------------
J. Michael Oakes, PhD phone 617/923-7747
New England Research Institutes extension 331
9 Galen Street fax 617/926-0144
Watertown, MA 02472 jmoakes@neri.org
----------------------------------------------------
>Date: Wed, 05 Jul 2000 14:44:13 -0500
>To: mcwirb@mcwirb.org
>From: Steve Clark
>Subject: The power of statistics
>
>A scenario for your consideration:
>
>A protocol proposes to examine communication processing in aphasic
>patients. The study would involve three different sessions, each on a
>different day, in which the patient (or an age matched control
>recruited from local nursing homes) met with a speech pathologist for a
>battery of word and sound association tests. The total time involved
>will be 3-5 hrs.
>
>The inclusion criteria for the protocol means that only a few patients
>( the aphasic group will be compared to the age-matched and control group.
>
>The local IRB raised the question as to whether the number of
>research and control subjects in the study would allow the investigators to
make
>meaningful statistical comparisons between the groups. The PI
>responded that aphasic patients who meet the inclusion criteria are hard
>to come by and the standard practice in the field is to study whatever
>patients the investigator can recruit, regardless of considerations of
>statistical validity.
>
>The issue is whether this research should be done as proposed.
>
>One argument holds that if there are not sufficient numbers of
>research subjects to make meaningful conclusions, then the research
>should not be done. Even though the study is minimally invasive, it
>involves time and effort of (usually) elderly individuals who have
significant problems
>communicating, and perhaps other problems associated with
>their CVA. Also, if diagnostic, prognostic and therapeutic conclusions are
>drawn from this sort of research in which the study population may not be
>representative of aphasic patients in general, then these clinical
decisions may
>not be made on the basis of adequate information.
>
>On the other hand, this is the sort of problem that arises when
>investigating rare diseases and pathologies. Should we not
>investigate such diseases/pathologies and lose the chance to obtain
>important insight into them simply because you may not be able to run
powerful
>statistical analysis on the results?
>
>How should an IRB handle this scenario?
>
>Thanks for your input.
>Steven S. Clark, Ph.D.
>Associate Professor of Human Oncology and
>Member, UW Comprehensive Cancer Center
>University of Wisconsin School of Medicine
>600 Highland Ave, K4/432
>Madison, WI 53792
>
>Office: (608) 263-9137
>FAX: (608) 263-4226
>
>ssclark@facstaff.wisc.edu
>http://www.humonc.wisc.edu/clark/
>
J . Michael Oakes
7/6/2000 9:10:00 AM
> Could anyone provide information about how oral histories are
> handled at your University?
This gets into that tricky area of what is research? These do not seem to be
research under any definition I am familiar with, but I am curious what others
think. If they are not research, I do not see why they are an IRB issue.
(There are other issues such as ownership rights to the material that should be
reviewed, and whether the subject understands that they will be made available
to the public. These would be for the University Counsel and copyright office,
however.)
Ed
Edward P. Richards
Executive Director - Center for Public Health Law
Professor of Law
University of Missouri Kansas City
(816)235-2370 Fax (816)235-5276
richardse@umkc.edu
http://plague.law.umkc.edu
Edward Richards
7/6/2000 9:04:00 AM
A Subject's Right to Withdraw Collected Research Data?
One other point: the main risk of ex-post retraction that I see is the
potential imputation of serious bias. Arguably, subjects most likely to
want to withdraw are those who have had negative experiences on the
study. The withdrawal of their data could make the results look better
than they actually are.
To my mind, withdrawal infers discontinuing prospective participation,
but does not mean that subjects have a right to alter what they previously
agreed upon and what already had been performed. Along these lines, we
modified our standard CF withdrawal language to say that if a subject
withdraws, they will be specifically asked to permit continued prospective
collection of followup data from their medical record.
jon merz
center for bioethics
university of pennsylvania
merz@mail.med.upenn.edu
Jon Merz
7/5/2000 3:59:00 AM
A Subject's Right to Withdraw Collected Research Data?
Steve ---
My sense is that the subject should have the right to terminate the durable
confidentiality risk. That would usually mean destruction of identifiers and
linking codes, but not necessarily destruction of data or samples.
Dale
Dale E. Hammerschmidt, M.D.
Associate Professor of Medicine, Univ. Minnesota
Editor, J. Lab. Clin. Med.
Director of Education in Research Ethics and Compliance
Box 480 Mayo Building; Minneapolis 55455
612-624-0123 (voice, Heme/Onc/BMT)
612-626-2640 (voice, Journal office)
612-626-2642 (fax)
hamme001@tc.umn.edu
Dale Hammerschmidt
7/5/2000 4:35:00 AM
A Subject's Right to Withdraw Collected Research Data?
More and more consent forms are containing language telling potential
subjects what data items can and/or cannot be withdrawn if they depart from
the research. This scenario illustrates why that is a good idea.
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: Steven Peckman [mailto:SPECKMAN@oprs.ucla.edu]
Sent: Friday, June 30, 2000 1:55 PM
To: mcwirb@mcwirb.org
Subject: A Subject's Right to Withdraw Collected Research Data?
Dear McWirbers,
Your insight and assistance regarding the following would be helpful.
SCENARIO
i. A subject enrolls in a research project that includes medical record data
extraction and questionnaires regarding medical care for X disease. Full
written informed consent is provided. The informed consent form indicates
that
the subject may withdraw from the research without penalty.
ii. The research procedures are performed. The data is obtained using
standard
instruments. There are 95 total subjects. The study is now closed to
accrual
and statistical analysis is performed.
iii. The subject returns 2 months later and requests to be withdrawn from
the
study. Part of the request is the removal of her data from the project.
iv. It would require a significant expenditure of time and resources for
the
investigator to identify the data, redact it, and re-do data analysis.
QUESTIONS:
1. When a subject withdraws from the research should her/his research
information also be withdrawn?
a. What should be the reasonable expectation placed on the investigator?
b. What if the data can be deidentified?
2. At what point is it impracticable to remove data/specimens from a
project.
3. What if the removal of such information negatively impacts the
statistical
analysis of the entire project? For example, the 1 out of 95 could be a
significant percentage, depending on the information.
The OPRR Guidebook discussing the development of cell lines states: ...the
underlying principle would be that withdrawal releases the subject from
providing further information or tissue samples, and perhaps requires the
removal of the subject's identity from all research records, but does not
require the investigator to eliminate the resulting data from the study or
to
destroy the cell line. [p5-48 - 5-49]
thank you for your help.
-steve
Steven Peckman
Associate Director-Human Subjects Research
Office for Protection of Research Subjects
University of California, Los Angeles
310.825.5344
speckman@oprs.ucla.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Evelyn Studer
7/5/2000 4:04:00 AM
A Subject's Right to Withdraw Collected Research Data?
>>> Janice Singer 07/03/00 01:39PM >>> wrote :
The Tri-Council Policy Statement (Canada) Ethical Conduct for Research
Involving
Humans states:
In cases where a subject expresses concerns about a study, the
researcher may
give the subject the option of removing his or her data from the
project. This
approach should be used only when the elimination of the subject's data
will not
compromise the validity of the research design, and hence diminish the
ethical
value of participation by other subjects.
I must admit I was surprised when I first read this formulation, but it
does make
sense, the rights of the many over the rights of the one. On the other
hand, our
REB discussed this issue just the other day, and a fellow researcher
pointed out
that a good researcher would take desertion into account when designing
the study,
and hence would not have a problem with this issue.
..................................................................................................................................................................
Janice,
Thanks for the reference. I believe the Tri-Council's Policy Statement
is a very informative and useful document.
For others in this forum, the URL is :
http://www.sshrc.ca/english/programinfo/policies/Index.htm
The excerpt you provide is on this page :
http://www.sshrc.ca/english/programinfo/policies/Sec02.htm#A
Regards,
Howard
Howard Mann
7/5/2000 6:47:00 AM
Survey of College Freshmen
I would also like to know the answer.
According to their website, the questionnaire was given last year to 350,000
students at 700 institutions.
If anyone wants more info, the CIRT website is at
http://www.gseis.ucla.edu/heri/heri.html
Andrew Cockburn, PhD
Director of Institutional Research Compliance/Biological Safety
West Virginia University
Morgantown, WV 26506-9006
Telephone: 304-293-7157
FAX: 304-293-4529
Email: acockbur@wvu.edu
> -----Original Message-----
> From: mcwirb-admin@mcwirb.org [mailto:mcwirb-admin@mcwirb.org]On Behalf
> Of Mike Kelly
> Sent: Wednesday, July 05, 2000 3:09 PM
> To: mcwirb@mcwirb.org
> Subject: Survey of College Freshmen
>
>
> This question is directed at university IRBs. It involves the Cooperative
> Institutional Research Program survey that is given to all incoming
> university freshmen at (we are told) over 200 universities. Results are
> tabulated at UCLA and published for the academic community. The
> survey was
> exempted by UCLA's IRB several years ago although the questions
> change from
> year-to-year. We at Georgia Tech began examining this survey a year ago
> after a parent complained that her 17 year-old daughter was required to
> take the survey in order to register for college, that parental permission
> was not sought, and that it contained sensitive questions. Our IRB had
> never been sent an application because the survey was declared exempt at
> its source and our local PI thought that eliminated need for local review.
>
> Our IRB just received a protocol for this year's survey and again have
> serious problems with it. (At our IRB's direction, students under 18 are
> now excluded from the survey here.) The survey is still claimed to be
> exempt. CIRP still claims that there are no sensitive questions -- yet it
> asks students about their alcohol consumption (a crime), whether they
> suffer from depression (a health problem that could affect future
> employability and insurability), their political and moral views, and
> family history. They must provide their full name and social security
> number to allow followup.
>
> At our insistence, the survey forms given to Georgia Tech freshmen must
> emphasize that completion of any or all questions is voluntary. Yet,
> proctors are told to convince the reluctant students to complete the
> forms. It's hard to imagine a group more vulnerable to coercion than
> college freshmen on their first day away from home.
>
> I'd like to hear from other university IRBs about their knowledge and
> handling of this national survey. I'm told that we're the only IRB that
> has voiced any concerns about the survey. Thanks for your comments.
>
> Mike Kelly
> IRB Chair
> Georgia Tech
>
>
>
>
>
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
Andrew Cockburn
7/5/2000 11:33:00 AM
A Subject's Right to Withdraw Collected Research Data?
>>> Dale E. Hammerschmidt 07/04/00
07:42PM >>> wrote:
Steve ---
My sense is that the subject should have the right to terminate the
durable
confidentiality risk. That would usually mean destruction of
identifiers and
linking codes, but not necessarily destruction of data or samples.
...........................................................................................................................................................................................
Hi,
There are two core issues here :
1. The nature and objectives of the research effort.
2. Maintaining the confidentiality of personally-identifiable
information.
An individual may not wish to participate in certain kinds of research
as an expression of cultural
or religious values. If, after the research is underway, a subject
acquires additional information about the research effort that motivates
him to withdraw his support, he should be able to do so ( subject to
reasonable practical constraints inherent in the research design).
An example : An immortalized cell line permits, in theory, ongoing
research, ad infinitum.
The donor of the sample from which it was derived should be able to
request destruction of the same.
( Here's an interesting notion : A subject claims that he has acquired
undisclosed information about the research that supports a claim that
the research is morally illicit. Not only does he wish to terminate his
participation, he wants to persuade the other subjects to do likewise,
claiming that many would likely do so after acquiring the information he
wishes to share. He requests a list of participants so that he can send
them a letter explaining his concerns. Would you comply ? How would you
respond to this request ?)
Regards,
Howard
Howard Mann
7/5/2000 6:47:00 AM
A Subject's Right to Withdraw Collected Research Data?
Did the study consent say what withdrawal from the study meant? Probably it
did not. It would have been ideal if the study consent indicated that
subjects could withdraw, but data already obtained would not be destroyed;
OR that withdrawal meant that the data already obtained would be destroyed.
It seems to me that if the subject was informed that he/she could withdraw,
and if the study consent did not place limits on what the meant, and the
subject requested removal of his/her data, then the data would have to be
removed. If the investigators have the capability of finding the data from
this subject, even if it takes a lot of effort, the data should be found and
destroyed. It seems there is a lesson here for all of us to be sure that
the study consents we approve are more specific about what withdrawal means.
Thomas G. Keens, M.D.
Chair, Committee on Clinical Investigations (IRB)
Childrens Hospital Los Angeles
-----Original Message-----
From: Steven Peckman [SMTP:SPECKMAN@oprs.ucla.edu]
Sent: Friday, June 30, 2000 10:55 AM
To: mcwirb@mcwirb.org
Subject: A Subject's Right to Withdraw Collected Research
Data?
Dear McWirbers,
Your insight and assistance regarding the following would be
helpful.
SCENARIO
i. A subject enrolls in a research project that includes medical
record data
extraction and questionnaires regarding medical care for X disease.
Full
written informed consent is provided. The informed consent form
indicates that
the subject may withdraw from the research without penalty.
ii. The research procedures are performed. The data is obtained
using standard
instruments. There are 95 total subjects. The study is now closed
to accrual
and statistical analysis is performed.
iii. The subject returns 2 months later and requests to be withdrawn
from the
study. Part of the request is the removal of her data from the
project.
iv. It would require a significant expenditure of time and
resources for the
investigator to identify the data, redact it, and re-do data
analysis.
QUESTIONS:
1. When a subject withdraws from the research should her/his
research
information also be withdrawn?
a. What should be the reasonable expectation placed on the
investigator?
b. What if the data can be deidentified?
2. At what point is it impracticable to remove data/specimens from
a project.
3. What if the removal of such information negatively impacts the
statistical
analysis of the entire project? For example, the 1 out of 95 could
be a
significant percentage, depending on the information.
The OPRR Guidebook discussing the development of cell lines states:
...the
underlying principle would be that withdrawal releases the subject
from
providing further information or tissue samples, and perhaps
requires the
removal of the subject's identity from all research records, but
does not
require the investigator to eliminate the resulting data from the
study or to
destroy the cell line. [p5-48 - 5-49]
thank you for your help.
-steve
Steven Peckman
Associate Director-Human Subjects Research
Office for Protection of Research Subjects
University of California, Los Angeles
310.825.5344
speckman@oprs.ucla.edu
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Tom
7/3/2000 6:02:00 AM
Incoming PI and Protocols
Dear MCWIRBERS
It almost sounds like a family reunion, doesn't it? But nobody's married, so you know what that makes us.
I am looking for advice from those of you who have managed the transfer of a PI and his protocols from another institution.
I have new Medical Director of our Cancer Center bringing in a truck load of new NSABP protocols. I have been in contact with the IRB that temporarily [temporary because the Instituion he is coming from went belly-up]has the responsibility for these subjects. So we are being very careful to make sure the transfer of responsibilty occurs in an orderly fashion.
Some of these NSABP projects are actively enrolling subjects. These will receive Full Board Review. Subjects will be notified of the change in IRB of Record for their study. My major concern with the active studies is the subjects who are still receiving drug, especially those that may opt not to drive here to receive treatment. How do you handle withdrawals? [I have not yet talked with the PI about these concerns, but will do so at my first opportunity] Since there is the potential that subjects will withdraw at this point, I feel re-consent is necessary. And that can be done when the subjects come for treatment.
Some projects are closed to enrollment, and have been closed for some time. The only contact with these subjects is for Follow-Up. These subjects will also be notified of the change in the IRB of Record. Do these studies need Full Board Review or can they be done on an Expedited basis?
Thanks for the advice.
Karl M. Nelson, Ph.D.
Director of Research
Chairman, Human Research Review Board
Aultman Health Foundation
Canton, Ohio 44710
330.438.7434 phone
knelson@aultman.com
Anonymous
7/3/2000 7:45:00 AM
A Subject's Right to Withdraw Collected Research Data?
The Tri-Council Policy Statement (Canada) Ethical Conduct for Research Involving
Humans states:
In cases where a subject expresses concerns about a study, the researcher may
give the subject the option of removing his or her data from the project. This
approach should be used only when the elimination of the subject's data will not
compromise the validity of the research design, and hence diminish the ethical
value of participation by other subjects.
I must admit I was surprised when I first read this formulation, but it does make
sense, the rights of the many over the rights of the one. On the other hand, our
REB discussed this issue just the other day, and a fellow researcher pointed out
that a good researcher would take desertion into account when designing the study,
and hence would not have a problem with this issue.
Anyhow, the for what it's worth, the Canadian perspective...
Janice Singer
Janice Singer
7/3/2000 10:28:00 AM
FYI: Responsibilities and problems in drug clinical trials
Hi,
These two slide shows indicate the complex hierarchy of responsibility associated with industry-sponsored trials :
Patient Misuse and Investigator Fraud in Clinical Trials: What Can Be
Done? Part I (6/27/2000)
http://www.fda.gov/cder/present/dia-62000/woolen1/index.htm
Who’s in Charge Anyway? Responsibility in Today’s Clinical Trial
Environment (6/27/2000)
http://www.fda.gov/cder/present/dia-62000/woolen2/index.htm
Regards,
Howard
Anonymous
7/3/2000 4:30:00 AM
reimbursement to providers for referring subjects
>What about paying a record-keeper for the work of reviewing the records and
>identifying patients that are possibly eligible for a study?
I think Paul is correct in identifying this as a separate issue. Here
it appears that one is talking about simply paying for work done,
rather than rewarding a specific clinical decision.
In this scenario, I'd be more worried about other things, like the
protection of the confidentiality of the medical record and the
legitimacy of approaching patients so identified.
Dale
Dale Hammerschmidt
7/2/2000 5:53:00 AM
reimbursement to providers for referring subjects
paul goebel wrote:
> I understand the concerns about paying a referral fee on a per capita basis.
>
> What about paying a record-keeper for the work of reviewing the records and
> identifying patients that are possibly eligible for a study? The payment
> would be either a set total fee or so much per hour of review time with no
> bonus or incentive paid on the basis of number of eligibles identified. I
> would be interested in comments about such an arrangement.
hi paul:
i personally would view that as a different scenario, on at least two
grounds. first, the record-keeper is presumably not in a care-giving
relationship with potential subjects, so the concerns about divided
loyalties and competing motivations are mitigated. second, this person
would appear to be performing work for the investigator. under these
circumstances, i think compensation would be reasonable and
appropriate. but now that we've resolved that question, others arise:
does the investigator and/or record keeper have legitimate access to the
records, for research purposes? who is going to make initial contact
with eligible subjects? (we would say someone the patient has reason to
know they're a patient)
dan
Daniel K. Nelson, Director, Human Research Studies
Research Associate Professor of Pediatrics and Social Medicine
University of North Carolina-Chapel Hill
Chapel Hill, NC 27599-7097
Phone: 919-966-1344
fax: 919-966-7879
e-mail: dnelson@med.unc.edu
Daniel Nelson
7/2/2000 5:48:00 AM
reimbursement to providers for referring subjects
A principal investigator has requested several times that he be allowed to pay residents, fellows, attending physicians and other health care providers for referring patients to him who meet specific enrollment criteria into an approved study. He has proposed direct payments in the form of cash, movie tickets,gift certificates. Our IRB has refused this. What is the experience of other IRBs? Does any allow direct payment for such a referral? Does anyone consider this to be acceptable or ethical?
Anonymous
7/2/2000 5:53:00 AM
Use of tissue from autopsies
I'm sceptical about this. If the sample was not identifiable there would
have been no way the family could prove they had standing to sue. Not
identified is not the same as not identifiable. I think the latter is
what the original poster was asking about.
> -----Original Message-----
> From: Diane Gilbert [SMTP:Diane.Gilbert@bmc.org]
> Sent: Thursday, June 29, 2000 10:53 AM
> To: Dale E. Hammerschmidt
> Cc: max perlman; mcwirb@mcwirb.org
> Subject: Re: Use of tissue from autopsies
>
> Case a few years back in Massachusetts: Investigator at prestigious
> research institution used autopsy sample for one of his courses. Sample
> was not identified. Family found out (can't remember exactly how).
> Family sued because were not consulted and, therefore, never consented.
> Family won big since had never given permission to use a sample of
> relative for any purpose.
>
> Diane C. Gilbert, CRA
> Boston Medical Center
> diane.gilbert@bmc.org
>
>
> Dale E. Hammerschmidt wrote:
> >
> > >I am seeking the opinions of colleagues regarding the feasibility in
> their
> > >jurisdiction of waiving consent for the removal of tiny samples of
> tissue
> > >at routine autopsy of infants or children.
> >
> > There are several issues:
> > -- A human subject is defined in the regs as a _living_ person from whom
> one
> > gets data by some sort of manipulation or about whom one gets
> identifiable
> > private information. Getting autopsy tissue is usually outside the
> regs,
> > unless the information generated might have impact on specific
> identifiable
> > living people.
> > -- That being said, there are strong reasons to get consent. The very
> simplest
> > is that some parents might object --- either in general or to the
> specific
> > research being done. For example, some religious groups have very
> strong
> > feelings about maintaining the integrity of the body.
> > -- If the autopsy is done because the death is a coroner's case, the
> > reasonable expectation is that its purpose is to gather the forensic
> > evidence necessary to answer legal questions about cause of death
> and the
> > likelihood (or details) of foul play. Removal of tissue for research
> is
> > NOT within most people's expectations (I'd guess). So the proposed
> > research may fail the sniff test because of its sneakiness titer.
> > -- If the autopsy is an elective autopsy that is being done with the
> consent of
> > the legal custodian of the remains (generally the child's parents,
> in the
> > scenario you propose), that consent process and form can be so
> structured
> > as to address research use of removed tissues. Getting consent for
> such
> > tissue needn't add very much to the sadness and awkwardness already
> > inherent in asking for an autopsy --- IF it's made part of the
> routine.
> > If it is brought back as a separate issue, it may be more painful.
> >
> > I think you have to get consent for this in order to be respectful of
> > people and their religious sensibilities. But whether or not it's an
> > IRB matter may hinge on local institutional policies, the
> > presence/absence of anybody else to address the issue, and the
> > possibility of the research to create confidentiality or
> > informational risk for living persons.
> >
> > Dale Hammerschmidt
> >
> > _______________________________________________
> > MCWIRB maillist - MCWIRB@mcwirb.org
> > http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Gullion Christina M
6/30/2000 2:16:00 AM
Use of tissue from autopsies
I am seeking the opinions of colleagues regarding the feasibility in their
jurisdiction of waiving consent for the removal of tiny samples of tissue
at routine autopsy of infants or children.
The research does not involve sensitive issues, or benefit for family
members other than altruistic feelings. The tissue for research would be
part of samples removed for routine histology from two organs, and would be
transferred to the researcher fully anonymized. Requesting the consent of
parents to take any aliquot of tissue at autopsy for research purposes is
intrusive. Is consent mandatory under these conditions?
Max Perlman
Chair Research Ethics Board
Hospital for Sick Children
Toronto, ON, Canada M5G 1X8
Max Perlman
6/30/2000 2:16:00 AM
Ann,
At my last position (research department and IRB manager), a floor nurse
brought to our attention a subject who experienced some problems in a study.
When he tried to withdraw from the study he got some resistance from the
sub-investigator who enrolled him. Upon interviewing this subject, he
revealed he had never understood the study in the first place, and felt
pressured to agree. When he was released he tried to withdraw and that is
when the nurse witnessed a conflict between the patient and the Sub-I. This
occurrence, along with some other rumors that subjects were being consented
literally on the table on their way to the cath lab, initiated a quality
check on our part. We had our sites provide us with the names and phone
numbers of their subjects. We called them and initiated the conversation
with something like I am with ______ hospital, and I understand you
recently took part in a research study. We would like to ask you a couple
of simple questions about your experience in this study. We then asked
questions such as Did you feel you were given enough time to make the
decision, and Do you feel you were pressured into doing the study, etc.
We wanted to make sure this was an isolated incident. Our results indicated
that it was isolated, as no one else reported feeling pressured - HOWEVER,
we did encounter a few What study? 's, which is a hard call to make on
whose fault that is, considering the consent process could have been
completely legitimate and a subject could have still forgotten that there
was research involved in the midst of his/her hospital stay. Regardless,
we felt this was the best way to assure past subjects were taken care of.
In addition, we had a series of meetings and discussions about the
individual incident, and spent time educating all investigators on the
importance and proper way to execute the consent process to help future
subjects. Hope this helps!
Linda Apholz
Clinical Research Associate
813-887-2572
-----Original Message-----
From: Ann [mailto:AStrong@SAIRB.COM]
Sent: Thursday, June 29, 2000 11:11 AM
To: 'mcwirb@mcwirb.org'
Subject: IRB Policies
I am interested to see if any IRBs interview study subjects for any
reason, whether it's to ask about how informed consent was presented or if
any IRB has actually sat in on the informed consent process with study
subjects.
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Linda
6/30/2000 2:16:00 AM
reimbursement to providers for referring subjects
I understand the concerns about paying a referral fee on a per capita basis.
What about paying a record-keeper for the work of reviewing the records and
identifying patients that are possibly eligible for a study? The payment
would be either a set total fee or so much per hour of review time with no
bonus or incentive paid on the basis of number of eligibles identified. I
would be interested in comments about such an arrangement.
Not an official OHRP or FDA message.
Paul W. Goebel, Jr.
Division of Human Subject Protections
Office for Human Research Protections
Department of Health and Human Services
6100 Executive Boulevard, suite 3B01, MSC-7507
Rockville, MD 20892-7507
Phone: 301-402-4372
email: pg122v@nih.gov
Fax: 301-402-4256
OHRP url: http://grants.nih.gov/grants/oprr/oprr.htm
> -----Original Message-----
> From: Dale E. Hammerschmidt [SMTP:hamme001@maroon.tc.umn.edu]
> Sent: Friday, June 23, 2000 11:04 AM
> To: mcwirb@mcwirb.org
> Subject: Re: reimbursement to providers for referring subjects
>
> Barbara ---
>
> You've already gotten a lot of good answers.
>
> We examined this a few years ago from more a common morality
> perspective. We
> concluded that, in theory, it could be OK to have a finder's reward if it
> were
> of a size and nature that it would only serve as a memory aid --- keep
> people
> from forgetting about the study when suitable patients came to hand. It
> would
> not be OK if it were of a size or nature that it could actually threaten
> the
> integrity of medical decision-making.
>
> From that theoretical perspective, we then moved to thinking about how one
> would
> ever develop the decision-making algorithm that would allow one reliably
> to
> decide which incentives were OK and which ones were not OK. That's where
> we had
> our brick-wall experience. We could easily identify some incentives that
> were
> obviously too great to allow. We could identify a few that most of us felt
> were
> trivial, and probably harmless. But the great majority of ones we actually
> saw
> (textbooks, course fees, tickets for nights out, etc.) were in the middle
> range,
> where some folks would be vulnerable and others would not, or where the
> authority relationship between the investigator and the referring person
> (often
> a trainee) would be key.
>
> We ended up deciding that, in practice, it made more sense simply not to
> allow
> such recruitment incentives. That also is consistent with the general
> impropriety of clinical referral kickbacks, as well as more recent
> statements on
> specific research referrals that have been made by some professional
> groups.
>
> Dale
>
> Dale Hammerschmidt
> Assoc Prof Med / (Hematology/Oncology/BMT)
> Editor., J. Lab. Clin. Med.
> Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
> 612-626-2640; 612-626-2642 (fax)
> InterNet
> 72662,76 (CompuServe)
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul Od
6/30/2000 5:04:00 AM
The new web site for the Office of Human Research Protections is
HTTP://OHRP.OSOPHS.DHHS.GOV
Paul W. Goebel, Jr.
Division of Human Subject Protections
Office for Human Research Protections
Department of Health and Human Services
6100 Executive Boulevard, suite 3B01, MSC-7507
Rockville, MD 20892-7507
Phone: 301-402-4372
email: pg122v@nih.gov
Fax: 301-402-4256
New OHRP url: http://ohrp.osophs.dhhs.gov
Paul Od
6/30/2000 6:19:00 AM
I am interested to see if any IRBs interview study subjects for any
reason, whether it's to ask about how informed consent was presented or if
any IRB has actually sat in on the informed consent process with study
subjects.
Ann
6/30/2000 2:16:00 AM
IRB Certification with ARENA/PRIM&R at Oct. Conference
I am interested in taking the IRB Certification exam through the ARENA/PRIM&R at the October Conference but, I have a few questions:
1) This will be the first examination date for the new IRB Certification Proagram. Depending on the results of the exam, could it be changed for the next group?
2) I know the exam is 250 multiple choice questions in 4 major areas. How do you study for the exam?
3) Will there be a pre-test, or maybe a work seminar that you can attend? Either now or in the future?
I haven't decided when I want to take the exam so I thought I would see if anyone else in the MCWIRB group had any comments, concers or questions?
Thanks in advance,
Patty Rensing,
IRB Coordinator,
Sarasota Memorial Hospital,
patty-rensing@SMH.com
Anonymous
6/29/2000 11:48:00 AM
Use of tissue from autopsies
>>> max perlman 06/28/00 08:02AM >>> wrote:
>>>I am seeking the opinions of colleagues regarding the feasibility in
their
jurisdiction of waiving consent for the removal of tiny samples of
tissue
at routine autopsy of infants or children.
The research does not involve sensitive issues, or benefit for family
members other than altruistic feelings. The tissue for research would
be
part of samples removed for routine histology from two organs, and
would be
transferred to the researcher fully anonymized. Requesting the consent
of
parents to take any aliquot of tissue at autopsy for research purposes
is
intrusive. Is consent mandatory under these conditions?
..................................................................................................................................................................................
Max,
I believe one should obtain consent from the parents. Individuals may
not want to participate in certain kinds of research as an expression of
religious, philosophic or cultural convictions.
The report of the NBAC concerning research using human biological
materials discusses this issue:
http://bioethics.gov/pubs.html
[ Page 67 : Treating persons who are moral agents. ]
[Page 69 : Objectionable, Unacceptable or Questionable Research]
The fact that the researcher may use unidentified tissue does not
negate the necessity of obtaining consent .
Regards,
Howard
Howard Mann
6/29/2000 11:49:00 AM
IRB Certification with ARENA/PRIM&R at Oct. Conference
This ceritifcation is educational and helpful, but not an accredited, nationally recognized certification.
>>> Woolridge, Linda D. 06/28 5:14 AM >>>
THERE IS ALSO AN IRB CERTIFICATION THROUGH.
THE NATIONAL ASSOCIATION OF IRB MANAGERS, INC.
WEB ADDRESS: www.naim.org
E-MAIL: Ballthomas@aol.com
Linda Woolridge, MBA, CIM
Medical Staff Services
Norton Audubon Hospital
One Audubon Plaza Drive
Louisville, KY 40217-9907
Phone: (502) 636-7148
Fax: (502) 636-7684
Email: linda.woolridge@nortonhealthcare.org
> -----Original Message-----
> From: Gary Chadwick [SMTP:gary_chadwick@urmc.rochester.edu]
> Sent: Tuesday, June 20, 2000 10:39 AM
> To: mcwirb@mcwirb.org
> Subject: re: IRB Certification with ARENA/PRIM&R at Oct. Conference
>
> The ARENA Council for Certification of IRB Professionals (CCIP) will have
> its
> first ever exam on October 28, 2000 in San Diego - in conjunction with the
> ARENA/PRIMR Annual IRB Conferences. Future exams will be given at
> locations
> across the country.
>
> While I would like to talk/email each of you who are interested, I can't
> possibly do it. Please contact the group who is handling the testing and
> logistics - Professional Testing Corporation (PTC), 1350 Broadway, 17th
> floor,
> New York, NY 10018 (212) 356-0660. They have a web site at www.PTCNY.COM
> where you can get/request information too.
>
> The Handbook that is available from PTC lists the eligibility requiements,
> the
> areas tested, reference materials, and other information about the exam.
>
> Last, I would like to point out that MCWIRB has a 'forum' on the CIP.
> This is
> a listing of the test areas and an opportunity for IRBers to submit
> questions
> for consideration for inclusion on future exams.
>
> Thank you all for your interest. See you in San Diego.
> Gary Chadwick,
> CCIP Chair
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Leilani Price
6/29/2000 11:48:00 AM
Use of tissue from autopsies
Case a few years back in Massachusetts: Investigator at prestigious
research institution used autopsy sample for one of his courses. Sample
was not identified. Family found out (can't remember exactly how).
Family sued because were not consulted and, therefore, never consented.
Family won big since had never given permission to use a sample of
relative for any purpose.
Diane C. Gilbert, CRA
Boston Medical Center
diane.gilbert@bmc.org
Dale E. Hammerschmidt wrote:
>
> >I am seeking the opinions of colleagues regarding the feasibility in their
> >jurisdiction of waiving consent for the removal of tiny samples of tissue
> >at routine autopsy of infants or children.
>
> There are several issues:
> -- A human subject is defined in the regs as a _living_ person from whom one
> gets data by some sort of manipulation or about whom one gets identifiable
> private information. Getting autopsy tissue is usually outside the regs,
> unless the information generated might have impact on specific identifiable
> living people.
> -- That being said, there are strong reasons to get consent. The very simplest
> is that some parents might object --- either in general or to the specific
> research being done. For example, some religious groups have very strong
> feelings about maintaining the integrity of the body.
> -- If the autopsy is done because the death is a coroner's case, the
> reasonable expectation is that its purpose is to gather the forensic
> evidence necessary to answer legal questions about cause of death and the
> likelihood (or details) of foul play. Removal of tissue for research is
> NOT within most people's expectations (I'd guess). So the proposed
> research may fail the sniff test because of its sneakiness titer.
> -- If the autopsy is an elective autopsy that is being done with the consent of
> the legal custodian of the remains (generally the child's parents, in the
> scenario you propose), that consent process and form can be so structured
> as to address research use of removed tissues. Getting consent for such
> tissue needn't add very much to the sadness and awkwardness already
> inherent in asking for an autopsy --- IF it's made part of the routine.
> If it is brought back as a separate issue, it may be more painful.
>
> I think you have to get consent for this in order to be respectful of
> people and their religious sensibilities. But whether or not it's an
> IRB matter may hinge on local institutional policies, the
> presence/absence of anybody else to address the issue, and the
> possibility of the research to create confidentiality or
> informational risk for living persons.
>
> Dale Hammerschmidt
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Diane Gilbert
6/29/2000 11:49:00 AM
Use of tissue from autopsies
Absolutely! This is an issue I have visited many times because an IRB I
chaired for many years oversaw human subjects protection for the medical
examiner's office. As I learned the first time around with this, some
religious traditions consider all human tissue to be sacrosanct and
inviolable after death. You should not take tissue samples without
permission period. It is a greater intrusion on people's rights to not ask
for consent in this case.
Daniel R. Vasgird, PhD
Office of Research Compliance
Research Foundation of CUNY
30 West Broadway, 11th Floor
New York, NY 10007
Ph: 212-4178485
Fax: 212-4178479
email: Daniel_Vasgird@rfcuny.org
-----Original Message-----
From: max perlman [mailto:mperlman@sickkids.on.ca]
Sent: Wednesday, June 28, 2000 10:03 AM
To: mcwirb@mcwirb.org
Subject: Use of tissue from autopsies
I am seeking the opinions of colleagues regarding the feasibility in their
jurisdiction of waiving consent for the removal of tiny samples of tissue
at routine autopsy of infants or children.
The research does not involve sensitive issues, or benefit for family
members other than altruistic feelings. The tissue for research would be
part of samples removed for routine histology from two organs, and would be
transferred to the researcher fully anonymized. Requesting the consent of
parents to take any aliquot of tissue at autopsy for research purposes is
intrusive. Is consent mandatory under these conditions?
Max Perlman
Chair Research Ethics Board
Hospital for Sick Children
Toronto, ON, Canada M5G 1X8
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Daniel
6/29/2000 11:49:00 AM
Use of tissue from autopsies
A number of years ago, in California, legislators interested in promoting
research on a common cause of death passed a state law allowing removal of
tissues from Coroner's autopsies for research purposes provided the removal
was not disfiguring to the body and the study was approved by the
appropriate IRB. Consent is not required for this under California law.
In the U.S., the definition of human subject for research purposes is .. a
living individual about whom an investigator obtains data through
intervention or interaction with the individual; or identifiable
information. Thus, some might even claim that such research is exempt from
IRB review and approval. Our IRB would want to review the protocol, but I
do not think we would require consent.
Thomas G. Keens, M.D.
Chair, Committee on Clinical Investigations (IRB)
Childrens Hospital Los Angeles
-----Original Message-----
From: max perlman [SMTP:mperlman@sickkids.on.ca]
Sent: Wednesday, June 28, 2000 7:03 AM
To: mcwirb@mcwirb.org
Subject: Use of tissue from autopsies
I am seeking the opinions of colleagues regarding the feasibility in
their
jurisdiction of waiving consent for the removal of tiny samples of
tissue
at routine autopsy of infants or children.
The research does not involve sensitive issues, or benefit for
family
members other than altruistic feelings. The tissue for research
would be
part of samples removed for routine histology from two organs, and
would be
transferred to the researcher fully anonymized. Requesting the
consent of
parents to take any aliquot of tissue at autopsy for research
purposes is
intrusive. Is consent mandatory under these conditions?
Max Perlman
Chair Research Ethics Board
Hospital for Sick Children
Toronto, ON, Canada M5G 1X8
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Tom
6/29/2000 11:49:00 AM
Use of tissue from autopsies
>I am seeking the opinions of colleagues regarding the feasibility in their
>jurisdiction of waiving consent for the removal of tiny samples of tissue
>at routine autopsy of infants or children.
There are several issues:
-- A human subject is defined in the regs as a _living_ person from whom one
gets data by some sort of manipulation or about whom one gets identifiable
private information. Getting autopsy tissue is usually outside the regs,
unless the information generated might have impact on specific identifiable
living people.
-- That being said, there are strong reasons to get consent. The very simplest
is that some parents might object --- either in general or to the specific
research being done. For example, some religious groups have very strong
feelings about maintaining the integrity of the body.
-- If the autopsy is done because the death is a coroner's case, the
reasonable expectation is that its purpose is to gather the forensic
evidence necessary to answer legal questions about cause of death and the
likelihood (or details) of foul play. Removal of tissue for research is
NOT within most people's expectations (I'd guess). So the proposed
research may fail the sniff test because of its sneakiness titer.
-- If the autopsy is an elective autopsy that is being done with the consent of
the legal custodian of the remains (generally the child's parents, in the
scenario you propose), that consent process and form can be so structured
as to address research use of removed tissues. Getting consent for such
tissue needn't add very much to the sadness and awkwardness already
inherent in asking for an autopsy --- IF it's made part of the routine.
If it is brought back as a separate issue, it may be more painful.
I think you have to get consent for this in order to be respectful of
people and their religious sensibilities. But whether or not it's an
IRB matter may hinge on local institutional policies, the
presence/absence of anybody else to address the issue, and the
possibility of the research to create confidentiality or
informational risk for living persons.
Dale Hammerschmidt
Dale Hammerschmidt
6/29/2000 11:49:00 AM
IRB Certification with ARENA/PRIM&R at Oct. Conference
THERE IS ALSO AN IRB CERTIFICATION THROUGH.
THE NATIONAL ASSOCIATION OF IRB MANAGERS, INC.
WEB ADDRESS: www.naim.org
E-MAIL: Ballthomas@aol.com
Linda Woolridge, MBA, CIM
Medical Staff Services
Norton Audubon Hospital
One Audubon Plaza Drive
Louisville, KY 40217-9907
Phone: (502) 636-7148
Fax: (502) 636-7684
Email: linda.woolridge@nortonhealthcare.org
> -----Original Message-----
> From: Gary Chadwick [SMTP:gary_chadwick@urmc.rochester.edu]
> Sent: Tuesday, June 20, 2000 10:39 AM
> To: mcwirb@mcwirb.org
> Subject: re: IRB Certification with ARENA/PRIM&R at Oct. Conference
>
> The ARENA Council for Certification of IRB Professionals (CCIP) will have
> its
> first ever exam on October 28, 2000 in San Diego - in conjunction with the
> ARENA/PRIMR Annual IRB Conferences. Future exams will be given at
> locations
> across the country.
>
> While I would like to talk/email each of you who are interested, I can't
> possibly do it. Please contact the group who is handling the testing and
> logistics - Professional Testing Corporation (PTC), 1350 Broadway, 17th
> floor,
> New York, NY 10018 (212) 356-0660. They have a web site at WWW.PTCNY.COM
> where you can get/request information too.
>
> The Handbook that is available from PTC lists the eligibility requiements,
> the
> areas tested, reference materials, and other information about the exam.
>
> Last, I would like to point out that MCWIRB has a 'forum' on the CIP.
> This is
> a listing of the test areas and an opportunity for IRBers to submit
> questions
> for consideration for inclusion on future exams.
>
> Thank you all for your interest. See you in San Diego.
> Gary Chadwick,
> CCIP Chair
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Linda D .
6/28/2000 2:35:00 AM
Are IRBs required to review investigational protocols dealing withdietary supplements, phytochemicals, homeopathic remedies,ayurvedic therapies, etc.?
It depends. For example, we have a study with St. John's Wort and Kava Kava that
required IRB review and approval to examine their potential interactions with other
drugs. These agents are usually excluded in clinical drug trials (dependent upon
the type of study).
Holly Silva wrote:
> Since herbal products/vitamins/minerals/antioxidants (FDA regulated as dietary
> supplements), phytochemicals, homeopathic remedies, Ayurvedic therapies,
> aromatherapy, and naturopathic therapies are not regulated as drugs by the FDA,
> are IRBs required to review investigational protocols dealing with these
> products?
>
> Similarly, are protocols with modalities such as Qi Gong, Feng Shui, T'ai Chi,
> Chi Kung, Reiki, Biofeedback, Chiropractic, or Acupuncture (needles regulated
> by FDA), appropriately reviewed by IRB? If not the IRB, how should healthcare
> corporations handle Informed Consents/safety issues for all of the above?
>
> How are hospitals’ pharmacies handling these ‘dietary supplements,’ since many
> hospital’s P&T committee rules only allow the pharmacies to dispense meds
> listed in the US Pharmacopoeia?
>
> We understand that most of these potential studies would be done on
> out-patients, but there may still be conflicts with existing pharmacy rules.
> We believe the rules specifically mention handling experimental drugs, but this
> clearly means drugs under study within FDA purview, which does not include
> ‘herbal products’ and ‘dietary supplements’.
>
> Holly Silva
> IRB Coordinator
> TriHealth
> (Bethesda & Good Samaritan Hospitals)
> Level 11, Unit J
> 375 Dixmyth Avenue
> Cincinnati, Ohio 45220-2489
>
> 513-872-1650 – Telephone
> 513-872-1549 – Fax
>
> holly_silva@trihealth.com
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Michael Jann
6/27/2000 3:14:00 AM
Are IRBs required to review investigational protocols dealing wit
Research with human subjects is research with human subjects.
Experimental drug protocols are experimental drug protocols.
===================================
The fact that the FDA does not regulate certain products may change the
regulatory mandate, but it doesn't change the ethical mandate for independent
review of risk-producing research.
If you have an MPA, it very likely assures that ALL research will be reviewed
according to the same standards, regardless of its funding source or FDA
accountability. In many institutions, the same mandate will be in your
institutional policies.
===================================
Sometimes, research into natural products has the very real risk that users
may be avoiding effective care (besides which, there's nothing more natural than
cobra venom).
Moreover, there is a fundamental conceptual disconnect in claiming that these
agents are highly effective therapies, but that they are not drugs and that they
have no dangers. Two examples:
--- St. John's Wort prepared in the US is not regulated, and cannot be assumed
to be free of the minor component that is a monamine oxidase inhibitor and
has the potential for serious drug interactions (the German prep is
monitored for this, BTW, and is much safer). My own mother suffered a
stroke when she began taking SJW in company with a drug that shouldn't be
mixed with an MAO inhibitor, and she had all the additional features
(hypertension, tremor, confusion) characteristic of such a drug
interaction.
--- I saw a patient in the ICU with new atrial fibrillation, rapid
ventricular response and consequent congestive heart failure. This had
been precipitated by taking Ma Huang as a dietary aid (turns out that
she was sub-clinically hyperthyroid --- we now sometimes refer to the
Ma Huang challenge test for hyperthyroidism.)
Finally (for now, anyway [gg]), there are societal risks in doing junk research.
How many times have you read: In studies at a major University... and been
completely unable to find any such study? If the IRB decides that there's no
significant risk to the individual participants, that doesn't mean there's no
risk at all and it doesn't automatically mean that it's OK to do bad research.
Dale
Dale E. Hammerschmidt, M.D.
Associate Professor of Medicine, Univ. Minnesota
Editor, J. Lab. Clin. Med.
Director of Education in Research Ethics and Compliance
Box 480 Mayo Building; Minneapolis 55455
612-624-0123 (voice, Heme/Onc/BMT)
612-626-2640 (voice, Journal office)
612-626-2642 (fax)
hamme001@tc.umn.edu
Dale Hammerschmidt
6/27/2000 3:14:00 AM
Who can be a principal investigator??
I recently ran across a good article on the subject since I had the
same question and was wondering whether some of our research pharmacists
might be able to act as PI on some of our clinical trials. The article can
be found in Pharmacotherapy 2000; 20(5);599-608. The Clinical Pharmacist
as Prinicipal Investigator: A Commentary from the American College of
Clinical Pharmacy It includes copies of the 1989 and 1990 response letters
from the FDA reiterating that clinical pharmacists can serve as PIs in
clinical trials. In the 1990 letter states that Qualified individuals who
are not M.D's can participate in clinical trials either as principal
investigators or sub-investigators provided that an M.D. or D. O. (or D.D.S.
depending upon the study) is either a sub-investigator or is listed in the
IMD as an individual who will be responsible for drug administration and
evaluation of patient safety.
-----Original Message-----
From: Gary.Dennison@arcw.org [SMTP:Gary.Dennison@arcw.org]
Sent: Friday, June 23, 2000 10:19 AM
To: mcwirb@mcwirb.org
Subject: Who can be a principal investigator??
I have had a question come in from one of my coordinators:
Must the principal investigator in a clinical trial where a drug is
being
utilized always be a Medical Doctor (MD/DO)?
I have not quickly found any regulation that stipulates that it must
be. The
1572 asks for education, training and experience that qualifies the
investigator as an expert in the clinical investigation of the drug
for the use
under investigation, but could this not also be another qualified
individual
like a D. Pharm.??
Input on this would be greatly appreciated!
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Lynne Moffitt
6/27/2000 9:44:00 AM
Are IRBs required to review investigational protocols dealingwithdietary supplements, phytochemicals,homeopathic remedies,ayurvedic therapies, etc.?
The main purpose of IRB review is to protect subjects - if it isn't clinical care, then
it changes risk/benefit and so requires IRB review - even if it is only expedited.
Since only the IRB can make the decision as to whether a study can be exempt from
approval or expedited - ANYTHING which is systematically changed about the clinical
care of a patient is subject to IRB review.
Michael Jann wrote:
> It depends. For example, we have a study with St. John's Wort and Kava Kava that
> required IRB review and approval to examine their potential interactions with other
> drugs. These agents are usually excluded in clinical drug trials (dependent upon
> the type of study).
>
> Holly Silva wrote:
>
> > Since herbal products/vitamins/minerals/antioxidants (FDA regulated as dietary
> > supplements), phytochemicals, homeopathic remedies, Ayurvedic therapies,
> > aromatherapy, and naturopathic therapies are not regulated as drugs by the FDA,
> > are IRBs required to review investigational protocols dealing with these
> > products?
> >
> > Similarly, are protocols with modalities such as Qi Gong, Feng Shui, T'ai Chi,
> > Chi Kung, Reiki, Biofeedback, Chiropractic, or Acupuncture (needles regulated
> > by FDA), appropriately reviewed by IRB? If not the IRB, how should healthcare
> > corporations handle Informed Consents/safety issues for all of the above?
> >
> > How are hospitals’ pharmacies handling these ‘dietary supplements,’ since many
> > hospital’s P&T committee rules only allow the pharmacies to dispense meds
> > listed in the US Pharmacopoeia?
> >
> > We understand that most of these potential studies would be done on
> > out-patients, but there may still be conflicts with existing pharmacy rules.
> > We believe the rules specifically mention handling experimental drugs, but this
> > clearly means drugs under study within FDA purview, which does not include
> > ‘herbal products’ and ‘dietary supplements’.
> >
> > Holly Silva
> > IRB Coordinator
> > TriHealth
> > (Bethesda & Good Samaritan Hospitals)
> > Level 11, Unit J
> > 375 Dixmyth Avenue
> > Cincinnati, Ohio 45220-2489
> >
> > 513-872-1650 – Telephone
> > 513-872-1549 – Fax
> >
> > holly_silva@trihealth.com
> >
> > _______________________________________________
> > 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
Randi L . Rutan
6/27/2000 6:14:00 AM
This is a multi-part message in MIME format.
------=_NextPart_000_000F_01BFE07D.C17027F0
Content-Type: text/plain;
charset=iso-8859-1
Content-Transfer-Encoding: quoted-printable
Regulations on medical research involving human subjects (Medical =
Research Involving Human Subjects Act) of 26 February 1998 in The =
Netherlands require that medical research in which persons are subjected =
to treatment or are required to behave in a certain manner shall be =
conducted in accordance with a research protocol written for the purpose =
and approved by a Medical Ethics Committee.
Anjo Strik
------=_NextPart_000_000F_01BFE07D.C17027F0
Content-Type: text/html;
charset=iso-8859-1
Content-Transfer-Encoding: quoted-printable
<!DOCTYPE HTML PUBLIC -//W3C//DTD HTML 4.0 Transitional//EN> Regulations on medical research involving human subjects (Medical =
Research=20
Involving Human Subjects Act) of 26 February 1998 in The Netherlands =
require=20
that medical research in which persons are subjected to treatment or are =
required to behave in a certain manner shall be conducted in accordance =
with a=20
research protocol written for the purpose and approved by a Medical =
Ethics=20
Committee. Anjo Strik
------=_NextPart_000_000F_01BFE07D.C17027F0--
Anjo Strik
6/27/2000 10:20:00 AM
Are IRBs required to review investigational protocols dealing with dietary supplements, phytochemicals, homeopathic remedies, ayurvedi c therapies, etc.?
In the UK situation, MRECs and LRECs are required to review all human
subject research involving the National Health Service - patients, staff,
resources etc. Thus the focus is not on the nature of the intervention or
research question but on the protection of human subjects. Observation
studies, survey research, epidemiological studies etc. all pass through the
system. I think this is the correct focus - just as much harm may follow
from a study that involves no clinical procedure as may result from trials
of new drugs.
Paul Wainwright
> -----Original Message-----
> From: Holly Silva [SMTP:Holly_Silva@trihealth.com]
> Sent: Monday, June 26, 2000 9:22 PM
> To: mcwirb@mcwirb.org
> Subject: Are IRBs required to review investigational protocols
> dealing with dietary supplements, phytochemicals, homeopathic remedies,
> ayurvedic therapies, etc.?
>
> Since herbal products/vitamins/minerals/antioxidants (FDA regulated as
> dietary
> supplements), phytochemicals, homeopathic remedies, Ayurvedic therapies,
> aromatherapy, and naturopathic therapies are not regulated as drugs by the
> FDA,
> are IRBs required to review investigational protocols dealing with these
> products?
>
> Similarly, are protocols with modalities such as Qi Gong, Feng Shui, T'ai
> Chi,
> Chi Kung, Reiki, Biofeedback, Chiropractic, or Acupuncture (needles
> regulated
> by FDA), appropriately reviewed by IRB? If not the IRB, how should
> healthcare
> corporations handle Informed Consents/safety issues for all of the above?
>
> How are hospitals' pharmacies handling these 'dietary supplements,' since
> many
> hospital's P&T committee rules only allow the pharmacies to dispense meds
> listed in the US Pharmacopoeia?
>
> We understand that most of these potential studies would be done on
> out-patients, but there may still be conflicts with existing pharmacy
> rules.
> We believe the rules specifically mention handling experimental drugs, but
> this
> clearly means drugs under study within FDA purview, which does not include
> 'herbal products' and 'dietary supplements'.
>
> Holly Silva
> IRB Coordinator
> TriHealth
> (Bethesda & Good Samaritan Hospitals)
> Level 11, Unit J
> 375 Dixmyth Avenue
> Cincinnati, Ohio 45220-2489
>
> 513-872-1650 - Telephone
> 513-872-1549 - Fax
>
> holly_silva@trihealth.com
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Paul
6/27/2000 5:56:00 AM
Who can be a principal investigator??
I have had a question come in from one of my coordinators:
Must the principal investigator in a clinical trial where a drug is being
utilized always be a Medical Doctor (MD/DO)?
I have not quickly found any regulation that stipulates that it must be. The
1572 asks for education, training and experience that qualifies the
investigator as an expert in the clinical investigation of the drug for the use
under investigation, but could this not also be another qualified individual
like a D. Pharm.??
Input on this would be greatly appreciated!
Gary Dennison
6/27/2000 9:44:00 AM
I'd greatly appreciate thoughts regarding a social psych protocol that involves a somewhat unusual form of deception.
The study involves approaching same-sex individuals on the street in which the experimenter indicates that (s)he has noticed the person before, finds them attractive, and then asks if they would either go out on a date or sleep with him/her. After the subject responds, the experimenter would inform the subject that this was a research study, have them sign an informed consent form, and ask a few additional questions (including one on sexual preference). (Although the protocol was not written this way, I'm sure that the investigator would be OK with a requirement that none of the subjects' responses--including the initial reaction--would be used if the subject declined to sign the consent form.)
This protocol has created substantial debate within the committee, for lots of reasons. The one I'd like input on is the argument that it is never acceptable to involve people in research (other than simple observation) without PRIOR consent. Since everyone is pretty much in agreement that the study cannot be done without that level of deception, this is a crucial point. This obviously goes beyond more typical deception research in which participants know they're involved in research, but aren't aware of the true purpose. OTOH, there is certainly plenty of precedent for this kind of research within social psychology (including studies using exactly the same methodology, but studying opposite-sex interactions, which the investigator wants to replicate with same-sex interactions).
Thanks!
Joe Rosse, Ph.D.
Chair, Human Research Committee
University of Colorado, Boulder
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Joe Rosse
6/26/2000 1:40:00 AM
Are IRBs required to review investigational protocols dealing with dietary supplements, phytochemicals, homeopathic remedies, ayurvedic therapies, etc.?
Since herbal products/vitamins/minerals/antioxidants (FDA regulated as dietary supplements), phytochemicals, homeopathic remedies, Ayurvedic therapies, aromatherapy, and naturopathic therapies are not regulated as drugs by the FDA, are IRBs required to review investigational protocols dealing with these products?
Similarly, are protocols with modalities such as Qi Gong, Feng Shui, T'ai Chi, Chi Kung, Reiki, Biofeedback, Chiropractic, or Acupuncture (needles regulated by FDA), appropriately reviewed by IRB? If not the IRB, how should healthcare corporations handle Informed Consents/safety issues for all of the above?
How are hospitals’ pharmacies handling these ‘dietary supplements,’ since many hospital’s P&T committee rules only allow the pharmacies to dispense meds listed in the US Pharmacopoeia?
We understand that most of these potential studies would be done with subjects in an out-patient setting, but there may still be conflicts with existing pharmacy rules. The rules specifically mention handling experimental drugs, but this clearly means drugs under study within FDA purview, which does not include ‘herbal products’ and ‘dietary supplements’.
Holly Silva/IRB Coordinator/TriHealth (Bethesda & Good Samaritan Hospitals)/Level 11, Unit J/375 Dixmyth Avenue/Cincinnati, Ohio 45220-2489/513-872-1650/Fax: 513-872-1549/E-mail: holly_silva@trihealth.com
Anonymous
6/26/2000 10:29:00 AM
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