Transfer of protocols to new institution
When this situation occurred at one of our Institutions we reviewed all the
materials that were part of the original protocol as well as all amendments,
revisions, and any administrative activities i.e. Investigators Brochures,
SAEs etc. as part of the initial review. We required all existing
participants be Re-Consented using our approved Consent Form. While this
process extended the amount of time our initial review took, we felt that
it was absolutely necessary in order to assume responsibility for and
protect anyone involved in the project. A meeting with the Investigators
prior to the actual review by your IRB is advisable in order to educate them
to your IRB's procedures and processes, this should allow for a smoother
transition.
Charlotte E. Pacheco, CIM
Director, Administrator
Lovelace Institutional Review Board
2441 Ridgecrest Dr. SE
Albuquerque, NM 87108
office: (505)262-7755
fax: (505)262-3606
email: cpacheco@lrri.org
-----Original Message-----
From: Lori Roesch [mailto:laroesch@execpc.com]
Sent: Tuesday, March 28, 2000 4:19 PM
To: mcwirb@mcwirb.org
Subject: Transfer of protocols to new institution
I am looking for advice on how to handle a transfer of protocols from
another
institution. I was informed that an entire practice is relocating from an
unaffiliated institution and the PIs will be bringing 4 active protocols to
our
institution. The protocols (the oldest is a couple of years old) have been
approved by the other institution's IRB (using the sponsor-submitted consent
document -EEK!) and many patients have been enrolled. A few questions come
to
mind. I will have the PIs submit the most current protocol, ICF, and
Investigator Brochure to our IRB for approval. Any new patients enrolled at
our
site will use the consent approved by our IRB. What about the patients
currently enrolled? Do they need to be re-enrolled with our approved
consent?
Will I be responsible for documents submitted and approved by the other IRB
prior to the protocols coming here (i.e. continuing review, modifications,
etc.)? Are there other things to consider that I haven't thought of?
Any advice is much appreciated. The investigators won't be here until
mid-August, so I have some time to make sure this transition is smooth.
Thank you.
Lori Roesch
IRB Administrator
Sinai Samaritan Medical Center, Aurora Health Care, Inc.
PO Box 342 W241
Milwaukee, WI 53201-0342
414-219-7744 / 414-219-7477 (fax)
laroesch@execpc.com
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Charlotte
3/29/2000 4:14:00 AM
Transfer of protocols to new institution
At 04:31 PM 28-03-00 -0800, Lynda Reed wrote:
>
>The subjects that are already enrolled, were enrolled under the other IRBs
>approval so you probably don't need to reconsent them. These subjects need
>to be included in the total number of subjects enrolled for purposes of the
>continuing review .
... Would not the requirement for a subject to sign the consent document
approved at the new institution derive from whether the subject continued
to receive treatment on the protocol from the previous or new institution?
If a subject will now be treated at the new site the necessity to provide
ongoing free and informed consent would seem appropriate.
Elisabeth
Elisabeth Clark
Research Ethics Officer
McGill University Health Center
elisabeth clark
3/29/2000 9:49:00 AM
Transfer of protocols to new institution
When I was involved with a transfer, we reviewed everything - original
protocol and addendums, original consent form, proposed new consent form for
new enrollees, enrollment information, AEs and SAEs. We made sure that the
study was feasible at our insitution with resources, nursing, pharmacy, lab.
Where are the currently enrolled patients going to be seen? Is the
investigator planning to see all participants at the new institution? The
transfer of institutions definitely falls under Significant new information
pertaining to continued participation.
For the current participants, an addendum to the original consent may
suffice to explain the new institution, update the new contact information
and revise the information regarding where study procedures will be
performed, and to review the study with the participant. It will be a great
opportunity to illustrate that informed consent is a process and not a
document. Ultimately it is up to your IRB and where you place your comfort
level.
Elizabeth
3/29/2000 9:49:00 AM
Transfer of protocols to new institution
When I was involved with a transfer, we reviewed everything - original
protocol and addendums, original consent form, proposed new consent form for
new enrollees, enrollment information, AEs and SAEs. We made sure that the
study was feasible at our insitution with resources, nursing, pharmacy, lab.
Where are the currently enrolled patients going to be seen? Is the
investigator planning to see all participants at the new institution? The
transfer of institutions definitely falls under Significant new information
pertaining to continued participation.
For the current participants, an addendum to the original consent may
suffice to explain the new institution, update the new contact information
and revise the information regarding where study procedures will be
performed, and to review the study with the participant. It will be a great
opportunity to illustrate that informed consent is a process and not a
document. Ultimately it is up to your IRB and where you place your comfort
level.
Elizabeth
3/29/2000 9:52:00 AM
The Baptist Health System has been active in
the MENTOR study since 1992. I took over the
administrative responsibilities for this IRB in
1998. This is the only study on file that allows
the Investigator to use the Sponsor consent.
I have received a request from an active
MENTOR investigator for the IRB to review and
open the McGhan study. I am wondering if I
will be met with resistance if I require that the
McGhan study use the IRBs template informed
consent. If anyone can assist me with what to
expect with the McGhan study I would
appreciate it.
Christy Klepetko
IRB Coordinator
210-297-8892
Christy Klepetko
3/29/2000 2:23:00 PM
IRB oversight of investigational device use in workplace -Reply
This sounds like a pilot study to me. I assume
that you will be collecting data and that, that
data will assist you in preparing future studies.
If the above is true IRB approval should be
obtained. In regards to consent, and the level
of review required that will be the decision of
the IRB per the protocol that you write.
I would be especially concerned about coercion
and confidentiality as your subjects work for the
manufacturer. I would not advise taking the
study to the subjects office as individuals that
do not wish to participate may feel coerced.
The names of those that participated should not
be made available to the individuals supervisor
as those who choose not to participate my
appear less loyal to the company.
Is the company large enough that such
measures of confidentially could be
maintained?
Christy Klepetko
IRB Coordinator
210-298-8892
Christy Klepetko
3/29/2000 2:23:00 PM
Transfer of protocols to new institution
I am looking for advice on how to handle a transfer of protocols from another institution. I was informed that an entire practice is relocating from an unaffiliated institution and the PIs will be bringing 4 active protocols to our institution. The protocols (the oldest is a couple of years old) have been approved by the other institution's IRB (using the sponsor-submitted consent document -EEK!) and many patients have been enrolled. A few questions come to mind. I will have the PIs submit the most current protocol, ICF, and Investigator Brochure to our IRB for approval. Any new patients enrolled at our site will use the consent approved by our IRB. What about the patients currently enrolled? Do they need to be re-enrolled with our approved consent? Will I be responsible for documents submitted and approved by the other IRB prior to the protocols coming here (i.e. continuing review, modifications, etc.)? Are there other things to consider that I haven't thought of?
Any advice is much appreciated. The investigators won't be here until mid-August, so I have some time to make sure this transition is smooth.
Thank you.
Lori Roesch
IRB Administrator
Sinai Samaritan Medical Center, Aurora Health Care, Inc.
PO Box 342 W241
Milwaukee, WI 53201-0342
414-219-7744 / 414-219-7477 (fax)
laroesch@execpc.com
Anonymous
3/29/2000 4:25:00 PM
Transfer of protocols to new institution
We would have the investigator submit the protocol to our institutions IRB
with our protocol cover sheet, consent form and referencing the page #'s of
the existing protocol for the other sections in our template.
The subjects that are already enrolled, were enrolled under the other IRBs
approval so you probably don't need to reconsent them. These subjects need
to be included in the total number of subjects enrolled for purposes of the
continuing review .
After IRB review/approval subjects would now read and sign the current
consent (that of the IRB approving institution).
Lynda Reed
Program Analyst/ IACUC Administrator
Naval Medical Center
CID
Suite 5
San Diego, CA 92134-5005
-----Original Message-----
From: Lori Roesch [mailto:laroesch@execpc.com]
Sent: Tuesday, March 28, 2000 3:19 PM
To: mcwirb@mcwirb.org
Subject: Transfer of protocols to new institution
I am looking for advice on how to handle a transfer of protocols from
another
institution. I was informed that an entire practice is relocating from an
unaffiliated institution and the PIs will be bringing 4 active protocols to
our
institution. The protocols (the oldest is a couple of years old) have been
approved by the other institution's IRB (using the sponsor-submitted consent
document -EEK!) and many patients have been enrolled. A few questions come
to
mind. I will have the PIs submit the most current protocol, ICF, and
Investigator Brochure to our IRB for approval. Any new patients enrolled at
our
site will use the consent approved by our IRB. What about the patients
currently enrolled? Do they need to be re-enrolled with our approved
consent?
Will I be responsible for documents submitted and approved by the other IRB
prior to the protocols coming here (i.e. continuing review, modifications,
etc.)? Are there other things to consider that I haven't thought of?
Any advice is much appreciated. The investigators won't be here until
mid-August, so I have some time to make sure this transition is smooth.
Thank you.
Lori Roesch
IRB Administrator
Sinai Samaritan Medical Center, Aurora Health Care, Inc.
PO Box 342 W241
Milwaukee, WI 53201-0342
414-219-7744 / 414-219-7477 (fax)
laroesch@execpc.com
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Lynda J Civ
3/29/2000 4:17:00 AM
Transfer of protocols to new institution
We have done this a couple of times...
We conduct two reviews simultaneously: an initial and a continuing review.
The initial review is of the stuff you mentioned - the usual stuff
(protocol, amendments, ability to perform, etc). The continuing review
summarizes all the PIs work on the study to date and, if it is
multi-center, the status of the overall study.
We accept the protocol (if approved) as of the date of transfer. Bygones
are bygones. We have have the file (as in the case of the IRB having
dissolved and forwarding the file) but we can not take responsibility
retroactively.
If they are continuing to enroll, we review and decide on the consent form
and may (ok probably will) require modifications.
For the enrolled subjects, we look at the signed consent form and the
current protocol and knowledge and determine if there should be a Consent
Addendum. Usually there is a reason but occasionally there isn't.
Erica
>I am looking for advice on how to handle a transfer of protocols from another
>institution. I was informed that an entire practice is relocating from an
>unaffiliated institution and the PIs will be bringing 4 active protocols to our
>institution. The protocols (the oldest is a couple of years old) have been
>approved by the other institution's IRB (using the sponsor-submitted consent
>document -EEK!) and many patients have been enrolled. A few questions come to
>mind. I will have the PIs submit the most current protocol, ICF, and
>Investigator Brochure to our IRB for approval. Any new patients enrolled at our
>site will use the consent approved by our IRB. What about the patients
>currently enrolled? Do they need to be re-enrolled with our approved consent?
>Will I be responsible for documents submitted and approved by the other IRB
>prior to the protocols coming here (i.e. continuing review, modifications,
>etc.)? Are there other things to consider that I haven't thought of?
>
>Any advice is much appreciated. The investigators won't be here until
>mid-August, so I have some time to make sure this transition is smooth.
>
>Thank you.
>
>Lori Roesch
>IRB Administrator
>Sinai Samaritan Medical Center, Aurora Health Care, Inc.
>PO Box 342 W241
>Milwaukee, WI 53201-0342
>414-219-7744 / 414-219-7477 (fax)
>laroesch@execpc.com
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Erica Heath
President, IRC
415-485-0717
heath
3/29/2000 4:25:00 PM
Exempt from the requirements of the regulations does not mean that the
responsibilities of the institution are over and done with. The claim of
exemption must have the concurrence of the Federal funding agency under the
Common Rule. Should the Federal agency determine that the research is not
exempt, then the institution must provide IRB review and certification.
In fact, some part of the research or some other circumstance could alter the
exemption. Continued oversight is not a bad idea.
Also, exemption from the requirements of the regulations does not alter the need
to comply with all applicable other federal, state and local laws. Nor does it
exempt from requirements of professional and ethical codes.
Obtaining informed consent is still an ethical and perhaps legal requirement,
although the specific elements of the regulations may not be required.
But it is interesting to note that the NIH IRB study showed that each of the six
exempt categories was used by fewer than 50% of the IRBs ( 394) responding,
except in the case of taste testing, where 54% of high volume IRBs and 51% of
low volume IRBs used the exemption. Overall, 73% of those reporting indicated
that IRBs were routinely involved in determining or confirming exemption.
Empirically, this seems to confirm that exemptions do not contribute to
reducing the workload of IRBs by as much as was the original intent. The reasons
for the limited use of exemptions and the high degree of involvement of IRBs in
the exemption process should be examined. At least, the burden of continuing
review ( though not as major a contributor of workload in time and level of
effort as initial review) in the case of exemptions is reduced. But since no
institution uses all of the exempt categories and in the case of each exemption
about half of the IRBs do not utilize them, the work saving device of
exemption has not realized the potential that the regulations had anticipated.
Charles Od
3/29/2000 5:00:00 AM
I would like to develop IRB guidelines for advertisements and other patient recruitments materials. The only information I have on this subject is from the FDA Information Sheets. Does anyone know where I can find additional information? Thank you!
Eileen Murphy, B.S.
Interim Coordinator
Institutional Review Board
Sharp HealthCare
San Diego, California
Anonymous
3/29/2000 9:46:00 AM
Transfer of protocols to new institution
At 04:31 PM 28-03-00 -0800, Lynda Reed wrote:
>
>The subjects that are already enrolled, were enrolled under the other IRBs
>approval so you probably don't need to reconsent them. These subjects need
>to be included in the total number of subjects enrolled for purposes of the
>continuing review .
... Would not the requirement for a subject to sign the consent document
approved at the new institution derive from whether the subject continued
to receive treatment on the protocol from the previous or new institution?
If a subject will now be treated at the new site the necessity to provide
ongoing free and informed consent would seem appropriate.
Elisabeth
Elisabeth Clark
Research Ethics Officer
McGill University Health Center
elisabeth clark
3/29/2000 9:52:00 AM
One device-related FDA guidance document is: Preparing Notices of
Availability of Investigational Medical Devices and for Recruiting Study
Subjects (http://www.fda.gov/cdrh/comp/2229.html).
Mike Southworth
The Cleveland Clinic Foundation
----------
> From: Eileen Murphy
> To: mcwirb@mcwirb.org
> Subject: Advertising
> Date: Tuesday, March 28, 2000 5:17 PM
>
> I would like to develop IRB guidelines for advertisements and other
patient
> recruitments materials. The only information I have on this subject is
from the
> FDA Information Sheets. Does anyone know where I can find additional
> information? Thank you!
>
> Eileen Murphy, B.S.
> Interim Coordinator
> Institutional Review Board
> Sharp HealthCare
> San Diego, California
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Rac
3/29/2000 9:46:00 AM
I can't recall this entire thread, but I take issue with Jerry Menikoff's
position, which I think goes too far toward the position that, if exempt,
the institution has no further responsibility for how the activity is
conducted.
Our MPA states: All human subject research that is exempt, as specified
herein, will be conducted in accordance with: (1) the Belmont Report, (2)
these institutions' administrative procedures to ensure valid claims of
exemption, and (3) orderly accounting for such activities.
I have always interpreted this to mean that the institution has a
responsibility to ensure that unless the activity meets requirements for
waiver of informed consent, informed consent must be obtained, even if the
study is exempt.
The real danger of misinforming researchers involves allowing them to harbor
the notion that if the activity is exempt, they don't have to worry about
such inconveniences as obtaining informed consent. In our workshops with
institutional researchers, we make a point to emphasize that they should
never assume that they are not required to obtain informed consent just
because the activity is exempt, or just because the activity is not
research.
I, for one, agree with Celia's original statement.
Mike Garrick
WA State DSHS/DOH
Human Research Review Board
> -----Original Message-----
> From: Jerry Menikoff [SMTP:jmenikof@kumc.edu]
> Sent: Monday, March 27, 2000 12:14 PM
> To: MCWIRB@mcwirb.org
> Subject: re: exemption
>
> Celia Walker wrote:
>
> >Thanks, Dr. MacKay, for making my points clearer: the regulations may
> say exempt from the policy, but in actuality, there are too many other
> concerns to allow prudent institutions to fully eliminate them from the
> radar screens. Our solution has been to abbreviate the process, but
> consider them similar to expedites.<
>
> Your prior claim was not merely about fully eliminating exempt
> projects from the radar screen--you initially took issue with Mike Kelly's
> (correct) observations about what it meant for something to be exempt. You
> stated, Just because a project meets exempt requirements
> doesn't mean that it necessarily meets requirements to waive either
> informed
> consent or documentation of informed consent -- although it often does.
> That seemed to be wrong--I haven't seen any other comments suggesting
> otherwise--and might misinform other readers of this list. If a project
> does indeed meet exempt requirements, then, as least from the federal
> government perspective, there is NO need to inquire further into the
> elements of informed consent, e.g., to make a determination that the
> criteria for waiving documentation of informed consent are met. The
> project is not subject to those requirements. And the reason for this is
> quite sensible, based upon the reasons that led to the project being
> declared exempt--the risk level and nature of the study. That, presumably,
> is how the exemption categories were created in the first place.
>
> Certainly, IRBs are free to impose additional requirements on such
> studies, as Mike Kelly indicated his institution chose to do. But for some
> IRBs that might be overworked, and barely meeting the requirements imposed
> on them by the federal regulations, it is inappropriate to say they should
> not take advantage of the greatly decreased work load created by the
> exemption categories. I would suspect that many IRBs are very much
> appreciative of the ability to declare projects exempt, and spend their
> limited time on projects that are more likely to impose greater risks on
> subjects. That is not imprudent, assuming an institution has correctly
> determined that a project was indeed exempt.
>
> Jerry Menikoff
> University of Kansas
>
>
>
>
> _______________________________________________
> MCWIRB maillist - MCWIRB@mcwirb.org
> http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Mike
3/28/2000 7:47:00 AM
Patent and Conflict of Interest
John,
Through my hat in the Office of Industrial Liaison I can tell you that we strongly discourage any faculty member from doing clinical research on any therapeautic he or she has been involved in with development. We further recommend to the company that licenses the product that they do clinical trials elsewhere to enhance credibility of the study. Occasionally we allow a pilot study to be performed within the institution, but with a different investigator than the one who did the original work.
Ed
Edward R. Burns, M.D.
eburns@aecom.yu.edu
Edward Burns
3/28/2000 10:58:00 AM
Our institution is comparing how other institutions handle the auditing of their research protocols. I would like to hear from other institutions about their procedure for auditing, such as if it is done internally, by whom, how often, guidelines followed. If you are contacting and outside agency; your decision for an outside agency, who developed the guidelines and procedure for the auditing, etc.
thanks
Pam Horner
3/28/2000 7:54:00 AM
I would appreciate any input on the following items noted by our IRB:
There has been some recent concern expressed with the IRB having a representative present during the consenting conference with the attending physician and the patient. It was questioned how effective this method would be for consent monitoring. If a physician does not normally properly consent his or her patients then that physician would surely conduct the consenting conference differently during an IRB audit, so how effective is this method?
Secondly, the IRB being present during the consent conference could be considered an intrusion on the physician/patient relationship. The IRB realizes the importance of establishing and maintaining a trusting relationship between the physician and patient. Could the consent auditing process could potentially damage that relationship?
OPRR mandates that the IRB ensure patients involved in research are adequately protected. Consent auditing is considered to be a part of that mandate. IRBs have some flexibility on how to structure the evaluation of the consenting process. One potential method could be the use of short evaluation form for assessing the consent process where a nurse or study coordinator completes an evaluation form after they have witnessed the consenting conference. How are other institutions conducting consent and protocol audits through the IRB?
Anonymous
3/28/2000 7:54:00 AM
Workshop on recruitment and retention of women in clinical trials
The Society for Women's Health Research is sponsoring a workshop that may be
of interest to you and others at your institution. the primary audience is
study coordinators, site managers, and study recruiters, but all who have an
interest in women and clinical trials are welcome!
Women in Clinical Research: Breaking Through the Barriers to Recruitment and
Retention.
May 18, 2000, New Orleans, LA
Please join us for a one-day workshop entitled “Women in Clinical Research:
Breaking Through the Barriers to Recruitment and Retention,” on May 18, 2000
in New Orleans, LA. The Society for Women’s Health Research is
co-sponsoring this workshop with the Association of Clinical Research
Professionals (ACRP), supported by a grant from Aventis Pharmaceuticals.
This workshop is being offered as a post-session seminar to ACRP’s annual
meeting, and is open to those not attending the ACRP meeting.
Key issues to be addressed in this meeting include:
The barriers to recruiting and retaining women in clinical trials;
Ethical issues relating to the informed consent process and women of
childbearing potential;
Successful strategies for recruiting and retaining women in clinical trials;
and
Successful approaches to public education and marketing of clinical trials.
This workshop will be an excellent opportunity for clinical research
professionals, research associates, clinical investigators, and regulatory
specialist to learn about and share successful strategies for advancing
women’s health research.
The meeting agenda and registration forms are available on the Society's
website at www.womens-health.org.
______________________________________
Sherry A. Marts, Ph.D.
Scientific Director
Society for Women's Health Research
1828 L Street NW, Suite 625
Washington, DC 20036
www.womens-health.org
202-223-8224 vox
202-833-3472 fax
Sherry Marts
3/28/2000 2:17:00 PM
Standard Consent Format and local IRB
One more thought from me on this subject. I know (and oh so well!!) how much
sponsors want control on the consent form. BUT...the whole purpose of local
IRB is that we on site know our population and are responsible for making
sure the consent is readable for our subjects. The local IRB has the final
say, not the sponsor or the feds.
I often have to provide education to sponsor reps and CRO folks on this
point. I'm very happy to negotiate so that we can agree on wording. But I
have had to remind them that the IRB has the final word on the issue. That's
our job and that's what is so very vital about local IRB review.
It's also the job of central IRBs, as well. While central IRBs are not part
of a local study, they still must be an advocate for potential subjects in
how the consent is written. Just having the elements of consent present is
not near enough. That's just the starting point. Often the real work is in
getting those elements into a readable form that has some chance of being
understood by a subject and of getting rid of extraneous, unrelated
information.
One of my IRBs just reviewed a study on unusual high pitched crying in
infants getting vaccinations. The consent included two paragraphs about
concerns over certain additives in vaccines. The vaccines used were FDA
approved vaccines; the study wasn't about the safety of the vaccines; the
additives weren't in the vaccines used; the study wanted to find if there was
a neurological reason for unusual high pitched crying with vaccines. We
removed the additive info because it obscured the purpose of the study.
I would really like to see the FDA be much stronger and clearer in letting
industry sponsor know that the IRBs have the final responsibility and the
final say on consent forms. There's so much time wasted over this issue,
when it should really be about correctly and adequately informing subjects
about the study.
End of hobby horse!
Rebecca M. Clark
Scripps Health/Children's Hospital IRBs
San Diego, CA
(858) 576-4008
rebcaclark@aol.com
Rebecca M. Clark
3/28/2000 8:31:00 AM
IRB Meetings via Telephone Conference Call
Department of Health and Human Services (HHS) regulations at 45 CFR 46.108(b)
require that Institutional Review Boards (IRBs) review proposed research at
convened meetings at which a majority of the members of the IRB are present . .
. .
Wherever possible, OPRR strongly recommends that such meetings take place with
all participating IRB members physically present. However, OPRR recognizes that
circumstances sometimes warrant conducting IRB meetings via telephone conference
call.
Effective immediately, OPRR will recognize as convened those IRB meetings
conducted via telephone conference call, provided that each participating IRB
member (i) has received all pertinent material prior to the meeting, and (ii)
can actively and equally participate in the discussion of all protocols.
Minutes of such meetings must clearly document that these two conditions have
been satisfied in addition to the usual regulatory requirements (e.g.,
attendance; initial and continued presence of a majority of members, including
at least one nonscientist member; actions taken by the IRB; the vote on such
actions; discussion and resolution of controverted issues).
Recognition by OPRR of IRB meetings convened via telephone conference call is
consistent with longstanding Food and Drug Administration (FDA) policy (46 FR
8967, January 27, 1981).
Tom Puglisi, PhD
Director
Division of Human Subject Protections
Office for Protection from Research Risks
Tom Od
3/28/2000 7:54:00 AM
Mike Kelly wrote
>One thing that hasn't been mentioned is that there are really two kinds of
>applications that are exempt. First is the human subject research that
>meets the exemption criteria of 46.101. The second is the protocol that
>involves human subjects (however loosely defined) but doesn't fit the
>definition of human subject research such as surveys done solely for
>internal program evaluation or pilot tests of a new instructional software
>package being considered for future classroom use. We've been inundated
>with the second category lately and are still wrestling with how to handle
>them to ensure ethical practices without further burying ourselves in paper.
>
>Mike Kelly
>Georgia Tech
>
We too are starting to see more of the second kind of project being
referred to us. So far, our response has been that it's not
research, and therefore does not need to be reviewed by the IRB.
I'll admit to some ambivalence on the issue of whether the IRB ought
to be looking at these sorts of quality assurance/customer
satisfaction projects. On the one hand, it clearly doesn't fall
within the purview of what the federal regulations require. On the
other hand, many of the methods and techniques employed in these
projects are ones that would normally be employed in real research
are ones about which an IRB might have concerns.
To some extent, I think the decision about whether an IRB ought to be
looking at these sorts of projects should be made at the
institutional level, and not by the IRB itself. IRBs were created to
satisfy federal and state requirements; expanding their role beyond
that is a decision that should be made by the institutional
community, not the IRB.
Jeff Willner
Just my .02
Jeffrey Willner, Ph.D. I speak only for myself
Department of Psychology jwillner@runet.edu
Box 6946, Russell Hall jwillner@james.psych.runet.edu
Radford University (540) 831-5341 (voice)
Radford, VA 24142-6946 (540) 831-6113 (fax)
Jeff Willner
3/28/2000 9:06:00 AM
Patent and Conflict of Interest
Seeking comments and guidance on the following situation:
1. University holds patent on a drug.
2. University has licensed patent to a drug company.
3. Said compny is now sponsoring research utilizing this drug.
4. Member of faculty at University wants to conduct clinical investigation. Faculty member is not financially interested.
5. Is this conflict of interest? What is pertinent regulation?
Anonymous
3/28/2000 10:58:00 AM
OPRR/FDA National Human Subjects Protections Workshop (June 8-9, 2000)
c OFFICE FOR PROTECTION FROM RESEARCH RISKS
c FOOD AND DRUG ADMINISTRATION
c NATIONAL HUMAN SUBJECTS PROTECTIONS WORKSHOP
c “Sensitivity in Research Involving Individuals with Cognitive Impairment, Genetics, and Tissue Banks”
c June 8 & 9, 2000
c Hyatt Regency Chicago
c On the Riverwalk
c Chicago, IL
Sponsors
Rush-Presbyterian-St. Luke’s Medical Center
Chicago, IL Partners
University of Illinois at Chicago
Chicago, IL
Chicago State University
Chicago, IL Collaborators
University of Chicago
Chicago, IL
Hines Veterans Administration Hospital
Hines, IL
Loyola University Medical Center
Maywood, IL
Cook County Hospital
Chicago, IL Overview
This workshop provides timely information and working solutions for IRB staff and members, investigators, research administrators, and institutional officials. Plenary and break-out sessions will be offered, along with OPRR and FDA updates. Experienced national and regional speakers will provide regulatory overview, practical guidance, and solutions. A subject-centered panel will provide invaluable reflections regarding research process and procedures. Featured speakers include Thomas M. Murray, Ph.D., Jeffrey M. Cohen, Ph.D., Paul W. Goebel, Jr., Bonnie M. Lee, Marjorie Speers, Ph.D., David Clark, Ph.D., Robert M. Nelson, M.D, Ph.D., Funmi Olopade, M.D., Mark Hochauser, Ph.D, Susan L. Rose and Susan S. Fish, Pharm.D., M.P.H.
Agenda
Thursday, June 8, 2000
7:30-8:30 a.m. Registration/Continental Breakfast
8:30-8:45 a.m. Welcome/Opening Remarks
Larry J. Goodman, M.D./Rush-Presbyterian-St.
Luke’s Medical Center
8:45-9:15 a.m. Evolving Concerns in Human Subjects Research
Jeffrey M. Cohen, Ph.D./OPRR
9:15-9:45a.m. FDA Update
Bonnie M. Lee/FDA
9:45-11:00 a.m. Genetic Research: Myth vs. Reality
Thomas M. Murray, Ph.D./The Hastings Center
Funmi Olopade, M.D./University of Chicago
Question and Answer Session
11:00-12:15 p.m. Beyond the Consent Form: Readability, Understanding, and Temporary Impairment Issues
Jeffrey M. Cohen, Ph.D./OPRR
Susan S. Fish, Pharm. D., M.P.H./Carestat, Inc. and Boston University
Mark Hochauser, Ph.D./Readability Consulting
Question and Answer Session
12:15-1:15 p.m. Lunch
1:20-2:20 p.m. Tissue Banking and Clinical Database Repositories
Marjorie Speers, Ph.D./National Bioethics Advisory Commission
Marianne M. Elliott, M.S./University of Illinois at Chicago
David C. Clark, Ph.D./Rush-Presbyterian-St. Luke’s Medical Center
2:30-4:00 p.m. Breakout Sessions
1. Audits as Part of the Continuing Review Process—Lisa R. Pitler Lipsky, R.N., M.S./Rush-Presbyterian-St. Luke’s Medical Center, Funeka Sihlali, B.S.N./Cook County Hospital
2. Continuing Education for Investigators, IRB Members, and the Human Subjects Protection Office—Jeffrey M. Cohen, Ph.D./OPRR, April Trenholme, M.A./Rush-Presbyterian-St. Luke’s Medical Center, Mary Rutz, M.A., Ph.D. (c)
3. Continuing Review—Robert M. Nelson, M.D., Ph.D./Children’s Hospital of Philadelphia, Paul W. Goebel, Jr./OPRR
4. Ethics in International Research/Acceptable Recruitment Practice—Lillian Hampton, C.I.M./Cook County Hospital
5:00-7:00 p.m. Cocktail reception
Friday, June 9, 2000
7:30-8:30 a.m. Continental breakfast
8:30-9:15 a.m. Keynote address: “Preventive Maintenance for IRBs,” David C. Clark, Ph.D, Director, Office of Research Affairs/Rush-Presbyterian-St. Luke’s Medical Center
9:15-11:15 a.m. Sensitivity in Research: A Subject-Centered Panel
Moderator: Susan L. Rose/Department of Energy
11:15-12:15 p.m. “Ask the Feds:” An Open Question and Answer Session
Jeffrey M. Cohen, Ph.D./OPRR
Paul W. Goebel , Jr./OPRR
Bonnie M. Lee/FDA
12:15-12:30 p.m. Wrap-Up
Meeting Site and Travel Information
Hyatt Regency Chicago Hotel
On the Riverwalk
151 East Wacker Drive
Chicago, IL 60601
(312) 565-1234 (phone)
(312) 565-2966 (FAX)
Hotel Reservations
To make your hotel reservations, please call (800) 233-1234 and identify yourself as a participant in the OPRR/FDA/Rush regional conference. Reservations must be made by April 25, 2000. Please be aware that the room block may fill before the April 25 deadline, so we encourage you to make your reservations early. Reservations made after this date will be received on a space and rate available basis.
Discounted single room rate: $185.00 per night before April 25, 2000
Discounted double room rate: $190.00 per night before April 25, 2000
Government rates are also available.
Getting to the Hotel
From O’Hare Airport Heading Eastbound: Take 190 and follow signs that say “To Chicago Loop” which will take you to 90 East (Kennedy Expressway). Exit at Ohio East (there are no turns) and turn right on Clark, just over the bridge turn left on Wacker Drive, go 5 blocks to Stetson and turn right. For the garage, take Ohio East to Michigan Avenue, turn right, the first street past Wacker is South Water, turn left, go to first stop sign which is Stetson and turn left, East Tower parking is on the right, West Tower parking is on the left.
From Midway Airport: Turn left out of airport onto Cicero, take Cicero about 2 miles to the entrance of I-55 (Stevenson Expressway) Northbound to Lake Shore Drive. Exit Randolph/Wacker, for check-in follow Wacker signs and go up the ramp and Hyatt is on the left. For the garage follow Wacker signs, stay on lower Wacker and turn left at Stetson St. East Tower parking is on the left and West Tower parking is on the right.
From I-90 Heading Eastbound: Exit Ohio East, take Ohio to Clark and turn right, take Clark to Wacker and turn left take Wacker to Stetson and turn right.
From 94 Edens Expressway: 94 will meet 90, follow directions from 90.
From 55 Stevenson Northbound: Take 55 to Lake Shore Drive North. Exit Randolph/Wacker, for check in, follow Wacker signs go up ramp and Hyatt is on the left. For the garage, follow Wacker signs, stay on lower Wacker to Stetson and turn left. East Tower parking on left and West Tower parking on right.
From 290 Eisenhower Expressway Eastbound: Drive east to Congress Parkway which dead ends into the city. Take Congress to Michigan Avenue turn left, go 10 blocks Wacker and turn right. For the garage, take Michigan to South Water and turn right, then turn left on Stetson and East Tower parking is on the right and West Tower on the left.
From 294 Heading Southbound: Take 294 to Kennedy (90) then follow directions from O’Hare.
From 294 Heading Northbound: Follow directions from either 55 or 290.
From the Northshore Rt. 41 Lake Shore Drive Southbound: Exit Illinois, Grand, and Wacker (same exit), follow Wacker signs and go up ramp for check-in. For garage, stay on lower Wacker to Stetson and turn left. East Tower parking on left and West tower parking on right.
From Indiana or Michigan 90/94 Dan Ryan: Follow signs for Lake Shore Drive North
From Indiana 64 North: Take 65 to 90 Chicago Skyway which will meet 90/94, follow directions for I-55 to Lake Shore Drive North.
The Hyatt Regency Chicago is located approximately 17 miles from O’Hare International Airport and 15 miles from Midway Airport.
Registration Fees and Procedures
Please complete the registration form and return it to the address listed below as soon as possible. Credit card information or a check must accompany this form. Registration forms that are sent via fax will not be processed until payment is received. The registration fee covers two continental breakfasts, coffee breaks, one lunch, a cocktail reception, and all meeting materials.
Registration Fee $150.00 before April 25, 2000
$200.00 after April 25, 2000
Group Rates Group of 4 from a single institution
$525.00 before April 25, 200
$600.00 after April 25, 2000
NOTE: Materials and Payment must be RECEIVED prior to April 25, 2000 to receive discounted rates.
Mail registration form and payment to:
April Trenholme, M.A.
Director, Education and Training
Office of Research Affairs
Rush-Presbyterian-St. Luke’s Medical Center
1653 W. Congress Parkway
Chicago, Illinois 60612
Rush-Presbyterian-St. Luke’s Medical Center federal tax ID number is 36-2174823
Cancellation Policy
Notification of cancellation must be received by the Rush-Presbyterian-St. Luke’s Office of Research Affairs in writing. Cancellations received prior to the early registration date, April 25, 2000, will be entitled to a refund, but will be subject to a $25.00 processing fee. Any cancellations received after April 25 will result in forfeiture of the entire registration fee.
Special Needs
If you would like to attend this workshop and require any special needs or accommodations, please contact April Trenholme, Director, Education and Training, by phone: (312) 942-5498, by FAX: (312) 942-2874, or E-mail: April_C_Trenholme@rush.edu for assistance. Rush-Presbyterian-St. Luke’s Medical Center is in compliance with the mandates of the Americans with Disabilities Act.
Anonymous
3/28/2000 1:44:00 PM
Mike Garrick wrote:
>I can't recall this entire thread, but I take issue with Jerry Menikoff's
position, which I think goes too far toward the position that, if exempt,
the institution has no further responsibility for how the activity is
conducted.
Our MPA states: All human subject research that is exempt, as specified
herein, will be conducted in accordance with: (1) the Belmont Report, (2)
these institutions' administrative procedures to ensure valid claims of
exemption, and (3) orderly accounting for such activities.
I have always interpreted this to mean that the institution has a
responsibility to ensure that unless the activity meets requirements for
waiver of informed consent, informed consent must be obtained, even if the
study is exempt.<
I am not saying that, in determining that a protocol is exempt, one shouldn't be making sure that the protocol is such that the subjects are told about what is happening--Hi, we are asking you to spend a few minutes completing a questionnaire, etc.--i.e., that they should be voluntarily participating in the study. What I thought was incorrectly stated--and I still think was incorrectly stated-- was that one was required to specifically be making determinations under the regulations (46.116 and 46.117) if, e.g., an exempt protocol does not provide for written documentation of informed consent.
The language you quote--applying the Belmont Report principles--would suggest a relatively flexible process of making sure that what the researchers are doing is ethical (that the subjects are voluntarily participating), as opposed to, e.g., verifying that all of the specific points in 46.116 and 46.117 are met. If the federal government felt that all of these specific points had to be met for exempt protocols, it could easily have said so in the regulations. And yet it did not.
I don't disagree with your point that investigators should be aware that the subjects need to be voluntarily participating, whether the project is exempt or not.
Jerry Menikoff
University of Kansas
Jerry Menikoff
3/28/2000 9:08:00 AM
informed Consent Disclosure
My institution (HMO) has a statement in the Informed Consent Document stating
(the institution) has no formal program for compensation for research related
injury. If you are injured as a result of participation in this study, medical
care will be provided under the terms of the HMO subscriber agreement. At a
recent IRB meeting one of our members informed the IRB that she had been told
by another instituions IRB that a research recipient/nor his insurer should be
responsible for research related injuries, I did not find a regulation. relating
to this situation.
Phyllis Kerr
3/27/2000 8:06:00 AM
Access to study records by Foreign Agents
Within the past several months, we have noticed a spate of pharma sponsored protocols with language in the CONFIDENTIALITY section of the Informed Consent Form (ICF) wanting to allow access to medical and research records by agents of foreign governments.
Following is a direct quote: Your child's medical and research records will be reviewed by XXX and may also be reviewed by the FDA and similar agencies of foreign governments...
We have a problem with the concept of agents of the Ministry of Health of TubaTuba arriving one fine day, asking to review the medical records of the subjects who participated in this study.
We contacted the FDA and were informed that under 21 CFR Part 56.111,7 the IRB is mandated to ascertain Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. One way to obtain this assurance is to ask that the sponsor provide copies of sops of how the confidentiality of data will be maintained.
That is fine for identifiedcountries operating under ICH regs but what about other, as yet unknown countries where the sponsor may decide to try and license/register the drug perhaps years hence?
Can anyone provide suggestions or insights into how to address this situation?
Thank you.
Alexandr E. Kosyak, R.Ph.
Director, Office of Human Research
The George Washington University
Medical Center
2300 I Street NW
Washington, DC 20037
(202) 994-2715
Fax (202) 994-0465
e-mail: resaek@gwumc.edu
Alexandr Kosyak
3/27/2000 3:57:00 AM
Access to study records by Foreign Agents
Yes, it is a problem when people from the uSA want to look at data collected
in Australia
Roselyn Drake
**********************************************************************
South Eastern Sydney Area Health Service
This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed.
This footnote also confirms that this email message has been virus-scanned and no computer viruses were detected.
**********************************************************************
draker@sesahs.nsw.gov.au
3/27/2000 3:57:00 AM
Celia, I don't think we're in significant disagreement. When a protocol
is exempted under 46.101, it frees us from some of the nits and picayunes
of the remainder of 45CFR46 and, perhaps, allows us to take a more
collegial approach. But as you say it certainly does not excuse us from
other regulations, and even the most innocuous study needs to meet the
norms of ethics and courtesy.
Indeed, we have been experiencing the increase in exemptable protocols that
you mentioned and an increase in the rigor with which we examine and
document them. I wouldn't be surprised to find that I, as Chair, now spend
MORE time on an exempt from further review protocol than on an average
expedited review.
One thing that hasn't been mentioned is that there are really two kinds of
applications that are exempt. First is the human subject research that
meets the exemption criteria of 46.101. The second is the protocol that
involves human subjects (however loosely defined) but doesn't fit the
definition of human subject research such as surveys done solely for
internal program evaluation or pilot tests of a new instructional software
package being considered for future classroom use. We've been inundated
with the second category lately and are still wrestling with how to handle
them to ensure ethical practices without further burying ourselves in paper.
Mike Kelly
Georgia Tech
At 11:08 AM 3/27/2000 -0700, Walker,Celia wrote:
>Thanks, Dr. MacKay, for making my points clearer: the regulations may say
>exempt from the policy, but in actuality, there are too many other
>concerns to allow prudent institutions to fully eliminate them from the
>radar screens. Our solution has been to abbreviate the process, but
>consider them similar to expedites.
>
Mike Kelly
3/27/2000 10:42:00 AM
Celia Walker wrote:
>Thanks, Dr. MacKay, for making my points clearer: the regulations may say exempt from the policy, but in actuality, there are too many other
concerns to allow prudent institutions to fully eliminate them from the
radar screens. Our solution has been to abbreviate the process, but
consider them similar to expedites.<
Your prior claim was not merely about fully eliminating exempt projects from the radar screen--you initially took issue with Mike Kelly's (correct) observations about what it meant for something to be exempt. You stated, Just because a project meets exempt requirements
doesn't mean that it necessarily meets requirements to waive either informed
consent or documentation of informed consent -- although it often does. That seemed to be wrong--I haven't seen any other comments suggesting otherwise--and might misinform other readers of this list. If a project does indeed meet exempt requirements, then, as least from the federal government perspective, there is NO need to inquire further into the elements of informed consent, e.g., to make a determination that the criteria for waiving documentation of informed consent are met. The project is not subject to those requirements. And the reason for this is quite sensible, based upon the reasons that led to the project being declared exempt--the risk level and nature of the study. That, presumably, is how the exemption categories were created in the first place.
Certainly, IRBs are free to impose additional requirements on such studies, as Mike Kelly indicated his institution chose to do. But for some IRBs that might be overworked, and barely meeting the requirements imposed on them by the federal regulations, it is inappropriate to say they should not take advantage of the greatly decreased work load created by the exemption categories. I would suspect that many IRBs are very much appreciative of the ability to declare projects exempt, and spend their limited time on projects that are more likely to impose greater risks on subjects. That is not imprudent, assuming an institution has correctly determined that a project was indeed exempt.
Jerry Menikoff
University of Kansas
Jerry Menikoff
3/27/2000 12:25:00 PM
Thanks, Dr. MacKay, for making my points clearer: the regulations may say
exempt from the policy, but in actuality, there are too many other
concerns to allow prudent institutions to fully eliminate them from the
radar screens. Our solution has been to abbreviate the process, but
consider them similar to expedites.
I, too, have been interested in the shifting work loads involved with exempt
and expedite categories. My sense is that our administrative office and the
IRB Chair have experienced vastly increased workloads as the number
increases of protocols which do not need full committtee review. So
although there is an overall savings of IRB time, there is an increased
burden on the Administrator, office, and Chair --- and those are links in
the system which have traditionally been burdened anyway.
I wonder if just a 2-tiered system would work: Level 1 review encompasses
the exempt and expedite categories and perhaps a few others, all no more
than minimal risk. Procedures are determined locally, but full-committee
review is not necessary unless a reviewer requests it. These would be
minimally regulated by the feds, although strict documentation must be kept
to verify the project is indeed a Level 1 project. Level 2 is our
traditional full-committee situation, and all the existing requirements
remain in place as far as how reviewed, what it is reviewed for,
documentation, etc. A system like this would allow an institution to
streamline the Level 1 processes to the essential minimum (for example,
should these be routinely reported on the agenda when IRB members can get
access in other ways and have open access to the IRB files? MUST
communication on simple situations still be in writing when a phone call
works better?).
_________________________________________________
Celia Walker, Regulatory Compliance
Colorado State University
970-491-1563 (v) 970-491-2293 (fax)
cwalker@research.colostate.edu
Celia
3/27/2000 8:42:00 AM
Physician-investigator ownership interest in CRO
Hi,
My query concerns the evaluation and management of potential financial
conflict of interest in the following scenario :
A physician-investigator has an ownership interest in the CRO involved
in the clinical evaluation of a pharmaceutical product. The
physician-investigator will perform surgery on the patient-subject,
during which time the product will be administered. The physician
-investigator will obviously bill the subject's insurance company for
the surgical procedure and will receive a proportionate share of the
yearly net- income of the CRO. The sponsor of the product pays the CRO
$5,000 per enrollee. The product will be provided free-of-charge.
My committee is concerned that this represents a significant financial
conflict of interest.
I am aware that the FDA also requires that the Sponsor disclose certain
financial interests its investigators have ( 63 FR 5233 ) - an issue for
another discussion.
I would appreciate any thoughts concerning this scenario.
How would you view this application for research ?
Regards,
Howard
Howard Mann
3/27/2000 12:24:00 PM
The George Washington University is aiming to start a Physician to Principal Investigator certificate program in September of 2000. it will be 3 course or 9 graduate credit hours. All will be in distant learning mode. Call me if you want more infor. 202 994 0844
MAS
Margaret Skelton
3/27/2000 8:06:00 AM
Were you to send me your address, I would send you a newsletter I wrote on
the topic.
Erica
>We are currently updating all our guidelines and applications and would like to
>update our approval documents as well. Would anyone be willing to share
>off-line samples of your letters for IRB approval, exemption certification,
>adverse events reponses, etc. Thank you.
>
>Susie Hayes, Compliance Coordinator
>The University of Memphis
>slhayes@memphis.edu
>
>
>_______________________________________________
>MCWIRB maillist - MCWIRB@mcwirb.org
>http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Erica Heath
President, IRC
415-485-0717
heath
3/25/2000 1:33:00 PM
I'm to fill out a Scope of Services Template in anticipation of our
JCAHO audit -- since we're a department of a regional hospital. The
categories are: Customers; Functions; Hours of Operation; Staffing;
Communication/Collaboration/Functional Relationships; Goals; Plans to
Improve Quality of Service.
If any one has done one of these recently and would be willing to share
what they said -- I'd be most appreciative.
Thanks a lot.
Mary
Mary L. Crumbaker
Administrative Director
Saccomanno Research Institute
St. Mary's Hospital; Grand Junction, CO
Ph: 970-244-2497; Fx: 970-241-4366
mcrumbaker@stmarygj.com
3/25/2000 1:33:00 PM
We are currently updating all our guidelines and applications and would like to update our approval documents as well. Would anyone be willing to share off-line samples of your letters for IRB approval, exemption certification, adverse events reponses, etc. Thank you.
Susie Hayes, Compliance Coordinator
The University of Memphis
slhayes@memphis.edu
Anonymous
3/25/2000 1:33:00 PM
We have reviewed telephone surveys (often RDD samples) which do not have a
written consent form, but a consent text.
We have reviewed anonymous in-person interview studies which had a consent
form, but we waived the requirement for a signature (e.g., waiver of
documentation).
We have reviewed mailed surveys which had an accompanying cover letter with
the required elements of consent. Sometimes a study will request signed
consent with a mailed survey, particularly if access to confidential records
is requested. Sometimes, completion of the survey is considered consent
(e.g., waiver of documentation).
It all depends on the context, study population, focus of the research,
sensitivity of the questions, and a host of other issues. There is no one
answer.
Sometimes (often?) researchers will say that getting consent will bias the
study. Gee. Unless they meet the criteria in the fed regs (and whatever
local laws, policies, etc. would apply), they will just have to revise their
procedures.
Maggie
Maggie Frederick, MPH
Review Coordinator
DSHS Human Research Review Section
P.O. Box 45205
Olympia, WA. 98504-5205
(360) 902-8075
FAX: (360) 902-0705
Email: fredem@dshs.wa.gov
> -----Original Message-----
> From: Matt Westbrook [SMTP:matt@fuller.edu]
> Sent: Thursday, March 23, 2000 1:51 PM
> To: mcwirb@mcwirb.org
> Subject: re: waiving informed consent
>
> Charles:
>
> You make a unique point without meaning to, I suppose! In projects that
> involve surveys or questionnaires, I often have investigators who claim
> (as
> well as experienced IRB members) that participation alone in the survey
> documents consent. This is true. However, it does not document INFORMED
> consent. Therefore, there should be a consent document accompanying the
> survey
> outlining the normal requirements, and yes, the signature line can be
> omitted
> if it is the only link (and poses a confidentiality risk). I often
> recommend
> to my investigators that THEY sign the consent document that accompanies
> each
> questionnaire along with a witness (if necessary) signature.
>
> Sorry, but I had to make the clarification. It is just a pet peeve of
> mine
> because of my experience with the issue.
>
> Matt Westbrook
> Travis Research Institute
> (626) 584-5538
Maggie
3/24/2000 5:35:00 AM
Operational Benchmark Committee
I realize that we are all striving to build operational models, involving automated systems, process flows, audit processes etc. to ensure compliant as well as timely review of human subject research.
I was wondering if anyone would like to participate in a benchmarking committee to exchange ideas and compare processes, systems, procedures etc. I would propose a twice yearly meeting commitment and a requirement of open and honest exchange of information with an intent to discuss both strengths and weaknesses.
I realize that ARENA & PRMR & FDA & OPRR provide great seminars. However, I have particibated in benchmarking committees in other areas of healthcare and have found them to be an extremely useful exercise toward creating standards of operation and quality improvement.
If anyone is interested please e-mail me at papagnp@ccf.org
Thank you
Anonymous
3/24/2000 10:26:00 AM
Mike Kelly wrote: Unless your assurance and procedures exceed the
requirements of 45 CFR 46,
waiver of written consent for an anonymous survey is a non-issue. 46.101
exempts surveys from the policy if they are anonymous OR ask no sensitive
questions. (Our exemption criteria requires anonymity AND no sensitive
questions.) On exempt surveys we ask the PIs to include elements of
informed consent (e.g., voluntariness, risk, contact information) but do
not ask for a signature. On surveys that are not exempt we do ask for
written consent and only occasionally waive it under 46.116.
Determining whether a project is exempt, expedite, or full review is one
matter. Determining consent requirements IS ANOTHER STEP, and rests on
different regulations. Just because a project meets exempt requirements
doesn't mean that it necessarily meets requirements to waive either informed
consent or documentation of informed consent -- although it often does.
Documentation of the IRB determination should specifically address both
issues, not simply: it meets the exempt requirements of §__46.101(b) and
therefore does not require documentation of informed consent. This
complexity is one of the chief reasons the category exempt doesn't release
institutions from much administrative load, in my mind.
_________________________________________________
Celia Walker, Regulatory Compliance
Colorado State University
970-491-1563 (v) 970-491-2293 (fax)
cwalker@research.colostate.edu
Celia
3/24/2000 8:59:00 AM
Operationalization of Study as Addendum to App.
Our IRB, located in a community hospital, has decided that an addendum to the IRB Application is in order. This would address what is required to roll out the study operationally.
We're looking at a need to address, amongst other things,in-servicing staff; the scope and content of the in-servicing material; a timeline and schedule for in-servicing; the impact of same on the clinical staff during in-servicing; determining additional work loads and the financial effect of the study on our institution; etc.
Would appreciate input and examples of addenda. Please feel free to respond off list. Thank you!
Rebecca Eveland
IRB Administrator
Hillcrest Medical Center
1120 South Utica Avenue
Tulsa, OK 74104
918.579.1072
reveland@hillcrest.com
Anonymous
3/24/2000 8:17:00 PM
Access to study records by Foreign Agents
When I've encountered these, it has usually been the understanding of the local
PI that this was language put there as a reminder that there might be other
governments involved, or that the form might be used as a model for the study
when implemented also in another country. Accordingly, we've felt no barrier to
removing it when the US is the only country involved, or to changing it to be
more specific when it's been US/Canada (the only ones I remember). I don't think
the sponsors have ever objected.
Are they now demanding that the wording remain that broad? I'd think that would
be unacceptable to many IRBs, many institutions and many subjects.
Dale
Dale Hammerschmidt
Assoc Prof Med / (Hematology/Oncology/BMT)
Editor., J. Lab. Clin. Med.
Box 480 Mayo Bldg., Univ. Minn., Mpls. 55455
612-626-2640; 612-626-2642 (fax)
InterNet
72662,76 (CompuServe)
Dale Hammerschmidt
3/24/2000 5:35:00 AM
Christy,
When my investigators do these types of anonymous, standard surveys, we don't
waive consent. We waive the need to sign the consent. We usually require a
written letter/memo explaining the survey and using required elements of
consent. Then at the bottom there is a statement such as If you agree to
participate in this survey, you are giving your consent by filling out the
form and returning it.
Even your investigators would have a very hard time saying this wouldn't work!
Rebecca M. Clark
Scripps Health/Children's Hospital IRBs
San Diego, CA
(858) 576-4008
rebcaclark@aol.com
Rebecca M. Clark
3/24/2000 10:03:00 AM
Access to study records by Foreign Agents
My IRBs have seen a few of these and the studies were sponsors by non-US
companies. We just clarified that if foreign agents reviewed the medical
files (as opposed to the case report forms), they would do only at our
institution under supervision.
Rebecca M. Clark
Scripps Health/Children's Hospital IRBs
San Diego, CA
(858) 576-4008
rebcaclark@aol.com
Rebecca M. Clark
3/24/2000 10:00:00 AM
I can not imagine an IRB approving a consent that contains information that
is then marked N/A. It is our responsibility to make the consent as clear
and easy to read as possible. It seems to me that whatever IRB (and I would
like to know which one it is) that requires inapplicable language to remain
in a consent is more concerned with policy than in doing the right thing.
We give our investigators a fill in the blanks type version on disk, with
instructions and helpful hints for building a consent. At no time is
information left in that does not apply to the study, nor should any
pertinent information be left out because it doesn't fit into a specific
format. Templates should be guides, tools to assist, not a stumbling block,
no matter what you are trying to accomplish.
-----Original Message-----
From: Susan Delano [mailto:CORCSJD@OMH.STATE.NY.US]
Sent: Thursday, March 23, 2000 1:57 PM
To: mcwirb@mcwirb.org
Subject: re: Standard Consent Format
Howard,
Thanks for the link to your template. I would like to add my 2 cents
worth.
Templates such as yours are very useful for investigators and IRBs, and help
to
create a readable and complete consent form.
My concern is with some institutions' use of a fill in the blanks consent
form, which often results in significant amounts of information being
labeled
n/a. These consent forms do not provide the flexibility to provide project
specific information in a way that maximizes subject understanding. In fact,
they can be confusing to a subject who reads an entire section, only to find
out at the end that it doesn't apply to the study they are being asked to
consent to. Consent forms are long enough without including 'standard
language' that does not apply to the particular circumstance.
Susan
Susan J. Delano
Director of Clinical Research Administration
Research Foundation for Mental Hygiene, Inc.
corcsjd@omh.state.ny.us
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Joan
3/24/2000 5:27:00 AM
I've learned quite a bit in the past couple of weeks on what qualifies as an exempt study. Now my question is how do other institutions handle exempt studies after that designation/approval is made? Should they be kept on file, followed like other studies, or as soon as the designation is made does the IRB have any other responsibility to them?
Thank you for your help,
Pam Gonzales
IRB Specialist
SWTMH IRB/MSTH IRB
San Antonio, TX
Anonymous
3/24/2000 5:35:00 AM
Hello,
I would like to ask a question , If an IRB has 13 members, a quorum would be seven people. If the IRB was voting on an oncology study and 5 of the 7 people there were either oncologists on staff who would be accruing patients or research associates, can these 5 people vote? or is this a conflict of interest?
Anonymous
3/24/2000 8:53:00 AM
Has FDA officially adopted ICH Guidelines?
>>> Ryan, Lanue 03/23/00 08:02AM >>>
I am new to IRBs. What does ICH mean? Thanks(Mr.) Lanue B. Ryan, MA
ICH = International Conference on Harmonization. ICH is an organization that brings together regulatory authorities and pharmaceutical industry representatives from Europe, Japan and the United States in an effort to reduce the differences in product registration requirements in these regions. Other regions have started to adapt to ICH standards as well, but they are not formal members. You can find out more about ICH at their website: www.ifpma.org/ich1.html.
Kenneth Malcolm, MS, RAC
Mosaic Technologies, Inc.
Kenneth Malcolm
3/24/2000 5:32:00 AM
But does it have to be a form per se? Or could it be formatted like a
letter from the investigator so long as all the necessary points are
made? In effect, a letter of agreement?
>>> Matt Westbrook 03/23/00 04:50PM >>>
Charles:
You make a unique point without meaning to, I suppose! In projects
that
involve surveys or questionnaires, I often have investigators who claim
(as
well as experienced IRB members) that participation alone in the
survey
documents consent. This is true. However, it does not document
INFORMED
consent. Therefore, there should be a consent document accompanying
the survey
outlining the normal requirements, and yes, the signature line can be
omitted
if it is the only link (and poses a confidentiality risk). I often
recommend
to my investigators that THEY sign the consent document that
accompanies each
questionnaire along with a witness (if necessary) signature.
Sorry, but I had to make the clarification. It is just a pet peeve of
mine
because of my experience with the issue.
Matt Westbrook
Travis Research Institute
(626) 584-5538
_______________________________________________
MCWIRB maillist - MCWIRB@mcwirb.org
http://www.mcwirb.org/mailman/listinfo.cgi/mcwirb
Jo Anne Bennett
3/24/2000 5:35:00 AM
Operationalization of Study as Addendum to App.
Rebecca,
All of my IRBs use a multiple sign off system for final approval of studies
that will use hospital resources. This allow the IRB to review and approve
the study on human subject issues, then send to on for administrative review.
This review covers issues of cost, staffing, etc., for doing the study in
the hospital. This has worked very well for us. It allows the IRB to do our
job without diluting it with administrative issues. It allows the hospital
to agree or disagree to allow the study to be done on site, with all the
bases covered.
I strongly recommend that the be a different committee. I've tried it both
ways and combining it with the IRB review didn't work. It weakened both
types of reviews.
Rebecca M. Clark
Scripps Health/Children's Hospital IRBs
San Diego, CA
(858) 576-4008
rebcaclark@aol.com
Rebecca M. Clark
3/24/2000 10:06:00 AM
Has FDA officially adopted ICH Guidelines?
Hello to all. I was contacted by a sponsor who requested a statement to confirm our IRB compliance with ICH Guidelines. Has the FDA officially adopted ICH Guidelines?
We provide a statement that we are in compliance with our MPA and 21 CFR Parts 50 and 56. I searched the MCWIRB archives and located a previous posting from Paul Goebel dated 09/23/98. He stated that although FDA does encourage compliance the ICH E6 standard, it is not a regulation.
What actions are other IRBs taking? Thank you.
Michelle Christiano, CCRC
IRB Compliance Coordinator
Medical College of Georgia
Office of Clinical Trials Compliance
1120 15th St., CJ-3301
Augusta GA 30912-7621
706-721-1480
706-721-1479 fax
mchristi@mail.mcg.edu
Anonymous
3/24/2000 5:35:00 AM
Celia Walker wrote:
>Determining whether a project is exempt, expedite, or full review is one
matter. Determining consent requirements IS ANOTHER STEP, and rests on different regulations. Just because a project meets exempt requirements
doesn't mean that it necessarily meets requirements to waive either informed
consent or documentation of informed consent -- although it often does.
Documentation of the IRB determination should specifically address both
issues, not simply: it meets the exempt requirements of §__46.101(b) and
therefore does not require documentation of informed consent. This
complexity is one of the chief reasons the category exempt doesn't release institutions from much administrative load, in my mind.<
I must admit that these comments do not make any sense to me. 45 CFR 46.101(a) begins by noting with a lead-in, except as provided in paragraph (b), which are the rules relating to determining which research is exempt. Accordingly, once something is determined to be exempt (from this policy--part 46), it would appear that NONE of the provisions in Part 46 apply to it--including the provisions relating to informed consent.
Thus, I would have thought Mike Kelly's initial comments were right with regard to the fact that an IRB which is concerned about consent issues in an exempt protocol is doing so because of its own voluntarily adopted more stringent rules, and NOT because of anything required by the federal government. Exempt would seem to mean just what it says--exempt. A determination that something is exempt releases IRBs and their institutions from virtually all of the things they usually have to worry about under these rules.
Jerry Menikoff
University of Kansas
Jerry Menikoff
3/24/2000 10:00:00 AM
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