Federal Demonstration Partnership Exempt Wizard
Coming to you soon!
The Federal Demonstration Partnership (FDP) has created a relatively short smart form to test pilot the effectiveness of investigator determinations of exemption. The purpose of this demonstration is to compare the determination of status (exempt versus not exempt) using the smart form versus the determination of status by an IRB staff member. If the demonstration is successful, the FDP will allow universities to implement the wizard using their own platforms. The desired outcome would be to allow investigators to make their own exempt determinations thereby freeing resources for IRB applications with a greater potential risk to subjects.
Why an exempt wizard?
Human subjects regulations can be a tremendous and increasing burden on investigators. While all of those individuals involved in research using humans as subjects agree that the safety of the research participants is of paramount importance, spending extensive amounts of investigator and IRB staff time on research that qualifies for an exempt determination is not a good use of resources. In fact, the Office for Human Research Protection (OHRP) has indicated that they are interested in the outcome of using a system such as a smart form to allow investigators to make exempt determinations.
Who else is participating?
Some other institutions who are participating in the demonstration are: Boston University, University of Michigan, Michigan State University, College of Charleston, Sacramento State, and New York University.
What does participation entail?
To determine if the smart form correctly identifies studies as exempt, each participating university will select a set of approximately 100 recent exempt determinations. For each study, the investigator of the study will receive an email asking if they would be interested in participating. If so, investigators will be asked to complete the smart form, using the information from their exempt determination.
Who/what is the Federal Demonstration Partnership?
The Federal Demonstration Partnership is a cooperative initiative among 10 federal agencies and 119 institutional recipients of federal funds. The FDP is a program sponsored by the Government, University, and the Industry Research Roundtable of the National Academies. Its purpose is to reduce the administrative burdens associated with research grants and contracts.
Registration of Clinical Trials
Change affecting UW oncology trials
Many journals, federal funding agencies, and industry sponsors require registration of clinical trails at the federal website ClinicalTrials.gov, before beginning the trial. Posting the trial results is also required. See http://www.clinicaltrials.gov.
The Protocol Office at Fred Hutchinson Cancer Research Center (FHCRC) has agreed to continue to do the registration for UW investigators whose research is reviewed by the FHCRC IRB on behalf of the UW IRB. However, the UW will be listed as the "responsible party" on the registration site.
The Protocol Office will also continue to work with the National Cancer Institute and several oncology cooperative groups to coordinate and assist with posting of trial results.
This gracious offer by the Protocol Office is made under the auspices of the multi-institutional Cancer Consortium (which is housed at FHCRC). It significantly reduces the investigator's burden with respect to the Regulatory requirement. We are deeply appreciative to FHCRC and the Protocol Office.
Linda Mendelson is the contact person for this process in the FHCRC Protocol Office. She can be reached at 206-667-5767 or firstname.lastname@example.org.
New Clinical Trials Administrator
December 31, 2012: Arna Elezovic's last day
January 10, 2013: Brecken Cardinal's first day
As many of you already know, Arna Elezovic is leaving the Human Subjects Division (HSD) at the end of December. This fall she entered the UW graduate program in History, and she will be pursing her studies full-time.
Brecken Cardinal will become our Clinical Trials Administrator on January 10, 2013. Brecken is currently a Regulatory Analyst at Western IRB (WIRB), where she has been assessing regulatory issues (including relationships with other IRBs) for a few years. Her WIRB experience and relationships will be invaluable in this position. She has a Master's degree in Experimental Psychology and has worked on several research projects. Brecken is looking forward to setting up "getting to know you" meetings and sessions with key groups and individuals at UW locations, Seattle Cancer Care Alliance, and Fred Hutchinson Cancer Research Center. We hope you will join us in welcoming Brecken to her new position.
During the first two weeks of January, clinical trials activities will be handled by Karen Moe (email@example.com, 206-543-7246).
Please join us in thanking Arna Elezovic for her ten years of outstanding service at HSD. Arna began as the first Minimal Risk Review Coordinator before moving to UW IRB Committee A. She then spent time working on policies and procedures before taking on the then-new position of Clinical Trials Administrator, with responsibilities for overseeing the use of WIRB and the Hutch IRB by UW researchers. Her work on behalf of UW researchers has been consistently excellent, efficient, and friendly.
Thank you, Arna - we will miss you!
REMINDER - The New Use of Identifiable Biological Specimens/Data Form is Here!
If you will
be conducting research that only involves identifiable biological specimens
and/or data, a substantially revised form with new guidance has been created
titled: Use of Identifiable Specimens/Data. These have replaced the old
"Medical Records Review" form and instructions.
The form is limited to researchers who
are not directly interacting with people, but who are reviewing identifiable
private information about individuals and/or analyzing identifiable specimens.
When should you complete this
application? Here are some examples of projects that involve review of
identifiable information or specimens (either retrospective or prospective)
that are appropriate for this form:
- medical records;
- protected health information (PHI);
- employment data;
- study records;
- pathology specimens;
- data and/or specimens from a repository.
The form is
available on the HSD website:
and should be
used in direct conjunction with the guidance:
As of December 31, 2012, HSD will no longer accept the old "Medical Records Review"
any questions about the form to firstname.lastname@example.org.
The form is also available in Word.
New and Revised Documents
You may have noticed that HSD has been releasing new or revised policy, procedure, and guidance documents at a brisk pace. This is a major effort that will continue during the coming year, due to:
- Campus requests
- HSD's goal of increasing transparency and knowledge about the IRB review process
- The increased frequency of federal regulatory changes
We generally release and post all new and revised documents on the last Friday of every month. We use this newsletter to alert you to those new documents. We hope you like our format for presenting the information, and we welcome feedback and suggestions. (email@example.com)
||Training in the Protection of Human Subjects
UPDATED training sections in Modification Form, Human Subjects Review Application (13-11), Status Report Form, Use of Identifiable Biological Specimens/Data Form, Repository Form, and the Center, Program, or Training Grant Application
||Change of requirement to submit documentation from funders who require refresher/renewal of training in the protection of human research subjects. Rather than documentation, we are now requesting researchers to simply state on the form how often the refresher/renewal is required.
|Link for more information
||See the forms themselves, linked above.
||December 28, 2012
UPDATED Human Subjects Review Application (13-11)
||Question #3 of Section VII.F. regarding who pays for adverse events has been expanded to create clarity.
|Link for more information
||December 28, 2012
Quick Tips from HSD
Washington State IRB
The UW IRB is the only IRB for me! Go Huskies!
Hmm, not so fast...
Quick Tips knows that the University of Washington is like a city, with just about every service imaginable, including Quick Tips' home, the UW's Institutional Review Board (IRB). (If there was a comfy cot, Quick Tips might never leave the UW Tower.) But there are some research activities that need to be reviewed by a different IRB instead of the UW IRB.
The Washington State IRB (WSIRB) reviews research activities that are:
- Sponsored by the Washington State Department of Social Health Services (DSHS), Department of Health (DOH), or Department of Labor & Industry (L&I);
- Conducted by an employee or agent of DSHS, DOH, or L&I;
- Using any DSHS or DOH property or facility;
- Using DSHS, DOH, or L&I non-public information to identify or contact human research subjects or prospective subjects; or
- Using non-public identifiable records or specimens from DSHS, DOH or L&I.
The University of Washington has a cooperative agreement with the WSIRB, where we rely on their IRB review of research that involves any of their records, properties, facilities, employees or agents. If the funding is coming through the UW, but the research involves one of the above agencies, the review should be performed by the WSIRB instead of the UW IRB.
Examples of DSHS records include:
- Child welfare, foster care (CAMIS)
- Temporary Assistance for Needy Families (TANIF)
Examples of DOH records include:
- Trauma registry (WSTR)
- Cancer registry (WSCR)
- Birth records
If you want to interview mothers of special needs children under the age of five, link birth records to the state cancer registry to evaluate childbearing after a cancer diagnosis, or use DUI assessments from a DSHS contractor to study severity of alcohol abuse, all these things would be under the jurisdiction of the WSIRB.
When you submit an IRB application to WSIRB, don't forget to use their forms (not the UW forms) and don't forget to include WSIRB's "Appendix E" form which requires a signature from HSD. This authorizes WSIRB to do the IRB review instead of the UW IRB. Questions? Email firstname.lastname@example.org.
So get off campus and visit WSIRB on the web at: http://www1.dshs.wa.gov/rda/hrrs/default.shtm
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