PRINCETON UNIVERSITY             Office of Research and Project Administration

                                                                        Research Compliance Group

                                                                        4 New South Building, Princeton, NJ 08544-0036

                                                                        Phone:  609.258.3976

 

 

 

TO:       Chairs and Administrators in the behavioral, life, and social science departments

FROM:  Joe Broderick, Secretary of the Institutional Review Board for Human Subjects

DATE:  August 24, 2009

http://www.princeton.edu/orpa/memos/IRB_Annual_Memo_files/image001.gif 

This memo is to remind you that research at Princeton University that involves human subjects must receive prior approval from the Institutional Review Board for Human Subjects (IRB). The IRB is charged by the federal government and by the University Research Board (URB) with protecting the interests of human research subjects.  We are eager to do this in a manner that interferes as little as possible with the autonomy, research plans, and specific timetables of individual researchers.

Toward this complex end, we have developed procedures that we believe are sensitive to the varied traditions of the different academic disciplines, and also consistent with current federal guidelines.  Relevant aspects of these procedures are briefly outlined below.  More information can be found on the IRB website at http://www.princeton.edu/orpa/irb.htm, including the NIH Guidelines/Belmont Report and the Code of Federal Regulations governing the protection of human research subjects.

Also listed on the IRB website is the 2009-2010 meeting schedule. Please note that the deadline for consideration at the September meeting is September 9, just two days after the Labor Day holiday.  We would appreciate your bringing this information to the attention of the members of your department.

New for 2009-10

The IRB is always looking for ways to streamline processes and provide a higher level of customer service so we are taking a number of initiatives this academic year:

The IRB staff has prepared new training modules for completion of the Questionnaire A and the Questionnaire B in addition to a module providing a general introduction to the IRB. These modules can be found on the IRB website under the Training section.

We are beginning a process of primarily electronic reviews of proposals for Questionnaire A’s (non-exempt proposals).  While we cannot completely eliminate the need for paper copies, we will now require an original and EIGHT copies (rather than nineteen). 

To submit a Questionnaire B (exemption request), send an electronic copy by email and ONE signed original.  In most cases, the review can begin upon receipt of the emailed version of the proposal.  The Questionnaire B is reviewed by IRB staff, so submission is not governed by the meeting schedule of the IRB.  Also beginning this year, the IRB staff will reconfirm the exempt status on an annual basis. 

Does my research fall within the jurisdiction of the IRB?

The IRB has a flow chart providing guidance on what should and what should not be submitted to the IRB for review.  The memo and accompanying documents can be accessed through the IRB website or directly through this URL: http://www.princeton.edu/~orpa1/memos/flowchartmemo.pdf.

Training and certification of researchers whose research involves the use of human subjects

As required by federal regulation and our faculty rules, all researchers who use human subjects in their research studies must be certified through the completion of an appropriate training program.  This requirement includes all members of the IRB.  The required training program can be completed online at:  http://phrp.nihtraining.com/users/login.php

Please note that all researchers are expected to complete the certification process prior to submission of their questionnaires to the IRB for review.  Also, please note that the training and certification requirement applies to all student researchers as well.  If you have any questions about this process, please contact Joe Broderick at jbroderi@princeton.edu or call 8-3976.

Undergraduate student research

All human subjects research conducted by undergraduate students must be approved by the IRB prior to initiation.  If appropriate, please notify your departmental representative to make sure that undergraduate researchers understand this requirement.  Departments are responsible for ensuring that their students receive IRB clearance, even for off-site summer research if it is going to be used for their independent work requirement or any other Princeton University purpose.

Questionnaire A

Each investigator should send a signed original and EIGHT copies of the Questionnaire A to the attention of Joe Broderick, Secretary of the IRB, ORPA, 4 New South.  All questionnaires must be submitted to the IRB by the deadline on the IRB website and on the Questionnaire A form.  

The Board members will review each research description to determine whether subjects are at a psychological, social, or physical risk and, if so, whether there are ways to reduce the potential risks involved without distorting the goals of the research.  Feedback to the investigator (usually within a week of the meeting, via email) typically signifies either approval or the requirement for changes or submission of additional information for the IRB’s review.  Resubmission or clarifications are often requested when the information is insufficient for informed decisions concerning risk.  Flat disapprovals are exceedingly rare.

Questionnaire B

We also have procedures whereby investigators may, in effect, claim exemption from review even though their research involves human subjects, respondents, or informants.  By answering Questionnaire B (see http://www.princeton.edu/orpa/compliance/questb.doc) and checking the appropriate exemption category, the investigator accepts the responsibility of assuring the Board that no risks will be involved in the conduct of his research.  The IRB Criteria for Exemption is included with the Questionnaire B.  The Questionnaire B is typically reviewed by the IRB staff and is therefore not subject to the deadlines for convened meetings of the IRB.  If the IRB staff has concerns regarding the research, the principal investigators will be advised accordingly.

Annual review

Under federal regulations, all research involving human subjects must be reviewed at least annually.  As part of those requirements, the IRB has an Annual Review Questionnaire, which asks specific questions about developments relating to the use of human subjects and the research program since submission of the initial proposal to the Board for its review and approval.  Additionally, under Board procedures, proposal for continuing research are limited to two annual reviews subsequent to initial proposal submission.  Research continuing into a fourth year and beyond requires the submission of a new Questionnaire A, after which the annual review/new proposal submission cycle may be repeated indefinitely.  Failure of investigators to complete annual renewals by the renewal date (generally the day before the first year anniversary of the protocol’s original approval) may result in approval for the protocol being terminated. 

Starting this year, exempt protocols (Questionnaire B’s) will also undergo an annual reconfirmation of exempt status.

Addendum to an approved proposal

If, during the course of the research but prior to the annual review anniversary, an investigator wishes to make significant changes in a study that would affect the use of human subjects, the Secretary of the IRB should be consulted about the need to submit an addendum or an amendment to the currently approved proposal by the Board.

Expedited reviews

It is expected that almost all proposals for IRB review can be accommodated within the normal review procedures outlined above.  However, on an exception basis, a PI can request an Expedited Review of a proposed study.  This is done when there is an urgent need to begin the research quickly and, although the research may raise some ethical issues, the PI has safeguarded against them by incorporating appropriate precautions.  In this case, responses to a Questionnaire A will be read by a member of the Board (usually the Board chairman) and the investigator will learn within approximately a week of submission whether it has been tentatively approved with the understanding that this tentative approval must be confirmed at the next regular meeting of the Board.  We recommend that this request be reserved for research that raises no questions concerning protection from risks beyond those to be expected in everyday life, and where unique circumstances require commencing the research prior to the next regularly scheduled meeting of the IRB.

Important information about IRB review procedures is also readily available at the Office of Research and Project Administration (ORPA) website.  The URL for the Institutional Review Board for Human Subjects is: http://www.princeton.edu/orpa/irb.htm.  If you have any questions, please contact Joe Broderick at jbroderi@princeton.edu or 8-3976 or Susan Maloney at smaloney@princeton.edu or 8-3105.