Policy for Social and Behavioral Sciences

To:                   Deans, Chairs, Directors, Faculty, Staff

From:              Michael E. Breton, Ph.D.

                        Associate Vice President of Research
                        and Sponsored Programs

Date:               5/14/2004

            Re:       Human Subjects in Research: Policy for Faculty and Student Projects with Special Reference to  the Social and Behavioral Sciences

___________________________________

This memo provides guidance for human subjects research projects conducted by faculty, students and staff at Rutgers University working in the social and behavioral sciences. It is important for researchers to first determine if the work they will be doing is human subjects research.  As all who conduct research using human subjects should know, Federal regulations and University policy require review of research protocols involving human subjects by an Institutional Review Board (IRB) for the Protection of Human Subjects in Research.   However, Federal research requirements for social and behavioral research may not be as obvious or as unambiguous as in the other sciences. As an institution holding a Federalwide Assurance, Rutgers University must review and approve all research projects involving human subjects research prior to the  commencement of research, whether or not the project is funded.  

This guidance document is intended to help you make a determination of whether or not your work requires IRB review. The two different circumstances in which IRB review would be required are as follows:

The research proposal meets both of the Federal regulatory definitions for research and human subjects.

Research is defined as a systematic investigation…designed to develop or contribute to generalizable knowledge.   Examples of such projects are: research development testing, pilot studies, clinical studies, surveys, certain program evaluations, ethnographies, and oral history projects.

Human Subject is defined as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (such as data sets that contain identifiable information).  It is vital to note that in order to qualify under this definition information must be obtained about an individual.  Merely obtaining information from an individual about a process, policy, etc. (but not another living individual), will not require IRB review.

In addition, although class exercises generally do not meet the federal definition of research, Rutgers IRB policy requires that class exercises, which include human subjects, may need to be submitted to the IRB for review.  Note that courses in research methods and class assignments involving research with human subjects (e.g., surveys, oral histories) require IRB review. 

To assist you in making this assessment for student or course related research projects go to <http://orsp.rutgers.edu/Humans/documents/hsstursh.asp>.  Such a course related exercise must entail only minimal risk to participants (i.e. may only involve the subjects in experiences that are like those encountered in the daily life of a normal and healthy adult).  If uncertain whether the project or class exercise requires review, a copy of the research proposal or a description of the class project (including the detailed account of the aims of the research or class exercise, the research methodology, and recruitment methods) should be submitted to the IRB so that a determination can be made whether the project or class exercise requires review. Please note:  Class exercises that are specifically instructional in nature and take place in a public setting, only involve the learning of research techniques, and involve anonymous participation, do not require IRB review.

If a determination is made that a submission is needed to the IRB, there are three different types of IRB review that could take place.  They are as follows.

·        Exemption from IRB Review: Federal regulations allow for certain types of research to be exempt from IRB review.  Generally, social behavioral research qualifies under the exemption regulations so long as the research is minimal risk, participation is anonymous, and does not involve minors.   Specific details regarding the six exemption categories may be found on-line at: <http://orsp.rutgers.edu/Humans/documents/hsexempt.asp>.  Please note that the IRB must determine if the research is exempt, and so, the investigator or instructor must submit an Exemption application for IRB review.

·        Expedited Review: If the conduct of research or class exercise does not fall under the exemption categories, the research may be eligible for expedited review. In order to qualify for the federally defined categories of expedited review, the research must be minimal risk, must not involve prisoners or parolees, and must not place the subjects at-risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, or be stigmatizing.  Specific details regarding the expedited categories may be found on-line at: <http://orsp.rutgers.edu/Humans/documents/hsexped.asp>. Application to Request Expedited or Full Review will need to be submitted to the IRB.

·        Full Board Review:  Research or class exercises not meeting either exempt or expedited review will be reviewed by the full IRB.  If the IRB determines the research to be greater-than minimal risk, it will advise the investigator of additional protections that must be provided to the research subject. Application to Request Expedited or Full Review will need to be submitted to the IRB.

Below are additional points that should be considered as you prepare your application to the IRB:

·        Plan ahead: Submission dates are as follows:

o       Exemption form: There is no specific date for submission of exempt applications, since they are reviewed on a rolling basis.

o       Expedited and Full Review:  The application must be submitted by the 12^th of the month, for IRB review the following month.

o       Special instructions for instructors: Since research has to be conducted in the limited time scope of a semester, instructors should submit materials for IRB review two months prior to the planned start of the project or class.

·        Participate in the Human Subjects Certification Program: Completion is required for faculty, students and staff involved in the design or conduct of human subjects research. The program, which provides an overview of human subjects protections issues, can be easily accomplished in a variety of ways:  1. an on-line tutorial can be found at:  <http://orsp.rutgers.edu/HSCPLetter.asp>  2. a hard copy version may be requested from my office or 3. Departments or instructors may request from my office a two-part Human Subjects Certification Film. Completion of the educational certification course is documented by ORSP.

·        Provide informed consent to participants following IRB review and approval:  Informed Consent is cited in the Code of Federal Regulations (45 part 46.111(a)(4) and states that: Informed Consent will be sought from each prospective subject or the subject’s legally authorized representative in order to allow them to make informed decisions.  The Informed Consent form must be submitted with the IRB application.  If you are conducting a research project or class exercise involving human subjects you must provide prospective participants with written information about the possible risks and the potential benefits of their involvement, with accurate detail about the research described in lay language. Sample Informed Consent forms may be found at <http://orsp.rutgers.edu/Humans/downloads/Expedited/icguidanceprep2.htm>.  The IRB may determine that a waiver of informed consent or oral consent is appropriate under some circumstances.  Investigators must keep informed consent documents for at least 3 years after the completion of the study or class.

The Research Integrity and Compliance Unit of the Office of Research and Sponsored Programs (ORSP) provides administrative support to the IRB. The human subjects website, <http://orsp.rutgers.edu/human.asp>, contains guidance on human subjects research, forms, templates for informed consent, deadlines and educational certification programs.

While Rutgers University has an exemplary record of human subjects protections, it is only by working together that this distinction may be maintained.  If you need additional information or guidance please contact me or:

Additional information and submission of materials should be sent to Michelle Gibel, CIM, IRB Administrator, Office of Research and Sponsored Programs, gibel@orsp.rutgers.edu, 732-932-0150, ext. 2104.

Karen Janes, Associate Director, Research Integrity and Compliance, Office of Research and Sponsored Programs, janes@orsp.rutgers.edu, 732-932-0150, ext. 2105.

 Return to ORSP Home