Show More


Human Subject Research Review Procedure

Introduction

The purposes of this procedure are as follows:

  1. The primary reason is for the protection of the rights and safety -- both physical and emotional -- of human subjects. The subjects benefit and DePauw benefits by these efforts to ensure responsible conduct and informed participation by human subjects.
  2. A review procedure that upholds human research standards also protects the researcher in two ways:
    • It helps to assure that the research is done properly according to standards for ethical and responsible research conduct
    • Compliance with institutional standards and procedures shifts the burden of responsibility to the University if a subject makes a complaint or brings legal action
  3. Federal and professional standards require institutional review and approval of human subject research. In fact, federal grant proposals require advance approval of subject procedure
  4. Students learning how to do research should also learn about research ethics and the need for review procedures

Human Subject Review Procedures

These procedures apply to activities engaged in for the purpose of research, which means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge, whether or not the activities are conducted under a program which is considered research for other purposes (e.g., some demonstration and service programs may include research activities).

Research with human subjects will be conducted in a manner consistent with federal guidelines and the guidelines of the professional organizations of the disciplines. (See Appendix A.) The policies and procedures described here and in implementing documents apply to all members of the University, including faculty members, administrators, staff and students.

Activities that involve manipulation of humans or data obtained from them for other purposes (e.g., work done to study the effectiveness of common educational techniques, or for the purpose of institutional assessment) should be guided by similar principles, but do not come under the purview of the Institutional Review Board. Researchers must report any relevant changes in their research procedures to the Board.

Category I Research

Criteria:

Category I research involves no more than everyday stress, minimal risk, most field observations, and the study of existing data. If participants can be identified, the research must receive an expedited review or full review as described below. To qualify as Category I, all of the following must be true. The research:

  • Does not involve a special or protected population (e.g., participants under 18 years of age, prisoners, in/outpatients, mentally/physically disabled, pregnant women)
  • Does not involve deception (beyond not informing subjects about every aspect of this study and hypotheses)
  • Poses no reasonably foreseeable physical risks to participants
  • Poses no reasonably foreseeable stress or discomforts to participants (beyond everyday levels)
  • Does not involve private records (e.g., medical and/educational data linked to names)
  • Does not probe for sensitive personal information (including disease/disorder/disability status)
  • Obtains informed consent from participants (if all other conditions are met there may be cases-field studies, for example-when informed consent is not required; the category I form asks for an explanation/justification in such cases)
  • Does not present offensive, threatening, or degrading material
  • Preserves confidentiality of participants
  • Debriefs participants (there may be exceptional circumstances--field studies--where debriefing is not feasible; the category I form will asks for an explanation/justification in such cases)

Research procedures must satisfy basic requirements. (see Appendix B.)

Procedure:

Faculty and students whose research meets the above criteria should fill out the Category I form. The form may be obtained from the Office of Academic Affairs or from the DePauw IRB web site. Researchers should complete the form, attach any additional information that is requested, and submit the proposal to the Office of Academic Affairs. Students must have a faculty sponsor endorse and sign the form. One or more members of the IRB will review the proposal and respond, generally within 10 working days. Category I research requires approval; research may not begin until researchers have received notification of approval from the IRB reviewer(s).

Category II. Expedited Review Research

Criteria:

The research involves minimal/some risk, or deception or moderate stress, or intrusive procedures such as venipuncture. The research must satisfy basic requirements.

Procedure:

The researcher(s) submits a proposal to the Office of Academic Affairs. Students must have a faculty sponsor endorse and sign the form. Two or more members of the IRB will review the proposal and respond, generally within two (working) weeks. Category II research requires approval; research may not begin until researchers have received notification of approval from the IRB reviewers.

Category III. Full Review Research

Criteria:

The research involves more than minimal risk, or use of specially vulnerable populations, for example, children, prisoners, pregnant women, or persons with mental or physical disabilities.

Procedure:

The researcher(s) submits a proposal to the Office of Academic Affairs. The project description should give special attention to the nature of potential risks, how the risks will be managed, and the qualifications of the researchers for conducting research of this nature. Students must have a faculty sponsor endorse and sign the form. The full committee will review the proposal and respond, generally within two (working) weeks. Category III research requires approval; research may not begin until researchers have received notification of approval from the IRB.

Composition of the Board

The Institutional Review Board must consist of at least five members, appointed by the chief academic officer, on the recommendation of current members. The members must have varying backgrounds sufficient to assure complete and adequate review of research activities commonly conducted by the institution. The committee must be sufficiently qualified in expertise, experience and sensitivity to issues such as community attitudes (which might arise from their race, gender or cultural backgrounds). In addition, the committee should strive for diversity of intellectual and methodological traditions in its membership. If the IRB regularly reviews research involving a vulnerable category of subjects, consideration must be given to inclusion of one or more individuals who are knowledgeable in working with these subjects. The committee must include at least one person whose chief concern is scientific issues and at least one whose primary concerns are in nonscientific areas, and at least one member neither affiliated with the institution nor a member of the immediate family of a person affiliated with the institution. A member who has a conflicting interest (Conflicts of Interest as covered by the policy established by the Committee on Faculty and the Administration and published in the Personnel Policies section (Appendix 3) of the Academic Handbook or other conflict such as serving as a consulting researcher or having a relationship to the subject of the research) may not participate in a review, except to provide information. The IRB may invite individuals with special expertise to assist in a review, but that person may not vote. Full reviews must be carried out at the convened meetings with a majority of members present, including the nonscientific member; approval requires a majority vote of those present.

General Procedures

The IRB must have written procedures for carrying out its reviews, for determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review, and for securing reports of proposed changes in a research activity and for ensuring that such changes will not be initiated without IRB approval except when necessary to eliminate immediate hazards to the subject. The IRB is responsible for determining its procedures within these guidelines, with the input of affected initials and the chief academic officer. The policies of the IRB must be in accord with the guidelines of the appropriate federal agencies and the various professional organizations of the disciplines; modifications in policies must be approved by the chief academic officer.

Appendix A

The federal guidelines are available at the Web site of the Office for Human Research Protections (http://ohrp.osophs.dhhs.gov/index.htm).

Other Resources:

Appendix B

The following basic principles apply to all categories of research:

  • Informed consent. Subjects' participation must be voluntary and informed. Before participation, subjects must receive an explanation of the purposes of the research, what they will be asked to do, and any potential risks involved. They must be told that they may refuse to participate in the study and may discontinue participation at any time.
  • Protection from harm. Stress to subjects shall be minimized as much as possible. Signed consent must be obtained from all subjects.
  • Anonymity and/or confidentiality must be observed when possible. If anonymity or confidentiality cannot be maintained, the investigator must provide strong justification.
  • Risks to subjects must be outweighed by the sum of the benefit to subjects and the importance of the knowledge to be gained.
  • Debriefing. The exact nature and purpose of the student must be explained to subjects after completing the study; subjects have a right of access to a report of the results of the study.
(This list of principles was excerpted from the guidelines of the Denison University Institutional Review Board.)

(Adopted by the University, October 1998; modified December 2007)