Institutional Review Board Policy

Purpose

Eastern Mennonite University has established an Institutional Review Board (IRB) to review and approve research on human subjects, as described herein. The purpose of this review is to meet EMU’s legal requirement under the Federal Office of Human Research Protection (OHRP) to protect individual rights to give informed consent for voluntary participation in research. The following OHRP definitions apply:

• Research – a systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.
• Human subjects –living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.
• Informed consent – a person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure; in giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence.
• Minimal risk - the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

All EMU faculty and students who propose research and non-EMU personnel who propose research on EMU personnel shall submit their proposals to the IRB using the on-line submission process found on the IRB website. Researchers shall also notify the IRB immediately of any changes in the research that may relate to this policy following approval of the proposal. Complaints about research conducted by or with EMU community members will be directed to the IRB for response.

Research proposals fall into one of three categories as follows:

Classroom. Classroom research projects that involve human participants for instructional purposes only and that involve no more than minimal risk to the participants are considered classroom research. This type of research requires the instructor to approve the projects and submit a Faculty Assurance Form to the IRB. This form serves as the IRB proposal for all projects in the class and such projects are exempt from full Board review. If a student’s project does not meet the definition of classroom research or if the student plans to present research findings outside the realm of the actual classroom, then the student should submit a separate IRB proposal following the online procedures described herein.

Expedited. Research projects that do not involve vulnerable populations or more than minimal risk to the participants are considered expedited and are exempt from full Board review. Researchers must submit proposals for such projects using the online procedures described herein. Proposals may be submitted at any time and are reviewed by the Chair and one other Board member.

Full Board Review. Research projects involving vulnerable populations, or possible risk to participants, require full Board review. Researchers must submit proposals for such projects using the online procedures described herein at least one week prior to each monthly IRB meeting.

SEE FLOW CHART

Procedures

The researcher for proposed expedited or full Board review research is to submit an online proposal form to the IRB Chair.

The online proposal  includes  the following elements:

1. Name(s) of researchers, including email contact information
2. Faculty Approval of Student Research form
3. Title of Research Proposal
4. Start date and duration of study
5. Brief description and purpose of research
6. Research methods, including brief descriptions of participants, procedures and apparatuses
7. Participant informed consent, including a description of how anonymity and confidentiality shall be maintained and possible risks and benefits to the participant
8. Plans for dissemination of results
9. Attachments – researcher-created apparatuses, and letter(s) of informed consent

Research proposals requiring full Board review are due one week prior to the monthly meeting of the IRB. Meeting dates and proposal due dates are published on the EMU IRB website. If there are no proposals submitted for full review, monthly meetings may be cancelled.

Research proposals are sent directly to the Chair of the IRB via the on-line submission process. The Chair decides if a proposal requires full board review, using the Full Board Review Guidelines that follow. If a research proposal does not require full Board review, the Chair will send written verification of the decision to the researcher and report the action at the next Board meeting. Copies of all received proposals and written responses will be filed electronically.

Proposals requiring full Board review will undergo initial review by the IRB at a regularly scheduled meeting. Board members are to apply the ethical guidelines and make a decision to approve or disapprove the research. The Board may request modifications to the proposal. A majority of the members must be present in order to take action on a proposal.

The Board shall have full authority to approve or deny approval of proposed research. The Chair shall submit a formal letter via email notifying the primary contact person of the Board’s decision. Notification of disapproval shall include rationale and provide opportunity for the researcher to respond in person or in writing.

Research proposals are granted approval for a one-year period, according to OHRP Federal guidelines. If research extends beyond a period of one year, the researcher shall submit an online request for extension using the IRB Addendum/Extension for Approved Projects. The Chair shall notify the researcher of approval for the extension. This procedure assures continuing review.

The Board has the right to discontinue a research project that is not being conducted in accordance with the approved proposal or in cases of unexpected harm to participants. Notification of such to the researcher(s) should include rationale. As implied here, researchers must inform the Board immediately if any harm occurs.

The Board is to retain on file the minutes of all meetings, as well as copies of all research proposals and correspondence.

Ethical Guidelines

The following guidelines shall be used to review research proposals:

1. Participants are protected from unnecessary physical or emotional harm, psychological distress, and undue influence; and risks are monitored during the project.

2. Potential short range benefits of the research outweigh any potential risks.

3. Informed consent is provided to participants in writing. Informed consent includes:

a. Explanation of purposes, procedures, and timetable of the research.

b. Description of potential risks if present and means of treating these if harm could occur (i.e., list of available counseling services with contact information).

c. Description of any expected benefits.

d. Description of provision for anonymity and/or confidentiality.

e. Description of voluntary nature of participation and ability to discontinue participation if desired.

f. Names of people to contact for answers to questions.

g. If applicable, separate statement and signature line for permission to audio or video tape participants?

If informed consent is not to be obtained, the risk must be minimal and justification must be provided in the proposal (e.g., the inability to conduct the research if participants are informed of its purpose).

4. Steps are taken to protect privacy of participants.

5. Selection of participants is equitable.

Composition of the Institutional Review Board

The Board shall have a minimum of five members with varying backgrounds and expertise. The following additional requirements shall be met:

1. Both males and females shall be included.
2. One member shall be a lawyer, ethicist or theologian.
3. One member shall be a person whose primary concerns are in nonscientific areas, who is from the community outside EMU, and who is not an immediate family member of an EMU employee.
4. One member shall be a student.
5. A member may not participate in decision making if she/he has a conflicting interest.
6. Persons with additional expertise may be invited to serve on the Board if needed.

The Board shall be appointed by the Provost. The Board shall elect the Chair for a term of two years.

Approved by President’s Cabinet, April 12, 1989 after review by Academic Council

Updated for name, December, 1994

Revised and approved by the President’s Cabinet, November, 2006

Revised and approved by the President’s Cabinet, May, 2011