Institutional Review Board Policy

Purpose

EMU has established an Institutional Review Board (IRB) to review and approve research on human subjects, except where such research is exempted as described herein. The purpose of this review is to meet EMU’s legal requirement under the Federal Office of Human Research Protection to protect individual rights to give informed consent for voluntary participation in research. The OHRPdefines research as follows:

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Procedures

All EMU faculty and students who propose research, and non-EMU personnel who propose research on EMU personnel that requires IRB review, shall complete IRB-approved researcher training and then submit their proposals to the IRB using the online 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.

The IRB requires all researchers submitting proposals to complete the online researcher training provided by NIH (the website requires the establishment of a no-cost account). This training covers basic concepts, principles, and issues related to the protection of research participants. When training is successfully completed, the researcher will receive a certificate. This certificate should be saved (as an image or pdf file) and kept on file – proof of training is required when submitting an IRB proposal. Training must be successfully repeated every four years (see instructions on the NIH website for how to repeat the course).

Categories of Proposals and Review

Research proposals fall into one of three categories as follows:

Full Board Review Research Proposals
Research projects that involve more than minimal risk to participants and/or that involve vulnerable populations 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. Researcher training is required prior to submission.

Expedited Research Proposals
Research projects that involve no more than minimal risk to participants and do not involve vulnerable populations but are presented beyond the realm of the actual classroom, including thesis publication, are eligible for expedited review. Researchers must submit proposals for such projects using the online procedures described herein; however, these projects may be reviewed by the Chair and one other Board member at any time. Researcher training is required prior to submission.

Classroom Research Proposals
Research projects are considered classroom research if they 1) involve human participants for instructional purposes only, 2) involve no more than minimal risk to participants, and 3) do not involve vulnerable populations. Completion of researcher training is up to the discretion of the course instructor. 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 the 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 publish or present research findings outside the realm of the actual classroom (including thesis publication), then the student should submit a separate IRB proposal following the online procedures described herein.

Proposal Process

The researcher for the proposed research is to submit an online proposal form to the IRB Chair.

The online proposal for Expedited and Full Board Review includes the following elements:

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

The proposal for Classroom Research includes the following elements:

1. Name(s) of supervising faculty, including email contact information
2. Faculty Assurance Form
3. An addendum listing the classroom projects to be approved

Research proposals requiring full Board review are due one week prior to each monthly meeting of the IRB. Meeting 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 online submission process. The Chair decides if a proposal requires full Board review using the IRB Proposal Decision Tree. If a research proposal does not require full Board review, the Chair will send written verification of the approval 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 be evaluated 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. Modifications may be required. 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 only granted approval for a one-year period, according to OHRP Federal guidelines. If research extends beyond a period of one year, and the research procedures have not changed, then the researcher shall request an extension by emailing the IRB Chair. If research extends beyond a period of one year, and the research procedures have changed, then the researcher must submit a new proposal. This procedure assures continuing review.

Upon concluding the research project, the researcher will complete and submit to the Board the online Follow-Up Report. This report documents the conclusion of the study and participation in the project, as well as any unanticipated events and complaints.

Researchers must inform the Board immediately if the research deviates from the proposal or if any harm or adverse event occurs to research participants. The Board will review reports of harm to participants on a case-by-case basis and determine if significant harm has occurred. 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 significant harm to participants. Board notification of such to the researcher(s) should include rationale.

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 (see the EMU template). Informed consent includes:
   • Explanation of purposes, procedures, and timetable of the research.
   • 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).
   • Description of any expected benefits.
   • Description of provision for anonymity and/or confidentiality.
   • Description of voluntary nature of participation and ability to discontinue participation if desired.
   • Names of people to contact for answers to questions.
   • 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 reasons must be justifiable (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 the director of institutional research and effectiveness.
5. One member shall be a student.
6. A member may not participate in decision making if she/he has a conflicting interest.
7. 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 renewable term of two years .