III. Review of research

Muhlenberg College’s IRB shall review and have the authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. In reviewing research, the IRB is committed to protecting the interests and rights of human subjects and to carry out its charge in a way that minimizes interference with the autonomy and objectives of individual researchers.

All review of research requires the researcher(s) to submit the appropriate form as well as supporting documentation including the research protocol, informed consent forms, recruitment materials, and any grant application(s) relating to the proposed research.  These materials shall be distributed to the appropriate reviewer(s), who will typically have between 5 to 10 days to consider the proposal before any action is taken.  For proposed research requiring full committee review, the review shall occur at a convened meeting at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.  The IRB committee will establish meeting dates of no less than twice a month and will distribute meeting dates to the faculty prior to the start of each semester. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.  For expedited review or review to determine that proposed research is exempt, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB or Departmental Coordinators.  In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research.  A research activity may be disapproved only after full committee review as described above.

The IRB shall notify researchers in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure IRB approval of the research activity.  Under expedited or exempt review categories, the reviewer will notify the researcher as well as the IRB chairperson, who will update other members of IRB at regular meetings.  Reports from Departmental Coordinators are to be made to the IRB Chairperson annually (typically in April).  The IRB chairperson will submit a written report of all proposal review decisions and other actions annually to the Signatory Official.  A general report of IRB activities will be provided to the Faculty at or before the last regularly scheduled faculty meeting of the academic year.

If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision (e.g. risks outweigh benefits).  A researcher(s) may initiate an appeal in writing to the IRB Chairperson.  The researcher may submit information pertinent to the proposal and may request a meeting with the IRB. The IRB may request additional information relevant to the proposal from either the researchers or others. The appeal will be considered by the full IRB and the decision will be determined by a majority vote of all voting members of the IRB.

Muhlenberg College is committed to academic freedom, and given its educational function, the IRB is committed to working with researchers to develop proposals that meet ethical standards as articulated by this College policy and federal guidelines. As specified in federal guidelines, research covered by this policy that has been approved by the IRB may be subject to further review by College officials.  While officials might be able to restrict an approved project based on considerations other than ethical grounds, they may not approve the research if it has been disapproved by the IRB. College officials will provide the researchers with rationale for any administrative decision that restricts research.

Continuing research must be reviewed annually either by the IRB Chairperson or the Departmental Coordinator.  It is the responsibility of the researcher to initiate this review (see Appendix D).  The Chairperson may, at his/her discretion or in consultation with members of the IRB, deem a proposed project as involving higher risk to human subjects and specify in the approval letter the need for and terms of more frequent review.  If at any time there are substantive changes in the research plan, the researcher must resubmit a modified proposal to the IRB Chairperson or Departmental Coordinator for review and further action.

Following approval, researchers are expected to proceed with their study in accordance with the research protocol as approved. Researchers must promptly report (within two weeks) any unanticipated problems involving risks to subjects or others to the IRB. The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the researcher and appropriate institutional officials (typically, within two weeks), and (if applicable) to the appropriate granting agency official within four weeks.

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