Policy on Human Subjects: Institutional Review Board

Updated as of July 1, 2018

1. Purpose of the Institutional Review Board (IRB)

To protect human subjects involved in research conducted by persons affiliated with Wesleyan University.

If human subjects are involved in research, the IRB reviews and approves those aspects of research protocol that may have an impact on the human subjects of the research, solely for the purpose of protecting those human subjects. The need for IRB approval extends to any manner of research, including experiments, interviews, surveys, and other data collecting methods. This process is designed to protect the rights and welfare of human participants by ensuring that they are selected equitably, participating voluntarily, fully informed of the risks and benefits of the research, and that the research minimizes risks to humans and protects their privacy and confidentiality.

The IRB must review and approve externally sponsored ongoing projects at least once a year and all projects involving human subjects whenever changes occur in the research design.

The IRB must be notified of any unanticipated problems involving risks to subjects or others, including physical or psychological injury to subjects, improper disclosure of private information, economic loss, or other potentially harmful occurrences.

2. Scope

The IRB is responsible for reviewing, either with a full board review or an expedited review, all research involving human subjects conducted by faculty, researchers, students, or staff of Wesleyan University.

3. Process for Submitting Projects to the IRB

a. Application Instructions

For the most up to date information, see:

Anyone planning research involving human subjects needs to submit to the IRB the following information:

(1) A copy of the research proposal including a summary of the research, a description of the subject population, and the method by which subjects will be recruited. If IRB review by the full committee is warranted, the principal investigator should submit ten (10) copies of the research protocol.

(2) The research protocols (e.g., recruitment letter, poster, ad, etc.)

(3) The Informed Consent Statement which will be used in the research and an explanation of the method by which informed consent will be obtained.

(4) The process by which subjects will be debriefed following the study.

(5) An explanation of how subjects’ privacy will be guaranteed.

A description of how the data will be stored, for how long, and how and when it will be destroyed, as well as who is responsible for the data during this period.

b. Schedule of Meetings

Student research should be submitted to the IRB according to the following timetable:

(1) First semester course research—by last week of October
(2) Second semester course research—by last week of February
(3) Summer research—by mid-April

For exact deadline dates, please check the IRB’s website.

Most often, though not always, student proposals are given an expedited review.

Faculty, administration, and research grants are currently being reviewed on an as needed basis—with the stipulation that the full committee can be convened ten days after the materials (as outlined above) have been submitted to the IRB.

The schedule for an expedited review is usually two to three days following receipt of the materials (as described above).

c. Communication of status of application

Principal investigators generally are informed of the status of the proposal within a day or two following the meeting. In some cases, clarification, revisions or changes to the protocol are necessary prior to formal approval. In such cases, the investigator is sent a memo with the recommended revisions and is asked to comply by instituting the changes and the principal investigator is expected to confirm the changes recommended. A formal letter and/or memorandum of approval is usually mailed by the IRB chair to the principal investigator within a week after the meeting, or when warranted, after the recommended revisions to the protocol have been made.

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