The Office of Sponsored Programs and Research

IRB

Human Subjects Protection in Research-
Frequently Asked Questions

1. WHY SHOULD I BE CONCERNED ABOUT THE PROTECTION OF HUMAN SUBJECTS?

It is the ethical thing to do, and it is mandated by Federal Regulations, 45 CFR 46.

2. WHAT ARE THE MAJOR REQUIREMENTS OF 45 CFR 46?

The regulations require institutions conducting research involving human subjects to establish Institutional Review Boards (IRBs). IRBs reviews research (biomedical, social or behavioral) prospectively from the viewpoint of protecting the rights and safeguarding the welfare of human research subjects.

3. HOW DOES THE IRB PROTECT THE RIGHTS AND WELFARE OF HUMAN RESEARCH SUBJECTS?

The IRB prospectively reviews all research involving human subjects. In addition, the IRB conducts continuing review of each approved protocol at least annually. The IRB may modify, suspend or terminate approval of research that has been associated with serious harm to subjects, or is not being conducted in accordance with the IRB’s decisions, stipulations or requirements. Committee membership is diverse with expertise in the sciences, ethics, and other non-scientific areas, thereby fostering a comprehensive approach to the protection of human subjects.

4. WHAT ACTIVITIES QUALIFY AS HUMAN SUBJECTS RESEARCH?

Simply stated, “any systematic attempt to collect information and gain generalizable knowledge about humans” would qualify. Federal Regulations 45 CFR 46 defines research as “a systematic investigation, including research development, testing, evaluation, designed to develop or contribute to generalizable knowledge”. They define human subject as “a living individual, about whom the investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

5. HOW DO I KNOW IF MY STUDY NEEDS TO BE REVIEWED BY THE IRB?

All studies conducted by MSU faculty, students or administrators will need to be reviewed by Morgan’s IRB if human subjects or participants are involved. The Committee will decide what needs to be exempt. This provides protection for the participants, the researcher and the institution. If you are not sure, contact the IRB administrator in the Office of Sponsored Programs at X3447 or the IRB chair at extension 4030.

6. WHAT MATERIALS DO I NEED TO SUBMIT TO THE IRB?

Submit your packet to the IRB administrator including the following:

(a) project summary

(b) completed and signed “Human Subjects Application Form”;

(c) the research protocol;

(d) the informed consent form;

(e) any interview questions, questionnaires, tests, etc.

7. HOW LONG DOES THE APPROVAL PROCESS TAKE?

The IRB generally meets monthly and applications must be submitted to the IRB Administrator at least ONE week prior to the monthly meeting. Late applications will be reviewed in the subsequent meeting. To get a copy of the IRB meeting dates and the corresponding deadlines for submitting applications, please call Extension 3447 and ask for the IRB Administrator.

8. I HAVE MORE QUESTIONS THAT HAVE NOT BEEN ANSWERED HERE. WHAT SHOULD I DO?