Welcome

Purpose:
This policy is designed to protect the rights of human research subjects, to meet the requirements for an IRB for the Higher Learning Commission and to comply with Federal Regulations 45CFR 46.

Who is affected:
All MSSU personnel and students who conduct research using human subjects must have their research reviewed. Research is defined as  a systematic investigation designed to develop and contribute to generalizable knowledge  (45 CFR 46), including surveys, tests, observations or experiments where results could be reported in professional meetings and/or publication. If the results are not distributed outside the classroom, institutional setting or are solely for program review and/or evaluation, they need not have IRB approval. All personnel and students must adhere to ethical guidelines at all times when using human subjects in research.

Who is involved:
An Institutional Review Board is appointed by the Vice President of Academic Affairs. Two representatives of each academic school, two representatives whose primary concerns are in nonscientific areas, two members from the community outside of MSSU, the Assistant Vice President for Assessment and Institutional Research (IRB Manager), and the Assistant Vice President for Academic Affairs serve for three year terms. Academic departments who routinely conduct several minimal risk research projects may establish a Departmental Review Panel (DRP). The DRP can set guidelines consistent with the IRB policies and their discipline s professional ethical guidelines.

Training:
IRB and DRP members must complete training, which is available from http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp .

Types of Reviews:
(See Review Types - Policy Part Two)

1) Exempt Review

Exempt review is used for research presenting less than minimal risk (see page 3-5 IRB Policies), which would involve no known physical, emotional, psychological, or economic risk, to nonvulnerable subjects. Nonvulnerable subjects are people who can give truly voluntary informed consent, which excludes children, people with mental disabilities, prisoners, and pregnant women, if there is potential for harm to the fetus.

2) Expedited Review

Expedited review is used for research presenting minimal risk (see page 5-7 IRB Policies) to nonvulnerable participants or less than minimal risk to vulnerable participants. Minimal risk includes research involving surveys, questionnaires, interviews, voice, video recordings, noninvasive clinical procedures that do not involve anesthesia, sedation, x-rays, microwaves, collection of blood by finger stick, heel stick, ear stick or venipuncture.

3) Full Review

Full review is used for research not qualifying for Exempt or Expedited Review.

Review Procedures:
Researchers must complete a Human Subject Review Application (See attached form and p. 9-11 IRB Policies for explanation of informed consent and debriefing). Please see the attached flowchart for a summary of review procedure.

1) Exempt Review

If a project originates in a department with a DRP and the research supervisor or principle investigator believes that the research is exempt, then it is reviewed by a reviewer on the DRP. If a DRP is not in place, then one IRB member will review the research.

2) Expedited Review

If a research project originates in a department with a DRP and the research supervisor or principle investigator believes that the research meets the expedited criteria, then it is reviewed by a reviewer on the DRP and one IRB member. If a DRP is not in place, then it is reviewed by two IRB members.

3) Full Review

If a research project requires full review, the Application will be sent to the IRB manager requesting a full review. The IRB will meet the second and sixth weeks of the spring and fall semesters to conduct full reviews. Approval requires a majority vote of members present.

The IRB manager informs the research supervisor or principle investigator of the IRB decisions in writing for all types of reviews. All documentation is stored at the office of the IRB Manager.