Review Process

All Marist human subject research projects must undergo review and approval by the IRB prior to initiating research activities. The Federal Regulations for Protection of Human Research Subjects (CFR 45 Part 46) specify three categories of review (exempt, expedited, and full board) that an IRB can use to make a determination regarding human subjects research.

Exempt Review:

Under federal regulations, certain types of research may be exempt from further IRB review if the study involves no more than “minimal risk” and falls into one or more of six exempt categories. Minimal risk is defined by the federal regulations as the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. The determination of exemption may not be made by the investigator. Exempt reviews are conducted by at least one member of the IRB. In order to qualify for review via exempt procedures, the research must not be greater than minimal risk and must fall into at least one of the exempt categories defined by federal regulations

Summary of Exempt Categories:

1. Education research
2. Surveys, interviews, educational tests, public observations (that do not involve children)
3. Studies of public officials
4. Analysis of previously-collected, anonymous data
5. Public benefit or service program
6. Consumer acceptance, taste, and food quality studies

Expedited Review:

The IRB may use an expedited review procedure when the research involves no more than “minimal risk” to the subjects and where the only involvement of human subjects will be in one or more of the expedited category. For example: blood draws; non-invasive specimen samples; data collected from running on a treadmill; sensitive identified interviews; and secondary data analysis from non-public sources. 

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Full Review:

A full board review is required for research that is not eligible for exempt or expedited review. In short, research that is judged to involve more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a full board review. Individuals intending to conduct research that requires a full board review should allow ample time to complete the review process.

The following categories of research require full IRB approval:

• Projects for which the level of risk is determined by the IRB Chair to be greater than minimal.

• Projects that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants.

• Projects that involve sensitive or protected populations (such as children or cognitively disabled individuals).

• Projects that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal).

Extension of Previously Approved Research

To request re-approval, the researcher must complete and submit the IRB Extension Review form along with any required material as described in the instructions. This form is to be used in cases in which a researcher would like to extend the deadline of a previously approved and currently active study. No other changes to the proposal regarding procedure or personnel is allowed.  

The Chairperson can approve both Expedited and Full Reviews, however, the chair may direct review to the entire committee. For full review, the outcomes of review of amendments by the convened board are the same as the options outlined under Initial Review by the Full Board.

Amendments to Previously Approved Research

A researcher may amend his/her approved protocol by submitting an IRB Amendment Review form. Minor changes can be approved by expedited review.  All other changes will be reviewed by the full board.  

The Chairperson can approve both Expedited and Full Reviews, however, the chair may direct review to the entire committee. For full review, the outcomes of review of amendments by the convened board are the same as the options outlined under Initial Review by the Full Board.