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Types of Human Subjects Review

Exemption Review

Applicability

Under certain circumstances, human subject research activities subject to the IRB may be granted exempt status.  The significance of exempt status, which may be requested by an investigator when submitting an application to an IRB and may be granted by the IRB Chair or designees, is that the research activity is not monitored by the IRB. Assuming the project does not change, it also is not subject to continuing IRB oversight. Exempt status does not, however, lessen the ethical obligations to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct. Thus, depending on the circumstances, researchers performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.

It is the policy of Siena College IRB that to be deemed exempt, human subjects research activities must be reviewed and determined to fall within one or more of the explicit exemption categories listed in the federal regulations. Review the Exemption Review Policy for further information. 

IRB Review Process

Under exempt review process, the review is carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB.  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 review in accordance with procedure set forth in §46.108(b).

Application Submission

Please submit one (1) original hard copy of the required sections for exempt review to Siena Hall, Room 202.

Expedited Review

Applicability

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

Examples of expedited review include, but are not limited to:

  • Interviews or surveys on non-sensitive topic areas
  • Observation of classrooms involving no interaction with students or disruption of daily classroom work
  • Anonymous, non-interactive observation of public behavior
  • Research involving no psychological intervention or deception
  • Anonymous telephone or mail questionnaires on innocuous topics

IRB Review Process

Under an expedited review procedure, the review is carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB.  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 review in accordance with the non-expedited procedure set forth in §46.108(b).

Application Submission

Please submit one (1) original hard copy of the IRB Application for review with all accompanying materials (i.e., Informed Consent Form, instrumentation, debriefing statement) and required signature(s).  Please submit the IRB application to Siena Hall, Room 202.

Full Board Review

Applicability

Full board review involves a convened meeting at which the majority of the membership of the IRB are present, including at least one member who primary concerns are in nonscientific areas. 

IRB applications that involve the following areas may require full board review:

  •  Research that involves interaction with minors (under the age of 18)
  •  Research placing humans at psychological or physiological risk that is greater than minimal risk
  •  Research on special populations (i.e., prisoners and mentally incompetent individuals)
  •  Research involving pregnant women
  •  Research involving deception
  •  Research involving sensitive topic areas

IRB Review Process

Under the full review procedure, this type of review is first determined by the IRB chairperson after careful examination of the application submitted. For the research to be approved, it must receive the approval of a majority of those members present at the meeting. The PI may be requested to attend a full board meeting to discuss the proposal and answer questions posed by the IRB.  A typical full review may take between 1-3 months before a decision is rendered. 

Application Submission

Please submit one (1) hard copy with original signature(s) of the IRB Application with all accompanying materials (i.e., Informed Consent Form, instrumentation/survey, NIH Certificate of Completion, debriefing statement).  Please submit IRB applications to Siena Hall, Room 202.

As of September 1, 2014