The Code of Federal Regulations, Title 45, Part 46, published by the Office for Human Research Protections defines the following review levels and definitions:

Exempt Determinations

Exempt research must be minimal risk. If your research involves minors, pregnant women, prisoners or other vulnerable populations, it is not eligible under the Exempt category.

Exempt categories include (see regulations for full details):

  1. Research conducted in educational settings, instructional strategies or techniques, curricula, or classroom management methods...
  2. Research involving surveys, interviews, observation of public behavior, education tests (cognitive, diagnostic, aptitude, achievement)...
  3. Bening behavioral interventions in conjunction with the collection of information...
  4. Secondary research use of identifiable private information or identifiable biospecimens...
  5. Research and demonstration projects that are conducted or supported by a Federal department or agency...
  6. Taste and food quality evaluation and consumer acceptance studies...
  7. Storage or maintenance for secodary research for which broad consent is required...
  8. Secondary research for which broad consent is required...

When an Exempt level protocol is submitted to the IRB, the IRB Administrator will review first and send back any modifications or additional questions to the Principal Investigator. Once the IRB Administrator's modifications have been addressed, the IRB Chair will review and approve the protocol once all modifications have been addressed. Exempt level protocols will expire five years after the approval period and require IRB renewal if research activities continue beyond the five years.

Review Level Determination

The following topics or methods are typically NOT eligible for Exempt Review:

  1. Vulnerable populations (prisoners, pregnant women, etc.)
  2. Social or behavioral interactions/interventions with minors
  3. Specifically seeking subject groups of a distinct ethnicity, race, or religion
  4. Initial collection of human biospecimens
  5. Blood draws
  6. Body sensors, body measurements, or physical detection tests
  7. Invasive procedures
  8. Drugs, substances, and medical devices
  9. Matters relating to civil litigation
  10. Research procedures involving deception when the subjects are unaware that they are being deceived
  11. When identifiable, questions posed to subjects seeking answers that, outside the research, could place the subjects at risk of criminal or civil liability, or be damaging to their financial standing, employability, education advancement, or reputation
  12. When identifiable, questions posed to subjects about their own sexual or criminal behaviors or alcohol/substance abuse
  13. Questions posed to subjects about their own suicidal thoughts
  14. More than minimal risk research

Expedited Review

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more categories by the federal Office for Human Research Protections may be reviewed by the IRB through the Expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. 

  1. Expedited level protocols will be reviewed initially by the IRB Administrator who will send back any modifications or additional questions to the Principal Investigator. Protocols will be reviewed by at least two committee members of the IRB with the following possible outcomes:

                    a. The reviewers will unanimously approve or disapprove the proposal. Either reviewer may require that

                        further modifications to the proposal be made prior to approval.

                    b. Reviewers can recommend that the application be reviewed by the Full Committee at a convened IRB

                        meeting.

        2. Protocol decisions will be presented to the full IRB for approval at the next meeting.

        3. Minor amendments in previously approved research may be reviewed and approved by the Chair.

Expedited level protocols will expire in five years after the approval period and will need to be renewed for continued research. Some protocol submissions qualify for Exempt but are submitted as Expedited; in these situations, the protocols will be reviewed through the Exempt process.

Use of Secondary Data

The use of secondary data is allowed at all levels of review. However, when the seconary data is private and identifiable, while be obtained from sources that were not originally deemed "research", and the researcher will not be gaining consent, it does not fit within the Exempt level categories and will need to be submitted as an Expedited (category 5 or 7) review.

IRB protocols that fall into this category will be reviewed by the IRB Administrator and IRB Chair and will not be handled in the same "Expedited" procedure due to the level of risk (minimal) unless deemed higher risk upon review. If the level of risk is higher than minimal, the standard Expedited review process will be followed.

The two main categories for Exempt review for secondary research are the following:

Exempt Cateogry 4 - Secondary research use of identifiable private information or identifiable biospecimens (consent is not required if at least of the following criteria is met):

  1. Data is publicly available.
  2. Information is recorded by the investigator in such a manner that the identity cannot be readily ascertained.
  3. Research involves only information collection and analysis involving the investigator's use of identifiable health information; or
  4. Research is conducted by, or on behalf of, a Federal department or agency.

Or

Exempt Category 8 - Secondary research for which broad consent is required.

Based on these two categories, the secondary research explained in this section would not fit these categories due to the access to identifiable and private information and consent not being used.

Therefore, the Expedited categories (5 and 7) will be used whith state the following:

Expedited Category 5 - Research involving materials (data, documents, records, or specimens, that have been collected, or will be collected for non-research purposes.

Or

Expedited Category 7 - Research on an individual group or group characteristics or behavior (e.g., perception, cognition, motivation, identity, language, communication, cultural beliefs/practices, and social behavior) or eploying a survey, interview, oral history, focus group, program, or human factors evaluation, or quality assurance methodologies.

Full Committee Review "FCR"

Research involving more than minimal risk and/or vulnerable populations (e.g., children, economically or educationally disadvantaged persons, severely ill or mentally ill persons, veterans, pregnant women, or prisoners) must be reviewed by the Full Committee. IRB (FCR) protocols that involve a conflict of interest may also be subject to FCR.

When a FCR is submitted, the IRB does the following:

  1. Initial review by the IRB Administrator who will send back any modifications or questions to the PI to address.
  2. The IRB Administrator will assign an IRB committee member as a primary reviewer to present the protocol at the IRB meeting.
  3. The IRB Administrator will send the Full Committee protocol to the committee to review the FCR protocol. All committee members are expected to review the FCR protocols.
  4. The IRB will review and discuss protocosl and may make one of three determinations:
    1. Approve: The IRB may make a motion and vote to approve the protocol as submitted.
    2. Return for Modification: If additional information or clarification is required to secure approval, the IRB Program Administrator will communicate the items from the committee to the PI. There are two options for approval after a return for modification:
      • Return for Modification and Approve by Subcommittee Designated Member Review (DMR): Responses to committee comments are returned and voted upon by a subcommittee. If the subcommittee votes unanimously that the concerns were adequately addressed, the protocol is approved. If the subcommittee does not vote unanimously for approval, the protocol is returned for modification and the PI must resubmit the protocol for full committee consideration.
      • Return for Modification and approved by the IRB Administrator: Minor modifications such as updating personnel training or other entity approval letters may be approved by the IRB Administrator upon resubmission.
    3. Withold approval: If a majority of the IRB believes that the proposed research activities pose too much risk for the subjects, the proper expertise or facilities are not available, or the protocol lacks sufficient details, the protocol will be disapproved. In such cases, the IRB will provide feedback to the PI and make recommendations regarding potential resubmission.

Full Committee level reviews expire in five years, however, an interim review is required annually, to continue research.

MSU IRB operates by consensus. To be approved, a protocol must receive a majority vote (>50%) from the IRB committee. Any member's request for clarification or revision of an application will be documented in the IRB's final decision and will be recorded in the minutes.          

IRB Application Instructions 

Determinations

See the definition of Human Subjects Research for more information. Review level decisions will be made by the IRB but please contact the IRB Office for determination assisatance and review level questions. 

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