MSU HRPP Manual Section 8-8-B

8-8-B, Exemption Category 8

Exemption Category (8)
(i) Research involving benign interventions in conjunction with the collection of data from an adult subject through verbal or written responses (including data entry) or video recording if the subject prospectively agrees to the intervention and data collection and at least one of the following criteria is met:

(A) The information obtained is recorded in such a manner that human subjects cannot be identified directly or through identifiers linked to the subjects; or

(B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.

(ii) For the purpose of this provision, benign interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. If these criteria are met, such benign interventions might include research activities in which a subject is asked to read materials, review pictures or videos, play online games, solve puzzles, or perform cognitive tasks.

(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception as described in paragraph (d)(3)(iv) of this section.

(iv) For the purpose of this provision, authorized deception is prospective agreement by the subject to participate in research where the subject is informed that  he or she will  be unaware of or misled regarding the nature or purposes of the research.

Exclusions
To qualify for exemption category (8), the research project must not include any of the following:

  • Federal funding or federal training grants

  • FDA regulated

  • Sponsor or other contractual restrictions

  • Clinical interventions (including clinical behavioral interventions)

  • Prisoners as subjects

  • Receipt of an NIH issued certificate of confidentiality to protect identifiable research data

  • Be a project for which MSU serves as the IRB of record

  • Children as research subjects

If any of the above criteria become applicable to a project determined exempt under this flexibility initiative, the IRB office must be promptly notified prior to implementation of the criteria and the project must be reviewed and approved in accordance with the appropriate review level (e.g. expedited, full board).

Requirements
The requirements in HRPP Manual 8-1, “Exemptions” apply to activities that meet the criteria for exemption category (8).Research studies which meet the above criteria for exempt category (8) will be evaluated and determined exempt by IRB staff and/or the IRB chair when appropriate. See the following HRP Manual section for review procedures: HRPP Manual 8-1 “Exemptions.”

Process
The investigator must submit an exempt application or renewal application to the IRB. Review procedures as defined in the HRP Manual will be followed for applications under consideration for exempt category (8). See HRPP Manual 8-1 “Exemptions.”

IRB staff will review the application and determine if the research meets the criteria for exempt category (8). The IRB staff will provide the criteria to the PI to confirm that the research does not include any exclusions. If the PI confirms that the project satisfies inclusion and exclusion requirements. and the research study meets the criteria for the flexibility initiative, the exempt determination will be documented and processed in accordance with HRPP Manual 8-1 “Exemptions.” In addition, a worksheet will be used to document the exempt category (8) determination. The completed worksheet will be placed in the file.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 12-11-2015. Revision 1 approved by Assistant VP Regulatory Affairs on 7-21-2016.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 8-8-B, Exemption Category 8.