SOM 2510 - Consenting for Medical Education Research

Authorizing Body:

Office of Research

Date Issued:

September 7, 2018

Last Update:

October 23, 2026

Last Review: 

October 23, 2026

Rationale: 

The purpose of this policy is to codify a process by which medical education research may be conducted using student data/records that are collected primarily for educational purposes. This policy is intended to minimize the burden on student study subjects that would be imposed by the alternative approach of requiring a separate consent for every research query. Using a single consent process, students are provided with the option to voluntarily participate as study subjects in medical education research that fulfills the criteria specified in this policy.

Scope and Applicability:

All students enrolled in the School of Medicine.

Standard Practice Guideline:

Students may provide one-time consent for participation in all IRB-approved medical education research projects that use student data and educational records. The use of this one-time consent is permitted under the following criteria only:

1. The data/information covered by this consent includes only those data that are collected for legitimate educational purposes (i.e., records directly related to a student and maintained by the University or its agent) and any related, relevant information associated with those data that is already contained in those educational records (e.g., demographic data). 
2. The data/information covered by this consent does not include those elements specifically excluded by the Oakland University FERPA policy or FERPA, and for the purposes of this consent also excludes: a) in-class assignments or papers not collected by the instructor or professor; b) any assignment data collected through the longitudinal PRISM courses; c) comments on clinical performance evaluations that are specifically designated as “for formative purposes” or “student information only”; d) any information related to disability student services-granted accommodations; e) advising or counseling notes intended to support advising of individual students; f) student emails sent through Moodle; g) criminal background checks; and h) content contained in letters of recommendation.
   

Research that uses data that falls outside of these stipulations and/or that requires data collection for anything other than legitimate educational purposes is not covered by this release and would require a study-specific records release signed by the students participating in those projects. Use of these data for the purposes of program evaluation, as determined by OU-IRB, does not require student consent.

Procedures:

1. During the M1 orientation, medical students will be solicited for consent to use the educational records data described in this policy. Students are given instructions on how to opt in and give their consent for the release of data under the terms restricting its use as described in this policy. 
2. Students may withdraw their consent by contacting the Office of Medical Education (meded@Oakland.edu) at any time. The withdrawal of consent will apply to any studies for which data extraction has not yet occurred.

Definitions: 

See Oakland University FERPA Policy/Guidelines for key definitions related to educational records. 

Related Policies and Forms:

Oakland University FERPA Policy
Oakland University 860 Information Security
Use of Student Data for Research

Appendix:

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