Authorizing Body:

Author:

Jason Wasserman, Ph.D.

Date Issued:

Last Update:

Scope and Applicability:

Purpose and rationale:

The purpose of this guideline is to codify a process by which medical education research can be conducted using existing student data/records that are collected primarily for educational purposes.  This guideline 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 will be provided with the option to voluntarily participate as study subjects in medical education research that fulfills certain criteria specified in this guideline.

Standard Practice Guideline:

Students may provide a single consent for participation in medical education research that uses existing student data and educational records. The use of a single consent and waiver of the requirement for separately consenting for each individual study is permitted under the following criteria only:

1. The data/information covered by this consent includes only those data that were 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). 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 teacher or professor; b) any assignment data collected through PRISM (a wellness curriculum); 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 system; g) student comments in notepad tool; h) criminal background check; and i) content contained in letters of recommendation.
2. Access to the appropriate selected datasets are limited to OUWB faculty and staff who have obtained the IRB approval necessary for the conduct of the research including without limitation standards for maintenance of confidentiality.
3. All requests for access to datasets from the educational records of students should be submitted to the Director of School of Medicine Records and Registration. Prior to release of such data, the OUWB Office of Medical Education must verify the appropriateness of the use requested based on the educational context in which the dataset was designed and collected. This verification will be indicated by a signature of an Associate Dean for Education or his or her designee.  Additional stakeholders such as course directors (for assignment-level data in courses), the Assistant Dean for Admissions (for data contained in the AMCAS file), or the Associate Dean for Clinical Education may need to be involved in determining the appropriateness of the use of data for study purposes.  
4. Students may withdraw their consent by contacting the Associate Dean for Preclinical Education at the Office of Medical Education at any time (see procedures below).

Procedures:

1. At the beginning of the M1 year, and again at the beginning of the M3 year, medical students will be solicited for consent  to use  the educational records data described in this policy by faculty with approved research designs.  If a student does not sign the form at either the beginning of the M1 or M3 years, they are considered to have not given their consent from that point forward, until such a time as they do sign a consent form.  
2. Students who opt in and give their consent to the release of the above described data, under the terms restricting its use described in these guidelines.  Students may withdraw their consent by contacting the Associate Dean for Preclinical Education at the Office of Medical Education at any time and filling out the withdrawal of consent form. This withdrawal of consent will apply to any studies for which data extraction has not already occurred.
3. OUWB faculty and staff wishing to access the educational data covered under these guidelines must secure appropriate approvals from and the OU Institutional Review Board and the Office of Medical Education (as described above). 

Definitions:

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

Related Policies and Forms:

Oakland University FERPA Policy/Guidelines

Oakland University Information Security

Medical Education Research Data Access Form