Randolph-Macon College has elected to follow a dual-path for research involving human subjects.

Most projects that involve students performing research as part of a course will follow the “Student-generated Human Subject Research” pathway.  The purpose of these HSR projects is usually to teach the students about research.  Obtaining IRB approval for student-generated HSR involves less documentation and a shorter application, but still requires a faculty or staff member PI to supervise the research.  Student projects that involve more than minimal risk or protected populations cannot use this application process.

All projects that are part of a faculty or staff member’s research, that are grant-funded, or that involve protected populations or more than minimal risk should follow the “Faculty or Staff Generated Human Subject Research” pathway.

The required documents for each research pathway can be found below.  Please email the IRB chair at IRB@rmc.edu if you have any questions about the process or documentation.

Please note that students may not be listed as Primary Investigator on ANY project at Randolph-Macon College. 

Student-Generated Human Subject Research

The following documents must be included in all applications. Additional documents could be necessary depending on the nature of the proposed research.

  1. Student Generated Research IRB Application
  2. Informed Consent Template Student

Primary Investigators must also have a current CITI certification on file with the IRB.

Faculty and Staff Generated Human Subject Research

The following documents must be included in all applications. Additional documents could be necessary depending on the nature of the proposed research.

  1. Faculty and Staff Generated Research IRB Application
  2. Informed Consent form
  3. CV or Resume for all investigators
  4. Financial Interest Disclosure Form (one for each member of the research team)

All investigators must have a current CITI certification on file with RMC.  If investigators are externally certified, please include a copy of the certificate in your submission.

Modifying an Approved Project

Approved IRB applications at Randolph-Macon College no longer expire.  If you need to modify an approved project (change a protocol, add or remove a PI or co-PI, etc.) please download, fill, and submit the IRB Project Change Form to IRB@rmc.edu.  

Standard Operating Procedures for the Human Research Protection Program

This manual is based on applicable federal regulations, Virginia state statues, and Randolph-Macon Policy as they pertain to the conduct of human subject research at Randolph-Macon College.

The SOP July 2021 (SOP) manual is intended to be a dynamic and useful document. We welcome your comments about the contents and structure. If you have suggestions on how to improve the document, please send your suggestions to the Provost’s Office.

Projects Approved at Other Institutions

Faculty and staff members conducting research projects that have been approved by an IRB at another institution do not need to seek IRB approval at Randolph-Macon College.  The IRB requests that the researcher alert the IRB Chair in these situations so that we may note that the project is being conducted on our campus.  If possible, please provide the chair with the approval certificate for our records.

External Research Projects Involving Human Subjects (HSR)

The Randolph-Macon College IRB generally does not allow for external research projects involving human subjects to be conducted on our campus by those who are not members of our campus community.  Please contact the IRB at IRB@rmc.edu for more information about this policy.