July 2020

Ethical concerns arise when Johns Hopkins staff or students serve as volunteers in Johns Hopkins clinical research. These concerns relate primarily to the risks of possible undue pressure and potential loss of confidentiality.

On January 21, 2020, Johns Hopkins University adopted the "Enrolling Employees in Human Subject Research Policy (GEN010)". The JHM IRBs will review applications in accord with this policy.

On January 21, 2020, Johns Hopkins University adopted the "Enrolling Students in Human Subject Research Policy". The JHM IRBs will review applications in accord with this policy.

Faculty who submit applications that will involve students and employees must address the following points:

• Investigators must have strict protections in place to protect confidentiality. Threats to confidentiality are greater when volunteers are members of the Hopkins community, especially when they are known to research staff.
• Recruitment of Employees and Students is allowed but they may not be solicited directly on a personal basis. Acceptable recruitment methods are: 1) posting of IRB-approved flyers/ads, and 2) sending written notices/invitations to those individuals who have previously agreed to receive such solicitations. Solicitations should not be in person or by telephone.
• Investigators may not enroll Employees or Students who report directly to them, except when the research is designated by the IRB as minimal risk. Individual exceptions for studies where there may be therapeutic benefit, but greater than minimal risk, will be considered by the IRB on a case by case basis. IRB chairs or their IRB member designees may decide such individual cases.