The safety of participants in clinical research is of paramount importance. There are many federal, state and institutional regulations and policies in place to protect participants in clinical research. The University of Maryland, GCRC Research Subject Advocate works to enhance these protections by providing additional oversight for the research and acting as an independent advisor to the GCRC Advisory Committee and staff, research investigators and study participants.

Independent Oversight

RSA activities which provide additional oversight include:

• Review protocols to ensure research is designed safely, ethically and in accordance with all applicable regulations and policies
• Monitor research activities to ensure the research is carried out in compliance with the most recently IRB-approved protocol
• Ensure timely reporting of adverse events
• Assist in the development of Data and Safety Monitoring Plans (DSMP) and monitors compliance with the plan once approved
• Review protocol modifications, annual reports, and reportable events
• Acts as a liaison with the Human Research Protections Office (HRPO)

Advocacy for Study Participants

The RSA is available to assist research participants in understanding clinical research and the role they play in the research process. Study participants are encouraged to contact the RSA with any questions they have about enrolling or participating in a clinical trial. The RSA can assist resolving any conflict or problems encountered during the research. Research participants may also request the RSA be present during the informed consent process.

Resource for Investigators

The RSA is available to assist investigators to understand and comply with the ethical guidelines and regulatory requirements for research involving human subjects. Investigators are encouraged to contact the RSA for consultation at any stage of the research process. Areas of assistance include:

• Protocol and consent development
• Data and safety monitoring
• Informed consent process
• Advocacy and consent monitoring for vulnerable populations
• Regulatory compliance
• Good Clinical Practice guidance
• Quality improvement processes
• SOP development
• Study documentation
• IND application and maintenance

Contact:

Research Subject Advocate
University of Maryland Medical Center
South Hospital, 10th floor, Rm. S10D07
(410) 328-8141