Human Subjects Protection Unit (HSPU)
The Human Subjects Protection Unit (HSPU) is made up Clinical Research Advocates (CRAs) who assess, develop and implement human subjects’ protections for potentially vulnerable participants enrolling in research. HSPU functions include: assessing and monitoring NIMH participants, consulting with researchers and the National Institutes of Health Institutional Review Board (NIH IRB), and training researchers to obtain informed consent. The HSPU is part of the Ability to Consent Assessment Team (ACAT), which provides these services throughout the NIH Clinical Center (CC) .
NIMH Toolkit for Human Subject Research Protections
The HSPU created the NIMH Toolkit based on the NIMH’s experience conducting research with potentially vulnerable subjects. The aim is to help research organizations assess, implement, and refine appropriate levels of human subjects protections during all phases of research (submission of the initial protocol to the IRB through participant transition out of the protocol).
Click here to access NIMH Toolkit
The HSPU provides the following participant protections per protocol requirement, policy mandate or investigator request:
Protocol-specific assessment tools are developed and administered to determine a potential participant’s ability to provide informed consent. .
Ability to Execute a Durable Power of Attorney (DPA)
HSPU assesses potential participants without consent capacity for their ability to identify a surrogate decision-maker for healthcare decisions in research and may assist with the process of completing the NIH Advance Directive for Health Care and Research Participation (NIH-200) .
Legally Authorized Representative (LAR) Assessment
HSPU assesses the LAR’s understanding of the specific protocol and willingness to serve in this capacity.
HSPU monitors and documents the quality of the informed consent conversation between the investigator and potential participant. This ensures the potential participant understands the required elements of the consent and agrees to participate.
This process protects the rights of minors and adults without decision-making capacity by ensuring the quality of the assent discussion and verifying the agreement of the potential participant to participate in research.
For all NIMH inpatient protocols, the HSPU verifies ongoing informed consent through regular visits with participants to assess their current wishes, understanding and concerns regarding continued participation in the protocol.
The HSPU consults with investigators regarding appropriate ’ protections. . This may include assistance in the application of federal, NIH, CC , and NIMH human subjects research regulations and policies. Additionally, HSPU is available to review protocols prior to initial submission to the NIH IRB for appropriate protections for potentially vulnerable populations.
Training, Education & Presentations
The HSPU presents throughout the CC on topics related to human subjects’ protections.
HSPU provides a 2-part training on obtaining informed consent which is open to all and required for all NIMH investigators, CC post-doc IRTAs and Visiting Fellows, and CRTAs, who will obtain informed consent.
- Elements of a Successful Informed Consent training
- Objective Structured Clinical Examination for the Evaluation of the Informed Consent Process (OSCE IC) (copy in the NIMH Toolkit link above)
Katherine W. Todman, MSW, LCSW-C
Julie Brintnall-Karabelas, MSW, LCSW-C
Carol J. Squires, MSSW, LCSW
HSPU Phone 301-232-2984