Human Subjects Protection Unit (HSPU)
The Human Subjects Protection Unit (HSPU) is made up of Clinical Research Advocates (CRAs) who serve as independent monitors. The CRAs 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 interdisciplinary team members, and training investigators 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 participants. The aim is to help research organizations assess, implement, and refine appropriate levels of human subjects’ protections during the phases of research from the initial protocol submission until the participant transitions 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:
Capacity Assessment
A generic capacity assessment as well as protocol-specific assessments were developed by HSPU. These assessments are administered by the CRAs to determine a potential participant’s ability to provide informed consent for research. The generic capacity assessment is available for researchers in the NIMH Toolkit (above).
Ability to Execute a Durable Power of Attorney (DPA)
When potential participants lack capacity to give informed consent, HSPU assesses and individual’s ability to identify a legally authorized representative (LAR) for healthcare decisions in research and may assist with the process of completing the NIH Advance Directive for Health Care and Research Participation (form NIH-200, revised 7-20).
Legally Authorized Representative (LAR) Assessment
HSPU assesses the LAR’s understanding of the specific protocol and willingness to serve in this role.
Consent Monitoring
As an independent monitor, HSPU oversees and documents the quality of the informed consent discussion between the investigator and potential participant, including NIH employees. Independent monitoring ensures the investigators discuss the required elements of the informed consent document and confirms that the participant agrees to participate free from coercion.
Assent Monitoring
This process serves to protect the rights of minors and adults without decision-making capacity by overseeing the quality of the assent discussion and verifying the agreement of the potential participant to volunteer for research.
Participant Monitoring
For all NIMH inpatient protocols, the HSPU verifies ongoing informed consent through regular visits with participants to assess their research preferences, understanding and concerns as they volunteer in protocols. HSPU attends interdisciplinary rounds on the NIMH inpatient unitsConsultation
The HSPU consults with investigators regarding appropriate human subject protections. This may include assistance in the application of federal regulations as well as NIH, CC and NIMH policies. HSPU is available to review human subjects’ protections within protocols prior to initial submission to the NIH IRB and throughout research participation.
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 recommended for some NIMH investigators and required for all CC post-doc IRTAs and Visiting Fellows, and CRTAs, who will be obtaining 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)
OCD/HSPU Staff
Julie Brintnall-Karabelas, MSW, LCSW-C
301-402-6787
Carol J. Squires, MSSW, LCSW
301-402-6845
HSPU Phone: 301-232-2984
Email: nimhhspu@mail.nih.gov