Human Subjects Protection Unit (HSPU)
The Human Subjects Protection Unit (HSPU) is made up of clinicians who function as Clinical Research Advocates (CRAs) to 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 CRAs are also on the Ability to Consent Assessment Team (ACAT), which provides these services throughout the NIH Clinical Center upon request.
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 Institutional Review Board through subject transition out of the protocol).
Click here to access NIMH Toolkit
The HSPU provides the following human subjects protections per protocol requirement or researcher request:
Protocol-specific assessment tools are developed and administered to determine a potential participant’s ability to provide informed consent. Capacity assessments may be mandated by the NIH IRB or requested by the researcher.
Ability to Assign a Surrogate Decision-Maker
When a protocol is approved for surrogate decision-maker consent, CRAs assess the potential participant’s ability to identify a surrogate decision-maker for healthcare decisions in research and may assist the potential participant with the process of completing the NIH Advance Directive for Health Care and Medical Research Participation form.
Surrogate Decision-Maker Assessment
For protocols approved to enroll a potential subject through surrogate consent, CRAs assess the surrogate decision-maker's understanding of the specific protocol and willingness to serve in this capacity.
CRAs monitor and document the quality of the informed consent conversation between the researcher 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. This monitoring may be protocol mandated or requested by the researcher.
For all NIMH inpatient protocols, CRAs verify ongoing informed consent through regular visits with subjects over the course of their participation to assess current wishes, understanding and concerns regarding continued participation in the protocol.
CRAs consult with researchers regarding appropriate human participants’ protections for enrolling potentially vulnerable subjects. This may include assistance in the application of federal, NIH, Clinical Center and NIMH human subjects research regulations and policies. Additionally, CRAs are available to review protocols prior to initial submission to the NIH IRB for appropriate protections for potentially vulnerable populations.
Training, Education & Presentations
CRAs provide trainings throughout the Clinical Center on a wide-range of topics related to human subjects’ protections for potentially vulnerable populations. The Elements of a Successful Informed Consent is a required training for all researchers obtaining informed consent whose protocols are under the auspices of the NIH IRB. CRAs administer an Objective Structured Clinical Examination (OSCE) for the Informed Consent Process to researchers to evaluate their professionalism, communication skills as well as the quality of the informed consent process.
OCD Staff / Clinical Research Advocates (CRAs)
Julie Brintnall-Karabelas, MSW, LCSW-C
Carol J. Squires, MSSW, LCSW
Katherine W. Todman, MSW, LCSW-C
HSPU Phone 301-232-2984