Office of the Clinical Director - HSPU/MCRU
The NIMH OCD established this multidisciplinary team, made up of Clinical Research Advocates (CRA’s)to provide several protective functions for vulnerable subjects enrolled in greater-than-minimal risk studies at the NIMH. These functions include those of monitoring the informed consent discussion conducted between investigator and subject, assessing subject capacity to enroll in research studies, and providing ongoing monitoring over the course of research participation.
Julie Brintnall-Karabelas, 301-402-6787
Mary Ellen Cadman, 301-402-6842
RN, MSN, MSW
Carol J. Squires, 301-402-6845
Katherine J. Whorton, 301-496-8782
HSPU Pager 102-11158
CRAs review new protocols for appropriate human subjects safeguards and provide language as needed prior to the initial review by the Combined Neuroscience Institutional Review Board (CNS IRB).
CONSENT & ASSENT MONITORING
CRAs monitor and document in CRIS the informed consent process for all NIMH inpatients and potentially vulnerable outpatient subjects as stipulated by the CNS IRB. This ensures subjects’ understanding as the investigator explains the elements of research including the voluntary nature, study design, risks, benefits, alternatives to research and confidentiality.
Protocol specific assessment tools are developed and implemented to determine a subject’s ability to provide informed consent by assessing four domains: understanding, appreciation, reasoning, and choice. Capacity assessments may be mandated by the CNS IRB or requested by the investigator.
ABILITY TO APPOINT AN NIH ADVANCED DIRECTIVE/DURABLE POWER OF ATTORNEY
For protocols approved to include subjects without decision making capacity, the HSPU in coordination with the Clinical Center (CC) Bioethics Department, will assess the subject’s ability to appoint an NIH DPA.
ASSESSMENT OF SURROGATE UNDERSTANDING
For protocols approved to utilize surrogate consent, prior to signing consent forms the HSPU in coordination with CC Bioethics Department will assess the surrogate’s understanding of the specific protocol.
CRAs are available upon request for consultation on any of the above mentioned areas.
TRAINING & MENTORING
CRAs provide "Elements of a Successful Consent" Training throughout the year. Additional training and mentoring is provided for clinical staff and students in the above areas.
To view an online training regarding conducting a successful Informed Consent, go to:
Marketing and Community Relations Unit (MCRU)
Susanna Sung, LCSW-C 301-402-3235
Kalene DeHaut, LCSW 301-594-3188
Kathleen Samiy 301-435-2169
MCRU provides patient recruitment support for clinical research studies conducted at the NIMH IRP. They provide comprehensive and collaborative patient recruitment plans including marketing and community relations that reach out to diverse and unique research study participants. MCRU is available to work in partnership with investigators to help develop recruitment plans that are strategic, customized, and tailored to distinguish individual studies and to effectively and successfully connect mental health populations with specialized researchers. The MCRU team has extensive expertise and professional experience in marketing, design, and community relations in the health field. Services include, but are not limited to:
-Recruitment Material review for IRB approvals
-Comprehensive marketing plans
-Design and materials development
-Events planning/speaking engagements
-Recruitment database development
-Web-based recruitment consultation