| NATIONAL INSTITUTES OF HEALTH | SEARCH THIS SITE |
 |
      |
| Reducing the burden of mental illness and behavioral disorders through research on mind, brain and behavior | ||||||||||
| ||||||||||
| Office of the Clinical Director – Human Subjects Protection Unit (HSPU) and Marketing and Community Relations Unit (MCRU) (formerly the Central Office for Recruitment and Evaluation (C.O.R.E.)) The Office of the Clinical Director (OCD) at the National Institute of Mental Health (NIMH) established the Central Office for Recruitment and Evaluation (C.O.R.E.) in July 1999. This multidisciplinary team was formed to provide vulnerable subjects with an additional level of protection when participating in clinical trials. In 2007 the C.O.R.E. was re-organized into two units: the Human Subjects Protection (HSP) Unit and the Marketing and Community Relations (MCR) Unit. The mission of the HSP unit is to monitor human subjects safeguards. The mission of the MCR unit is to facilitate the recruitment of mental health consumers into clinical trials. HSPU and MCRU Staff Jean Murphy, R.N., M.S.N. Supervisor, Associate Clinical Director 301-496-1337. Cherri Stanmore, Program Assistant 301-402-6846. HSPU Clinical Research Advocates
MCRU Staff
HSPU Activities TRIAGE OF RESEARCH INQUIRIES Individuals who contact the Intramural Research Program are referred to the appropriate program staff after a brief screening by the HSP staff. Referral services are provided to community resources to applicants for whom research participation is not appropriate. HISPANIC OUTREACH INITIATIVE Referrals are provided for prospective research subjects whose primary language is Spanish in order to increase the participation of this population in research protocols. PROTOCOL PRE-REVIEW The HSPU staff reviews new protocols and recommends human subjects safeguards prior to the initial review by the Institutional Review Board (IRB). CONSENT MONITORING The HSPU staff witnesses, monitors, and documents the protocol consent process for all inpatients and those vulnerable outpatient subjects as stipulated by the IRB. This ensures the subject’s understanding as the investigator explains the elements of research including the voluntary nature, study design, risks and benefits, alternatives to research, and confidentiality. To schedule, please call Pager 102–11158. CAPACITY ASSESSMENT Tools are devised and implemented for multiple protocols, as stipulated by the IRB or as requested by investigators, to assess the subject’s ability to understand, appreciate, reason, and choose their participation in clinical research. For such designated protocols, this assessment must be completed prior to any research participation. To schedule a capacity assessment, please call Pager 102–11158. RESEARCH MONITORING The HSPU staff monitors and documents long-term participation of subjects in protocols. As an objective third party, the staff continually assesses and reviews subjects’ capacity and willingness to participate in clinical research. The HSPU staff are available upon request for consultation on any of the above mentioned areas by contacting Jean Murphy. TRAINING/MENTORING Training and mentoring is provided for clinical staff and students in the above areas. For more information, please contact Jean Murphy at 301-496-1337. A clinical telephone interviewing class is also available. Marketing and Community Relations Activities: AD APPROVAL All patient and healthy volunteer recruitment materials (which can include ads, flyers, brochures, articles, etc.) must contain certain logos/identification and other requirements, and go through a MCRU, IRB-NIH approval process. For assistance with materials development call Susanna Sung at 301-402-3235. MARKETING CONSULTATION While Branches are responsible for funding and planning their recruitment activities, MCRU staff is available to provide expertise in designing or reviewing marketing plans for any study recruiting mental health patients. Healthy volunteers are recruited through the CC Healthy Volunteer Office. Please apprise Susanna Sung of all recruitment efforts and results in order to share effective recruitment techniques among the Branches. Jody Miller (301-594-3188) will provide community outreach for any Branches recruiting mental health patients. The MCRU staff should be apprised of all outreach efforts conducted by a Branch in order to avoid duplication of community contacts and ensure that NIMH presents a coordinated image to the public. |
|
| Site Map | Subscribe | Staff Directories | Contact NIMH DIRP | Employment Opportunities | Copyright | Policies | FOIA |
 |
 |
 |