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NIMH Recruitment of Participants in Clinical Research Policy

Purpose

To ensure effective and efficient recruitment of participants into NIMH-supported clinical research studies.

Background

The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. Effective clinical research relies on the ability of researchers to meet recruitment goals. This policy will allow NIMH staff to more effectively monitor the recruitment of participants in NIMH-sponsored clinical trials and other clinical research studies.

Policy

NIMH will ensure that investigators establish recruitment milestones from the outset of a clinical research project and that progress is monitored throughout the course of the research. This policy applies to clinical research studies proposing to enroll 150 or more subjects per study, and all clinical trials, regardless of size.

Procedure

  • A recruitment plan must be established for all NIMH extramural-funded clinical research studies proposing to enroll 150 or more subjects per study, and all clinical trials, regardless of size. When developing milestones for recruitment, consideration must be given, as appropriate, to recruitment plans for females and males, members of racial and ethnic minority groups, and children. In addition, consideration must be given to the timing of milestones to ensure that recruitment will end with sufficient time remaining within the proposed project period to allow for necessary follow-up and analysis. At any time during the project period, if the research design requires modification based on scientific results or other unexpected events, the assigned NIMH Program Official should be notified, and the terms and conditions of the award may need to be revised.
  • In accordance with the terms and conditions of the award, the principal investigator (PI) provides NIMH with progress reports on actual recruitment progress. At any time, if recruitment falls significantly below the milestones projected by the PI/recipient and agreed to by NIMH, NIMH will determine viable options depending on the severity and duration of the recruitment shortfalls. Generally, NIMH will first advise the PI/recipient to correct the deficiencies. If the PI/recipient fails to correct the deficiencies, NIMH will take further action, in accordance with Public Health Service policy (i.e., suspension, termination, or withholding of support) 1.

Responsibilities

  • PI/recipient proposes the research project and its target population, including composition, and determines the preliminary recruitment milestones for the recruitment phase of the study. In accordance with the terms and conditions of the award, the PI submits interim reports on actual recruitment progress. If changes to the recruitment targets are needed, the PI/recipient ensures that changes are submitted to NIMH for prior approval either through the annual progress report or a prior approval request. 2
  • NIMH Program Officials review the proposed recruitment milestones for appropriateness and feasibility, and request any additional information needed from the investigator prior to award. Together with staff in the NIMH Grants Management Branch or the NIMH Contracts Management Branch, the Program Official determines the terms and conditions of the award and discusses them with the PI/recipient.
  • NIMH Grants Management Specialists and/or Contract Specialists ensure that NIMH actions comply with federal regulations and NIH policy. They receive documents for inclusion in the official grant or contract files and specify the appropriate terms and conditions for the award statement. Awards will not be issued without proper documentation:
    • Pre-determined recruitment milestones that are expected to be met by the PI/recipient.
    • Recruitment milestones for members of racial and ethnic minority groups.
    • Any other identified requirements for completion of the approved research project.
  • Clinical Trials Operations and Biostatistics Branch (CTOBB) monitors compliance with the NIMH recruitment policy and coordinates the recruitment milestone reporting process.  CTOBB consults with Program Officials in cases of recruitment deficiencies to determine appropriate action.

Definitions

  • Clinical Research: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanism of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. Note: Studies falling under Exemption 4 for human subject research are not considered clinical research by this definition.
  • Clinical Trial: A research study 3 in which one or more human subjects 4 are prospectively assigned 5 to one or more interventions 6 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. 7
  • Extramural Awards: Funds provided by the NIH to researchers and organizations outside the NIH.

Resources

1 See NIH Grants Policy Statement Part 2, Subpart A, 8.5.2 at http://grants.nih.gov/grants/policy/nihgps_2013/nihgps_ch8.htm and Federal Aquisition Regulations Part 49 at https://www.acquisition.gov/sites/default/files/current/far/html/FARTOCP49.html.

2 See http://grants.nih.gov/grants/policy/nihgps_2013/nihgps_ch8.htm#_Requests_for_Prior.

3 See Common Rule definition of research at 45 CFR 46.102(d).

4 See Common Rule definition of human subject at 45 CFR 46.102(f).

5 The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

6 An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

7 Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.