Terms and Conditions for Recruitment of Participants in Clinical Research
Supported by the National Institute of Mental Health, National Institutes of Health
Effective June 1, 2005
This policy relates to recruitment of participants in clinical research studies, whether single site or multi-site, which expect to enroll 150 or more human subjects and are supported by NIMH grants, cooperative agreements, and contracts. For those clinical studies submitted as collaborative R01s (in response to PA-01-123 or its reissuance), if the recruitment across all sites combined proposes to enroll 150 or more subjects, then the policy applies. In those cases where an individual research grant/contract/ cooperative agreement consists of multiple studies that do not involve pooled analysis across studies (i.e., the studies are independent and independently analyzed), the policy will apply only to those independent studies that enroll 150 or more human subjects.
NIH defines human clinical research as: (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.
In the past, some NIMH-sponsored research studies have not maintained an acceptable rate of recruitment, necessitating extensions in the time and funding needed to conduct the research. However, given the pressing need to support research that will reduce the burden of mental illness and behavioral disorders, in conjunction with declining fiscal growth, there is no longer the same flexibility to accommodate projects that exceed their proposed timeline and funding.
Purpose of Policy
The purpose of this policy is to ensure that realistic recruitment targets are established from the onset of a clinical research project for the recruitment phase of the study, and that these targets are met throughout the course of the research. Mutually agreed-upon recruitment milestones (i.e., cumulative recruitment targets at set intervals) will be included in the terms and conditions of the award. If, at any time in the project period, the research design requires modification based on scientific results or other unpredicted events, the terms and conditions of the award may need to be modified. When developing milestones for recruitment, consideration must be given, as appropriate, to recruitment plans for women and men, members of racial and ethnic minority groups, and to children (defined by NIH as individuals under the age of 21) and in accordance with the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects, and the NIH Policy for Data and Safety Monitoring.
The principal investigator/institution proposes the research project and its target population, including composition, and determines the preliminary recruitment targets for the recruitment phase of the study. NIH also requires a description of the proposed outreach programs for recruiting sex/gender and racial/ethnic group members as subjects. Each proposed clinical trial must have a data and safety monitoring plan.
The peer review process assesses items such as relevance of the scientific question to the study population; acceptability of the relevant power calculations (including, as appropriate, calculations to detect sex/gender, racial/ethnic, and age differences, and appropriateness of proposed outreach and recruitment strategies for total recruitment and for recruitment of women and men, racial/ethnic minorities, and children.
NIMH program staff review the research application/proposal and the summary statement/technical review for appropriateness and feasibility of recruitment strategies and targets. NIMH program staff contact the principal investigator/institution, when necessary, to obtain additional information.
The National Advisory Mental Health Council reviews, as necessary, any issues related to proposed recruitment targets and strategies in grant applications.
NIMH program staff, prior to award, will request any additional information needed on milestones for recruitment targets (e.g., total population, women/men, and members of racial and ethnic minority groups) from the principal investigator/institution. Together with staff of the Grants Management Branch (GMB) or the Contracts Management Branch (CMB), program staff determines the terms and conditions of the award and discuss them with the potential grantee/contractor. The Grants Management Specialists or Contract Specialists review documents for inclusion in the official files and prepare special terms and conditions for the award statement. Awards will not be issued without appropriate documentation, i.e., one or more letters that define plans for meeting recruitment targets.
Terms and Conditions
NIMH program and GMB or CMB staff identify and review the following information from documents provided by the principal investigator/institution:
- Recruitment milestones that are expected to be met by the investigator/institution at specific time periods.
- Recruitment targets for women, members of racial and ethnic minority groups, and children as appropriate.
- Any other identified requirements for completion of the approved research project.
The GMB or CMB and program staff develop appropriate footnotes for the award that relate to recruitment milestones and the funds awarded. If, at any time, recruitment falls significantly below the milestones projected by the principal investigator/institution and agreed to by NIMH, NIMH will consider taking one or more actions, depending on the severity and duration of the recruitment shortfalls. NIMH generally will work with the grantee/contractor to correct the deficiencies before taking action, but in the case of continuing shortfalls, NIMH, in accordance with PHS policy, will consider suspending, terminating or withholding support and in some instances, may choose to negotiate a phase-out of the award.
Monitoring Award Performance
In accordance with the terms and conditions of the award, the investigator/institution provides NIMH program staff with progress reports on reaching recruitment milestones. Data and Safety Monitoring Boards may review the data and provide advice to NIMH, but this does not abrogate the responsibilities of NIMH program and GMB or CMB staff to monitor recruitment and determine whether the terms and conditions of the award are being met.