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NIMH Policy – Recruitment of Participants
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
Introduction
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.
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