Terms and Conditions for Accrual of
Research Subjects in Research
Supported by the National Heart, Lung,
and Blood Institute
National Institutes of Health
Revised: June 1999
Introduction
This policy relates to accrual of research subjects in
clinical trials and epidemiologic studies that expect to recruit 150 or more
human subjects (in one institution or in a multi-institutional project) and are
supported by NHLBI grants, cooperative agreements, and contracts. In the past,
due to lags in recruitment, it was sometimes necessary to extend the period of
recruitment and add new funds. Fiscal limitations require that recruitment
plans proceed as approved at the time of award, or as subsequently formally
revised, to avoid any need for additional funding.
Purpose of
Policy
The purpose of this policy is to ensure that the
commitment between the NHLBI and the principal investigator/institution is met
or that appropriate action is taken if it is not. It is expected to result in a
more clearly defined commitment relative to accrual of subjects, better
planning for recruitment, and improved recruitment.
Mutually agreed-upon accrual milestones (i.e., rates
for recruitment) 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. In developing milestones for
accrual, consideration must be given, as appropriate, to women and members of
minority groups (NIH Guidelines on the Inclusion of Women and Minorities As
Subjects in Clinical Research. NIH Guide For Grants and Contracts. March 18,
1994).
Responsibilities
The principal investigator/institution proposes the
research project and its target population, including composition.
The Scientific Review Administrator or contract
officer, as appropriate, requests any additional information needed to review
the proposed recruitment goals and strategies and the adequacy of the study
population related to women and minorities.
The peer review process assesses such items as
relevance of the scientific question to the study population; acceptability of
the relevant power calculations (including, as appropriate, that for detection
of gender and racial/ethnic differences); and appropriateness of proposed
recruitment strategies for total and for women and minority study populations.
The NHLBI program staff review the research application and the summary
statement (or proposal and review summary) for appropriateness and feasibility
of recruitment strategies and accrual. They contact the principal
investigator/institution, when necessary, to obtain additional information.
The National Heart, Lung, and Blood Advisory Council
reviews, as necessary, any issues related to proposed recruitment targets,
strategies, and accrual in grant applications.
The NHLBI program staff, prior to award, requests any
additional information needed on milestones for accrual (e.g., total, women,
members of minority groups) from the principal investigator/institution.
Together with staff of the Grants Operations Branch (GOB) or the Contracts
Operations Branch (COB), program staff determine the terms and conditions of
the award and discuss them with the potential recipient of NHLBI support. The
GOB or COB staff review documents for inclusion in the official files and
prepare special footnotes (i.e., 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 recruitment accrual.
Terms and
Conditions
The NHLBI program and GOB or COB staff identify and
review the following information from documents provided by the principal
investigator/institution:
- Accrual milestones that are expected to be met by
the investigator/institution at specific time periods.
- Accrual of women and members of minority groups, as
appropriate.
- Any other identified requirements for completion of
the approved research project.
The GOB or COB and program division staff develop
appropriate footnotes for the award that relate to accrual milestones and the
funds awarded. If, at any time, accrual falls significantly below the
milestones projected by the principal investigator/institution and agreed to by
the NHLBI, the NHLBI will consider ending support and negotiating a phaseout of
the award. Certain PHS policies must be followed as plans are put into place to
terminate a grant or contract. The PHS policies involve such items as
appropriate notification of intent and opportunities to respond. However, if
the principal investigator/institution provides a description of problems and
offer to terminate the award, this meets all PHS requirements.
Monitoring Award
Performance
In accordance with the terms and conditions of the
award, the investigator/institution provides the NHLBI program staff with
progress in reaching the accrual milestones. The Data Safety and Monitoring
Board may review the data and provide advice to the NHLBI, but this does not
abrogate the responsibilities of the NHLBI program and GOB or COB staff to
monitor accrual and determine whether the terms and conditions of the award are
being met. The NHLBI staff must notify the Director, NHLBI, in writing, when
accrual milestones have not been met.
Issued: August 1995
Revised: June 1999
|
