4.0 NIH Policies Governing Inclusion of Women, Minorities and Children in Clinical Trials; Data and Safety Monitoring; Data Sharing: and the Health Insurance Portability Act

5.0 Peer Review Criteria for Competing CCSG Applications

6.0 Comprehensiveness

4.1 Inclusion of Women and Minorities in Clinical Trials (NIH Policy)
The provision of clear documentation about the accrual of women and minorities in clinical trials is essential. If the application is not approved in this respect, a grant award cannot be issued until a corrective plan and adequate response to the critique is submitted and approved by NCI. Under the NIH policy, clinical research is defined in Instructions for PHS 398 (Rev. 5/01) Section IIIA.

When the reviewers evaluate the section of the application on the inclusion of women and minorities in clinical research, they will consider whether the accrual of women and minorities to therapeutic trials is proportionate to the general cancer patient population (nationally) and to the cancer patient population in the cancer center's primary catchment area. Reviewers will evaluate accrual to nontherapeutic trials separately using similar criteria. Although accrual to both therapeutic trials and nontherapeutic trials are important, one does not substitute for the other, and therefore the data for each type will need to be presented and assessed separately. When there is substantial under-representation, the adequacy of the institution's policies, specific activities and a corrective plan become critical in convincing peer reviewers that the institution is serious about addressing the problem and is investing the appropriate effort to correct under-accrual. In addition, if the population of the catchment area of the cancer center has limited ethnic diversity, it will be important to discuss what the institution is doing to broaden the ethnic diversity of its clinical trial accrual, since the aim of this policy is to assure that the results of clinical research are generally applicable.

For the purposes of these guidelines, the definition of ethnic and racial categories as stated in the NIH policy for inclusion of women and minorities in clinical studies will be used. See Instructions for PHS 398 (rev. 5/01).

In addition, the revised PHS 398 (5/01 version) requires applicants to provide data on the composition of proposed study populations in terms of gender and racial/ethnic groups. For CCSG applications, this requirement is limited to projected accrual to phase III studies that utilized CCSG resources and are not funded by any other PHS grant mechanism. Table formats for both targeted/planned enrollment and actual enrollment may be found in the PHS 398 grant application.

Inclusion of Children in Clinical Trials (NIH Policy)
It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and/or ethical reasons not to include them. This policy applies to all competing applications.

All investigators proposing research involving human subjects should read the “NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects” that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. As part of the scientific and technical merit evaluation of the research plan, reviewers will be instructed to address the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion.

4.3 Data and Safety Monitoring Plan
NIH policy (http://grants.nih.gov/grants/guide/notice-files/not98-084.html), with additional description at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html, requires that grantees have procedures in place for data and safety monitoring (DSM) of clinical trials (See Part I, 9.3.2.1).

CCSG applications should provide within the text of the application a summary of the DSM Plan. The entire DSM Plan should NOT be provided within the text but made available at the time of the site visit should the peer reviewers need additional information for their determination of acceptability.

Data and safety monitoring functions are most appropriately addressed within the Clinical Protocol and Data Management Shared Resource, however they may be located elsewhere. They should not be the direct responsibility of the same Protocol Review and Monitoring System (PRMS) that oversees scientific aspects of cancer clinical trials.

By NIH review criteria, the peer reviewers will be responsible for determining the acceptability of the plan. Peers are expected to define the weaknesses of an unacceptable DSMP and to reflect any weaknesses in the priority score. The final approval of a DSMP in its original form or later modified form is the responsibility of the staff of the Cancer Centers Branch.

4.4 Data Sharing
The Final NIH Statement on Sharing Research Data was released on February 26, 2003 (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why data sharing is not possible. CCSG awardees should adhere to the data-sharing policy, based on the source of funding for the research involved. If the CCSG provides direct support for the generation of research data (e.g., pilot projects supported through developmental funds, early phase clinical trials conducted with funds from Protocol Specific Research Support) or funds core resources that serve as the final repository of data (e.g., a high throughput DNA array analysis core), a plan must be submitted for data sharing that is in accordance with the NIH Statement. If core resources are being used in support of NIH funded research grants (e.g.,R01s) in excess of $500,000, the investigator of the NIH grant is responsible for providing a data sharing plan to the funding source and adhering to that plan; no additional action is required of the Cancer Center for these grants.

Reviewers will not review the proposed data-sharing plan, thus it is not factored into the determination of scientific merit or priority score. Program staff will be responsible for assessing the appropriateness and adequacy of the proposed data sharing plan.

Additional information on data sharing is available at http://grants2.nih.gov/grants/policy/data_sharing/.

4.5 Health Insurance Portability and Accountability Act
The NIH released a notice in the NIH Guide on February 5, 2003 regarding the impact of the HIPAA Privacy Rule on the review, funding and progress monitoring of grants (http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html). The Privacy Rule is administered and enforced by the Office for Civil Rights of the Department of Health and Human Services. NIH is not involved in the enforcing or monitoring compliance with this rule. New and competing continuation CCSG grant applications will continue to be evaluated using the existing review criteria found in the Guidelines and the PHS 398. Funding decisions for CCSG awards will continue to be based on merit, programmatic considerations, and availability of funds. Program staff will seek resolution of issues or problems noted in the summary statement with investigators.