HHS Strategic Goals and Objectives - FY 2001 . Objective 6.7 - Strengthen Mechanisms for Ensuring the Protection of Human Subjects in Research and the Integrity of the Research Process.

09/29/2000

We will strengthen mechanisms for ensuring protection of Human geneticshuman subjects by:

  • increasing and enhancing the educational opportunities for clinical investigators and Institutional Review Board (IRB) members and staff to facilitate their understanding and application of federal requirements for the protection of human subjects.

  • issuing specific guidance on informed consent.

  • promoting the use of accreditation of human-subject-protection programs and certification of IRB staff and members, as part of the NIH grant award process and the assurance process.

  • clarifying existing conflict of interest regulations and developing new conflict of interest policies for the biomedical research community.

  • pursuing legislation to enable FDA to levy the civil monetary penalties for violations of informed consent and other requirements.

6.7 Implementation Strategies
  • Training/Staffing
  • Improving Procedures
  • Accreditation
  • Monetary Penalties
  • Research
  • We will strengthen the integrity of the research process by:

  • increasing staffing and, where appropriate, improving our review procedures for ensuring research integrity, and applying these improvements to enhance the monitoring of research institutions.

  • enhancing the way we address and resolve allegations of research misconduct; for example, adopting a standardized definition of research misconduct and consistent policy for resolving allegations across the various federal research agencies.

  • in collaboration with the scientific community, providing and facilitating required expanded training in the responsible conduct of research for our partner institutions.

HHS Agencies contributing to this objective:

AHRQ
CDC
FDA
NIH
OS

  • expanding efforts to conduct research on issues affecting research integrity, including methods to maximize effective training in responsible research, types of federal regulations that are effective and efficacious, and identification of institutional systems and processes that can be adopted to ensure responsible research.