Resources for Research Bases
Regulatory Requirements
Background
The Federalwide Assurance (FWA) is the only type of new assurance of compliance accepted and approved by the Office of Human Research Protection (OHRP) for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance.
FWAs also are approved by OHRP for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question. There are two versions of the FWA and the Terms of Assurance, one of each for domestic (U.S.) institutions and for international (non-U.S.) institutions.
More information on FWA can be found at: http://www.hhs.gov/ohrp/assurances/assurances_index.html
CCOP Research Base Requirements for FWA
Each Research Base establishes mechanisms to meet FDA regulatory requirements for clinical trials involving NCI-sponsored (DCP or DCTD) investigational agents and DHHS/PHS regulations for the protection of human subjects.
At a minimum, the Research Base must be able to:
- demonstrate that each participating group has a current approved assurance on file with the Office of Human Research Protections (OHRP);
- demonstrate that each protocol and informed consent is approved by the responsible Institutional Review Board (IRB) prior to patient entry, that each investigator has a current FDA Form 1572 and curriculum vitae on file with the Pharmaceutical Management Branch, (PMB), CTEP, DCTD;
- demonstrate that each patient (or legal representative) gives written informed consent prior to entry on study;
- implement the CTEP requirement for storage and accounting for investigational agents provided under DCP/DCTD sponsorship;
- establish an on-site audit program for periodic data verification and review of regulatory responsibilities at each CCOP, cooperative group member, cooperative group affiliate program, and cancer center affiliate institution;
- provide a method, upon DCP/DCTD request, of summarizing efficacy and
- toxicity data to be included in DCP/DCTD's annual reports to the FDA for each investigational agent;
- establish a method for the timely reporting of all serious and unexpected toxicities;
- verify completion of education on the protection of human research participants for all investigators involved in the design or conduct of research involving human subjects; and
- institute data and safety monitoring plans for all phase I and II clinical trials and establish and maintain Data and Safety Monitoring Committees (DSMCs) for all Phase III clinical trials in accordance with the NIH and NCI's policy for Data Safety and Monitoring of Clinical Trials. Data Monitoring Plans need to be approved by NCI/CTEP or DCP staff.
This page was last updated on March 1, 2005.
