Howard Mann, M.D.
Program Associate, Division of Medical Ethics, University of Utah School of Medicine, Salt Lake City, Utah.
The ASSERT statement represents a declaration and elaboration of the necessary requirements for the ethical conduct of human subjects research in the form of randomized controlled clinical trials. It serves both as an explication of scientific and ethical precepts constitutive of the proper conduct of clinical research and, in particular, a proposal intended to operationalize these precepts in the context of review of proposals for trials by research ethics committees. The latter aspect is effected through the formulation of a checklist of items to be addressed in formal applications for research, and systematically evaluated by research ethics committees.
The checklist encompassed within the table below contains informational items pertinent to each of the five sections to be addressed in the Application for Research. Hyperlinked items in the description sections will direct the reader to separate pages wherein elaboration is provided. Some of the hyperlinks will take the reader to pages on the CONSORT Web site, where specific examples and elaboration will be found. Each linked page will open in a new browser window -- close this window to return to the checklist.
Research Ethics Committees should incorporate this checklist in their Applications for Research, and reference this Web site in the application to assist investigators in complying with ASSERT's requirements.
Applicants for research approval should use this checklist to ensure that all the associated items are addressed in the Application for Research. Commercial sponsors of drug trials typically provide investigators with an Investigators Brochure in compliance with Good Clinical Practice (1), the latter formulated by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2), for use in drug trials. While the brochure may address certain aspects of the checklist items in a limited fashion, it is not a substitute. The checklist items may be considered constitutive of a Protocol Summary for distribution to members of the research ethics committee evaluating the trial application.
In multicenter trials, local research ethics committees are unable to influence the design of a trial submitted for review by local investigators, the latter having been recruited to participate by the trial's Steering Committee or a contracted third party . The committee may request amendments or changes to the submitted Informed Consent document, but actual approval is reduced to a take-it-or-leave-it proposition. By endorsing the ASSERT statement, and considering only applications that are in conformity with its itemized requirements, committees will help assure the ethical conduct of research.
Research ethics committees have been criticized for not paying sufficient attention to the relevance of the research they approve; ensuring that clinical equipoise is present at trial inception; and ensuring the public dissemination of the results of the trials they approve (3). By endorsing the ASSERT statement and conducting continuing review of the research until the trial's results are reported, committees will be positioned to respond to such concerns.
Funding agencies may also stipulate provision of pertinent checklist items in applications for research funding. Such agencies have an obvious interest in ensuring the responsible use of limited financial resources. In particular, the requirement for scientific and social value is relevant to such agencies.
Because the checklist represents a structured approach to the ethical conduct of research, it may also be used as an evidence-based research tool to determine whether compliance with the ASSERT statement results in improvements in the conduct and reporting of trials. Authors of manuscripts submitted for publication should be encouraged to report whether the trial was approved by a research ethics committee, and whether it was conducted in conformity with the ASSERT statement. This will enable researchers to determine whether this leads to a verifiable improvement in associated parameters such as the assurance of clinical equipoise at trial inception; the publication of trial results, whether positive or negative; and the reporting of results in conformity with the CONSORT statement.
References available online are hyperlinked.
3. Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ 1996; 313:1390-1393.