Improving access, ethics
Recommendations for federal agencies, IRBs
The Presidential Commission for the Study of Bioethical Issues offered 14 recommendations for improving oversight of human subjects research:
Improve access: Every federal agency or department that sponsors human subjects research should make information available about all studies including title, investigator, location and funding. This information should be collected in some centralized way, either through a comprehensive federal database or through links to various agency systems.
Investigate effectiveness: Conduct research into whether existing human subjects protections are, in fact, effective at protecting subjects.
Study compensation: The government should move "expeditiously" to study the scope of such injuries and determine whether there should be a national system for compensating subjects. If it's determined that there should be, HHS should work on a pilot study to determine the proper mechanism for doing that.
Provide response: Because previous calls for compensation systems have gone unanswered, the commission asks for an official reply, saying why the current system should be changed or retained.
Highlight ethics: Make the ethical underpinnings of regulations more explicit. This addresses a common complaint that oversight focuses more process than actual protection. The regulations should explicitly state the ethical reasons for the regulations. This should be done either by HHS or the Office of Science and Technology Policy.
Detail responsibilities: Amend Common Rule to address investigator responsibilities. This change would put the Common Rule in sync with FDA regulations and international standards.
Educate about ethics: IRBs and other institutional officials, professional societies, licensing bodies and journals should work to improve the conversation about researchers' responsibilities. Institutions should provide more rigorous education about ethics and human subjects research at undergraduate, graduate and professional levels.
Promote equivalence: The Office for Human Research Protection (OHRP) should adopt or revise the 2003 Health and Human Services Equivalent Protections Working Group's recommendations to determine when a country's protections are equivalent to those of the U.S. and allow research to go forward without unnecessarily requiring that the letter of all U.S. regulations be followed.
Engage community: OHRP should look to the Joint UN Programme on HIV/AIDS and the AVAC Good Participatory Practice Guidelines to provide standardized guidance on effective community engagement standards in research. After this guidance is developed, studies should be conducted to evaluate its effectiveness.
Ensure capacity: Funding agencies should ensure that the sites being chosen for research can adequately protect subjects, whether that capacity exists already or is built up in order to carry out studies.
Select sites ethically: OHRP and federal funding agencies should develop a plan for how to ethically select research sites, taking into account how the proposed study meets the needs of the local community. OHRP should develop guidance based on this plan.
Ensure ethical design: In dealing with the question of whether it is ethical to allow placebo or a treatment that is below the "best proven intervention" in a control arm, the commission says that it is permissible in limited circumstances: The intervention is not known to be best for the study populations for various reasons (genetic, infrastructure, etc.); and the scientific and ethical case has been reviewed carefully (elements of this review include limiting duration of the placebo or comparator, carefully monitoring subjects, making sure there are rescue measures if serious symptoms develop and withdrawal criteria for people who have adverse events).
Promote reform: The commission endorses certain elements of the ANPRM, including calibrating level of oversight to level of risk, eliminating continuing review for some low-risk studies, reducing unnecessary or duplicative IRB review in multisite studies, creating standardized consent forms with understandable language, seeking harmonization of regulations among all federal agencies, and working toward developing a federal government-wide data collection system for adverse event reporting.
Respond (or justify status quo): Because previous sets of recommendations have been passed by previous boards with no real response by the federal government, the commission recommends that the Office of Science and Technology Policy or other federal entity respond to these recommendations with plans for changes or with an argument for retaining the status quo. Other agencies, including OHRP, may be a part of this response.
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