Research with Human Volunteers

Medical physicists are often involved in research with human volunteers. Frequently the physicist serves as the principal investigator or a co-investigator for the research. Before human volunteers are involved in research in the United States, the research must be authorized by an Institutional Review Board (IRB) after an appropriate degree of scrutiny. Further, the research must be reviewed and reapproved at least annually, and sometimes more frequently. IRB approval is required for all projects involving human volunteers except those that are exempt because they pose no risk of personal injury or loss of privacy to the participant. Inclusion of students or subordinate employees as research volunteers is of particular concern to IRBs, because these individuals may feel they are not free to decide whether or not to participate. Institutional Review Boards review proposals for research with human volunteers according to the principles of the Belmont Report.1 These principles are Autonomy; Beneficence; and Justice. Autonomy expresses the right of individuals to be treated with dignity and respect, and to decide of their own free will whether or not to participate in a study after becoming fully informed of the benefits and risks of the study. Beneficence declares that some potential benefit must accrue from the study, either to the participant or, more often, to similar individuals in the future. Justice means that all persons are treated equally in their eligibility to participate in the study, within the limits of the study design. In the United States, Institutional Review Boards are accountable to the U.S. Office of Human Research Protections in the preservation of these principles within their institutions, and IRBs in turn hold principal investigators responsible for protecting the rights of volunteers according to the Belmont Principles. A manuscript submitted to Medical Physics that describes research with human volunteers must include a statement saying that the research was approved and overseen by an Institutional Review Board in the United States or its equivalent if the research is performed in another country. Manuscripts that describe research with human volunteers without a statement of IRB (or equivalent) approval will not be accepted for publication in the journal. Research with human volunteers relies on a relationship of trust between the investigator and the volunteer. The volunteer trusts the investigator to keep risks to the lowest possible level, conduct the research in the manner explained to the participant and approved by an IRB or equivalent entity, preserve the confidentiality of the volunteer's identity, and report the results honestly and fairly, whether or not they turn out as expected. This relationship of trust extends to all research studies, including those in which a product (e.g., a drug or medical device) from a commercial sponsor is being evaluated. In cases where study results are different from those anticipated, the report may be sent to the sponsor (if there is one), but the results may remain unpublished because unfavorable or ambiguous results may be of unsufficient scientific interest. In 2004, the International Committee of Medical Journal Editors (ICMJE) addressed the issue of nondisclosure of unfavorable results in a Statement on Clinical Trial Registration.2,3 The ICMJE statement expresses the requirement that registration in a public clinical trials registry is required for publication of any manuscript, irrespective of country of origin, in any of the journals edited by the Committee's membership. Members of the Committee are the editors of JAMA, New England Journal of Medicine, New Zealand Medical Journal, Norwegian Medical Journal, Canadian Medical Association Journal, Lancet, MEDLINE, Annals of Internal Medicine, Croatian Medical Journal, Dutch Journal of Medicine, Journal of the Danish Medical Association, Annals of Internal Medicine, and Medical Journal of Australia. Approximately 120 other medical journals have endorsed the Statement on Clinical Trial Registration. Registration of a clinical trial must be in a registry that is accessible to the public at no charge, open to all prospective registrants, and managed by a not-for-profit entity. The registry must be electronically searchable and able to verify the validity of its data. At the time of the statement's release, only one registry met the requirements. It is the registry sponsored by the National Library of Medicine (NLM) and accessible at www.clinicaltrials.gov. Information about the registry is available at http://prsinfo.clinicaltrials.gov. Reports eligible for inclusion in the NLM clinical trials registry are those described by the statement “Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.” Medical intervention is defined as “any intervention used to modify a health outcome,” and includes drugs, surgical procedures, devices, behavioral treatments, process-of-care changes, etc. An eligible trial must have at least one prospectively assigned concurrent control or comparison group.3 In 2006 the Fair Access to Clinical Trials (FACT) Act was introduced in both the U.S. Senate by Senator Dodd (D-CT) and in the U.S. House of Representatives by Congressman Markey (D-MA). These bills would expand the mandate for registration of clinical trials beyond that expressed by the Committee of Medical Journal Editors. Both bills were referred to committee, and no action has been taken to date by either arm of Congress. At this time Medical Physics encourages but does not require registration of appropriate studies in the NLM clinical trials registry prior to publication of results in the journal. One reason for not making registration a requirement is that some manuscripts describe data acquired in a study for which none of the authors is the principal investigator and thus may not control whether the research is registered or not. Another reason is reluctance to position the journal as a moral agent to influence the behavior of its authors. On the other hand, many journals, including several prominent imaging journals, have adopted the position of the Committee of Medical Journal Editors. Whether Medical Physics should endorse the position is an agenda item at the journal's next editorial board meeting in Minneapolis. Appreciation is extended to Daniel Bourland Ph.D. for raising the issues addressed in this editorial, and for helpful comments on the editorial from Dr. Bourland, Andrew Karellas Ph.D., Elizabeth Krupinski Ph.D., and David Rogers Ph.D.

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