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Research Ethics: Comments Submitted by APA
The Draft of the NBAC Report on Ethical and Policy Issues in Research Involving Human Participants
February 16, 2001
Eric M. Meslin, PhD
Executive Director
National Bioethics Advisory Commission
6100 Executive Blvd., Suite 5B01
Rockville, MD 20892-7508
Dear Dr. Meslin:
The American Psychological Association (APA) appreciates the opportunity to comment on the draft of the National Bioethics Advisory Commission’s (NBAC) report on Ethical and Policy Issues in Research Involving Human Participants. APA is the largest scientific and professional organization representing psychology in the United States, and is the world’s largest association of psychologists. Its membership includes more than 159,000 researchers, educators, practitioners, and students. Through its Science Directorate, the APA focuses on advancing psychology as a science and promoting the needs and interests of research psychologists and academicians. In an effort to achieve these goals, the Science Directorate develops and manages programs for the research/academic community and consolidates the Association's science activities. In this regard, our comments pertain to the impact of the report’s recommendations on the conduct of vital behavioral and social science research.
NBAC should be commended for its ambitious and impressive undertaking. The NBAC draft report is extremely informative both to those who are not familiar with current research policy and its development, as well as to those who are experts in primary ethical issues pertaining to research with human participants. Its broad view, including historical contexts is useful in evaluating the current status of research with human participants. In addition, its exposition of complex issues, for example the sections on risk assessment and vulnerabilities in Chapter 3, are especially valuable, because the many specific, concrete ideas may facilitate clarification of these complex concepts.
APA recognizes the invaluable contribution of human participants to the research enterprise and is, and has always been, a strong proponent of the need to protect these voluntary research participants. Thus, APA applauds the Commission’s efforts in support of this endeavor. We also applaud the goal of creating a set of universal principles that are then flexibly applied, as appropriate, to the wide range of disciplinary and individual research contexts. Because the NBAC report is informed primarily from a biomedical research perspective, however, we are concerned that only cursory and inadequate attention has been paid to the parameters of behavioral (and social sciences) research, which generally entail different degrees and types of risk and intrusiveness.
In this set of comments, we will first articulate general comments on the overall report, then specific points within the report.
General Comments
Orientation: Although the draft report recommendations are extremely constructive and useful in outlining issues and mechanisms to ensure that the rights and welfare of research participants are well protected, the orientation, issues, and examples are primarily derived from and directed toward biomedical and clinical research. This diminishes the appropriateness for and applicability to the minimal or less than minimal risk research that forms the bulk of the research conducted in the behavioral and social sciences. Regulations based on the assumptions that high risk of harm and high degree of intrusiveness are the norm, may lead to the imposition of stipulations and requirements that unnecessarily constrain researchers and limit research, and often add little or nothing to human participants protection. We thus suggest that the report explicitly address differences between behavioral and biomedical research in several ways: by including examples from behavioral and social science fields; by further noting that definitions of risk and harm differ qualitatively across behavioral and biomedical interventions; and by additional discussion of mechanisms for oversight of minimal risk research.
Tone: In addition, although not stated explicitly, the underlying tone of the report is that investigators will not conduct sound, ethical research, in the absence of detailed regulation and monitoring. Although occurrences of extreme and dramatic abuses have been well publicized, such behavior is not characteristic of the vast majority of scientific investigators. Whereas there is no disagreement that investigators (and IRBs!) should receive continuing education about research ethics, and appropriate procedures for ensuring that the rights and welfare of the participants are protected, there should be increased recognition that a viable regulatory system will function best when researchers are treated as collaborators in the regulatory process.
We strongly recommend that the needs and sensitivities of investigators receive sufficient acknowledgement throughout the NBAC document, beyond the brief presentation at the beginning that research is usually a very good thing. This can be accomplished without compromising the standards for participant welfare and rights. It would involve bringing investigators more closely into the decision-making processes with the assumption that they are honest, ethical persons. Ensuring that scientific investigators receive sufficient credit and opportunities for involvement in the monitoring process will encourage scientists to be actively involved in ensuring the welfare of research participants, within a system that values the goals of conducting research to create new knowledge.
There are also pragmatic reasons that simply additional monitoring and stronger regulatory safeguards should not be added without involving scientists in the process. This is because there are potential negative effects of perceived over-regulation. Evidence suggests that burdensome regulations may lead some investigators to avoid putting research through IRBs altogether or to omit features of a protocol that could raise red flags (Ferraro, Szigeti, Dawes, & Pan, 1999; Liddle & Brazalton, 1996), putting themselves, their participants, and their institutions in possible jeopardy. Risks of discovery of such practices remain low for reasons noted in the report: IRBs are often not well trained, and do not expect such violations; and follow-up monitoring is often perfunctory, if attempted at all. In short, increased controls, especially passed down by poorly trained or overburdened IRBs, may backfire.
Structural and procedural issues
Creation of a single national office for oversight of research: The creation of a single national office - National Office of Human Research Oversight, (NOHRO) -- to oversee research policy and compliance has attractive features. In its balanced presentation of the issue in Chapter 2, NBAC recognizes the advantages and disadvantages of adding another bureaucratic layer as a means of solving existing complicated problems in the regulation and oversight of research with human participants. As the report acknowledges, a national office may not be responsive to rapid adoption of new issues, methods, procedures, and safeguards. In addition, such an office might have difficulty addressing the needs of different research cultures in the different disciplines and sub-disciplines.
This is particularly germane to the behavioral and social sciences. For example, privacy and confidentiality are the main issues relevant to most behavioral and social science research. A national oversight office would need a broad understanding of cultural and individual differences in privacy issues, and in the many mechanisms for assuring confidentiality. However, a "one size fits all" treatment is likely to overlook important issues in sub-fields or interdisciplinary research arenas. The proposed remedy for addressing this at the national level is to develop advisory committees, consisting of researchers in every subspecialty with whom NOHRO can consult, just as journals draw upon an editorial board comprised of experts in the relevant field. These should be people who regularly contribute to the literature on ethics and methodology. This solution, while appealing in principle, poses logistic challenges in implementation and may not guarantee that it will be any less unwieldy than the present system.
Because the establishment of a such single national office and its fulfilling the recommended mandates could take years, even assuming that the needed resources could be secured in a timely fashion, many of the serious problems in research noted in the report will likely continue. To avoid this, some of the recommendations may be re-framed in a way that would better allow early implementation. It may be worth considering rewording that would allow staggered implementation even before NOHRO is in place.
Need for an appeal mechanism, subsequent to IRB review: If mechanisms for monitoring and oversight are to be drastically increased, then some mechanism for investigator appeal of negative outcome of protocol review also needs to be established. Misunderstandings, biases, and conflicts of interest or simple lack of information on the part of those with the power to disapprove or modify research protocols may affect the reviews. The NBAC report reiterates the common belief that IRBs tend to be under-trained, overworked, and that decisions can be affected by biases and conflicts of interest, (see also Cohen, 1998), but does not accord investigators mechanisms for appealing their decisions. Increased control of research without increased opportunity for appeal may have the unfortunate effect of reinforcing the perceived injustice within the system. It is unclear from the draft report whether NOHRO would serve such a function. Thus, we recommend that some higher level of review (possibly at the national level) be made available to investigators and that this level be accorded the power to overturn a local IRB decision.
Alternative to private and public IRBs: There has been considerable discussion of creating external and private IRBs to accommodate those institutions that have research activities but that do not have IRBs, or to supplement existing local IRBs. Another option that is much simpler and largely avoids the potential for conflict of interest (i.e., approving protocols, even those with problematic features, as a means of continuing referrals), is the creation of a centralized pool of individual IRB consultants who do not make decisions, but can serve as ad hoc IRBs or advice IRBs on certain protocols, in the area of the consultant’s expertise, if needed. Such a service would be far less expensive than using an external IRB and, in many cases, may provide exactly what the institution is looking for to make its own decision. Since the consultant’s role would be confined to pointing out problems, and providing needed information and suggestions for consideration and would not involve actually making the decision, the conflict-of-interest problem would be circumvented. Although many institutions might already use such consultants (usually from within their own institution) in this capacity, an organized pool of experts available nationally may prove a valuable additional asset.
Reducing administrative burden: Although it does narrow the definition of research, the report also expands the range of activities that fall under the system. In its discussion of the need for flexibility of review mechanisms contingent upon the nature of the research and the risks involved, NBAC does not address the possibility of on-line reviews of simple studies involving no significant risk. Under current regulations, such an expedited review procedure is prohibited. Given that the workload of IRBs would increase dramatically under the proposed oversight system, NBAC needs to take into consideration innovations that may facilitate review. In the absence of exempt categories of research, a new on-line mechanism for conducting reviews would enable IRBs to operate with 1 to 3 day turn-around on some kinds of protocols, thereby considerably reducing administrative burden.
Definitional issues
Definition of research: As the report notes, efforts to define “research” have been driven historically by the need to differentiate between clinical (biomedical) research and clinical practice. Extending resulting definitions to the non-medical research settings where the bulk of behavioral and social science research takes place has proven problematic. In the current report the distinction between research and non-research activities in non-biomedical or non-clinical settings (with the exception of public health and health services research) is unclear. For example, the categorization of activities related to program evaluation or quality improvement that require data collection and analysis from human participants in an industrial or educational setting is not clear. The case becomes especially murky when the objective of an evaluation may not be for the direct benefit of the employees, but to increase productivity (and profits) for a company Further guidance is needed to enable IRBs to review such protocols more effectively and efficiently.
Research by students: The NBAC approach to defining research is an improvement over the definition provided in the current regulations. By identifying key features that should be incorporated into a revised definition of research, NBAC has eliminated some of the ambiguity inherent in the current definition. Thus, the definition is in one sense much narrower, and while it appropriately excludes certain vital pedagogical activities such as classroom demonstrations in introductory psychology classes, there are other similar activities that might generate new knowledge (such as a senior thesis), that might appropriately be regulated as research activities.
However, although student experience in the research process including designing a study, collecting and analyzing the data and writing the final report should also require obtaining protocol approval via an IRB-like review, formal review of such research by the local IRB should not be mandatory. Instead departments might be encouraged to institute a review panel that regularly reviews student projects. This is an important distinction, since under current regulations a department or university may, at its discretion, insist on IRB review of all student research proposals regardless of intent of the activity (i.e., purely pedagogical demonstrations versus pedagogical plus generation of new knowledge)-one of the key features that NBAC recommends should be incorporated into the definition of research. But to foist these minimal or less than minimal risk research protocols on an overworked IRB creates unacceptable delays and may be counterproductive, leading some instructors to discontinue the research requirement, rendering the training of the future behavioral scientists less than optimal. Thus NBAC needs to provide clearer definitions of activities that may be classified as pedagogical and those that constitute research.
Need for clear guidelines on "local standards": Another issue that relates to the process by which IRB decisions are made, is the need for better guidelines for the application of “local standards” to IRBs decisions. Whereas it is clear that application of "local standards" can have a legitimate role in approving or disapproving protocols, it may sometimes be misused to justify otherwise seemingly arbitrary decisions. A recommendation indicating that an IRB decision based on the application of local standards should be accompanied by a clear statement of the bases for doing so would be welcomed by investigators and does not soften the ethical stance. This would simply makes IRBs more accountable for their decisions and reduce the frustrations experienced by investigators who follow federal regulations and then feel ambushed by what may be perceived as an idiosyncratic and unjustified negative decision by the local IRB.
Training issues
Research ethics training at the undergraduate level: Becoming familiar with and adhering to human research participant regulations is an integral part of the scientific education of students in training, including supervised undergraduate students, who conduct research. However, the educational needs of this population of very junior investigators requires increased attention, including the development of educational materials for faculty to use while training these students. The simple statement in the NBAC report that students who conduct research are also considered to be “investigators” does not address the special issues associated with this group.
Whereas the risks involved in student-conducted research are usually minor, especially in the behavioral and social sciences, their needs should be addressed if only because so many research participants (usually recruited from “subject pools” maintained by the training departments) are involved in this type of research. It is important to stress the need to follow standard guidelines, to provide appropriate supervision, and to ensure that students understand the concepts of risk, confidentiality, and the ethical principles on which policies, codes, and regulations are based. APA believes that educational interventions are the best way to help ensure that students will conduct research properly and that tomorrow’s scientists are ethically astute. Research training need not unduly be hampered by regulation, especially when research experience is almost a prerequisite for admission into good graduate programs. But this almost invisible operation requires mention and more attention.
Need for increased funding at the federal level for research ethics training: To thoroughly educate scientists and IRBs, opportunities (federal grants or contracts) for the best research ethicists to produce educational materials need to be increased. Currently the few opportunities available from the National Institutes of Health (NIH), such as the short-course and research on research ethics programs are of small scale and do not fill the need. Such training cannot be considered an educational mission of institutions alone, in large part because many institutions lack the additional resources and/or faculty with sufficient expertise. NBAC might recommend mechanisms to enable institutions to establish research ethics training programs, such as recommending that professional scientific societies be encouraged to develop discipline-specific educational resources that would be freely available to the field.
Other issues
Risk analysis: As IRBs consider risks involved in research, it is important that they be adequately equipped to appropriately judge psychological risks. Psychological risks should be placed on a continuum, which is anchored on one end by physical harm. This is especially relevant to IRBs representing institutions without research programs that involve use of physically invasive techniques. Without an “anchor” at the far end that involves the assessment of serious risks of physical harm, the IRB may alter its frame of reference so that more minor psychological risks may be perceived as major risks
Impact of issue being studied on IRB risk analysis and decisions: An issue that is extremely relevant to risk analysis but one that the NBAC report did not address is the role that the subject matter of the proposed study plays in IRB decisionmaking. For example, in a provocative study it was found that, when asked to review hypothetical research proposals identical in their proposed treatment of human participants but differing in their sociopolitical sensitivity, IRBs were twice as likely to reject socially sensitive proposals. Non-sensitive proposals that did not include ethical problems were approved 95% of the time, but comparable, sensitive ones were approved only 40%-50% of the time. On the other hand, researchers asked to judge pairs of deliberately flawed experiments that were identical except for the importance of their subject matter were significantly more likely to overlook methodological problems and to recommend publication when they perceived the topic to be important. Thus, it would be advantageous to provide greater guidance to IRBs when asked to review research involving controversial, sensitive, or high stakes content.
Deception research: The report addresses the issue of “deception” only cursorily, but warrants further exploration. In some sub-domains of psychology, such as social psychology, deception research is often the only method by which an empirical question can be adequately answered. This is a difficult ethical issue that is continually debated among psychologists, but certain safeguards to allow research using deception techniques can minimize risk. The recommendations in the draft report relate to risk assessment, and it is unclear how deception research would be reviewed. Although the recommendations do not explicitly disallow it, generally it would appear that deception research would not meet an acceptable criterion under the NBAC recommendations. We recommend that deception research be routinely treated in the “greater than minimal risk” category, requiring a full IRB review. This would still allow for well-designed, important research that presented an acceptable plan for debriefing research participants in a timely manner (and perhaps allowing them to withdraw the results of their participation at that time) and should be explicitly figured into any new system of research oversight.
Specific Comments
Chapter 2, Page 6, Line 19 - 31: Research involving special ethical considerations, such as…, or research involving individuals with vulnerabilities, should be reviewed by an IRB that has more expertise and experience in these special issues than a local IRB is likely to have…
… recommended the use of a special standing panel to review research studies involving persons with mental disorders that may affect decisionmaking capacity…
… one of the roles of this panel was to issue guidance that would permit local IRBs to review and approve certain types of research.
The recommendations in this section are confusing. The underlying assumption is that local IRBs may not be qualified to review certain types of research (for example, involving persons with vulnerabilities), which should be reviewed by a more experienced review body (for example, a special standing panel). But another of the charges of this panel is to issue guidance enabling the local IRB to review such research. Mechanisms by which review functions will revert to a local IRB and mechanisms for determining adequate IRB training need to be specified.
Additionally, the draft report recommends the setting up of specially trained and accredited IRBs and regional or national review bodies as options for providing heightened review. The details of such a multi-layered system need to be carefully elucidated, so as not to further complicate an already complex system of oversight. For example, NBAC/NOHRO would need to clearly identify the entity-the local IRB or the regional/national body-that would be responsible for on-going monitoring of the project after initial review and approval by the regional/national panel.
Chapter 2, Page 12, Line 17 - 20: By either employing investigators or allowing research to be conducted in its facilities, each institution engaged in research must take responsibility for the ethical conduct of that research. Moreover, each institution has an obligation to ensure that research is conducted in accordance with all applicable federal and state laws, regulations, and procedures.
The obligations of institutions involved in research are unclear. For example, it is not clear how this requirement would apply to a public elementary school in which a social scientist is conducting a survey (on a non-sensitive issue). Would the public school be required to have an IRB-like body that would review and approve the protocol? Would school officials have to be knowledgeable about all the laws and regulations pertaining to research with humans? Such requirements would make it possible to sustain important research that is currently conducted in public institutions.
Recommendation 2.1: Congress should pass legislation mandating that all research involving human subjects be covered under federal regulation, regardless of funding sources. (Also, just prior to the recommendation’s presentation on page 25, it is stated that, “Private institutions conducting human research …would be required to register with the NOHRO.”)
The all-inclusive coverage of research along with registration of any private institution that conducts research is particularly problematic for some disciplines that combine research and practice in the private sector. For example, consider the case where a company is developing a selection battery and collects personnel data primarily for the purpose of improving selection practices. Such data collection may be considered routine practice in the corporate setting. Yet, when these same data are used as part of an effort to gather validation data for research purposes, it would, under current regulations, be considered a minimal risk research situation. Requiring a private company to register with some system may result in a company refusing to allow the research, effectively eliminating entire research venues. Recommendation 2.1 thus needs to be refined, so that entire areas of research are not eliminated.
Chapter 2, Page 38, Line 20: … activities that should be on a list of non-research are journalism, market surveys, … and other defined practice activities in public health, medicine, psychology, and social work.
Further guidance is needed on the last categories of non-research activities. For example, consider the case of an independent clinical psychologist who is interested in comparing two standard forms of psychotherapy and wants to publish his/her findings (with all the necessary precautions to ensure privacy and confidentiality of the client/participants, etc.) about the efficacy of each therapy. It is unclear from the draft report whether this would be considered research.
Also, while “defined practices” in medicine and public health are to some extent easy to identify, further guidance concerning defined practices in psychology is needed. Psychology has its applications in numerous settings-hospitals, classrooms, work place, community, and so on. Activities that might be considered accepted practice by those in the field may not necessarily be viewed in the same light by those outside the field.
Chapter 2, Page 12, Line 13 - 14: For some research there may be more than one relevant institution, for example an university-affiliated investigator conducts research in a prison, (add) or in an educational, industrial or corporate setting…
Inclusion of an example from behavioral science.
Chapter 3, Page 17, Exhibit 3.2: Research Equipoise
As stated in the report, by modifying the medical concept of clinical equipoise to research equipoise, NBAC intends to broaden the term “so that it can be applied to other areas of practice”. (Line 16). Despite this intent, however, the discussion is rooted in the biomedical model and is less accessible to non-clinical, basic behavioral science settings. The examples of how a test of research equipoise may be applied to other research studies (Chapter 3, Page 18) are in terms of “evaluation of ‘interventions’ designed to benefit those who receive it.” Examples of how the test of research equipoise would be conducted in a non-clinical research setting-for example in a study of basic mechanisms of behavior such as memory, attention, emotion, etc-would be extremely useful.
Recommendation 3.1 Consistency in risk and benefits judgments
The distinction between research solely to answer research questions and research that may be of benefit to the participant is useful. The flow chart is also helpful. However, the discussion of the distinction is in terms of biomedical and clinical issues. NBAC needs to explore this issue further to determine how this distinction might fit other types of research, such as an evaluation study of a training program or evaluations of educational programs.
Recommendation 3.2: The National Office of Human Research Oversight (NOHRO) should issue regulations defining minimal risk as the probability and magnitude of harm that is normally encountered in the daily life of the general population, and describe review requirements for various types of research studies involving no more than minimal risk. …
APA has some concerns about Recommendation 3.2 (Chapter 3, page 27) which defines minimal risk as the probability and magnitude of the harm normally encountered in the daily lives of the general population. The arguments for a relative standard of risk (see Chapter 3, p. 23) are far more persuasive than an absolute standard. We do not believe that a relative standard would impose greater burdens on individuals who are seriously ill; it could, in fact, have an opposite effect. It would permit terminally ill patients the opportunity to participate in a risky experimental, but possibly beneficial research procedure. By contrast, the absolute standard defined by NBAC would deny such participation because the study would be deemed to have more than minimal risk for a healthy person. The risks and benefits have to be assessed in terms of the condition of the actual participant, not some theoretically "healthy person."
Recommendation 3.6: Criterion #3 for waiver of informed consent - The research study could not feasibly be carried out without the waiver, due to the financial or procedural burden of contacting participants.
APA recommends that the third criterion for waiver of informed consent be revised to mirror that currently in the regulations. Thus, the criterion would read: The research study could not feasibly be carried out without the waiver. Assuming that most cases of unfeasibility are due to cost or time is erroneous. There are instances of minimal risk research where the very act of obtaining informed consent would alter or interfere with the phenomenon being studied, for example if social desirability alters response types. Thus, amending the criterion as indicated above, would ensure that some types of important research is not restricted.
Chapter 3, Page 57, Line 1 - 3: Because the perspectives and experience of vulnerable persons can differ considerably from those who are not vulnerable, vulnerable persons should be encouraged to participate in study design and oversight processes.
Although the intent of this recommendation appears reasonable, it is neither realistic nor practical to assume that vulnerable persons would and could routinely be involved in study design and oversight processes. Although obtaining the perspective of the population being studied, regardless of vulnerability, might be extremely beneficial to the research, to suggest that prospective participants should be involved in the design phase of a study is contentious. If what is meant is that the investigator has the obligation to conduct pilot work to ascertain how best to ensure ethical conduct of a study involving vulnerable populations, then that requirement needs to be stated more explicitly. Otherwise, the recommendation is ambiguous and open to misinterpretation.
Chapter 4, Page 2, Line 13 - 28: Education has been a major focus of previous reports…develop topic-specific educational materials (NBAC, 1999b, 1998).
As noted in the report, education has been the key focus of reports by various Commissions over the years, as is the case with the present draft. But as a review of the current research system clearly indicates, very few, if any, of these recommendations have been implemented. However, over the last few years, there have been renewed efforts to implement some of these educational requirements, for example, the NIH requirement of research ethics certification for all individuals submitting grant applications. To ensure that training in research ethics becomes a critical part of science education NBAC should suggest ways in which NOHRO as well as professional scientific societies might assist institutions in developing educational programs and curricula.
Chapter 4, Page 17, Line 17 - 20: Investigators may be reluctant to ask informal questions of IRBs if there is a chance that a question may trigger closer monitoring of a research study. Likewise, there is similar hesitancy of IRBs to seek advice from OHRP/OPRR on difficult cases, because inquiry may trigger an investigation.
If the dual goal of promoting good science and protecting human research participants is to be achieved, there needs to be a dramatic change in the culture and climate in which research is conducted. In addition to revisions to the regulatory and oversight systems, and education of all personnel involved in the research enterprise, there needs to be a change in the sometimes antagonistic and hostile relationship between investigators and IRBs
Chapter 4: Discussion of accreditation and certification
The report is sensitive to the need to create a system that is workable but does not create a much heavier burden on researchers, IRBs, and a national monitoring system. For the most part, a great deal of effort has gone into trying to accomplish this, and some good suggestions have been made. However, the recommendations for accreditation of research programs and certification of research personnel need to be further examined. Care should be taken to ensure that such a system could be instituted without leading to rigidity and to a great deal of cost in both implementation and monitoring of the system.
Recommendation 4.8: The National Office of Human Research Oversight (NOHRO) should issue new regulations setting minimum percentage requirements for IRB membership composition and quorum determination for members who 1) are not otherwise affiliated with the institution, and 2) whose primary concerns are in non-scientific areas. At least fifty percent of the IRB members should be otherwise not affiliated with the institution and at least 50% of the IRB members should be non-scientists.
The recommendation that 50% of IRB members be nonscientists and/or public members unaffiliated with the institution (see Recommendation 4.8, Ch. 4, p. 25) creates new and serious problems. This would mean that half of the IRB membership would likely have no expertise in the subject matter of the protocol and may, as a result, default from reluctance to pass anything that is not comprehensible to them. The capacity of nonscientists to engage in an appropriate and fair risk/benefit analysis is highly questionable. We do not disagree that public membership is an important element or that more than one member is reasonable because no one person can represent “the public.” But the function of the public member primarily is to serve as a community “voice” to help guide and possibly offer important insights that might not be readily apparent to those trained to conduct research with human participants.
On a more practical level, it may be impossible to recruit such members to IRBs, particularly if the positions are unpaid. Thus, if one of the rationales for increasing the number of nonscientists on IRBs is to reduce conflicts of interest, then there are other more adequate and plausible mechanisms for dealing with these conflicts. For example, by developing a comprehensive institutional policy on conflict of interests, which clearly delineates the rights, responsibilities, and obligations of all personnel involved in the research process.
Conclusion
Social and behavioral scientists are increasingly subject to an oversight system better suited to biomedical research. The NBAC report is no exception, and as mentioned above, there needs to be increased attention to the concerns of the behavioral sciences and increased use of behavioral science research examples in the report. It is important to emphasize that the level and type of risks generally encountered in psychological research are different from those associated with biomedical research. Risk associated with the bulk of psychological research is minimal or less than minimal. When there is an appreciable level of risk in behavioral research, it tends to arise because vulnerable populations are studied (e.g., children, the mentally ill, the elderly) or because there are issues of privacy and confidentiality. It does not generally involve physical harm. It is of course vital to ensure the protection of the rights and welfare of participants in behavioral research, and to avoid psychological harm, but it is important to acknowledge the generally lower level of risk in physically non-invasive research.
As noted above, we remain concerned that social and behavioral research is and will continue to be over-regulated. There are many reports of research protocols that are subjected to “overkill” review, even when the research is minimal risk, requiring “speedy administrative review.” It is recommended that NBAC suggest mechanisms by which non-physically invasive research with human participants that involve neither deception nor greater than minimal risk can be regulated through an expedited review procedure. This sentiment is issued at the end of Chapter 3 and briefly noted elsewhere, but might warrant a clearly distinct category of its own.
To summarize, although the draft report attempts in various places to briefly acknowledge the differences between biomedical research and research in the behavioral and social sciences, the final version of this document would benefit greatly from more input from psychologists and other social scientists. This might render the report more accessible to and applicable to these non-medical research areas.
We hope that our comments prove informative in your deliberations of this fundamental component of the scientific enterprise.
Sincerely,
L. Michael Honaker, PhD
Chief Operating Officer
American Psychological Association