Responsible Research A Systems Approach to Protecting Research Participants (2003) / Chapter Skim
Currently Skimming:
4 The Participant-Investigator Interface
4 The Participant-Investigator Interface
Pages 108-135
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 108... ...
This chapter discusses how protections should be incorporated into research from the moment a research question is conceived to the point that individuals are recruited and provide their informed, voluntary consent to proceed. A qualified, properly trained investigator and an informed participant together provide the best opportunity for maximizing participant protections, as the most elaborate protection system imaginable will not work if the investigator does not carry out his or her ethical duties and the research participant does not knowingly and willingly .
|
From page 109... ...
Regardless of the expertise of the investigator, a poorly designed human research protocol is unethical. If the data cannot be validated or replicated, research participants have been exposed to risk or have volunteered their time for no useful purpose.
|
From page 110... ...
The key determination to be made is whether a research study contributes sufficiently to the greater good to justify the resources consumed. Recommendation 3.1 calls for "Institutional Review Boards" (IRBs)
|
From page 111... ...
The committee has adopted the term "Research Ethics Review Board" (Research ERB) for this purpose.
|
From page 112... ...
posed. Protocol Development The diverse origins of research proposals influence how their designs emerge and how the protection of research participants is ensured.
|
From page 113... ...
The individual investigator is therefore responsible for arranging the same features of research design referred to above and for considering the elements of participant protection. It should be clear that the investigator working on his or her own to develop a human research protocol needs extensive education and preparation for that role.
|
From page 114... ...
tuition reimbursement. A formal mentoring 5The IRB Forum is designed to provide a platform for conversations among IRB professionals, via e-mail, about ethical, regulatory, and policy issues involved in research with human participants.
|
From page 115... ...
In addition, adherence to institutional policies and federal laws and regulations governing human research and research integrity should be part of each faculty, staff, and student's annual performance evaluation. Sanctions for nonadherence and unethical behavior should be unequivocal and effective.
|
From page 116... ...
The committee concurs that it is the responsibility of the research organization to establish the level of initial and continuing instruction appropriate for individuals with different responsibilities. This committee's previous report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs, addressed the utility and potential value of an accreditation program for Human Research Participant Protection Programs (IOM, 2001a)
|
From page 117... ...
However, the importance of the research question should demonstrate sufficient possibility of adding to the fund of useful knowledge in order to consider involving volunteers. Merely adding to a company portfolio or to the publications on an investigator's curriculum vitae, for example, are not useful expenditures of human capital, let alone sufficient reasons to subject research participants to the risks inherent in any research protocol (including instances in which no physical or psychological harm would result)
|
From page 118... ...
Research organizations, and particularly Research ERBs, should be apprised of the potential conflicts of interest of researchers, their staff, spouses. and dependents.
|
From page 119... ...
and the report on IRBs by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1978, informed consent and IRB review have served as the primary procedural safeguards in human research in the United States (National Commission, 1978, 1979~. The centrality of informed consent to the research process was reiterated in a 1982 report by the subsequent President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, which identified informed consent as an "ethical imperative" to distinguish it from and raise it above the de minimus nature of law or regulation (1982b, phi.
|
From page 120... ...
Recommendation 4.1: The informed consent process should be an ongoing, interactive dialogue between research staff and research participants involving the disclosure and exchange of relevant information, discussion of that information, and assessment of the individual's understanding of the discussion. The ethical ideal of informed consent, grounded in the philosophical concept of autonomy, represents a departure from the paternalistic traditions of medicine revealed in the Hippocratic text, in which physicians were told to direct their commitment to the health and well-being of their patients, but were not instructed to foster their independence of thought or individual choice.
|
From page 121... ...
The idea of the process of informed consent as one that provides for sharing information with and educating the research participant has fallen prey to the idea of informed consent as a document to be signed by the participant, constructed by the research sponsor or site to comply with the regulations. In medical treatment and clinical research, these documents typically include lengthy descriptions of diagnoses, prognoses, treatment alternatives, risks and benefits of the alternative treatments, the risk of no treatment, the right to refuse, the commitment to provide care even in the face of refusal, and the injury compensation policy of the sponsoring institution.
|
From page 122... ...
Informecl Consent as an Ongoing Process Emerging data show that informed consent is most effective as an evolving process, as opposed to a static, one-time disclosure event and/or signing of a consent form. Jeremy Sugarman, an expert on informed consent and the ethics of research involving humans, advised the committee during his testimony that informed consent should be considered an inherent component of the research process itself (not an adjunct exercise)
|
From page 123... ...
Additional documents (or appendixes to the basic consent form) that contain the boilerplate language directed at the legal protection of the institution rather than informing participants represent disclosure documents.
|
From page 124... ...
This process would facilitate understanding rather than impede comprehension, which, unfortunately, is often the result of the present use of lengthy consent forms. Accomplishing the goal of real understanding as a precondition to a meaningful decision to participate will require a sea change in Research ERB and investigator perception and practice.
|
From page 125... ...
In addition, special attention to the informed consent process should be provided for participants with language barriers, diminished capacity, and known vuinerabilities both to facilitate informed consent and to avoid denying special groups access to human studies. The Therapeutic Misconception As mentioned in Chapter 3, in clinical research, informed consent often does not produce an appropriate understanding of the nature of research in participants because of the pervasiveness of the "therapeutic misconception" (Appelbaum et al., 1982; Churchill et al., 1998; King, 1995~.
|
From page 126... ...
This phenomenon once again highlights the need to distinguish the informed consent process from the consent form and for investigators to take an active role in ensuring that consent is voluntary and informed. The need for further research and evaluation of the informed consent process became abundantly clear from the committee's investigation of the literature and from the testimony of experts and research participants.
|
From page 127... ...
However, the central feature of ensuring that the informed consent process occurs and is effective lies in the commitment to this effort of the investigator and every member of the research team. Heeding the Collective Rights and Interests of Participant Communities The concept of "community" in the context of research has been discussed for some time and became part of official federal policy when FDA and NIH published new rules for the waiver of consent in emergency research (FDA, 1996; NIH, 1996~.
|
From page 128... ...
Where culture or custom requires that permission of a community representative be granted before researchers may approach potential research participants, researchers should be sensitive to such local requirements. However, in no case may permission from a community representative or council replace the requirement of a competent individual's voluntary informed consent (2001a, p.
|
From page 129... ...
Thus, the historical and somewhat mythical basis of the investigator/subject relationship in which the individual volunteers out of altruism and despite risks is being supplanted by a new reality in which research participants sometimes demand access to trials, are often backed by an advocacy movement, and are ready to confront the research enterprise when mistakes are made or injustices arise. The Role of the Incliviclual Research Participant Research participants are a diverse group of individuals who enter into the research setting for a variety of reasons and who play important roles in the research process.
|
From page 130... ...
Research participants should be assisted in expanding their knowledge about the clinical research process by being offered educational materials and by being encouraged to ask questions of the investigator or other members of the research team. This is particularly important for studies involving greater than minimal risk and those protocols enrolling patients rather than healthy volunteers.
|
From page 131... ...
In either case, the study and its analysis would be negatively affected, and more significantly, these individuals may cause undue harm to themselves or other participants. The Need for the Participant Perspective Within the Protection Program If the research enterprise is to remain relevant to the public, it should incorporate the realities and interests of research consumers, including those of potential research participants and the general public.
|
From page 132... ...
. A degree of skepticism regarding such practices serves to stimulate and enhance discussion and is vital to creating a robust and .
|
From page 133... ...
Such partnerships shouici inclucle the clevelopment of policies that will encourage and facilitate increased participation in the protection program by unaffiliateci members (e.g., hoicling Research ERB meetings cluring the evening so that unaffiliateci members clo not have to miss work to attend (Ranci Reeci, 2001~. Basic Research Education Needs Before enrolling in any research stucly, potential research participants shouici be provicleci with basic information regarding the research process, inclucling the implications of the experimental nature of the incliviclual projects that they may be considering.
|
From page 134... ...
As discussed in Chapter 3, individuals asked to serve in an oversight capacity within protection programs as a participant or community representative should be provided with the background knowledge and tools to fulfill this role. For example, unaffiliated members of Research ERBs should be provided with educational opportunities regarding the history of research, the need for ethical review, the methodology of research design, the federal regulations governing research, the role of advocacy for participants, and the processes for protocol review, as well as information on how to assess risk and consider possible benefits and the group dynamics pertinent to Research ERB deliberations.
|
From page 135... ...
The voluntary informed consent of research participants is essential for ethically sound research involving humans. In order to ensure that participants provide truly informed consent, the informed consent process should be interactive and ongoing, rather than focused on the signing of a written consent form.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.