Ethical Conduct of Clinical Research Involving Children (2004) / Chapter Skim
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6 Payments Related to Children's Participation in Clinical Research
6 Payments Related to Children's Participation in Clinical Research
Pages 211-228
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From page 211... ...
Although they are often appropriate and desirable, payments related to research participation may raise ethical questions. The researcher asking the questions above was probing for how much influence payment might have on a child's decisions about research participation.
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From page 212... ...
The committee found the above categories helpful in distinguishing differences among types of payments and discussing payment practices that may unduly influence decisions about research participation. Often, however, research protocols lump payments into one sum, which can make it difficult to determine whether a payment (and how much of payment)
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From page 213... ...
ETHICAL PRINCIPLES AND REGULATORY POLICIES Ethical Concerns About Payments to Children and Parents As discussed in Chapter 5, ethical standards for participation in research require that the agreement to participate be freely given, that is, be neither coerced nor unduly influenced by psychological, financial, or other pressure. The major concern about financial incentives -- as defined above-is that they may distort decisions about research participation, especially for economically disadvantaged individuals or families.
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From page 214... ...
What is excessive in one situation may not be in another, and reasonable people may sometimes differ in their judgments. Although payments to research participants may have different purposes, for example, fairness, payments may also be intended to influence enrollment decisions.
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From page 215... ...
supplements federal regulations with guidance on a variety of topics. Its primary guidance on payment to research participants appears to be provided by Protecting Human Research Subjects: Institutional Review Board Guidebook, which
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From page 216... ...
Much of the guidance is relevant to pediatric research, but some does not apply. For example, the additional protections provided to child research participants would likely preclude approval of the kinds of higher-risk studies that might, for healthy adult volunteers, provide larger-than-usual incentive payments for the acceptance of greater research risk.
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From page 217... ...
. USE OF PAYMENTS IN RESEARCH INVOLVING CHILDREN Little systematic information is available about the use of various kinds of payments or other incentives for participation in either adult or pediatric studies.
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From page 218... ...
The guidelines do not sanction varying payment based on the risk presented by a study. TDN has received favorable comments from several IRBs regarding the helpfulness of its standardized approach that is consistent across studies and sensitive to ethical issues regarding payment.
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From page 219... ...
Although the study did not focus specifically on pediatric research, the results raise concerns about the adequacy of institutional information and policies on payment. According to the investigators, only one respondent reported that no studies involved payments to research participants, and another respondent had no information.
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From page 220... ...
cited earlier, only 6 of 128 of the IRB chairs whose responses were included in the analysis reported that their IRBs had written policies about payments to research participants. Of the five written policies reviewed by the authors, all permitted payment related to expenses or burdens associated with participation.
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From page 221... ...
stated that remuneration, compensation, and indemnification are ethical payment practices based on current societal standards. It also observed that "serious ethical questions arise when payment is offered to adults acting on behalf of minors in return for allowing minors to participate as research subjects" (AAP, 1995, p.
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From page 222... ...
In addition, organizations that accredit IRBs include such compensation as a requirement of accreditation. Payments to Physicians for Recruiting Child Research Participants Although the committee was not asked to examine the issue of payment to clinicians for enrolling child patients in research, this is an increasingly important issue in pediatric research.
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From page 223... ...
The recruitment by physician-investigators of their own patients as research participants also raises concerns. It is an attractive and convenient research strategy, especially given the challenges of recruiting sufficient numbers of children for pediatric studies.
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From page 224... ...
Written Institutional Policies on Payment Even in the absence of data about the impact of payment practices on parent and child judgments, IRBs and research institutions should develop written policies on payments related to research participation. By developing such policies, IRBs can consider how different practices may serve or compromise ethical principles for the conduct of human research outside of the context of an individual protocol.
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From page 225... ...
. Recommendation 6.1: Institutional review boards, research institu tions, and sponsors of research that includes children and adolescents should adopt explicit written policies on acceptable and unacceptable types and amounts of payments related to research participation.
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From page 226... ...
Recommendation 6.2: In addition to offering small gifts or payments to parents and children as gestures of appreciation, investigators may also -- if they minimize the potential for undue influence -- act ethically to reduce certain barriers to research participation when they · reimburse reasonable expenses directly related to a child's partici pation in research; · provide reasonable, age-appropriate compensation for children based on the time involved in research that does not offer the prospect of direct benefit; and · offer evening or weekend hours, on-site child care, and other reasonable accommodations for parental work and family commit ments. Although controversial, it may be appropriate under certain circumstances to pay adult volunteers larger amounts for agreeing to participate in higher-risk research that will not directly benefit them.
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From page 227... ...
Chapter 2 also described the challenges that pediatric investigators face, including recruiting sufficient numbers of children for many kinds of studies. Given the combination of government policies and existing recruitment problems in some areas of research, policymakers, research institutions, and IRBs should be attentive to the recruitment practices proposed in pediatric protocols and should strongly discourage or forbid bonuses or similar financial incentives to physicians for enrolling their pediatric patients in research.
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From page 228... ...
The process of developing written policies should encourage more systematic reflection on the fit between different payment practices and the ethical standards for clinical research involving children.
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