DEFINITIONS: See Definition of Human-Subjects Research POLICY STATEMENT: In order to ensure that taxable payments are appropriately reported to the IRS, and to the research subject, Investigators must follow the procedures described in this Policy. In my view, offering modest amounts of money is unlikely to obscure risks or impair the judgment of most individuals. Pace C, Miller F, Danis M. Enrolling the uninsured in clinical trials: an ethical perspective. To avoid making children commodities, some argue that parents should not receive money as incentive for their childs research participation (50, 51). Consequently, institutions making payments to study participants are required to report these payments to the Internal Revenue Service (IRS) if total payments (not including reimbursement for actual expenses such as parking or travel) made to the participant by the institution exceed $599 in any calendar year. Finally, OHRP asserts that IRBs should not consider remuneration as a way of offsetting risks when deciding whether research should be approved. sharing sensitive information, make sure youre on a federal . In contrast, in a wage-payment model, subjects are offered payment as compensation for the time and contribution they make to the research. Phone: (301) 435-8710; Fax: (301) 496-0760; E-mail: GUID:1BB27FE0-DBB9-4DF7-95DB-203AC4E26F1E, GUID:10B616D0-3AF1-451F-A80F-6FCF263A1964. Before sharing sensitive information, make sure youre on a federal government site. As far back as the 1820s, William Beaumont, whom many consider to be the father of gastric physiology, gave patient Alexis St. Martin a French Canadian voyageur suffering from an incompletely healed gunshot wound to the stomach food, lodging, clothing, and $150 for the opportunity to study his stomach contents for 1 year (1). 2004. Paying research participants in exchange for their participation is a common and, in general, acceptable practice. A .gov website belongs to an official government organization in the United States. As noted above, both OHRP and FDA guidance recommend prorating payment to participants in line with the proportion of study participation an individual has completed, rather than withholding all payment unless participation is complete. incorporated into a contract. Healthy volunteers, who are frequently paid and unlikely to benefit medically from research participation, are often attracted to research and motivated to participate by money. Federal government websites often end in .gov or .mil. o All information concerning payment, including the total amount, schedule of payment(s), and any plan for prorating payments if a participant does not complete the study should be described in the informed consent document. Department of Clinical Bioethics, Clinical Center, NIH, Bethesda, Maryland, USA. US Code of Federal Regulations, title 45, part 46. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. But, as Wilkinson and Moore argue, even people with few options may still have the ability to make decisions for themselves and thus be capable of autonomous consent (42). Payments to Research Subjects over $100 per occurrence must be paid directly to the individual via University check. Content created by Office for Human Research Protections (OHRP), Attachment A - Addressing Ethical Concerns, Payment to Research, September 30, 2019 Letter to the HHS Secretary. Payment to research subjects may occur in one of the four ways listed below: Reimbursement: Payments that are directly related to expenses that are incurred from participating in the research study. Instead, the FAQs go on to say: Because influence is contextual, and undue influence is likely to depend on an individuals situation, it is often difficult for IRBs to draw a bright line delimiting undue influence. government site. McNeill P. Paying people to participate in research: why not? Payments for research participation: Don't tax the Guinea pig PDF HUMAN SUBJECT PAYMENTS - Northwestern University Concern about incentive payments should not mask concern about allowing a research study to proceed at all. van Gelderen C, Savelkoul T, van Dokkum W, Meulenbelt J. 200 Independence Avenue, S.W. not providing subject payments from personal funds and seeking reimbursement). Appreciation can be shown by awarding a wide range of amounts of money as well as nonmonetary gifts. Dickert N, Grady C. Whats the price of a research subject? An appreciation model conceives of money as a reward or token of appreciation for a subjects contribution to research. The Institutional Review Board (IRB) should determine that the risks to subjects are reasonable in relation to anticipated benefits [21 CFR 56.111(a)(2)] and that the consent document contains an adequate description of the study procedures [21 CFR 50.25(a)(1)] as well as the risks [21 CFR 50.25(a)(2)] and benefits [21 CFR 50.25(a)(3)]. An official website of the United States government. attractive that [it can] blind prospective subjects to potential risks or impair their ability to exercise proper judgment . 3.8 Research Subject Compensation and Reimbursement Unless it creates undue inconvenience or a coercive practice, payment to subjects who withdraw from the study may be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. Break Funding Payments In the event of (a) the payment of any principal of any Eurodollar Loan other than on the last day of an Interest Period applicable thereto (including as a result of an Event of Default), (b) the conversion of any Eurodollar Loan other than on the last day of the Interest Period applicable thereto, (c) the failure to borrow, convert . The views expressed here are those of the author and do not necessarily reflect the views or policies of the NIH or the US Department of Health and Human Services. Proration may not achieve that goal; instead, a completion bonus may be necessary and should be permissible with certain safeguards. Most important is the recognition that IRBs and investigators have a variety of mechanisms to help transform anyone like Potential Participant 2 at least into someone like Potential Participant 1, avoiding concern about undue influence while still allowing incentive payments. In this regard, money may enable individuals to take part who otherwise could not afford to participate or who are not willing to make a financial sacrifice in order to do so. However, remuneration to subjects may include compensation for risks associated with their participation in research and that compensation may be an acceptable motive for agreeing to participate in research. On this issue, the FDA Information Sheet states that [p]ayment to research subjects for participation in studies is not considered a benefit that would be part of the weighing of benefits and risks; it is a recruitment incentive. Even though IRBs are directed not to consider payment in their approval decisions, they should be aware that potential participants are likely to include payment in their weighing of potential benefits and risks of harm. Human Subjects Office / IRB Hardin Library, Office 105 600 Newton Rd Iowa City, IA 52242-1098. Importantly, this does not mean that the right to withdraw necessarily has been compromised. Office of Good Clinical Practice, Updated Jan. 25, 2018, Also see these FDA Information Sheets:"A Guide to Informed Consent""Recruiting Study Subjects. Tishler C, Bartholomae S. The recruitment of normal healthy volunteers: a review of the literature on the use of financial incentives. When incentive payment is contingent on a participants study completion (i.e., a completion bonus), its purpose is specifically to encourage participants who might otherwise withdraw not to do so. With regard to incentives, proration would help encourage participants to continue participating until each scheduled checkpoint, which can avoid undue influence so long as the conditions for study approval and adequate participant decision-making remain satisfied, as discussed below. Undue influence has been defined by some scholars in the research ethics literature as occurring when there is an (1) excessive offer of something valuable or desirable that leads to (2) poor judgment or a compromised decision-making process, which in turn leads to (3) a decision to engage in harmful activity that seriously contravenes the decision-makers interests or obligations. Unlike the other 3 models, appreciation payments may have little impact on study recruitment, as appreciation is often reserved until the study ends. . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Washington, D.C. 20201 However, empirical evidence demonstrating that payment is necessary and/or effective for the recruitment of clinical research subjects is limited. For example, in a study lasting only a few days, an IRB may find it permissible to allow a single payment date at the end of the study, even to subjects who had withdrawn before that date. Motivated by cash payments or an attractive financial package, an individual could have less interest in evaluating or understanding study details, reading the consent form, or attempting to understand the goals, purposes, and risks associated with a study. While still possibly able to facilitate recruitment, wage-like payments are unlikely to unduly influence individuals to enroll in research to which they object (46). Payment of any type is intended to facilitate enrollment, which it cannot do if participants are not made aware of the offer. If unable to submit comments online, please mail written comments to: Dockets Management Also outside the scope of this document are payments intended to reimburse or compensate study participants in the event of study-related injury. Motives and perceptions of healthy volunteers who participate in experiments. . Payment information should also be included in consent forms. Careful attention to eligibility criteria in the screening history, physical examination, and laboratory tests can minimize, although not eliminate, the possibility of misrepresentation in order to enroll in research trials. Other than reimbursement for reasonable travel and lodging expenses, IRBs should be sensitive to whether other aspects of proposed payment for participation could present an undue influence, thus interfering with the potential subjects' ability to give voluntary informed consent. Official websites use .gov Here, reasons for providing payment, payment models, ethical concerns, and areas for further research are examined. Influence of race, clinical, and other socio-demographic features on trial participation. However, investigators and IRBs should review the offer of money and other inducements outlined in clinical research proposals, especially for research on the margin of reasonable risk or with groups of people that are more likely to be attracted by an offer of money. This form is used if cash payment is made at the time of the visit to the research participant. In contrast to payment for participation, FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence. With this approach, IRBs can protect typical participants in the target population from research that would be objectively harmful. Paying Subjects to Take Part in Research: A New Perspective on - ACRP Importantly, the regulations do not require elimination of influence, but rather that investigators minimize the possibility of undue influence. However, making it possible for a child to participate in research can be inconvenient and costly for parents, and the amount of risk children can be exposed to in research is strictly limited by federal regulations (52). However, as articulated in this document, SACHRP believes that this guidance does not go far enough in easing concerns about offers of payments to research participants. Models of payment for the participation of research subjects. 4.0 General Principles 4.1. FDA Publishes Clarification about Payment and Reimbursement to Research Making accrual of reimbursement and compensation payments contingent on study completion is inappropriate because it conflates such payments with incentives, using them to encourage completion rather than as intended that is, to reimburse a participants costs or compensate for a participants time and burden. Examples include providing payment for transportation . Dunn L, Gordon N. Improving informed consent and enhancing recruitment for research by understanding economic behavior. IRBs should review the justification for and the amount and schedule of payment and decide whether these variables are appropriate given the particular study and the population to be recruited. OHRP FAQs currently define undue influence as potentially occurring through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance. They do not, however, explicitly define what would make a reward excessive or inappropriate. Paying research subjects: an analysis of current policies Consent Form Guidelines and Suggested Wording | Human Research It does not establish any rights for any person and is not binding on FDA or the public. NIH. Federal government websites often end in .gov or .mil. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. PDF Payments to Human Subjects for Participatio in Research Halpern S, Ubel P, Berlin J, Asch D. Randomized trial of $5 versus $10 monetary incentives, envelope size, and candy to increase physician response rates to mailed questionnaires. Methods of Payment and Reimbursement Method of payment Investigators can pay participants by various methods including cash, check, or gift card. Guidance for institutional review boards and clinical investigators: payment to research subjects. Prorating payment for studies involving multiple visits minimizes the possibility of inappropriately influencing someone to remain in a study just to receive a lump sum payment at the end. For example, an individual interested in a well-paying MRI study could jeopardize his safety by concealing the history of a shrapnel injury that otherwise would exclude him. Unlike reimbursement or compensation which seek, respectively, to restore subjects to a pre-research financial baseline or to acknowledge the time and burdens of participating in research, incentives are intended to improve recruitment and retention by influencing subjects to enroll, remain enrolled in the research, and complete specific or all . The https:// ensures that you are connecting to the American Academy of Pediatrics Committee on Drugs. Human Subject Protection (HSP), Informed Consent, Investigation, Investigational Device . Free-living volunteers motivations and attitudes toward pharmacological studies in man. Aby J, Pheley A, Steinberg P. Motivations for participation in clinical trials of drugs for the treatment of asthma, seasonal allergic rhinitis, and perennial nonallergic rhinitis. Receive the latest updates from the Secretary, Blogs, and News Releases. It is the policy of the Mayo Clinic Office for Human Research Protection (OHRP) and Mayo Clinic IRB that investigators will not involve human beings as subjects in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. Updates to Payment and Reimbursement to Research Subjects - Information Grady C, Dickert N, Jawetz T, Gensler G, Emanuel E. An analysis of U.S. practices of paying research participants. ", Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions). payments to a company to organize a research study, analyze data, sample analysis, etc. One study showed a willingness of subjects to conceal information from investigators in lower-risk studies, but this willingness was not associated with payment (20). SUBJECT: Payments to Research Participants . Randomized trial of financial incentives and delivery methods for improving response to a mailed questionnaire. From a practical perspective, the total elimination of any possibility of undue influence is likely to be infeasible or substantially overprotective, or to make research difficult or impossible to carry out. On the other hand, in longitudinal or long-term studies, where certain data points are critical to the study, it may be appropriate to use escalating incentives or completion bonuses, as long as they are not offered to compensate for increasing risk. Thus, SACHRP takes the position that payment raises concerns about undue influence when it appears likely to inhibit potential participants adequate consideration of and reflection about important study features, such as risks, burdens, and discomforts, and impair their understanding of the research and their participation in it. Emanuel EJ. Elsewhere, my colleagues and I have argued that conceptualizing payment as compensation in the form of a wage payment is the most ethically appropriate model because it recognizes the contribution subjects make to research and is relatively standardized across studies. Further, limited evidence suggests that the offer of payment does not obscure the risk perception of potential research participants (20, 21), and there are no data to suggest that it does. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. All comments should be identified with the title of the guidance. Consequently, some find carefully calculated payment to compensate parents for time and inconvenience acceptable and unlikely to contribute to significant distortions in parental judgment (53), while others believe that compensation to parents should be limited to reimbursement for expenses (51). Tips for Compensating Research Participants | 2021 | IRB Blog Alternatively, payment could help recruit individuals who believe they should be fairly compensated for their time and effort. Completion bonuses and escalating incentives would be commonly employed as incentives for subjects to meet data points or complete a study. In the research proposal submitted to their IRB, investigators should describe the rationale for payment, how the dollar amount was calculated, and how and when payment will be made. SACHRP believes that this approach is problematic. Further empirical and conceptual research is needed to resolve when and how payment should be offered in pediatric research. An adequate consent process enables participants to decline participation in research that would be subjectively harmful according to their own judgment of their interests, values, and obligations. Finally, although we have focused on financial payments, similar issues may be relevant for other types of non-financial benefits offered to all research participants. This means that the availability and amount(s) of payment should not be highlighted to a greater extent than other relevant information about a study or in a way that obscures such information. Some commentators believe that the act of paying research subjects is wrong (7), maybe even coercive, while others find it an acceptable and perhaps necessary part of recruitment for clinical investigation (8, 9); others see payment of at least healthy subjects as fair and appropriate (10, 11). Offering payment to clinical research subjects, in an effort to enhance recruitment by providing an incentive to take part or enabling subjects to participate without financial sacrifice, is a common yet uneven and contentious practice in the US. Some say that financial incentives are also necessary to overcome barriers unique to certain subgroups in the population, such as lack of awareness or distrust. Because advertising is the first step in the consent process, payment information on advertisements should be truthful, clear, and appropriately contextualized with regard to study risks and burdens.
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