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The CRRO Corner By Farrah A. Belizaire, BS, Clinical Research Recruitment Specialist, The ReSPECT Registry, Clinical Research Resources Office (CRRO) Appropriate Language Regarding Financial Payment in Research Studies Investigators commonly use some form of financial payment as part of a recruitment plan in a research study. Compensation may specifically reimburse a research subject for expenses incurred while participating in a study. On the other hand, remuneration offers an appropriate reward to research subjects to thank them for completing study-related activities1. Whether it is compensation or remuneration, a financial payment may be given in the form of cash, gift cards to local stores, or other incentives of cash value such as food or parking vouchers. How much to reimburse or reward research subjects for their participation in a study continues to be a concern for investigators. Avoid Overemphasizing Payment • Advertisements can state whether or not study subjects will receive some form of payment for their time and effort in participating in a study. However, it is not appropriate to overemphasize the payment or the cash amount through large or bolded type, or prominent placement in the ad itself. Advertisements that emphasize payment create a powerful first impression that can be coercive2. Once a subject has been motivated to join a study by the way the payment was advertised, their ability to make an informed decision about whether the study is right for them may be difficult. Balance Payment with the Expected Study Commitment • Investigators should consider whether or not the amount of financial payment is equitable compared to the expected study-related activities and time invested. The payment to subjects should be balanced against the amount of time, effort, and various tasks to be completed by the subject. Latterman and Mertz (2001) conducted an analysis to evaluate subject payments in various types of research studies. They looked at 109 studies involving 146 subject populations. They found that the range of payments analyzed had cash values ranging from $1 to $730, and that these payments were related to the time and level of activity requested of participants. This study reinforced the importance of determining appropriate compensation or remuneration for a subject based on the study. An investigator can take several steps to ensure this: Evaluate (1) the number of interactions between subjects and researchers (one visit vs. several visits); (2) the number of tasks in a visit (single or multiple surveys, interviews, focus groups, etc.); (3) the length of time of participation (one-time commitment vs. participation over an extended period of time (days, months, or years); and (4) the types of interactions (invasive vs. non- invasive tasks such as blood draws vs. telephone survey)3. These study commitment factors are important measurable criteria that may help researchers assess an appropriate amount of financial payments for various activities. Avoid Misrepresenting the Benefits • A common misconception is that a financial payment is a benefit to participating in a study, which it is not. Payments are considered a recruitment tool because they are either intended to entice subjects to join a particular study or to thank study subjects for their time and effort4. Thus, recruitment material should avoid making claims that promise or guarantee benefits. Terms such as "new treatment," "free medical care," or "free medication" are not acceptable. Such language may lead potential study subjects to believe that they are not involved in a research study. Any form of payment to research subjects must be IRB-approved to assure that the amount, type, and schedule of payments avoid undue influence5. A financial payment that presents undue influence would have a value that is inconsistent with the time and effort required of study subjects6. For help creating appropriate recruitment material for your study, the Clinical Research Resources Office (CRRO) offers investigators the ReSPECT Registry as a tool to support recruitment and retention strategies. Call the Recruitment Team at (617)638-8862 or email respect@bu.edu for more details. ______________________________ 1. "Remuneration of Research Subjects." Partners Human Research Office. Partners IRB. Web. 15 May 2012. <http://healthcare.partners.org/phsirb/remun.htm>. 2. Dresser, Rebecca. "Payments to Research Participants: The Importance of Context." American Journal of Bioethics 1.2 (2001): 46-47. Project MUSE. MIT, 2001. Web. 14 May 2012. <http://muse.jhu.edu/journals/american_journal_of_bioethics/v001/1.2dresser.html>. 3. Latterman, Jessica and Merz, Jon F. "How Much Are Subjects Paid to Participate in Research?" American Journal of Bioethics 1.2 (2001): 45-46. Project MUSE. MIT, 2001. Web. 14 May 2012. <http://muse.jhu.edu/journals/american_journal_of_bioethics/v001/1.2latterman.pdf> 4. "Payment to Research Subjects." U.S. Food & Drug Administration Regulatory Information. U.S. Department of Health and Human Services, 18 Oct. 2010. Web. 14 May 2012. <http://www.fda.gov/regulatoryinformation/guidances/ucm126429.htm>. 5. "Patient Compensation Regulatory Guidelines." Good Clinical Practice: A Question & Answer Reference Guide 2011. Barnett International, 6. "Informed Consent - FAQs." Human Research Protections FAQs Related to Informed Consent. U.S. Department of Health and Human Services, 2012. Web. 22 May 2012. <http://answers.hhs.gov/ohrp/categories/1566>. The CRRO, the Recruitment Services Program, and the ReSPECT Registry are supported by the Boston University Clinical Translational Science Institute, the Department of Medicine, and the Office of Clinical Research. |