Honorarium or coercion: use of incentives for participants in clinical research.
Abstract: Nurses are frequently involved in the recruitment of subjects for clinical research studies when their patients are potential study participants. As professionals, it is nurses' responsibility to make sure that patients are treated with beneficence when they are included in clinical research. Financial incentives are frequently used to encourage participation, and the concern has been raised that this practice could be coercive, especially for people who have limited financial resources.
Subject: Incentives (Business) (Usage)
Nurses (Services)
Author: Groth, Susan W.
Pub Date: 03/22/2010
Publication: Name: Journal of the New York State Nurses Association Publisher: New York State Nurses Association Audience: Academic Format: Magazine/Journal Subject: Health; Health care industry Copyright: COPYRIGHT 2010 New York State Nurses Association ISSN: 0028-7644
Issue: Date: Spring-Summer, 2010 Source Volume: 41 Source Issue: 1
Topic: Event Code: 280 Personnel administration; 360 Services information Computer Subject: Industry hiring
Product: Product Code: 8043100 Nurses NAICS Code: 621399 Offices of All Other Miscellaneous Health Practitioners
Geographic: Geographic Scope: United States Geographic Code: 1USA United States
Accession Number: 242591405
Full Text: Nurses often participate in, or are asked to invite or encourage patients to participate in, clinical research. Often, nurses don't think about the role that incentives play in the recruitment and retention of research subjects and whether they are reasonable, appropriate, and in the best interest of all individuals involved. Participants are a major component of research and without them science would not be able to move forward into clinical practice. However, nurses must always uphold the ethical standards of respect, beneficence, and justice.

There are two areas to consider when discussing the use of incentives in research: 1) clinician incentives to invite patients to participate, and 2) participant incentives to enroll and remain in research studies. Controversy resides in the ethical aspects of conflict of interest for clinicians and the risk of coercion of vulnerable participants. This discussion focuses on participant incentives, specifically on the use of financial incentives for participants. The issue is whether monetary payment could unduly influence potential participants to enroll in a study against their better judgment (Halpern, Karlawish, Casarett, Berlin, & Asch, 2004), or that a study sample could be compromised due to enrollment of subjects vulnerable to financial incentives (Dickert, Emanuel, & Grady, 2002). There are indirect forms of financial incentives that are sometimes utilized, such as giving gifts or coupons to participants, but these appear to be less controversial, although nurses should also pay attention to such gifts in terms of magnitude and reasonableness.

Establishing a balance between the need to encourage research participation, yet avoid coercion that affects the integrity of a study sample or compromises respect for individuals and justice, remains a challenge for the research community. Study subjects are an essential part of the research endeavor, and recruitment and retention costs continue to increase. In this author's opinion, the use of financial incentives enhances recruitment and retention by treating participants justly and with respect by recognizing and acknowledging their commitment to science and the effort they expend to participate.

Concerns and alternatives to financial incentives

The first concern with financial incentives is that they increase the cost of the study. However, there are alternative ways to motivate individuals to participate in clinical studies that do not utilize financial incentives. For example, motivational interviewing is a technique incorporated into protocols that motivates participants to remain involved in a study (Goldberg & Kiernan, 2005). Emphasizing the opportunity provided by participating along with the benefits experienced as a study participant are examples of reinforcement of the positive aspects of involvement (Ott, Twiss, Waltman, Gross, & Lindsey, 2006). In addition, addressing deterrents and appealing to altruistic motivation can encourage participation (Ott et al., 2006). Use of culturally sensitive recruitment materials aimed at particular populations is another means of promoting participation (Staffileno & Coke, 2006). Finally, developing a protocol that is responsive to participants, such as flexible scheduling, frequent contacts, and creation of a nurturing relationship, can promote retention in a research study (Staffileno & Coke, 2006).

The second concern of financial incentives is that they may provide inducements to participate in a study for financial purposes only. Vulnerable populations may be at particular risk because they can be enticed by the financial reward and thus may be more willing to accept any study risks. Disenfranchised individuals or people with limited financial resources are deemed at risk of enrolling in research for financial gain alone (Dickert et al., 2002). This fear may grow out of a history where vulnerable populations have been treated unfairly and the subsequent recognition of the need for measures to protect them, for example, the Tuskegee studies of syphilis (Dunn & Chadwick, 2002).

Participants have expressed that participant payment is inappropriate (Russell, Moralejo, & Burgess, 2000). In a study of 54 highly educated, unpaid participants, some of whom were healthcare workers, interviewed about payment for study participation, more than 56% did not agree with financial incentives (Russell et al., 2000). This opinion was expressed by a majority of those who completed questionnaires regardless of education level, prior research experience, gender, or whether or not they held healthcare jobs. The respondents clearly recognized the risks and benefits of research participation, along with the challenges and drawbacks of participating, and yet supported the concept of a "moral duty" to participate. The respondents indicated that the risks of payment for participation included sample bias, unethical behavior of enrollment purely for financial gain, and undue influence.

Value of financial incentives

Although there are alternatives and concerns, these do not negate the value and importance of providing financial incentives for participation in research studies. Based on the literature, this writer concluded that financial incentives are motivating and should not be ignored when dealing with the challenges of recruitment and retention. When applied in a reasonable manner, financial incentives are not an unjust inducement to participation and are an approach that acknowledges participants for their time and effort. Financial incentives can contribute to minority participation without using coercion (Halpern et al., 2004). In fact, payment affirms participants' value and the importance of their participation (Russell et al., 2000). It can also equalize the burden placed on them in terms of time and cost of participation (Russell et al., 2000).

A review by Yancey, Ortega, and Kumanyika (2006) suggests that across multiple studies, financial incentives increased response rate and increased it specifically for minorities. Concern over undue coercion was not necessarily founded on empiric evidence. Case in point, a qualitative study of 58 minority women, who could be considered vulnerable to financial incentives due to their minority status and gender, both of which placed them at increased risk of income below poverty level, suggested that financial incentives were not a primary motivator (Linden et al., 2007). These women were interviewed in a focus group to assess their willingness to participate in randomized trials. The women expressed a general reluctance to participate in clinical trials, but did indicate that they would weigh the costs and benefits in terms of inconvenience, expense, and the time commitment of participation, along with how important they felt the research was, how much they trusted the system, the opportunity they were given for an informed decision, and their sense of potential risk. The personal meaningfulness of the research (for them or their community) also would have an effect on their decision-making. Participants in this study were recruited from churches, so the results are limited in terms of generalizability and not reflective of the larger non-churchgoing community.

Apprehension about undue inducement should not be a major deterrent for the use of financial incentives. Halpern and colleagues conducted a study of 126 participants to determine how the effects of different payment levels influenced decision-making of participants (Halpern et al., 2004). This was accomplished by interviewing 126 eligible participants for what they thought was an ongoing clinical trial in which they could enroll in the near future. Once the initial hypothetical clinical trial was described, they were asked to indicate willingness to participate in each of 9 trials identical to the original trial except for alteration of three factors: previous participant adverse effects, payment amounts, and percentage of participants who would be given the placebo. The findings suggested that participants weighed multiple factors when considering study participation. People were more willing to participate as the risk of adverse events decreased, as risk of being given a placebo decreased, and as payment level increased. Income was not related to willingness to participate. In fact, payment had a nonsignificant trend of influencing wealthier individuals to a greater extent than those with lower incomes. Overall, 34% of the 126 participants were more willing to participate as the payment levels went up, and one-third indicated payment was an important factor in their decision-making. Level of income was not a factor and possibly had a lesser influence for lower-income individuals. It is important to note that there was no evidence that the typical payment levels appeared to be coercive--people continued to weigh all aspects of the risks and/or benefits of participation.

A systematic review addressing compliance with healthcare treatment using financial incentives is applicable to this discussion. Across II randomized controlled trials, financial incentives were more effective than other methods for improving health behavior compliance (Giuffrida & Torgerson, 1997). Economic theory supports that financial incentives can change behavior and that linking incentives to actual outcomes, rather than participation, can effect change (Finkelstein, Linnan, Tate, & Birken, 2007). This process was examined with weight loss using various approaches to financial incentives in the context of a weight-loss program. The odds of achieving a clinically significant weight loss were 5.4 times greater for those with the largest payment as opposed to no financial remuneration. Paid participants were 4 times more likely to comply with measurement time points than nonpaid participants. The authors concluded that the financial incentives were less costly than the annual costs of obesity to society. These results suggest that financial incentives can improve study participation and also motivate people to change behavior.

Participant costs, such as travel to a research site, are a factor when individuals decide whether to become involved in a research study. The personal meaning or value of participation must be greater than the hassles and costs that go along with involvement (Linden et al., 2007). Additionally, the studies that did not incur participant costs did better at recruitment. Financial incentives are a means to offset participant costs. Recognition of the effort and cost of participation by payment for time and effort affirms the value of the individual and demonstrates respect for them (Russell et al., 2000).

The burden of research participation can be equalized by offering payment for participation. Compensation, if it has the intended effect, might increase the willingness of those who would not volunteer under other incentives and equalize the burden across populations (Russell et al., 2000), thus decreasing the inequities in participation.

Conclusion

Financial incentives are a valuable option that promotes participation in research studies, especially when determination of payment is based on the cost and effort expended by the participant as a form of respect and just reward for willingness to participate. Use of financial incentives can enhance enrollment, without undue coercion of any particular population, and can serve as a means to equalize study participation.

Nurses who participate in or invite patients to participate in research should understand that there are issues around the use of financial incentives and the role they play in clinical research. Incentive dollar amounts likely reflect the level of risk, time commitment, and effort expected of the participant, and the Institutional Review Boards who review studies prior to initiation should assess whether amounts are reasonable and participants are protected. However, as professionals, it is the responsibility of nurse clinicians and researchers to make sure that persons are treated with respect, justice, and beneficence whenever they are invited to participate in clinical research.

CE Activity Alert:

Put your reading to work! Turn to page 21 for a 0.8-hour CE activity related to this article.

CE Activity: Honorarium or Coercion: use of Incentives for participants in Clinical Research

Thank you for your participation in "Honorarium or Coercion: Use of Incentives for Participants in Clinical Research," a new 0.8-hour CE activity (CE activity code: 87THWJ) offered by NYSNA to RNs and LPNs. NYSNA members and nonmembers are invited to take part in this activity, and you do not need to be a resident of New York State.

INSTRUCTIONS:

In order to receive contact hours for this educational activity, participants must:

* Read the article on page 11 of this issue of Journal.

* Successfully complete the posttest with a minimum score of 80%. Participants have two attempts to successfully complete the posttest.

* Complete an evaluation.

* Mark your posttest answers and evaluation responses on the answer sheet provided on page 23.

The participant will also need to pay a fee of $5 for NYSNA members and $10 for nonmembers. Participants can pay by check (made out to NYSNA; please include "Journal CE" on your check) or credit card. The completed answer sheet and evaluation form may be mailed or faxed back to NYSNA. See the evaluation form for more information.

GOAL:

The goal of this educational activity is to explore the appropriate use of incentives in clinical research.

OBJECTIVES:

1. Describe the appropriate use of incentives in clinical research

2. Identify the various types of incentives used in clinical research

3. Understand the inherent challenges of utilizing incentives in clinical research

The New York State Nurses Association is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

NYSNA has nothing to declare related to this educational activity. NYSNA wishes to disclose that no commercial support was received for this educational activity.

All other planners/presenters involved with the development of this independent study have declared that they have no vested interest.

Honorarium or Coercion: use of Incentives for participants in Clinical Research

Please answer the questions below using the answer sheet on page 23. Complete the answer sheet by putting the letter of your answer next to the corresponding question number. Each question has only one correct answer. A score of 80% is needed to successfully pass this posttest.

The 0.8 contact hours for this program will be offered until August 31,2013.

1. Financial incentives enhance recruitment and retention of research subjects by:

(a) Enticing them with financial rewards

(b) Increasing the cost of the study

(c) Fair and respectful treatment

2. Potential study subjects weigh the pros and cons of study participation prior to agreeing to participate.

(a) True

(b) False

3. Appropriate incentives for clinical research include:

(a) Gift cards

(b) Use of culturally sensitive materials for recruitment

(c) Emphasis on benefits of participation

(d) Money

(e) All of the above

4. The underlying ethical principles adhered to when incentives are used in clinical research include all of the following EXCEPT:

(a) Beneficence

(b) Respect

(c) Equalization

(d) Justice

5. Financial incentives are reflective of all of the following EXCEPT:

(a) Level of risk

(b) Coercion

(c) Expectation of effort

(d) Time commitment

[ILLUSTRATION OMITTED]

References

Dickert, N., Emanuel, E., & Grady, C. (2002). Paying research subjects: An analysis of current policies. Annals of Internal Medicine, 136(5), 368-373.

Dunn, C. M., & Chadwick, G. L. (2002). Protecting study volunteers in research (2nded.). Boston, MA: Centerwatch.

Finkelstein, E. A., Linnan, L. A., Tate, D. F., & Birken, B. E. (2007). A pilot study testing the effect of different levels of financial incentives on weight loss among overweight employees. Journal of Occupational & Environmental Medicine, 49(9), 98l-989.

Giuffrida, A., & Torgerson, D. J. (1997). Should we pay the patient? Review of financial incentives to enhance patient compliance. BMJ, 315(7110), 703-707.

Goldberg, J. H., & Kiernan, M. (2005). Innovative techniques to address retention in a behavioral weight-loss trial. Health Education Research, 20(4), 439-447.

Halpern, S. D., Karlawish, J. H., Casarett, D., Berlin, J. A., & Asch, D. A. (2004). Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Archives of Internal Medicine, 164(7), 80l-803.

Linden, H. M., Reisch, L. M., Hart, A., Jr., Harrington, M. A., Nakano, C., Jackson, J. C., et al. (2007). Attitudes toward participation in breast cancer randomized clinical trials in the African American community: A focus group study. Cancer Nursing, 30(4), 261-269.

Ott, C. D., Twiss, J. J., Waltman, N. L., Gross, G. J., & Lindsey, A. M. (2006). Challenges of recruitment of breast cancer survivors to a randomized clinical trial for osteoporosis prevention. Cancer Nursing, 29(1), 21-31.

Russell, M. L., Moralejo, D. G., & Burgess, E. D. (2000). Paying research subjects: Participants' perspectives. Journal of Medical Ethics, 26(2), 126-130.

Staffileno, B. A., & Coke, L. A. (2006). Recruiting and retaining young, sedentary, hypertension-prone African American women in a physical activity intervention study. Journal of Cardiovascular Nursing, 21(3), 208-216.

Yancey, A. K., Ortega, A. N., & Kumanyika, S. K. (2006). Effective recruitment and retention of minority research participants. Annual Review of Public Health, 27, 1-28.

Author Note

This article was made possible by Award Number KL2 RR 024136 from the National Center for Research Resources. The content is solely the responsibility of the author and does not necessarily represent the official views of the National Center for Research Resources or the National Institutes of Health.

Susan W. Groth, PhD, RN, WHNP-BC

Susan W. Groth is an assistant professor at the University of Rochester School of Nursing in Rochester, NY.
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