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Published in final edited form as: IRB. 2014 ; 36(6): 7–12.

Practical Considerations for Implementing Research Recruitment Etiquette Maria E. Gyure, MS, CGC [Research Coordinator], Virginia Commonwealth University, Sanger Hall, 11th Floor, 1101 E Marshall St. P.O. Box 980033 John M. Quillin, PhD, MPH [Assistant Professor/Genetic Counselor], Virginia Commonwealth University Vivian M. Rodríguez, MS, MA [Clinical Psychology Doctoral Student], Virginia Commonwealth University

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Monika S. Markowitz, PhD [Director], Office of Research Integrity and Ethics, Virginia Commonwealth University Rosalie A. Corona, PhD [Associate Professor], Dept of Psychology, Virginia Commonwealth University Joseph F. Borzelleca, Jr., MD, MPH [Associate Professor], Obstetrics and Gynecology, Virginia Commonwealth University Deborah J. Bowen, PhD [Professor], Community Health Sciences, Boston University Alexander H. Krist, MD, MPH [Associate Professor], and Family Medicine, Virginia Commonwealth University Joann N. Bodurtha, MD, MPH [Professor] Institute of Genetic Medicine, Johns Hopkins University

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Ethical considerations are central to the design and conduct of all aspects of clinical research, and for the participant, these considerations begin at recruitment. Ethics are paramount to the informed consent process.1 However, less attention has been devoted to addressing the ethical and practical considerations in the process of approaching potential participants in order to recruit them into a study. For the purposes of this article, we will discuss the relationship between the concept of etiquette and the ethics of human subject recruitment, identify areas that deserve more attention from investigators and Institutional Research Boards (IRB), and provide a useful framework for aiding in the potential training of those recruiting human subjects.

The Current State of Subject Recruitment Ethics Proposed recruitment processes are typically part of a research plan that the IRB reviews, but these reviews have varying levels of consideration for the overall recruitment

Contact Author: Phone (804)628-4902, Fax (804) 828-7094, [email protected]

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environment within a particular clinical setting. IRB attention to the recruitment process, as a part of the ethics review of the research protocol itself, is based on the Belmont Principles drafted in 1979.2 These well-known principles – respect for persons, beneficence, and justice – form the underpinning of federal regulations for human research protections.3 The principle of justice addresses thoughtful practices of recruiting fairly and equitably across varied demographic characteristics of potentially eligible individuals. The principle of respect for persons applies to the need to appropriately contact, approach, and inform prospective participants of research endeavors while observing their right for privacy and confidentiality. The principle of beneficence is enacted in considerations of benefit and risk or burden within the recruitment experience. These highly-regarded principles of research ethics comprehensively apply to recruitment activities. The investigator and recruiter should certainly desire to promote respect for persons, a high regard for beneficence, and close attention to justice. While these principles undergird the language in a study consent document, they have a less explicit, but no less important, role when approaching and interacting with potential study participants during the recruitment process.

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Given the human relationships that may develop throughout the conduct of clinical trials, especially interactions with research recruitment staff and patients, we propose a concept of recruitment etiquette for framing the sensibilities involved in an ethical recruitment process. Recruitment etiquette focuses on sensitive demeanor, astute observation, cultural and ethnic awareness, appreciation for the overall research environment and a polite manner in approaching the recruitment process. The following section highlights these practical and procedural approaches to recruitment, which we have utilized in our recruiting processes and have found to be beneficial.4 Recruitment Etiquette

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Broadly defined, etiquette encompasses the customs or rules governing behavior regarded as correct or acceptable in social or official life.5 We use the term “recruitment etiquette” to emphasize the importance of a general tone of reciprocal respect for individuals and selfawareness on the part of recruiters. The concept of etiquette evokes an old-fashioned sense of good manners and values that are highly relevant to the recruitment process. Such values include: respect, responsibility, compassion, and cultural sensitivity. Despite the recognition of these principles and values as important in conducting ethical research, there has been insufficient attention to the aspect of etiquette in recruiter-participant interactions, generally. Numerous studies have shown that how people are approached affects their willingness to participate in research as well as their overall attitude toward research. One study utilizing focus groups consisting of 28 recruiters at a women’s health clinic found that a majority of recruiters recognized the importance of demonstrating respect and adopting a nonjudgmental stance when approaching potential participants.6 Patel et al discussed the importance of interpersonal skills when recruiting. 7 The authors posited several attributes that are desirable in recruiters, including an ability to be respectful, tactful, and approachable as well as displaying a caring and compassionate attitude. These attributes are equally valuable when interacting with potential participants’ family members, significant others, IRB. Author manuscript; available in PMC 2015 November 01.

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and/or peers. Numerous professions emphasize the use of similar attributes, and go so far as to include them in their core ethical codes. The National Society of Genetic Counselors (NSGC) advises genetic counselors to have respect for not only the counselee, but also for the client’s beliefs, inclinations, circumstances, feelings, family relationships, and cultural traditions.8 To supplement our discussion, we illustrate recruitment etiquette in practice based on two studies. Both examples of recruitment efforts are in busy outpatient health settings that involve demographically diverse patients. Further, the clinical setting is made more complex by the presence of research recruiters from different studies sometimes competing for participants – a situation often arising in academic medical centers. Although many of the ethical considerations are applicable to other recruitment settings such as inpatient, community based, telephone based, and mail/internet based research, discussion here is limited to recruitment in the outpatient setting.

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Beyond the ethical and humanitarian benefits of integrating etiquette into subject recruitment, doing so likely will improve the quality of scientific findings, specifically by encouraging greater enrollment, thus ensuring the study sample is representative of the target population. The Role of Justice within Recruitment Etiquette

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Study enrollment can present challenges, not only in terms of obtaining sufficient numbers of participants, but also for ensuring that the sampled population does not reflect bias. Recruiting fairly and equitably across populations of potentially eligible individuals is important to ensure the external validity of clinical trials. The Belmont Report9 states that injustice arises from social, racial, sexual, and cultural biases institutionalized in society. While the report speaks strongly against the overrepresentation of vulnerable groups, the same principle is applied to ensure there is not under-representation of these groups, particularly racial and ethnic minorities.10 Under-representation of cultural minority groups is a particular concern, as recruitment bias potentially leads to study findings that are not broadly applicable, thus perpetuating a cycle of health disparities.11 Participation in research by a diverse population of individuals is needed to build our capacity to address health disparities in a culturally competent, evidence-based manner12 and reverse the historical underrepresentation of minorities in clinical research. Successful recruitment strategies should feature culturally appropriate approaches13, such as the need to match perspectives of ethnic minority groups and researchers across cultural and structural styles14. In our work in women’s health, face-to-face recruitment efforts within a waiting room, along with culturally tailored study materials, enhanced our success in recruiting ethnic and racial minorities into hereditary breast cancer studies.15 There is additional evidence that personalized recruitment approaches might be more efficacious for recruiting ethnic and racial minority groups to participate in cancer genetics research16. The utility of culturally tailored study materials has also been evaluated in a variety of studies.17 Brown and colleagues have written that the success of recruitment within studies can be directly impacted by the communication skills of recruiters, their ability to relate to subject populations, along with their maneuverability within the subjects’ communities.18 We IRB. Author manuscript; available in PMC 2015 November 01.

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propose that research etiquette, as it relates to justice, encompasses cultural awareness and can enhance recruitment.

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Historical under-representation of women and minorities in clinical research has been well documented in the literature.19 Given the characteristics that typify etiquette closely align with principles of cultural humility, 20 ensuring appropriate recruitment etiquette could aid in breaking down barriers to the recruitment of a culturally diverse study sample. Suggested approaches for addressing this challenge include focusing on community and personal relationships prior to and during recruitment and also utilizing culturally tailored study materials.21 We provide a draft training tool for dissemination to and discussion with recruiters to clinical trials and other research studies. Table 1 presents a framework for enhancing ethical research recruitment practices. Recruitment Etiquette and Respect for Persons

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Respect for persons is central to an ethical process of informed consent. Participant recruitment comes early within the process, such that actually obtaining informed consent may not occur if recruitment efforts were unsuccessful. Respecting an individual’s autonomy and protecting those with reduced capacity for autonomy are critical components of the principle of respect for persons. Recruiters should use etiquette characteristics of respect and sensitivity to ensure a completely autonomous decision is made on the part of the participant and that coercion of no kind takes place (see Table 1). Traditionally, physicians can be viewed as an authority figure, contributing to an unbalanced sense of power in the physician-patient relationship. Recruiters should be aware that they may also be viewed as figures of authority, which can diminish a prospective participant’s perception of their personal autonomy. Promoting a setting of equality rather than one of authority can more easily be achieved by taking a few extra steps. Incorporating a third party not viewed as an authority figure may benefit the recruitment process within the context of autonomy, particularly in the situation of physicians who recruit patients as participants.22

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We have found that developing rapport and trust with potential participants is critical and can be aided by displaying qualities of empathy and genuineness on the part of the recruiter. When approaching potential participants who are seated, crouching to eye level or sitting in an open seat near them can increase rapport and minimizes the perceived power differential that may exist between recruiter and participant. Being cognizant of word choices and tone of voice can be especially important when recruiting in a healthcare setting. Concerns about privacy and confidentiality can arise when recruitment occurs in a public setting. Questions recruiters ask to determine eligibility may be personal in nature, and participants cannot be assumed to wish to share this information while in the presence of accompanying family members, peers, or strangers. Strategies helpful in these situations include asking participants if they are comfortable with being asked questions in this setting, bringing the participant to a more private area, and establishing practices to specifically address the issue of privacy within the recruiting environment. While the principle of respect for persons has a foundation within interactions with human subjects, it also applies to respect for staff and additional recruiters present in the recruiting

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environment. In our experience of outpatient recruiting environments, the presence of multiple recruiters for assorted studies adds complexity that requires cooperation and observance of etiquette that may not necessarily be anticipated as a study is designed. Having multiple recruiters within the same setting may also create a competitive environment. Within our experience, we have found that making contact with fellow recruiters and coordinators prior to recruitment, along with acknowledging one another at the start of each recruiting day, enhanced relationships and aided in the development of rapport. This basic observance of etiquette improved communication and allowed for a more symbiotic recruiting environment.

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Respect for colleagues should also translate into respect for their participants. For instance, imagine you are actively engaged with a participant and another recruiter approaches and attempts to recruit the person with whom you are working. How would you feel? How would your participant feel? It is likely that the feelings of disrespect may arise, while the participant may feel confused and objectified. Situations like this can communicate mixed messages about the presence of researchers to others. Advance communication among principal investigators, study coordinators, and clinic administration can ensure that an appropriate number of studies are permitted in a particular setting at any one time or day. This precaution is likely to increase participant autonomy as well as minimize research fatigue on the part of participants. Recruitment Etiquette and Beneficence The role of beneficence calls for investigators to reduce harm, maximize potential benefits, and secure the well-being of participants. Recruitment for human research subjects within a variety of settings can provide challenges that may not always be anticipated by investigators or IRBs. These can include the presence of additional competing studies, unknown physical or emotional states of participants, available space to maintain privacy, and potential survey fatigue. Considerations of confidentiality, although most closely associated with the principle of respect for persons, also minimize the risk to participants in the recruitment setting.

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Although healthcare settings can be particularly appropriate for studies with possible dissemination outcomes that include incorporation of the research in ongoing clinical care,23 participants recruited from these environments are first, and foremost, patients. Care must be taken to ensure there is no disruption to their medical care by the recruitment interview or process. This can be achieved by detailing a specific plan in the study protocol as to how study procedures will be implemented in a specific environment with the aim of minimizing any interference on work flow. Furthermore, study recruiters must take into consideration that patients commonly are seeing providers for reasons tangential to the study for which they are being recruited. It is possible that they are in physical discomfort, anxious, or stressed about their upcoming visit especially when there is the potential for receiving dramatic news from their provider (e.g., biopsy result, pregnancy loss, or complication). Depending on the particular study, recruiters may or may not be privy to these reasons; therefore, recruiters must be sensitive to special circumstances that may affect their interaction with a participant, specifically in healthcare settings. Recruiters must identify if a

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potential participant appears visibly distressed. A recruiter can take a more sympathetic tone, acknowledge their situation, ask if they wish to continue with recruitment, or even abandon recruitment. 24 Consideration for beneficence within protocols can and should benefit recruiters as well. Recruiters should feel supported, and although typically working alone, they should also feel the presence of the investigative team. Interactions with the public can occasionally be unpredictable. Communication channels should be in place for recruiters, allowing for contact with other team members (see Table 1). Efficient modes of communication such as direct office phone numbers and/or pagers should be utilized to allow the recruiter to quickly and effectively receive guidance on an unexpected situation. Having appropriate contacts and protocols in place to address issues, complaints, and other problems that may arise is essential for all research studies.

Strategies and Suggestions for Investigators and the Institutional Review Board (IRB) NIH-PA Author Manuscript

Recruitment etiquette should be viewed as a major component in the ethical conduct of clinical research. The Institutional Review Board (IRB) or individual IRB reviewer consider whether a study can be conducted as described. Sufficient enrollment is necessary so that participants are not placed at potential risk for being in a study that cannot be completed. Ensuring that research staff, particularly recruiters, are knowledgeable about cultural values and norms, family dynamics, and social issues related to the population can enhance the recruitment and retention of diverse participants.25 In addition to its anecdotal face value, apparent in our recruiting experiences, there is growing literature support for the value of etiquette in clinical encounters.26 We are not aware of empirical evidence that supports the impact of etiquette training on human subjects’ recruitment, making this a potential goal of future research in the area.

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The IRB requires research ethics education of all individuals involved in human subjects research. While all recruiters must undergo IRB-required research ethics training, they may also benefit from more specific attention to the etiquette aspects of recruitment. We suggest that the concept of recruitment etiquette can complement principle-based research ethics training with which many are familiar (e.g. CITI training). Though some research shows that education and behavior change techniques using checklist or goal oriented behaviors are effective in performance improvement and may be useful in enhancing ethical recruitment practices,27 Nicholson and colleagues document a role modeling approach to training research staff by piloting different approaches, frequent team reporting, and emphasis on convenience and communication with participants.28 Others address, generally, the necessity of ongoing training for researchers in three key areas of recruitment: sensitivity, flexibility, and adaptability.29 Clearly, research is needed to determine the best approach to teaching research etiquette and evaluating the adoption of etiquette principles. The principal investigator has a significant role in setting up the circumstances for study recruitment. Planning the recruitment process, anticipation of likely recruitment scenarios, and ensuring that study personnel are knowledgeable about the research protocol and the

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expected recruitment activities cannot be emphasized enough. Initial training on the protocol and regular research team meetings are crucial for ensuring that recruitment issues are identified and that new circumstances are dealt with promptly. The IRB should be cognizant of plans for protocol training and periodic recruitment status reports, such as process evaluations, with the study recruiters. According to the National Institute of Mental Health’s guidelines for the recruitment of participants into clinical research, staff training directly impacts recruitment and retention. The guidelines recommend that all staff communicating with potential participants receive proper and ongoing training.30 Further, they suggest research staff should reflect the diversity of the groups desired for enrollment. For example, staff should represent diversity of racial/ethnic background, language proficiency, and cultural knowledge, in addition to diversity of scientific discipline and research experience. Additional strategies found helpful during our studies included advance permission and communication with directors and staff of the recruiting environment. When this critical piece is absent, it can create confusion among staff and potentially, among additional recruiters who may be drawing their participants from the same environment (see Table 1).

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Routine process evaluations, or internal evaluations of the recruiting process performed by team members, have proven useful as well (see Table 1). With studies that include multiple recruiters, it can be essential to monitor areas such as consistency of information given, time spent, and even recruiters’ awareness of etiquette. This system of internal checks and balances were regularly reported within continuing reviews and progress reports. Lastly, to aid in developing rapport, as well as trust relationships with participants, we have found that having recruiters provide contact information, such as their work email addresses and phone numbers, to participants, has been very effective (see Table 1). Often, when smaller issues arise (contact information changes, lost incentives, minor complaints, etc), participants may feel more comfortable speaking to someone with whom they already have a relationship.

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Recruitment for a study is the introduction most participants have to the clinical research setting, hence it is a crucial part of human subjects research. We suggest practical recommendations for recruitment that build upon the principles within the Belmont report and we propose a research etiquette framework for use in initial recruiter training, as well as ongoing monitoring of recruitment. We propose that researchers and staff recognize the importance of the concept of ‘recruitment etiquette’, understand its component parts, and undertake systematic efforts enabling recruiters to feel more comfortable and competent when implementing it in their recruiting efforts. We encourage attention to this aspect of research as it impacts participants, the potential representativeness of the research results, and the relationships built in recruitment settings.

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Acknowledgements NIH-PA Author Manuscript

The work discussed in this paper is funded in part by a grant from the National Cancer Institute, No. R01CA140959-01. The Kin Fact Study was reviewed and approved by the Virginia Commonwealth University Institutional Review Board (IRB #HM12164). We wish to thank the faculty and staff members of the VCUHS Women’s Health Clinic for their cooperation and support during recruitment.

References

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1. Smith-Tyler J. Informed consent, confidentiality, and subject rights in clinical trials. Proceedings of the American Thoracic Society. May; 2007 4(2):189–93. discussion 193. [PubMed: 17494730] Steinke EE. Research ethics, informed consent, and participant recruitment. Clinical Nurse Specialist. Mar-Apr;2004 18(2):88–95. quiz 96-7. [PubMed: 15164670] 2. The Belmont Report: Ethical priniciples and guidelines for the protection of human subjects of research. Government Printing Office; Washington, DC: 1979. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 3. US Department of Health and Human Services. Protection of Human Subjects. 45 CFR 46; US Department of Health and Human Services. Institutional Review Boards. 2011:21. CFR 56. 4. Bodurtha JN, Quillin JM, Tracy KA, Borzelleca J, McClish D, Wilson DB, et al. Recruiting diverse patients to a breast cancer risk communication trial--waiting rooms can improve access. Journal of the National Medical Association. Aug; 200799(8):917–922. [PubMed: 17722671] 5. Complete & Unabridged. 10 th ed.. Harper Collins; 2009. etiquette n.d. Collins English Dictionary. 6. Brown BA, Long HL, Milliken N. What’s to know about study recruitment? We asked recruiters. Women’s Health Issues. May-Jun;2002 12(3):116–121. [PubMed: 12015183] 7. Patel MX. Challenges in recruitment of research participants. Advances in Psychiatric Treatment. 2003; 9(3):229–238. 8. NSGC Code of Ethics. [Accessed 6/27/2012] 2012. Available at: http://www.nsgc.org/Advocacy/ NSGCCodeofEthics/tabid/155/Default.aspx 9. See ref. 2, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979 10. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. The National Academies Press; Washington, DC: 1994. Front Matter. 11. Bowen DJ, Hay JL, Mayer J, Kuniyuki A, Meischke H, Harris J, et al. Predictors of recruited melanoma families into a behavioral intervention project. Contemporary Clinical Trials. Oct 8.2011 12. UyBico SJ, Pavel S, Gross CP. Recruiting vulnerable populations into research: a systematic review of recruitment interventions. Journal of General Internal Medicine. Jun; 2007 22(6):852– 863. [PubMed: 17375358] Yancey AK, Ortega AN, Kumanyika SK. Effective recruitment and retention of minority research participants. Annual Review of Public Health. 2006; 27:1–28. 13. Smith YR, Johnson AM, Newman LA, Greene A, Johnson TR, Rogers JL. Perceptions of clinical research participation among African American women. Journal of Women’s Health (Larchmt). Apr; 2007 16(3):423–428. 14. Levkoff S, Sanchez H. Lessons learned about minority recruitment and retention from the Centers on Minority Aging and Health Promotion. Gerontologist. Feb; 2003 43(1):18–26. [PubMed: 12604742] 15. See ref. 4, Bodurtha et al. 2007, p. 921. 16. Hughes C, Peterson SK, Ramirez A, Gallion KJ, McDonald PG, Skinner CS, et al. Minority recruitment in hereditary breast cancer research. Cancer Epidemiology, Biomarkers and Prevention. Jul; 2004 13(7):1146–1155. 17. Sznitman S, Vanable PA, Carey MP, Hennessy M, Brown LK, Valois RF, et al. Using culturally sensitive media messages to reduce HIV-associated sexual behavior in high-risk African American adolescents: results from a randomized trial. Journal of Adolescent Health. Sep; 2011 49(3):244– 251. [PubMed: 21856515] Powe BD, Faulkenberry R, Harmond L. A review of intervention

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studies that seek to increase colorectal cancer screening among African-Americans. American Journal of Health Promotion. Nov-Dec;2010 25(2):92–99. [PubMed: 21039289] 18. Brown BA, Long HL, Gould H, Weitz T, Milliken N. A conceptual model for the recruitment of diverse women into research studies. Journal of Women’s Health and Gender- Based Medicine. Jul-Aug;2000 9(6):625–632. 19. Hoyt MA, Rubin LR. Gender representation of cancer patients in medical treatment and psychosocial survivorship research: Changes over three decades. Cancer. Jan 31.2012 Ojha R, Thertulien R, Fischbach L. Racial under-representation in clinical trials: Consequence, myth, and proposition. Epidemiological Focus. 2008; 1(1):1–3.Frank G. Current Challenges in Clinical Trial Patient Recruitment and Enrollment. SoCRA Source. 2004:30–38. 20. Chang ES, Simon M, Dong X. Integrating cultural humility into health care professional education and training. Advances in Health Science Education: Theory and Practice. May; 2012 17(2):269– 278. 21. See ref. 15, Sznitman et al. 2011; See ref. 15, Powe et al. 2010; Corbie-Smith G, Williams IC, Blumenthal C, Dorrance J, Estroff SE, Henderson G. Relationships and communication in minority participation in research: multidimensional and multidirectional. Journal of the National Medical Association. May; 2007 99(5):489–498. [PubMed: 17534006] 22. Black L, Batist G, Avard D, Rousseau C, Diaz Z, Knoppers BM. Physician Recruitment of Patients to Non-Therapeutic Oncology Clinical Trials: Ethics Revisited. Frontiers in Pharmacology. 2013:4. [PubMed: 23372551] Kleiderman E, Avard D, Black L, Diaz Z, Rousseau C, Knoppers B. Recruiting Terminally Ill Patients into Non-Therapeutic Oncology Studies: views of Health Professionals. BMC Medical Ethics. 2012; 12-05:33. [PubMed: 23216847] 23. See ref. 4, Bodurtha et al. 2007. 24. Felsen CB, Shaw EK, Ferrante JM, Lacroix LJ, Crabtree BF. Strategies for In-Person Recruitment: Lessons Learned from a New Jersey Primary Care Research Network (NJPCRN) Study. The Journal of the American Board of Family Medicine. Jul; 2010 23(4):523–533. Thu, 08. 25. Dilworth-Anderson P, Williams SW. Recruitment and retention strategies for longitudinal African American caregiving research: the Family Caregiving Project. Journal of Aging and Health. Nov; 2004 16(5 Suppl):137S–56S. [PubMed: 15448291] 26. Burridge LH, Mitchell GK, Jiwa M, Girgis A. Consultation etiquette in general practice: a qualitative study of what makes it different for lay cancer caregivers. BioMed Central Family Practice. Oct 5.2011 12:110. [PubMed: 21970440] Reddy AK, Coats DK, Yen KG. An evidencebased approach to physician etiquette in pediatric ophthalmology. Journal of Pediatric Ophthalmology and Strabismus. Nov 1; 2011 48(6):336–339. [PubMed: 20964272] Rogers AI. Consultation etiquette: A proposed set of guidelines. American Journal of Gastroenterology. 2010; 105(7):1477–8. [PubMed: 20606653] 27. Hales BM, Pronovost PJ. The checklist--a tool for error management and performance improvement. Journal of Critical Care. Sep; 2006 21(3):231–235. [PubMed: 16990087] 28. Nicholson LM, Schwirian PM, Klein EG, Skybo T, Murray-Johnson L, Eneli I, et al. Recruitment and retention strategies in longitudinal clinical studies with low-income populations. Contemporary Clinical Trials. May; 2011 32(3):353–362. [PubMed: 21276876] 29. Knobf MT, Juarez G, Lee SY, Sun V, Sun Y, Haozous E. Challenges and strategies in recruitment of ethnically diverse populations for cancer nursing research. Oncology Nursing Forum. Nov; 2007 34(6):1187–1194. [PubMed: 18024345] 30. NIMH. [Accessed 6/13, 2012] Points to Consider about Recruitment and Retention While Preparing a Clinical Research Study. 2005. Available at: http://www.nimh.nih.gov/researchfunding/grants/recruitment-points-to-consider-6-1-05.pdf

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Table 1

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Incorporating Recruitment Etiquette into Clinical Trial Research Recruitment Etiquette: Proposed Considerations for Practice

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Associated Belmont Principle(s)

Considerations for IRB Actions for Oversight

1. Be polite, respectful, and practice cultural sensitivity with all participants, staff, and colleagues.

Justice, Respect for Persons

Process evaluations to be reported within continuing reviews

2. Be particularly aware of the recruiting environment as it relates to confidentiality. Be cognizant of word choice and tone of voice when approaching potential participants.

Respect for Persons, Beneficence

Process evaluations are done periodically by someone not actively involved with recruiting. Should include monitoring of word choice, equality of time, and noticeable reactions on the part of the participants.

3. Listen and show genuineness in responding to a participant who appears distressed or anxious.

Respect for Persons, Beneficence

Process evaluations including monitoring of word choice, equality of time, and noticeable reactions on the part of the participants. Protocols that outline appropriate contacts for recruiters in emergent situations

4. Recognize that participants are free to elect or decline joining a study without coercion.

Respect for Persons

Process Evaluations including monitoring of approach and demeanor of recruiters

When Communicating with Potential Participants

When Interacting with Clinic Staff and Recruiting Colleagues

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5. Recognize that potential participants recruited in healthcare settings are present for healthcare, the priority and flow of which cannot be compromised.

Respect for Persons, Beneficence

Additional section within proposals discussing how workflow of recruiting environment will be maximized.

6. Respect other recruiters by not interrupting while they are interacting with a participant; and be cautious when approaching a participant who has already been approached by another recruiter, as this may be overwhelming to some individuals.

Respect for Persons, Beneficence

Process evaluations to ensure close monitoring of recruiting staff

7. Acknowledge the presence of other recruiters and/or staff within the recruiting environment.

Respect for Persons

Process evaluations to ensure close monitoring of recruiting staff

For Communication Within the Research Team 8. Have a mechanism in place for addressing participant concerns and/or complaints related to the research protocol (i.e. study materials, recruiters, involvement within the study, etc). 9. Ensure participant and potentialparticipant questions are addressed and if an answer is unknown, have a system in place that provides the

Justice

Protocols that include providing contact information for study coordinator separately from consent documents.

Justice, Beneficence

Inclusive consent forms. Protocols that include providing contact information for study

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For Communication Within the Research Team recruiter access to proper resources.

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10. Be familiar with, and demonstrate an understanding of, IRB approved study protocols, as well as be able to discuss them with the study coordinator/principal investigator

coordinator/PI separately from consent. Beneficence

Protocols stating recruiting staff will complete all appropriate training (i.e. CITI, NIH’s PHRP training). Those training recruiters will have completed IRB Human Subject Research Training

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Practical Considerations for Implementing Research Recruitment Etiquette.

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