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Ethical Factors in the Recruitment and Retention of Research Participants. Frederick W. Luthardt, MA, MA Research Participant Advocate, ICTR Bayview CRU Compliance Specialist, JHM OHSR. Introduction …or, preaching to the choir. The real-world question: “Isn’t following the rules enough?

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ethical factors in the recruitment and retention of research participants

Ethical Factors in the Recruitment and Retention of Research Participants

Frederick W. Luthardt, MA, MA

Research Participant Advocate, ICTR Bayview CRU

Compliance Specialist, JHM OHSR

introduction or preaching to the choir
Introduction …or, preaching to the choir
  • The real-world question: “Isn’t following the rules enough?
  • Ethic principles are important to the conduct of human subjects research, and applicable along the entire arc of a study.
  • No guarantee: Ethical integrity does not lead to success…
  • Guarantee: Ethical failures can
    • compromise the integrity of the study
    • harm the rights, safety, and welfare of the participant
    • challenge the usefulness/quality of the study’s data
    • cause insomnia, locusts, plague, etc.
to do list
To do list…
  • Discuss current concerns with Recruitment and Retention in Human Subjects Research
  • Survey challenges faced by researchers
  • Look at the “back-drop” of Federal Regulations and Institutional Requirements
  • Present a brief review the history of research ethics, culminating with the Belmont Report
  • Summarize basic ethical principles
  • Examine some ways ethics can be applied to Recruitment and Retention
definitions
Definitions
  • Recruitment – getting the attention of and attracting potential research participants, i.e., “casting a net.”
    • Uses the IRB’s application distinction, recruitment is a distinct process from consent (i.e., “enrollment”).
    • In “the real world,” the process in on a wide continuum:
      • IRB approved newspaper ads, flyers, radio/TV spots, etc.
      • Sending IRB approved “Information Packets” after first contact (e.g., study FAQs, the IRB approved consent, etc.)
      • The “pre-enrollment” conversation (e.g., on the phone, face-to-face) has its own dynamic, with ethical implications
        • may include subtle (subjective) or direct (objective) “screening”
        • the actual private conversation can’t be feasibly monitored
definitions continued
Definitions continued…
  • Retention: Research participants remaining in the study for its duration, to provide evaluable data and attain study objectives.
    • Also referred to as “attrition” (participants leaving the study prematurely and/or being “lost to follow up”)
  • Can be influenced by the study itself or staff
  • Participants themselves can make or break retention.
the situation
The Situation
  • There are two basic recruitment scenarios:
    • Scenario #1: recruitment happens the day of consent (e.g., potential participants are approached and enrolled in a clinical setting, often without recruitment materials)
    • Scenario #2: the recruitment process precipitates from a person responding to a study’s newspaper ad or posted flyer, and may involve several encounters prior to consent
  • The focus of this presentation will be on #2, i.e., the “pre-consent” phase, followed by the issues related to retention
general recruitment issues
General Recruitment Issues
  • The recruitment of study volunteers is a top concern for researchers:
      • Many studies do not meet their recruitment goals
      • There is a disproportionate lack of women and minority representation in clinical trials.
      • IRB monitoring has found that many JHM studies have difficulty with recruitment/enrollment, at some point.
  • A major confounding affect to recruitment is the public’s understanding of clinical research:
      • potential volunteers may be reluctant to join a study based on many factors: education, socio-economic factors, fear, etc.
general retention issues
General Retention Issues
  • Retention (or “attrition”) may not be seen as rising to the level of recruitment (what I call the “Table 1 effect”)
  • However, retention is critical to the success of a trial because:
    • Keeping an evaluable proportion of the sample-size is necessary for statistical significance,
    • Continued or new funding may suffer
    • Longer therapeutics development, etc.
specific recruitment challenges
Specific Recruitment Challenges
  • Investigator side:
    • Unrealistic recruitment goals
    • Inadequate recruitment strategies
    • Inclusion/exclusion criteria too tight
    • Materials that are inaccurate or “oversell” the study
  • The Participant side:
    • Study’s relevance
    • Benefits (or harms)
    • History of research abuses
    • Respect (the “guinea pig” effect)
specific retention challenges
Specific Retention Challenges
  • Investigator side:
    • Study design requires high/impractical subject compliance
    • Expectations too high
  • The participant side:
    • Study demands are too high
    • Lack of immediate or perceived benefit
    • Take the money and run
    • Interpersonal issues
    • Disconnect between the consent and the study’s procedures. “Can’t spell ‘consent’ without ‘con.’”
federal regulations regarding recruitment
Federal Regulations Regarding Recruitment
  • “The [Informed Consent, Cf. 21 CFR 50.25] process may include recruitment materials, written materials, question and answer sessions, and measurements of subject understanding (i.e., the process of informed consent may involve more than just the informed consent document). http://www.fda.gov/downloads/AboutFDA/CentersOffices/DER/ManualofPoliciesProcedures/UCM02024.pdf
  • “HHS regulations at 45 CFR 46.109(b) require that IRBs ensure that information given to subjects [e.g., recruitment materials] as part of informed consent meets the requirements specified in the regulations at 45 CFR 46.116. http://www.hhs.gov/ohrp/policy/clinicaltrials.html
federal regulations regarding participant retention
Federal Regulations Regarding Participant Retention
  • Nothing specified in the CFR
  • However, enrolled subjects are free to withdraw at any time (in keeping with informed consent regulations)
  • Subjects may be withdrawn for safety reasons or other investigator determined grounds
  • Retention success or failure is determined by the Investigator
institutional jhm requirements regarding recruitment
Institutional (JHM)Requirements Regarding Recruitment
  • JHM IRB requires the following items be displayed on recruitment materials:
    • The name of the principal investigator;
    • The contact information to learn more about the study;
    • The condition under study and/or the purpose of the research;
    • A specific reference to “research study” in the text; and
    • The JHM IRB protocol number. http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/study_subject_recruitment.html
  • JHM IRB complies with the FDA/DHHS’s specified recruitment materials elements http://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm
institutional jhm requirements regarding retention
Institutional (JHM)Requirements Regarding Retention
  • IRB requires that Principal Investigators account for the retention of study participants:
    • At Continuing Review, participants who left the study early require an explanation
    • Participants who leave a study secondary to dissatisfaction or complaint, a serious event, etc., require reporting to the IRB.
    • Any retention problems may invoke further inquiry from the IRB
human subjects research history
Human Subjects Research History
  • Ethical Code
  • Nuremburg Code (1947)
  • Declaration of Helsinki (WHO) (1964)
  • Belmont Report (US) (1979, 1981)
    • FDA: 21 CFR 50, 56
    • DHHS: 45 CFR 46
  • Ethical Principle(s)
  • Autonomy; non-maleficence
  • Autonomy of all subjects, including children
  • Respect for persons Beneficence Justice
  • Ethical Practice(s)
  • Informed Consent, without coercion
  • Informed Consent; proxy consent
  • Informed consent Benefits/risks Fair enrollment and distribution of benefit(s)
the belmont report in detail
The Belmont Report in Detail
  • Has 3 main ethical principles focusing largely on informed consent and the conduct of human subjects research
    • Respect for persons
      • Subjects are autonomous and are free to join/withdraw
      • Respect necessitates informed consent
    • Beneficence
      • Benefit (direct or indirect), with minimization of harm
    • Justice
      • The study should be fair and equitable in its overall conduct, including subject selection and the distribution of risks/benefits.
the philosophy behind the belmont report
The “Philosophy” behind the Belmont Report
  • Where ethics and regulations come together
  • The Principles are considered “positive duties”
    • i.e., the Principles serve as guides for “what to do,” not “what not to do.”
    • “Prima facie” – compelling “on first face.”
    • Also involves, as ethicists say, “Ethical Comportment” i.e., intent
  • Ethical Principles are the groundwork for morals and rules (i.e., “pre-regulatory”)
the application of the ethical principles to the subject recruitment process
The Application of the Ethical Principles to the Subject Recruitment Process
  • The ethically sound recruitment materials and dialog ought to include the principles below as guides:
    • Respect for Persons:
      • Accurate information to assure the potential participant can make an informed, and voluntary decision to enroll and withdraw, without coercion or inappropriate inducement
      • Accurate and full disclosure of anticipated benefits (if any) and a disclosure of the possible risks of the study
    • Beneficence:
      • The recruitment process should ultimately describe all the steps to maximize the study’s benefit (if any) and minimize or avoid undue risk(s).
    • Justice:
      • The study should be seen by the participant as fair in that it’s open to all or those in the cohort who would stand to enjoy the possible benefits of the study. That the risks and benefits are interpreted by the participant as equitably distributed.
the application of ethical principles to subject retention
The Application of Ethical Principles to Subject Retention
  • Respect for Persons necessitates:
    • Continuous communication, where possible
    • The study remains relevant
  • Beneficence (non-maleficence) necessitates:
    • Attention to the participant’s “well-being.”
    • Attention to and management of adverse events
  • Justice necessitates:
    • That the participant has confidence and a sense of ownership in the study and its outcome.
  • The Ethical Principles do not “turn off” at the signing of the informed consent
additional moral implications that emerge from the ethical principles
Additional Moral Implications That Emerge from the Ethical Principles
  • Relevant to both Recruitment and Retention:
    • Understandable language
    • Sensitivity to the cohort
    • Respect for confidentiality
    • Reasonable compensation
    • The participant’s “take-away” should be that he/she is a valued stake-holder, and not a “guinea pig.”
the future of research participant recruitment today
The Future of Research Participant Recruitment…today
  • Social Networking, peer to peer
    • Facebook, MySpace
    • (Privacy, confidentiality, information security, as related to identity as a constituent of “personhood”?)
  • Web-based recruitment
    • Clinicaltrials.gov
    • Clinical Trial specific websites
    • Disease websites, support group blogs, etc.
    • (Accuracy of study benefits/risks, and results?)
  • CROs
    • PPD, Parexel, Covance, etc.
    • (Bias toward the sponsor’s interests over the human participant?)
take home points
Take Home Points
  • The Ethical principles are well-characterized in the regulations and represent the best-practice in the informed consent process
  • These principles are also useful for the planning and conduct of research participant recruitment
  • These principles, as extended beyond the consent process, may enhance participant retention
  • Overall, the research participant’s well-being is the primary aim and purpose through all stages of the investigation.
conclusion
Conclusion
  • Attention to the regulations and ethical principles, and the knowledge of them is crucial.
    • “tools and materials”
  • Intention to apply the ethical precepts, for their own sake as “the right thing to do.”
    • “applying artistry with meaning”
  • Ethical excellence in research combines both, in that the “spirit and letter” of the Research Principles are understood and implemented with the “moral will” to do so.
    • “the product is well-done”