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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 Participants…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… Participants

  • 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 Participants

  • 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 Participantscontinued…

  • 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 Participants

  • 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 Participants

  • 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 Participants

    • 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 Participants

    • 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 Participants

    • 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 Participants

    • “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).

    • “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.

    Federal regulations regarding participant retention
    Federal Regulations Regarding Participant Retention Participants

    • 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 Participants

    • 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.

    • JHM IRB complies with the FDA/DHHS’s specified recruitment materials elements

    Institutional jhm requirements regarding retention
    Institutional (JHM)Requirements Regarding Retention Participants

    • 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 Participants

    • 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 Participants

    • 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 Participants

    • 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 Recruitment Process

    • 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 Principles

    • Social Networking, peer to peer

      • Facebook, MySpace

      • (Privacy, confidentiality, information security, as related to identity as a constituent of “personhood”?)

    • Web-based recruitment


      • 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 Principles

    • 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 Principles

    • 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”