ETHICAL AND LEGAL ISSUES WITH HUMAN SUBJECTS AND COMMUNITY WORKERS - PowerPoint PPT Presentation

Loading...

PPT – ETHICAL AND LEGAL ISSUES WITH HUMAN SUBJECTS AND COMMUNITY WORKERS PowerPoint presentation | free to download - id: 4e5b8c-ODY0N



Loading


The Adobe Flash plugin is needed to view this content

Get the plugin now

View by Category
About This Presentation
Title:

ETHICAL AND LEGAL ISSUES WITH HUMAN SUBJECTS AND COMMUNITY WORKERS

Description:

ETHICAL AND LEGAL ISSUES WITH HUMAN SUBJECTS AND COMMUNITY WORKERS Sana Loue, J.D., Ph.D., M.P.H., M.S.S.A. Partners for Health: Communities and Researchers Working ... – PowerPoint PPT presentation

Number of Views:309
Avg rating:3.0/5.0
Slides: 45
Provided by: Sana1
Learn more at: http://www.lluophp.org
Category:

less

Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: ETHICAL AND LEGAL ISSUES WITH HUMAN SUBJECTS AND COMMUNITY WORKERS


1
ETHICAL AND LEGAL ISSUES WITH HUMAN SUBJECTS AND
COMMUNITY WORKERS
  • Sana Loue, J.D., Ph.D., M.P.H., M.S.S.A.
  • Partners for Health Communities and Researchers
    Working Together
  • Loma Linda University
  • March 11, 2010

2
ADVISORY
  • This training is not intended to be legal advice
    and does not provide legal advice with respect to
    any individual or situation. Individuals are
    advised to consult with their legal
    representative for any individualized legal
    advice.
  • Legal and ethical obligations may be consistent
    or may differ.

3
ROADMAP
  • Setting priorities
  • Privacy and confidentiality
  • Defining terms
  • Consequences of breach
  • Legal limits of confidentiality
  • Mechanisms to protect confidentiality
  • Issues to consider
  • Randomization procedures
  • Defining randomization
  • International and US perspectives
  • Working with multiple boards
  • ECs/IRBs, DSMBs, SABs, CABs
  • Differing perspectives
  • Strategies to resolve conflicts
  • Considering conflicts of interest
  • Ethical and legal issues

4
SETTING PRIORITIES
  • Priorities may differ between researchers and
    community.
  • Differences may be attributable to
  • Funding issues
  • Personal impact
  • Statistical data
  • Differing sensitivities
  • Demands of daily living
  • Strategies to resolve differences?

5
PRIVACY AND CONFIDENTIALITY
  • Defining the terms
  • Consequences of breach
  • HIPAA
  • Legal limitations on confidentiality
  • Procedures to maximize confidentiality
  • Issues to consider in CBPR

6
PRIVACY
  • Defined as the condition of being free from
    unauthorized observation or intrusion
  • Anonymous means that someone cannot be identified
    at all.
  • Confidential means that, although the person can
    be identified, their privacy and confidentiality
    are maintained to the extent possible
  • Safeguards to privacy
  • Closed offices
  • Sound proof areas

7
CONFIDENTIALITY
  • Refers to unauthorized disclosure of information
    relating to the individual
  • Distinguished from privileged communication,
    which refers to the legal right of a client to
    not have their communication disclosed in legal
    proceedings
  • applies to only certain types of communications
    with specified individuals in specified
    circumstances

8
POTENTIAL CONSEQUENCES OF BREACH OF PRIVACY OR
CONFIDENTIALITY
  • Legal implications
  • Insurance (life, health, disability)
  • Housing
  • Employment
  • Law enforcement implications
  • Interpersonal implications
  • Potential loss of relationships
  • Distancing
  • Labeling and secondary labeling
  • Psychological/emotional implications
  • Diminished self-esteem and self-worth
  • Felt/internalized stigma

9
HIPAA
  • Health Insurance Portability and Accountability
    Act of 1996 (HIPAA)
  • Includes the standards for an individuals
    privacy rights, to enable them to understand and
    control how their health information is used

10
LEGAL LMITATIONS ON CONFIDENTIALITY
  • Mandatory reporting requirements
  • Enumerated communicable diseases
  • Child abuse and neglect
  • Elder abuse and neglect
  • Partner violence (some states)
  • Duty to warn if there is imminent harm to self or
    identifiable other and the individual has the
    means to carry this out (Tarasoff v. Regents of
    the University of California, adopted in variety
    of forms by many states)
  • Audits by funding agency or institutional review
    board
  • Professional review

11
MECHANISMS TO PROTECT CONFIDENTIALITY
  • Computer passwords
  • Locked cabinets
  • Locked offices
  • Locked briefcases
  • Location of files
  • Location of discussions
  • Messages
  • Mailings
  • Certificate of confidentiality
  • Procedures for data sharing

12
CERTIFICATES OF CONFIDENTIALITY
  • Available from appropriate institute of NIH
  • Insulates data from most legal proceedings/issues
  • Information available at http//grants2.nih.gov/gr
    ants/policy/coc/appl_extramural.htm

13
CONFIDENTIALITY AND PRIVACY ISSUES FOR
CONSIDERATION IN CBPR
  • Participatory action research To what extent
    can/should the investigator be involved in the
    activity that he or she is observing?
    Legal/ethical issues?
  • In conducting shadowing, must the research team
    member identify him- or herself to all present as
    a researcher? Implications of disclosure?
    Nondisclosure?
  • To what extent should researcher be able to
    collect information about a third party without
    that individuals informed consent?

14
RANDOMIZATION PROCEDURES
  • Defining randomization
  • International documents

15
DEFINING RANDOMIZATION
  • Every individual has an equal probability of
    being assigned to any of the arms or treatments
    in the study
  • Procedure must be established before people are
    enrolled into study
  • Allows different arms of study to be as similar
    as possible

16
INTERNATIONAL DOCUMENTS
  • Helsinki Declaration
  • 32. The benefits, risks, burdens and
    effectiveness of a new intervention must be
    tested against those of the best current proven
    intervention, except in the following
    circumstances
  • The use of placebo, or no treatment, is
    acceptable in studies where no current proven
    intervention exists or
  • Where for compelling and scientifically sound
    methodological reasons the use of placebo is
    necessary to determine the efficacy or safety of
    an intervention and the patients who receive
    placebo or no treatment will not be subject to
    any risk of serious or irreversible harm. Extreme
    care must be taken to avoid abuse of this option.
  • 33. At the conclusion of the study, patients
    entered into the study are entitled to be
    informed about the outcome of the study and to
    share any benefits that result from it, for
    example, access to interventions identified as
    beneficial in the study or to other appropriate
    care or benefits.
  • Council of International Organizations of Medical
    Sciences (CIOMS)
  • Randomization preferred method for assigning
    individuals to study arms
  • when there is no established effective
    intervention
  • when withholding an established effective
    intervention would expose subjects to, at most,
    temporary discomfort or delay in relief of
    symptoms
  • when use of an established effective intervention
    as comparator would not yield scientifically
    reliable results and use of placebo would not add
    any risk of serious or irreversible harm to the
    subjects.

17
WORKING WITH MULTIPLE BOARDS
  • Institutional review boards/ ethical review
    committees
  • Community advisory boards
  • Scientific advisory boards
  • Data safety monitoring boards

18
POTENTIAL DIFFERENCES IN PERSPECTIVES BETWEEN
COMMUNITY AND DIVERSE BOARDS
  • Perceptions of risks and benefits
  • Views of risk-benefit balance
  • Procedures to be utilized for recruitment and
    enrollment
  • Need for written informed consent
  • Availability of waiver of consent
  • Acceptability of comparison in randomized trial
  • Emphasis placed on dissemination of findings

19
Ethical Review Committees Purpose
  • The primary purpose of ethics review committees
    should be to contribute to safeguarding the
    dignity, rights, safety, and wellbeing of all
    actual or potential research participants. (The
    World Health Organization, Operational Guidelines
    for Ethics Committees That Review Biomedical
    Research, 2000, p. 1)
  • WHO Guidelines review committees are to consider
    the principle of justice, which requires the
    equitable distribution of the burdens and
    benefits of research among all groups and classes
    in society.

20
ETHICAL REVIEW COMMITTEES Composition
  • The WHO Guidelines recommend that the review
    committee reflect diversity in expertise, age,
    gender, and community concerns.
  • It has also been suggested that ethics review
    committees reviewing HIV-related protocols
    include HIV health consumers among its members
    (National Health and Medical Research Council,
    2005).
  • Members of the review committee are to be free
    from bias and conflicts of interest. In this
    context, the WHO Guidelines define conflict of
    interest as arising
  • When a member (or members) of the EC holds
    interests with respect to specific applications
    for review that may jeopardize his/her (their)
    ability to provide a free and independent
    evaluation of the research focused on the
    protection of the research participants.
    Conflicts of interest may arise when an EC member
    has financial, material, institutional, or social
    ties to the research (World Health Organization,
    2000 21).

21
ETHICAL REVIEW COMMITTEES Functioning
  • The scope of the ECs review is quite broad and
    encompasses
  • the scientific design and conduct of the study,
  • the recruitment process,
  • the provisions developed to ensure the protection
    of the research participants,
  • the procedures to protect the confidentiality of
    the data,
  • the informed consent process and
  • community considerations.

22
ETHICAL REVIEW COMMITTEES Review Protection of
Participants
  • Suitability of investigators qualifications to
    conduct study
  • Plans to withhold/withdraw standard therapies for
    research and justification to do so
  • Provisions for medical care for participants
    during and following research study
  • Adequacy of medical supervision and psychosocial
    support for participants
  • Steps to be taken if participants voluntarily
    withdraw from study
  • Criteria for extended use, emergency use,
    compassionate use of study products
  • Arrangements and procedures for communication of
    study-related information to participants
    physician
  • Description of plans to make research product
    available to participants following close of
    study
  • Description of financial costs to participants
  • Rewards and compensation to be provided to
    participants
  • Provisions for compensation and/or treatment for
    participants in the event of injury, disability,
    or death attributable to participation in
    research

23
ETHICAL REVIEW COMMITTEES Review Protection of
Confidentiality
  • Description of persons having access to data
  • Measures to be taken to ensure confidentiality
    and security of information

24
ETHICAL REVIEW COMMITTEES Review Informed
Consent Process
  • Description of the process
  • Identification of individuals responsible for
    obtaining consent
  • Adequacy, completeness, and understandability of
    the written document
  • Justification for intent to include as
    participants individuals who cannot provide their
    own consent
  • Assurances that individuals will receive
    information during the course of participation
    that is relevant to their participation
  • Provisions for responding to participant
    questions and complaints during the course of the
    study

25
ETHICAL REVIEW COMMITTEES Review Community
Considerations
  • The impact on and relevance to the community of
    the research, e.g. stigma
  • Mechanisms and extent of dissemination of
    findings to the community

26
U.S. FEDERAL REGULATIONS AND INSTITUTIONAL REVIEW
BOARDS
  • At least 5 persons with specific skills
  • Ensure that risks of the research outweighed by
    the anticipated benefits
  • Ensure that the rights and welfare of research
    participants are protected
  • Ensure that informed consent will be obtained by
    adequate and appropriate means

27
DATA SAFETY MONITORING BOARDS
  • DSMBs were developed in order to monitor
  • on an ongoing basis the data collected during
  • the course of a study (Gordon, Sugarman, and
    Kass, 1998).
  • In order to provide adequate monitoring, the DSMB
    must include experts in all of the disciplines
    needed to ensure participant safety including, if
    relevant to the study, clinical trials experts,
    biostatisticians, bioethicists, and clinicians
    who are knowledgeable about the disease and the
    treatment or intervention that are the focus of
    the study.
  • The DSMB generally meets in an open session with
    the investigators and subsequently in a closed
    session during which the members review the
    emerging data.

28
DSMB RESPONSIBILITIES
  • Evaluate the progress of the trial, including
    data quality, recruitment, accrual and retention,
    participant risks and benefits, performance at
    the various trial sites, and scientific or
    therapeutic developments that could affect the
    participants safety or the studys ethicality
  • Make recommendations to the investigators, the
    IRB, and/or the institution regarding the need to
    continue with or terminate one or more arms of
    the study, or the entire study and
  • Protect the confidentiality of the data and the
    results of the monitoring.

29
TYPICAL SITUATIONS CONFRONTING DSMB Phase III
Clinical Trial
  • A phase III trial is often designed to compare a
    new treatment to a standard treatment or, now
    more rarely, to no treatment (placebo).
    Participants may be randomized to a particular
    arm (experimental treatment, standard treatment,
    or placebo) and the data may be masked.
  • These studies usually involve a large number of
    participants who are followed for longer periods
    of treatment exposure. There may be long term
    effects resulting from longer exposure to the
    study agent or there may be significant safety or
    efficacy differences between the control and
    study groups for a masked study.
  • A DSMB may perform monitoring functions to
    regularly assess the trial and offer
    recommendations concerning its continuation.

30
SABs Formation
  • Usually developed specifically for a particular
    study or center
  • Invited by the principal investigator or center
    director
  • Size determined by needs of center or
    investigator
  • Comprised of individuals with varying expertise,
    e.g. ethics, biostatistics, disease, behavior,
    study methodology

31
SABs Functions
  • To assist in developing future trajectory for
    research efforts
  • To provide information about possible funding
    opportunities
  • To provide feedback about current research and
    methodological approach
  • May meet face-to-face, teleconferencing,
    videoconferencing
  • Meetings often annual or semiannual, but may be
    more frequent

32
COMMUNITY ADVISORY BOARDS
  • Community advisory boards have often been
    employed in the context of community-based
    participatory research, also known as
    community-centered research (Cox et al., 1998
    Israel et al., 1998). This approach assumes that
    research is to be conducted as a partnership
    between the researchers and the community, with
    active community input and engagement in all
    aspects of the research process (Melton et al.,
    1988).

33
MODELS OF CABs IN HIV RESEARCH
  • The broad community model
  • Frequently observed in Thailand and Zimbabwe
  • Takes a long-term view of its role, focusing its
    attention on such issues as sustainability,
    independence in funding and accountability, and
    the promotion of community-initiated research
    (Morin, Maiorana, Koester, Sheon, and Richards,
    2003).
  • Membership consists of individuals from a broad
    spectrum of the community, including religious
    and political leaders, educators, and
    representatives from nongovernmental
    organizations (nonprofit organizations).
  • The population-specific model
  • Concerned with a specific research protocol and
    with the needs of specific groups at increased
    risk of HIV infection in the context of that
    protocol, such as injection drug users.
  • Representatives on such CABs are often drawn from
    the population/community participating in the
    research (Morin, Maiorana, Koester, Sheon, and
    Richards, 2003).
  • CABs of both models exist at the local and
    national levels.

34
CABs and HIV TRIALS
  • CABs have been developed in conjunction with both
    clinical trials for the treatment of HIV in
    infected persons and with HIV prevention trials.
  • CABs developed for clinical trials have
    frequently included HIV-infected persons.
  • CABs focusing on the prevention of transmission
    to uninfected individuals often reflect the
    interests of various communities that may be at
    increased risk for HIV infection (Morin,
    Maiorana, Koester, Sheon, and Richards, 2003).

35
CABs Functions
  • Provide guidance in the development of the
    informed consent process, the design of research
    protocols, and the design of recruitment and
    enrollment procedures
  • Serve as a bridge between research participants
    and the research team (Loue and Mendez, 2005
    Morin, Maiorana, Koester, Sheon, and Richards,
    2003 Strauss et al., 2001).
  • Confront and discuss ethical issues in the
    context of these roles, including the provision
    of care and treatment to those screened for trial
    participation, the protection of vulnerable
    populations, and the value of the proposed
    research to the host community (Morin, Maiorana,
    Koester, Sheon, and Richards, 2003).

36
CABS Barriers to Recruitment and Retention of
Members
  • Differences in
  • Language
  • educational and literacy levels
  • experience in the larger community
  • Difficulties identifying representatives form the
    community (Siskind, 2004)
  • The use of technical terms by researchers
  • Limitations of time and funds for child care and
    travel (Silver et al., 1996)
  • Increasing severity of illness member.

37
CAB MEMBER MOTIVATIONS
  • The existence of a mission statement has been
    associated with better attendance and more active
    participation of CAB members (Chovnick, 2005 Cox
    et al., 1998).
  • Individual motivations for participation on a CAB
    include
  • a commitment to fighting HIV/AIDS
  • a sense of legitimacy
  • the opportunity to contribute something
    meaningful to the community
  • material rewards such as reimbursements, lunches,
    and stipends (Morin, Maiorana, Koester, Sheon,
    and Richards, 2003). These material rewards
    have, however, been somewhat controversial.
    Researchers have reported that the provision of
    such benefits to CAB members in a rural area of
    western Kenya prompted concerns regarding the
    objectivity of the CAB members because the
    rewards were provided in the context of a high
    local level of unemployment and poverty (Odhiambo
    et al., 2004).

38
ETHICAL ISSUES IN FORMING A CAB
  • The selection of community representative who
    has the right to speak for a community
  • Conflicts resulting from the multiple roles of
    providers as advisory board members, research
    interviewees, and providers to study participants
  • Conflicting priorities of community members and
    researchers (Loue and Mendez, 2005).

39
SELECTING A COMMUNITY REPRESENTATIVE
  • How is community defined?
  • Is the individual selected in touch with that
    community?
  • If out of touch, individual may not be attuned to
    the sensitivities of prospective participants so
    that, inadvertently, prospective participants
    could be harmed by a lack of attention to their
    concerns.
  • Overemphasis on the communitys sensitivities
    could result in the termination of the research,
    thereby depriving individuals of not only the
    burdens of the research, but its benefits as
    well.
  • In both instances, the principle of respect for
    persons is violated because individuals are
    either not adequately protected from harm, or are
    not afforded an opportunity to decide for
    themselves whether or not to participate.
  • In the latter instance, the principle of justice,
    which seeks an equitable distribution of the
    benefits and burdens of research, may also be
    violated.

40
MULTIPLE ROLES OF CAB MEMBERS
  • Some of the CAB members may have professional
    relationships with individual who are
    participants in particular studies that are the
    focus of the CABs attention. Ethical issues may
    arise where the CAB member wishes to access for
    their use in a clinical context data collected
    from a particular participant in the research
    context.
  • Various strategies can be utilized to reduce the
    likelihood of such requests and/or to address
    such requests when they are made.
  • All CAB members can be advised at the
    commencement of their participation that no
    disclosures of research data will be made, other
    than in the aggregate.
  • Participants can be given the option to have
    specific information conveyed by the research
    team to named providers with a signed, written
    request/release of information from the
    participant.

41
DIFFERING PERSPECTIVES ACROSS BOARDS AND
COMMUNITIES
  • Perceptions of risks and benefits
  • Giving back to the community
  • Availability of information
  • Hard referrals to community resources
  • Involuntary termination of individuals
    participation in study
  • Whether arm or entire study should be terminated
  • Views of risk-benefit balance
  • Often IRB emphasis on physical harm, overemphasis
    by researchers and IRB on benefits
  • Procedures to be utilized for recruitment and
    enrollment

42
DIFFERING PERSPECTIVES ACROSS BOARDS AND
COMMUNITIES
  • Written informed consent
  • Problematic depending on history of participants
  • Readability level and language of consent forms
  • Availability of waiver of consent
  • Particular issue in research with children
  • Acceptability of comparison in randomized trial
  • Placebo v. standard treatment
  • Difficulty defining standard care
  • If true equipoise, unclear whether experimental
    condition will produce harm or benefit
  • Emphasis placed on dissemination of findings

43
STRATEGIES TO RESOLVE CONFLICTS
  • Only IRB has legal authority
  • Ability of PI to negotiate between boards
  • IRB practices
  • Community participation
  • Reliance on cultural expert

44
GUARDING AGAINST ETHICAL AND LEGAL PROBLEMS
  • Develop comprehensive study protocol to address
    various situations
  • Situations requiring informed consent
  • Procedures for disclosure of information
  • Procedures for notification/reporting
  • HIV test results
  • Child or elder abuse or neglect
  • Partner violence
  • Immediate threat to self or others
  • Procedures for disclosure and resolution of
    conflict of interest
  • Procedures for reporting, investigations, and
    resolution of sexual harassment issues
  • Develop guidelines for non-IRB boards interacting
    with study CAB, SAB, DSMB
  • Roles and responsibilities of board members
  • Parameters for access to study data and
    participant identity
About PowerShow.com