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Ethics in Violence Research with Vulnerable Populations April 24, 2006

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Human Subjects Protection in Research on Domestic Violence Perpetrators. Larry Bennett ... Ethical Issues in Conducting Research with Domestic Violence Victims ... – PowerPoint PPT presentation

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Title: Ethics in Violence Research with Vulnerable Populations April 24, 2006


1
Ethics in Violence Research with Vulnerable
PopulationsApril 24, 2006
  • Sponsored by
  • Interdisciplinary Center for Research on Violence
  • Criminal Justice Department
  • Office on Protection of Research Subjects
  • University of Illinois at Chicago

2
Purposes of Seminar
  • To present examples of sensitive practice in
    research and intervention with vulnerable
    populations
  • To discuss ethical dilemmas and methods of
    resolving them
  • To initiate a dialogue about these issues,
    especially in relation to violence research with
    vulnerable populations

3
Panelists
  • Sarah Ullman, Ph.D., Professor of Criminal
    Justice Overview of ethical practices examples
    from sexual assault research
  • Larry Bennett, Ph.D., Assoc. Professor of Social
    Work Human subjects protection in research with
    domestic violence perpetrators
  • Christine Helfrich, Ph.D., Asst. Professor of
    Occupational Therapy Ethical issues in
    conducting research with domestic violence
    victims
  • Carl Bell, M. D., Professor of Psychiatry and
    Public Health Cultural sensitivity in studying
    populations exposed to violence
  • Charles Hoehne, Assistant Director, Office for
    the Protection of Research Subjects
    Safeguarding vulnerable populations in research
    IRB viewpoints on certificates of confidentiality
    and mandatory reporting
  • Margaret Luft, Director of Counseling, Life Span
    Center for Legal Services and Counseling
    Research and Service Providers Can we establish
    a balance when worlds collide?

4
Overview of Ethical Practices and Examples from
Sexual Assault Research
  • Sarah Ullman
  • Department of Criminal Justice
  • Principal Investigator, UIC Interdisciplinary
    Center for Research on Violence

5
What are Vulnerable Populations?
  • Categories include
  • pregnant women
  • children
  • mentally ill
  • prisoners
  • economically disadvantaged
  • mentally/physically challenged
  • Also victims, offenders, their
    families/social networks

6
Weighing Risks vs. Benefits
  • Bias of researcher/IRB vs. those studied
  • Assess Risks inadequate informed consent,
    confidentiality, safety concerns for violence
    survivors, revictimization or retraumatization
    during the research due to the study
  • Assess Benefits private, safe disclosure of
    violence, community resource information, chance
    to help others, payment etc.

7
Minimizing Risks
  • Recruitment tailored towards empowerment
  • Consider participatory/collaborative research
  • Going beyond paper/pencil survey methods
  • Pilot testing instruments with victims
  • Avoiding methods/populations that are more likely
    to retraumatize already vulnerable groups
  • Using feedback from participants to improve
    sensitivity of research methods/assessments
  • Responding to survivors requests if possible
  • Giving back to participants community

8
Other Methods to Protect Participants Include
  • certificates of confidentiality
  • waiving parental consent for children in some
    cases
  • flexibility in research protocols to maximize
    participant safety
  • following up with participants to be sure they
    are safe/to give referrals/get consent on an
    ongoing basis if relevant

9
Collaborate with Community/Participants
  • Consider qualitative research or a qualitative
    component
  • Protect researchers, participants, collaborators
    vicarious trauma risks
  • Ask what community needs/wants
  • Develop safety plans
  • Give results back/collaborate in what is
    published/reported as appropriate
  • Assume you dont know everything check in with
    yourself, your participants, co-researchers etc!

10
Securing Initial IRB Approval
  • Be patient IRB should help you to identify
    biases you may be unaware of and risks you can
    minimize in your research plans.
  • Do a thorough and complete submission to the IRB
    of your research study plans.
  • Educate the IRB about your research
    population, study team expertise, context of the
    research, and any information from the
    field/research documenting your plans are ethical
    and safe.
  • Get advice from others doing similar research and
    only do what you have the resources and
    experience to handle.

11
Oh No, Not Another Deferral!
  • Violence research is almost always reviewed by
    the full board and should be. This protects you
    and your participants.
  • Dont feel badly when your research initially
    gets deferred this is typical, so expect it.
  • Communicate with the IRB and use them as allies.
    Call the OPRS with questions prior to and/or
    during the review process with questions,
    information to help the board etc.
  • Realize sometimes you cannot do exactly what you
    had planned and try to find another way

12
Conclusions
  • Research is a learning process and doing violence
    research is challenging, but important.
  • Learn from your mistakes and those of others and
    try to do your best to be sure your work is both
    scientifically and ethically sound.
  • Fully consider perspectives from outside
    academia, especially those who are and who work
    with victimized populations.

13
Human Subjects Protection in Research on Domestic
Violence Perpetrators
  • Larry Bennett
  • Jane Addams College of Social Work

14
Consent, Privacy, Harm
  • Coercion of batterers and their partners
  • Batterer program v. researchers standards of
    confidentiality
  • Necessity of partner data v. partner safety
  • Created and detected risks
  • Follow-up v. stalking

15
Coercion of Batterers and Their Partners
  • Prospect of return to court on a violation may
    subtly coerce batterers to participate
  • When possible, integrate research tools into
    agency assessment protocol
  • Partner may be coerced to participate by both
    batterer and by researcher
  • Fears both participation and non-participation
  • 50 of batterers not with index partner, 20 have
    new partners

16
Conflicting Standards of Confidentiality
  • Batterer programs often request waiver of normal
    conditions of confidentiality
  • Researcher must articulate the differences
    between programmatic confidentiality and research
    confidentiality
  • To participants
  • To program staff
  • To advocates affiliated with batterer program

17
Safety of the Batterers Partner(s)
  • Research on batterers usually requires data from
    partner for reliability
  • Partners are rarely in shelter, therefore at very
    high risk when providing data
  • Procedures to reduce risk
  • Establish privacy
  • Funnel questions
  • Debrief

18
Victim Contact Always Assume
  • Batterer has full access to her (e)mail
  • Batterer is listening on another phone line
  • Batterer is standing in the room during your
    phone conversation with victim
  • Batterer will come home during your home
    interview
  • Batterer will check all her phone logs
  • (Sullivan Cain, 2004)

19
Created and Detected Risk
  • Created Risk threat to victim from the research
    process
  • research process parallels abuse
  • n465 women
  • 20 report partner was listening during a
    follow-up interview
  • 10 report being questioned about the interview
  • Detected Risk suicide, threat to victim, child
    abuse
  • Threat rate 25 episodes/840 batterers (3)
  • (Gondolf, 2000)

20
Duty to Protect
  • Interviewer Assesses
  • How long has he felt this way?
  • Plans?
  • Drugs/alcohol use
  • Access to victim
  • Access to weapons
  • Interviewer Acts
  • Explain consequences and alternatives
  • Encourage him to contact the batterer program
  • If refuse/non-comply report threats to victim,
    program, police

21
When is Research Follow-up Like Stalking?
  • Follow-up may replicate batterers stalking/abuse
  • State coalitions of battered womens services now
    train advocates on phone privacy techniques
  • Tracking Protocol, Phone Protocol needed
  • Do not use professional locators

22
Ethical Issues in Conducting Research with
Domestic Violence Victims
  • Christine Helfrich, PhD, OTR/L, FAOTA
  • Department of Occupational Therapy
  • College of Applied Health Sciences

23
Research Paradigm
  • Principle of justice
  • Need to consult victims and advocates to
    ascertain risks when designing study
  • Emancipation Paradigm ensures beneficence and
    includes collaborative data collection methods to
    improve conditions for those studied

24
Study Design
  • Study design must ensure safety and sometimes
    this means needing to alter desired study designs
    to do so.
  • Sample recruitment and retention is affected by
    safety issues
  • Abuser knowledge of study participation
  • Abuser/legal system use of study information

25
Participation Issues of Power and Coercion
  • Informed Consent process needs to minimize issues
    of coercion and not re-victimize the participants
  • Incentives should not be coercive and need to
    maintain confidentiality (ie. Cash or gift cards
    vs checks)
  • Longitudinal Involvement is desirable however,
    safety and dependency issues must be considered

26
Cultural Congruence Throughout the Research
Process
  • Researcher must have cultural competence to go
    into the community and conduct ethical and
    effective research.
  • Recruitment and consent process must consider
    cultural aspects related to ethnicity and race,
    as well as the culture of the DV community.
    Issues of power and intimidation need to be
    carefully considered with this population.
  • Data analyses must consider the biases of where
    and how data was collected.
  • Dissemination process must carefully consider
    non-malfeasance in reporting results.

27
Ensuring Safety When the Research Itself
Engenders Danger
  • Safeguards for physical safety
  • Generic voice mail messages
  • Not identifying study name
  • Blocking caller ID
  • Pre-established code words to determine if safe
    to talk
  • Not leaving messages
  • Not giving out specific information regarding
    study to unknown callers
  • Resources for emotional/psychological safety
  • Established relationships with DV agencies,
  • Crises line phone numbers,
  • Referral sources

28
Cultural Sensitivity in Studying Populations
Exposed to Violence
  • Carl C. Bell, M.D., F.A.P.A., F.A.C.Psych.
  • C.E.O./President Community Mental Health
    Council, Inc.
  • Professor of Psychiatry, Professor of Public
    Health, University of Illinois
  • carlcbell_at_pol.net

29
Ethnocentric Multiculturalism
  • This aspect of Euro-American culture makes it
    difficult to appreciate cultural differences
    between different ethnic groups.
  • This aspect of Euro-American culture makes it
    difficult to appreciate diversity within racial
    groups.

30
Ethnocentric Monoculturalism
  • An example is the food pyramid graphic
    recommended by the U. S. Department of
    Agriculture which has milk and dairy products as
    a consumers only source of calcium.
  • Lactose intolerance occurs in
  • 70 of African Americans
  • 90 of Asian Americans
  • 74 of Native Americans
  • 53 of Mexican Americans
  • Only 15 of Whites are lactose intolerant

31
Racism
  • Racism is the practice of racial discrimination,
    segregation, persecution, and domination based on
    a feeling of racial differences or antagonisms
    especially with reference to supposed racial
    superiority, inferiority, or purity.

32
Oppressed/Oppressor - Relationships
  • In any effective and efficient submission-dominanc
    e system, it is critical for the oppressor to
    monopolize the perception of the victim.
  • One is victimized in proportion to the quality of
    space, time, energy, and mobility that one must
    yield or has yielded to the oppressor.
  • Conversely, the more one regains or commands
    control of these elements the less one is
    victimized.

33
Microinsults and Microaggressions
  • These mechanisms are nonverbal and kinetic, and
    they are well suited to control space, time,
    energy, and mobility of an African-American while
    at the same time producing feelings of
    degradation.

34
Violence in Different Ethnic Groups - General
  • In most murder cases involving a white or black
    victim, the offender was of the same race of the
    victim.
  • Poverty and social infrastructure account for the
    vast differences in rates of violence between
    African-Americans and Whites.
  • African-American rates are six times Latino
    rates are 2.3 times the Native America, Asian,
    White rates of homicide.

35
Violence in Different Ethnic Groups -
African-American
  • Interpersonal Altercation violence is a major
    from of violence occurring in the
    African-American community
  • Domestic homicide continues to be a problem in
    the African American community, but
    African-American women are no longer killing more
    African American men than vice versa.

36
Violence in Different Ethnic Groups - Latino
  • Gang-related violence is a major form of violence
    occurring in the Latino community
  • Latino men are not known to perpetrate domestic
    homicide.
  • Latino men tend to perpetuate violence in the
    street and, while gun violence predominates,
    there is a greater use of knifes.

37
Violence in Different Ethnic Groups - Native
American
  • Interpersonal altercation violence is a major
    form of violence in the Native American
    community.
  • Forty percent of Native American murder victims
    were killed by an offender who was not Native
    American
  • In 33 of the cases the offender was white.

38
Violence in Different Ethnic Groups
Euro-American
  • Suicide is a major form of violence occurring in
    the Euro-American community
  • Euro-Americans are the majority of offenders in
    Anger/revenge Domestic/romantic related mass
    murder
  • In Anger/revenge Domestic/romantic related mass
    murder there is a significant suicide dynamic

39
Lifetime Prevalence of CIDI Disorders in Fresno
and National Comorbidity Survey (NCS)(Vega,
Kolody, Aguilar-Gaxiola et al., 1998)
48.6
48.1
28.2
27.7
25
23.2
24.9
19.5
18.7
1.3
10.5
8
F r e s n o S t u d y
40
Outcome of Acculturative Interaction Between
Dominant and Nondominant Groups
41
African-Based Populations
  • Pre-slavery Africans in America
  • Africans in America subjected to various degrees
    of slavery
  • Recent African Immigrants in America
  • Recent African Refugees in America

42
Racism In Research
  • The history of research efforts in disadvantaged
    communities provides sufficient evidence of the
    ways in which African Americans have been
    exploited by both medical and research
    interventionists.

43
Racism in Psychiatry
  • G. Stanley Hall also declared that the medical
    treatment of the races was a different "as the
    application of veterinary medicine for horses is
    from that applied to the oxen".

44
Racism in Psychiatry
  • Carl Gustav Jung noted "The different strata of
    the mind correspond to the history of the races"
    and that the Negro "has probably a whole
    historical layer less" than the white man.

45
Racism in Psychiatry
  • Another example of the racist use of race in
    psychiatry can be found in Lauretta Bender's work
    on "Behavior Problems in Negro Children" (1939).
  • She noted that the two most distinguishing
    characteristics of Negro children were their
    ability to dance and their capacity for laziness.

46
Safeguarding vulnerable populations in research
IRB viewpoints on certificates of confidentiality
and mandatory reporting
  • Charles Hoehne
  • Assistant Director, Office for the Protection of
    Research Subjects

47
What Defines a Vulnerable Population?
  • Belmont Report
  • Respect for Persons - Persons with diminished
    autonomy are entitled to protection
  • Research implications
  • Acknowledge autonomy
  • Protect those with diminished autonomy

48
What Defines a Vulnerable Population?
  • Belmont Report
  • Justice One special instance of injustice
    results from the involvement of vulnerable
    subjects. Certain groups, such as racial
    minorities, the economically disadvantaged, the
    very sick, and the institutionalized may
    continually be sought as research subjects, owing
    to their ready availability in settings where
    research is conducted. Given their dependent
    status and their frequently compromised capacity
    for free consent, they should be protected
    against the danger of being involved in research
    solely for administrative convenience, or because
    they are easy to manipulate as a result of their
    socioeconomic condition.

49
What Defines a Vulnerable Population?
  • Examples of vulnerable populations commonly
    seen by the IRB
  • Students (UIC Psychology Subject Pool, Use of
    Classroom Time, Teachers recruiting their own
    students, for example)
  • Employees
  • Children
  • Pregnant Women
  • Wards
  • Individuals with diminished/diminishing capacity
  • Individuals with service needs (health, social
    services, etc)
  • Economically disadvantaged
  • Racial minorities
  • Prisoners

50
Protection of Vulnerable Populations (as per 45
CFR 46)
  • Subpart A Basic Protection for all Human
    Subjects
  • Subpart B Additional Protections for Pregnant
    Women, Human Fetuses, and Neonates
  • Subpart C Additional Protections for Prisoners
  • Subpart D Additional Protections for Children

51
Protection of Vulnerable Populations (as per 45
CFR 46)
  • Sometimes additional safeguards above and beyond
    Subparts A-D are required to satisfy 45 CFR
    46.111(1)
  • Risk to subjects are minimized (i) by using
    procedures which are consistent with sound
    research design and which do not unnecessarily
    expose subjects to risk,
  • Example Certificate of Confidentiality
  • AKA Section 301(d) of the Public Health Service
    Act 42 U.S.C. 241(d)

52
Certificate of Confidentiality
  • Issued by the National Institutes of Health (NIH)
  • DHHS Secretary may authorize persons engaged in
  • Biomedical, Behavioral, Clinical, Other Research
  • To protect the privacy of individuals who are the
    subjects of that research.
  • Protects investigators and institutions from
    involuntary release of identifying information
    in any
  • Civil
  • Criminal
  • Administrative
  • Federal, state or local legislative, or other
    proceeding
  • Protection is not limited to federally supported
    research

53
Certificate of Confidentiality
  • Research studies eligible for a Certificate must
  • Have IRB approval
  • Involve collection of identifying information
    and
  • Disclosure could have adverse consequences for
    subjects or damage their financial standing,
    employability, insurability, or reputation.

54
Certificate of Confidentiality
  • NIH Requirements
  • Informed consent document must explain the
    Certificates protections, including a fair and
    clear explanation of the limitations and
    exceptions
  • PI must submit documentation of IRB approval
  • PI must submit a copy of the IRB-approved
    informed consent document
  • PI and Institutional Official (Vice-Chancellor
    for Research, or his designee) must sign the
    application

cont.
55
Certificate of Confidentiality
  • NIH Requirements (cont)
  • PI must agree to protect against involuntary
    disclosure and to support and defend the
    authority of the Certificate against legal
    challenges
  • PI must agree to comply with federal regulations
    protecting human subjects and
  • PI must agree not to represent the Certificate as
    an endorsement of the research by DHHS or NIH.

56
Certificate of Confidentiality
  • Boundaries of Protection
  • Goes into effect on date Certificate is granted
  • Permanently protects identifiable data obtained
    during any time the Certificate is in effect
  • Does not protect against voluntary disclosure
  • Child abuse
  • Threat of harm to self or others
  • Reportable communicable diseases
  • Subjects own disclosure

57
Why dont more PIs obtain Certificates?
  • Lack of familiarity
  • Misconception that Certificates apply only to
    criminal behavior
  • Perceived low risk-benefit ratio
  • What is likelihood of a subpoena?
  • Takes too long (IRB process 30-45 days)

58
Mandated Reporting and the IRB
  • Remember-
  • A Certificate of Confidentiality does not trump
    mandated reporting requirements!

59
Mandated Reporting and the IRB
  • What is the IRB looking for?
  • PI should address mandated reporting in the
    application and informed consent document if
    there is a reasonably likelihood that abuse
    and/or neglect will be discovered.
  • Charles Hoehne does not speak for any or all of
    the UIC IRBs.

60
Mandated Reporting and the IRB
  • Assent and Parental Permission Issues PIs want
    to consider/address in their applications for IRB
    review
  • Will a child understand the concept?
  • Will a warning in the assent document decrease
    the likelihood that the child will report?
  • Will a warning in the assent document increase
    the likelihood that the child will report?
  • Will a warning in the parental permission
    document keep abusive parent from permitting the
    child to participate? If so, what are the
    implications?
  • Question Who are we trying to protect? The
    child? The parent? The Investigators? The IRB?
    The Institution? All?

61
Mandated Reporting and the IRB
  • Question Is the following language in the UIC
    Informed Consent Document template sufficient?
  • No information about you, or provided by you
    during the research, will be disclosed to others
    without your written permission, except a) if
    necessary to protect your rights or welfare, or
    b) if required by law.
  • Answer No, not if revelation of abuse or neglect
    is likely.
  • Suggestion Please carefully review the
    assent/consent/parental permission documents to
    make sure there is no contradictory information
    regarding confidentiality.

62
References/Resources
  • Link to DHHS http//www.hhs.gov/ohrp/
  • DHHS link to 45 CFR 46 Http//www.hhs.gov/ohrp/hu
    mansubjects/guidance/45cfr46.htm
  • DHHS Guidance on Certificates of Confidentiality
    http//www.hhs.gov/ohrp/humansubjects/guidance/cer
    tconf.htm
  • NIH Certificates of Confidentiality Kiosk
    http//grants.nih.gov/grants/policy/coc/index.htm
  • NIH Certificates of Confidentiality Slide
    Presentation http//www.grants.nih.gov/grants/pol
    icy/coc/slides_020503/sld002.htm
  • UIC Office for the Protection of Research
    Subjects http//tigger.uic.edu/depts/ovcr/researc
    h/protocolreview/irb/index.shtml (Phone
    312-996-1711)

63
Template Language for Informed Consent Document
if a Certificate will be obtained
  • Required Language
  • To help us protect your privacy, we have obtained
    a Certificate of Confidentiality from the
    National Institutes of Health. With this
    Certificate, the researchers cannot be forced to
    disclose information that may identify you, even
    by a court subpoena, in any federal, state, or
    local civil, criminal, administrative,
    legislative, or other proceedings. The
    researchers will use the Certificate to resist
    any demands for information that would identify
    you, except as explained below.
  • The Certificate cannot be used to resist a demand
    for information from personnel of the United
    States Government that is used for auditing or
    evaluation of Federally funded projects or for
    information that must be disclosed in order to
    meet the requirements of the federal Food and
    Drug Administration (FDA).
  • You should understand that a Certificate of
    Confidentiality does not prevent you or a member
    of your family from voluntarily releasing
    information about yourself or your involvement in
    this research. If an insurer, employer, or other
    person obtains your written consent to receive
    research information, then the researchers may
    not use the Certificate to withhold that
    information.

cont.
64
Template Language for Informed Consent Document
if a Certificate will be obtained
  • Required language (cont)
  • Researchers should include language such as the
    following if they intend to make voluntary
    disclosure about things such as child abuse,
    intent to hurt self or others, or other voluntary
    disclosures
  • The Certificate of Confidentiality does not
    prevent the researchers from disclosing
    voluntarily, without your consent, information
    that would identify you as a participant in the
    research project under the following
    circumstances The researchers should state here
    the conditions under which voluntary disclosure
    would be made. If no voluntary disclosures will
    be made, the researchers should so state.

cont.
65
Template Language for Informed Consent Document
if a Certificate will be obtained
  • Required language (cont)
  • Certificates of Confidentiality protect subjects
    from compelled disclosure of identifying
    information but do not prevent the voluntary
    disclosure of identifying characteristics of
    research subjects. Researchers, therefore, are
    not prevented from voluntarily disclosing certain
    information about research subjects, such as
    evidence of child abuse or a subject's threatened
    violence to self or others.
  • However, if a researcher intends to make such
    voluntary disclosures, the consent document must
    clearly indicate this. Furthermore, Certificates
    of Confidentiality do not prevent other types of
    intentional or unintentional breaches of
    confidentiality. As a result, investigators and
    IRBs must ensure that other appropriate
    mechanisms and procedures are in place to protect
    the confidentiality of the identifiable private
    information to be obtained in the proposed
    research.

66
Research and Service Providers Can we Establish
a Balance when Worlds Collide?
  • Margaret Luft
  • Director of Counseling, Life Span Center for
    Legal Services and Counseling

67
Everybody Wants to Know What Works (Efficacy)
  • But success is defined differently depending on
    where people start,
  • AND
  • Research is often used to validate a belief about
    what is right rather than to discover what is
    true.

68
Identify Distinct Constituencies
  • How you define success depends on who is asking
    the evaluative questions
  • Elected officials
  • Private donors
  • Corporate sponsors
  • Service providers
  • Client consumers

69
Elected Officials
  • Accountable to the general public
  • Stewards of the public purse
  • Need to see progress now
  • Balancing competing interests
  • Money has to be renewed every year
  • Efficacy Measurable outcomes

70
Private Donors
  • Guided by specific mission
  • Time limited commitments
  • Concerned with sustainability
  • Efficacy Measurable outcome
  • Efficacy Legacy

71
Corporate Sponsors
  • Want brand name to be associated with a winner
  • Good Public relations in community
  • Efficacy Improving image with customers and
    employees
  • Efficacy Spread the brand name.

72
Service Providers
  • Guided by mission to help
  • Need to find money continuously for operations
  • Overwhelmed with volume and scope of client needs
  • Barrage of demand from all funders to justify
    continuation of services
  • Formal evaluations frequently validate what they
    already know
  • Research money competes with services funding
  • Efficacy continuing services, client
    satisfaction

73
Client Consumers
  • Want relief in crisis
  • Want future to be better than the past
  • Know what works or does not work for them
  • Have been told what they should do by everyone
    (if it were that simple, they would already be
    doing it)
  • Discouraged by the lack of tangible help
  • Display cynicism about formal research, because
    it often fails to provide immediate relief or to
    produce the long term change necessary to improve
    the future
  • Efficacy improvement in life circumstances and
    increase in personal sense of accomplishment

74
How can Research Balance these Different
Definitions of Efficacy?
  • Government vs Private sustainability
  • Funders vs Clients who pays? who consumes?
  • Providers vs Funders Process/Product
  • Deliverables vs Impact counting things vs.
    measuring outcomes
  • Big picture vs One-person-at-a-time at what
    level does lasting change occur?

75
Service Provider Perspective
  • Push of funders
  • Do more with less
  • Pull of clients
  • Help me out of this mess
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