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

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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

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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?

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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

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What are Vulnerable Populations?

• Categories include
• pregnant women
• children
• mentally ill
• prisoners
• economically disadvantaged
• mentally/physically challenged
• Also victims, offenders, their
  families/social networks

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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.

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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

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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

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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!

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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.

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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

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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.

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Human Subjects Protection in Research on Domestic
Violence Perpetrators

• Larry Bennett
• Jane Addams College of Social Work

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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

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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

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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

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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

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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)

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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)

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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

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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

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Ethical Issues in Conducting Research with
Domestic Violence Victims

• Christine Helfrich, PhD, OTR/L, FAOTA
• Department of Occupational Therapy
• College of Applied Health Sciences

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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

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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

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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

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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.

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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

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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

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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.

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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
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Outcome of Acculturative Interaction Between
Dominant and Nondominant Groups
Nondominant individuals cultural identity variable Positive relations sought with dominant group Outcome of acculturation
YES YES Integration/ Bicultural
NO NO Marginality
YES NO Resistance/ Traditionalist
NO YES Assimilation/Over acculturated
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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

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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.

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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".

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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.

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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.

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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

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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

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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.

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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

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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

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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)

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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

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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.
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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.

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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

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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!

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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.

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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?

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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.

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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)

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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