Title: Ethics in Violence Research with Vulnerable Populations April 24, 2006
1Ethics 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
2Purposes 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
3Panelists
- 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?
4Overview of Ethical Practices and Examples from
Sexual Assault Research
- Sarah Ullman
- Department of Criminal Justice
- Principal Investigator, UIC Interdisciplinary
Center for Research on Violence
5What are Vulnerable Populations?
- Categories include
- pregnant women
- children
- mentally ill
- prisoners
- economically disadvantaged
- mentally/physically challenged
- Also victims, offenders, their
families/social networks
6Weighing 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.
7Minimizing 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
8Other 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
9Collaborate 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!
10Securing 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.
11Oh 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
12Conclusions
- 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.
13Human Subjects Protection in Research on Domestic
Violence Perpetrators
- Larry Bennett
- Jane Addams College of Social Work
14Consent, 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
15Coercion 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
16Conflicting 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
17Safety 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
18Victim 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)
19Created 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)
20Duty 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
21When 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
22Ethical Issues in Conducting Research with
Domestic Violence Victims
- Christine Helfrich, PhD, OTR/L, FAOTA
- Department of Occupational Therapy
- College of Applied Health Sciences
23Research 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
24Study 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
25Participation 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
26Cultural 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.
27Ensuring 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
28Cultural 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
29Ethnocentric 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.
30Ethnocentric 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
31Racism
- 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.
32Oppressed/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.
33Microinsults 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.
34Violence 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.
35Violence 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.
36Violence 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.
37Violence 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.
38Violence 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
39Lifetime 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
40Outcome 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
41African-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
42Racism 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.
43Racism 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".
44Racism 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.
45Racism 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.
46Safeguarding vulnerable populations in research
IRB viewpoints on certificates of confidentiality
and mandatory reporting
- Charles Hoehne
- Assistant Director, Office for the Protection of
Research Subjects
47What 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
48What 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.
49What 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
50Protection 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
51Protection 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)
52Certificate 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
53Certificate 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.
54Certificate 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.
55Certificate 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.
56Certificate 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
57Why 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)
58Mandated Reporting and the IRB
- Remember-
- A Certificate of Confidentiality does not trump
mandated reporting requirements!
59Mandated 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.
60Mandated 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?
61Mandated 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.
62References/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)
63Template 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.
64Template 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.
65Template 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.
66Research and Service Providers Can we Establish
a Balance when Worlds Collide?
- Margaret Luft
- Director of Counseling, Life Span Center for
Legal Services and Counseling
67Everybody 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.
68Identify Distinct Constituencies
- How you define success depends on who is asking
the evaluative questions - Elected officials
- Private donors
- Corporate sponsors
- Service providers
- Client consumers
69Elected 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
70Private Donors
- Guided by specific mission
- Time limited commitments
- Concerned with sustainability
- Efficacy Measurable outcome
- Efficacy Legacy
71Corporate 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.
72Service 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
73Client 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
74How 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?
75Service Provider Perspective
- Push of funders
- Do more with less
- Pull of clients
- Help me out of this mess