ethics in violence research with vulnerable populations april 24, 2006 sponsored by:...
TRANSCRIPT
Ethics in Violence Research with Vulnerable Populations
April 24, 2006
Sponsored by: Interdisciplinary Center for Research on
Violence Criminal Justice Department Office on Protection of Research Subjects University of Illinois at Chicago
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
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?
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
What are Vulnerable Populations?
Categories include: pregnant women children mentally ill prisoners economically disadvantaged mentally/physically challenged ** Also – victims, offenders, their families/social
networks
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.
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 survivor’s requests if possible Giving back to participants & community
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
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 don’t know everything – check in with yourself,
your participants, co-researchers etc!
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.
Oh No, Not Another Deferral!
Violence research is almost always reviewed by the full board and should be. This protects you and your participants.
Don’t 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
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.
Human Subjects Protection in Research on Domestic Violence Perpetrators
Larry Bennett Jane Addams College of Social Work
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
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
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
Safety of the Batterer’s 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 privacyFunnel questionsDebrief
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)
Created and Detected Risk
Created Risk: threat to victim from the research process
research process parallels abuse
n=465 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)
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
When is Research Follow-up Like Stalking?
Follow-up may replicate batterer’s stalking/abuse
State coalitions of battered women’s services now train advocates on phone privacy techniques
Tracking Protocol, Phone Protocol needed Do not use professional locators
Ethical Issues in Conducting Research with Domestic Violence Victims
Christine Helfrich, PhD, OTR/L, FAOTA Department of Occupational Therapy College of Applied Health Sciences
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
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 issuesAbuser knowledge of study participationAbuser/legal system use of study information
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
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.
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
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 [email protected]
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.
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 consumer’s only source of calcium.
Lactose intolerance occurs in:70% of African Americans90% of Asian Americans74% of Native Americans53% of Mexican Americans Only 15% of Whites are lactose intolerant
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.
Oppressed/Oppressor - Relationships
In any effective and efficient submission-dominance 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.
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.
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.
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.
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.
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.
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
0
10
20
30
40
50
Immigrants Us-BornMexican
Americans
NCS-Total
Affective Disorders Anxiety DisordersAny substance abuse/dependence Any disorder
Lifetime Prevalence of CIDI Disorders in Fresno and National Comorbidity Survey (NCS)
(Vega, Kolody, Aguilar-Gaxiola et al., 1998)
F r e s n o S t u d y
81.3
28.2
48.648.1
2527.7
23.224.9
10.5
18.7 19.5
Outcome of Acculturative Interaction Between Dominant and Nondominant
Groups
Nondominant individual’s
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
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
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.
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".
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.
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.
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
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
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.
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
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
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)]
Certificate of Confidentiality
Issued by the National Institutes of Health (NIH) DHHS Secretary may authorize persons engaged in:
a) Biomedical, Behavioral, Clinical, Other Research
b) 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:
a) Civil
b) Criminal
c) Administrative
d) Federal, state or local legislative, or other proceeding
Protection is not limited to federally supported research
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.
Certificate of Confidentiality
NIH Requirements: Informed consent document must explain the
Certificate’s 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.
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.
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:
a) Child abuse
b) Threat of harm to self or others
c) Reportable communicable diseases
d) Subjects own disclosure
Why don’t more PI’s obtain Certificates?
Lack of familiarity Misconception that Certificates apply only
to “criminal” behavior Perceived low risk-benefit ratio:
a) What is likelihood of a subpoena?
b) Takes too long (IRB process + 30-45 days)
Mandated Reporting and the IRB
Remember-A Certificate of Confidentiality
does not “trump” mandated reporting requirements!
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 IRB’s.
Mandated Reporting and the IRB
Assent and Parental Permission Issues PI’s want to consider/address in their applications for IRB review:
a) Will a child understand the concept?b) Will a “warning” in the assent document decrease the likelihood that
the child will report?c) Will a “warning” in the assent document increase the likelihood that
the child will report?d) 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?…
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.
References/Resources:
Link to DHHS: http://www.hhs.gov/ohrp/ DHHS link to 45 CFR 46:
Http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DHHS Guidance on Certificates of Confidentiality:
http://www.hhs.gov/ohrp/humansubjects/guidance/certconf.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/policy/coc/slides_020503/sld002.htm UIC Office for the Protection of Research Subjects:
http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/index.shtml (Phone: 312-996-1711)
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.
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.
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.
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
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.
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
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
Private Donors
Guided by specific mission Time limited commitments Concerned with sustainability
Efficacy = Measurable outcome Efficacy = Legacy
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.
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
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
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?”
Service Provider Perspective
Push of funders…
“Do more with less”
Pull of clients…
“Help me out of this mess”