Community Based Research:

Challenges and Complexities

1998 Summer Public Health Research Institute on Minority Health, UNC-CH

Summer Public Health Research Institute on Minority Health

July 13-17

University of North CarolinaChapel Hill, NC 27599

Stephen B. Thomas, Ph.D.Associate Professor of Community Health

Department of Behavioral Sciences and Health EducationDirector, Institute for Minority Health Research

Rollins School of Public HealthEmory University

Atlanta, GA

Sandra Crouse Quinn, Ph.D.Assistant Professor

Department of Health Behavior and Health EducationSchool of Public Health

University of North Carolina at Chapel HillChapel Hill, NC

Ethical Principles From the Belmont Report

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Belmont report: ethical principles and guidelines for the protection of human subjects of research. Washington, D.C.: Government Printing Office, 1988. (GPO 887-809.)

1. Respect for persons

• The recognition of the right of persons to exercise autonomy.

• People with diminished autonomy are entitled to protection.

2. Beneficence

• Do no harm.

• The minimization of risk incurred by research participants and the maximization of benefits to them and to others.

3. Justice

• The principle that research should not unduly involve persons from groups unlikely to benefit from subsequent application of the research.

• To broaden understanding of community

involvement in public health research

Purpose of Presentation

• Definitions of Community

• Barriers to Participation in Research

• Models of Community Involvement

• Research Ethics

• Where Do We Go From Here ?

NIH Revitalization Act of 1993

• There are many factors that operate in the recruitment and retention of study participants.

• Attitudes toward the scientific process, the researcher, and beliefs about the benefits and risks of involvement in research remain critical factors to be investigated.

Justification for Community Based Research

• Enhances the relevance, usefulness and use of the research data by all partners involved.

• Joins together partners with diverse skills, knowledge, expertise and sensitivities to address complex problems.

Justification for Community Based Research

• Improves the quality and validity of research by engaging local knowledge and theory based on the lived experience of the people involved.

• Recognizes the limitations a “value free” science and encourages a self-reflective, engaged and self-critical role of the researcher.

Justification for Community Based Research

• Acknowledges that “knowledge is power” and thus the knowledge gained can be used by all partners involved to direct resources and influence policies that will benefit the community.

• Strengthens the research and program development capacity of the partners.

Justification for Community Based Research

• Creates theory that is grounded in social experience, and creates better informed practice that is guided by such theories.

• Increases the possibility of overcoming the understandable distrust of research on the part of communities that have historically been the “subjects” of such research.

Justification for Community Based Research

• Has the potential to “bridge the cultural gaps that may exist” between partners involved.

• Overcomes the fragmentation and separation of the individual from his/her culture and context that is often evident in more narrowly defined, categorical approaches.

Justification for Community Based Research

• Provides additional funds and possible employment opportunities for community partners.

• Aims to improve the health and well being of the communities involved through increasing power and control over the research process.

Justification for Community Based Research

• Involves communities that have been oppressed on the basis of, race, ethnicity, class, gender and sexual orientation, in examining the impact of oppression and attempting to reduce and eliminate it.

Community Diagnosis is Critical

The diagnosis aims to understand facets of a community including, but not limited to:

1. culture2. values and norms3. leadership and economic structure4. means of communication5. social networks6. community institutions7. history

Definitions of Community

1. Community as a Locality

2. Community as Relational

3. Community as Collective Political Power

1. Community As a Locality

• Refers to the geographical notion of community -- the neighborhood, town or city

2. Community as Relational

• Refers to qualities of human interaction and social ties that draw people together.

3. Community as Collective Political Power

• Refers to organizing for social action

• The power of organized constituencies is the leverage for social change, regardless of whether that leverage comes from localities or organized interest groups.

Characterize the Target Population

1. Unit of Identity

2. Unit of Solution

3. Unit of Practice

1. Unit of Identity

• Psychological and cultural in nature

• Natural groups that people form for themselves to organize their relationships and identify with others.

2. Unit of Solution

• Defined as an aggregate of two or more units of identity that must pool their resources, mediate with wider society for more resources or do both.

3. Unit of Practice

• A social unit defined by public

health as targets for behavior change

intervention.

Community Is Formed When Multiple Units of Identity Extend and Interlock Themselves

• Strength of community identity is

best learned from its members.

Models of Community Involvement in Research

1. Participatory Action Research

2. Community Consultation in

Research

Participatory Action Research

"Systematic inquiry, with the collaboration of the affected by the issues being studied, for purposes of education and taking action or effecting social change”

(Green, 1995).

Participatory Action Research Is a Process Rather Than a Specific Methodology

1. Extensive collaboration

2. A reciprocal educational process

3. An emphasis on taking action

Ten Commandments of Participatory Research

1. Consult the community 2. Value process as ye value outcome3. Hold community objectives to be

the higher good

Thou Shalt:

Ten Commandments of Participatory Research (cont.)

4. Not covet the community's data 5. Not commit analysis of community

data without community’s input

Thou Shalt:

Ten Commandments of Participatory Research (cont.)

6. Not bear false witness concerning community members7. Not release findings before the community is consulted

Thou Shalt:

8. Train and hire community people 9. Not violate confidentiality

10. Freely confess thyself to be biased

Ten Commandments of Participatory Research (cont.)

Thou Shalt:

Community Consultation in Research

"the primary purpose of community consultation is to enlist potential participants as partners in solving the difficult dilemmas posed in sensitive research "

(Melton, et al, 1988, p. 576)

Community Consultation Should be Expected

to Foster Perceived Justice

1. Representation

2. Ethical appropriateness

3. Honesty

4. Consistency

The Impact of Community Consultation

on Perceived Justice

• Justice is important because the feeling of control is consistent with the humanization of relationships between researchers and participants.

• With perceived control comes diminished anxiety--therefore, serving the principle of beneficence.

Contemporary Examples of Controversies Involving Human Subjects in Medical & Public Health Research

1. Measles Vaccine Study in Los Angeles

2. HIVNET Study in Los Angeles

3. Needle Exchange Study in Anchorage, Alaska

1. Measles Vaccine Study in Los Angeles

• Late in 1996, news coverage of a measles vaccine study in Los Angeles revealed that children under the age of 12 months were receiving the Edmonston-Zabreb (EZ) measles vaccine, approved by the Food and Drug Administration only as a new investigational drug.

1. Measles Vaccine Study in Los Angeles (cont.)

• However, parents had not been properly informed that the vaccine was experimental, and that there had been adverse effects among children in Haiti and Africa.

2. HIVNET Study in Los Angeles

• In 1998, the HIVNET study in Los Angeles was halted when County Supervisor Yvonne Braithwaite Burke likened the study to "scientific racism,” and suggested that African Americans would be "subjected to medical atrocities under the guise of scientific research”.

2. HIVNET Study in Los Angeles (cont.)

• Both the Principal Investigator, Dr. Peter Kerndt, and the Los Angeles County public health director, Dr. John Schunhoff, acknowledged that sensitivity of the African American community to potential research dictated that community members be fully involved in oversight of the proposed study.

Tuskegee: From Science to Conspiracy to Metaphor

• The dissemination of oral histories about the Tuskegee Study of Untreated Syphilis in the Negro Male and fictional dramas like the HBO original movie “Miss Evers' Boys” may reinforce distortions in the historical record and provide moral justification for refusal to participate in any clinical research.

Participation in Medical & Public Health Research: Assessing Attitudes and Beliefs of AfricanAmericans in an Urban Hospital

Tuskegee: Conspiracy to Metaphor

• Five focus groups were conducted with African American patients between December 1996 and February 1997. Sixty participants were recruited from the two general medical clinics and the Oncology Clinic at an urban hospital in Atlanta, Georgia.

Preliminary Findings . . .

Perceived Risks of Participation in Research

• Focus group participants tended to be in favor of medical research, as long as they were not “guinea pigs.” As one participant stated, “… they always use our race as guinea pigs.”

Perceived Benefits of Participation in Research

• The discussion polarized around research that benefits the individual participant vs. research that benefits the broader society.

Understanding Informed Consent

“If you give consent, then you don’t have any legal rights. When you sign that paper, you sign all of your rights away because they have disclaimers all neatly typed up, reviewed by their lawyers to protect themselves from being sued."

(focus group participant, 1997)

Informed Consent and Building Trust

• To build community trust, researchers must verify that participants are fully informed about research procedures, costs, risks and benefits. This is the context in which the process of informed consent becomes a negotiated partnership between the researcher and participant, rather than simple adherence to legal procedures.

Exploring Knowledge about the Tuskegee Syphilis Study

• Throughout the focus group interviews, participants made reference to the Tuskegee Syphilis Study. Yet, when probed about historical facts, their knowledge was limited.

Strategies to Increase the Involvement of African Americans in Research

“Let people know the benefits of medical research along with the curriculum in public school. The myths about it should be dispelled.”

(focus group participant, 1997)

Strategies to Increase the Involvement of African Americans in Research

“If you can get the same thing from different people, you are apt to feel trust. When I signed [my consent form] they showed me a video explaining the risks and then the same thing was given to me in written form on the consent form. It made me feel more comfortable.”

(focus group participant, 1997)

The Race of the Researcher Is a Critical Issue

• History of distrust well documented

• May facilitate entree & provide preliminary understanding of resistance to research

The Race of the Researcher Is a Critical Issue (cont.)

• May assist in avoidance of mistakenassumptions

• May shape the research questions asked

Implications and Questions

• Matching investigator to population

• Is race sufficient to overcome distrust?

Barriers to culturally competent research

• Characterization of communities as “hard to reach”, marginalized

• Failure to appreciate indigenous knowledge

What Race Would You Like the AIDS Educator in Your Community to Be?

Sample Year N PreferBlack

Preferwhite

Racedoes notmatter

churchvolunteers 1991 224 49% 0% 51%women inclinic 1990 167 24% 4% 71%residentsof publichousing 1990 83 32% 5% 63%churchmembers 1990 1,001 46% 2% 51%

Lessons Learned

• Being invisible

• Be open to learning but also trust your instincts and experience

• Create an open atmosphere for discussions about racism

•Address assumptions

•Must do your own racial homework

“To open up to the culture’s soul is to allow one to become wet, to become soaked in the cultural and historical waters of those individuals who are involved in the experience”

(Friere, 1993)

• A set of academic and personal skills that allow individuals to increase their understand and appreciation of cultural differences and similarities within, among and between groups

Cultural Competence

• Requires a willingness and ability to draw on community-based values, traditions, and customs and to work with knowledgeable persons of and from the community in developing focused interventions, communications, and other supports

Work With Community Based Organizations

• Builds on community trust in the CBO

• Community’s trust includes judgment of competence

• Belief that the CBO is fair and unbiased;

• Belief that CBO cares about the community

"Investigators must recognize that simple compliance with protection of human subjects procedures is not sufficient. In order to successfully overcome distrust, community members must be fully informed about research procedures, costs, and benefits, and have representation on research advisory committees. Researchers should conduct their work with an attitude of respect for the humanity of study participants regardless of the social and cultural gulf which may exist between investigator and subject.”

(Thomas & Quinn, 1991)