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Completed Research: Maryland Center for Health Equity

Building Trust Between Minorities and Researchers

Although health and medical research has been instrumental in improving the health of Americans, the underrepresentation of minorities in research has limited their ability to benefit equally from scientific advances.

Building Trust between Minorities and Researchers (BT) was a bioethics research initiative designed to address the underrepresentation of many minority groups in research as part of the federal recognition of the importance of fostering greater participation rates of racial and ethnic minority populations in research.

The goals of the project were to:

  • Increase the participation of African Americans, Hispanics, and other minority populations in public health and biomedical research, including clinical trials.
  • Strengthen the capacity of investigators, institutional review board members, and other research personnel to work effectively with minority communities.
  • Create a sustainable infrastructure of training and educational initiatives which can be evaluated over time to determine their impact on improving minority participation in research.

These goals were accomplished through the efforts of five specific aims which included both research (Aims 1-3) and educational components (Aims 4 and 5).

Specific Aim 1
Conduct an online survey to delineate the attitudes of researchers toward engagement with minority communities, barriers to recruitment and successful strategies.

Specific Aim 2
Conduct telephone interviews with a sample of researchers engaged with minority communities to determine best practices for recruitment and engagement.

Specific Aim 3
Identify the level of knowledge of research, research terminology, informed consent procedures, human subjects protections and trust through a telephone survey with a nationally representative sample of racial/ethnic minority adults.

Specific Aim 4
Develop and pilot test a comprehensive educational program for racial/ethnic minority community members on participation in research, including clinical trials.

Specific Aim 5
Conduct with the organization, Public Responsibility in Medicine and Research (PRIM&R), ongoing educational sessions (webinars, pre-conference workshops) focused on enhancing capacity to ethically engage minorities in the research process and building skills for community-based research.

Building Trust Partners

Funding Support

The Building Trust between Researchers and Minorities bioethics research initiative was supported by Award Number 7RC2MD004766 (Quinn & Thomas, Principal Investigators) from the National Institute on Minority Health and Health Disparities (NIMHD) and the Office of the Director, National Institutes of Health (NIH).

The research component encompassed three of the specific aims and consisted of three major research studies.  These studies were designed to increase knowledge about minority participation in research, including clinical trials.  The studies included:

  • An online survey with researchers, research staff, IRB members, community members, and IRB staff,
  • In-depth interviews with principal investigators to study best practices to include racial and ethnic minorities in research, and
  • A national, random, digit dial telephone survey with African Americans and Hispanics/Latinos to understand knowledge and attitudes about health and medical research.

Building Trust between Minorities and Researchers

See select publications and presentations regarding this study on our publications page.

Principal Investigators:  Sandra C. Quinn, PhD and Stephen B. Thomas, PhD

Building Trust between Minorities and Researchers (BT) was a bioethics research initiative designed to address the underrepresentation of many minority groups in research.  While the grant period of the project is now complete, Building Trust remains a central theme of the M-CHE’s mission.

The BT Initiative featured five specific aims that included both research and educational components.  The research component encompassed three of the specific aims and consisted of three major research studies.  The studies included:

  1. An online survey of researchers, research staff, IRB members, community members, and IRB staff,
  2. In-depth interviews with principal investigators to study best practices to include racial and ethnic minorities in research, and
  3. A national, random-digit-dial telephone survey with African Americans and Hispanics/Latinos to understand knowledge and attitudes about health and medical research.

1. Online Survey of Researchers (Researcher Survey)

General Overview:  The purpose of this study was to delineate the attitudes of researchers toward engagement with minority communities, barriers to recruitment, and successful engagement.  This was accomplished via an on-line survey with PIs/co-investigators, research staff, and IRB members, from May-August 2010 (n=347).  Email invitations were sent through listservs of PRIM&R, Community-Campus Partnerships for Health, numerous clinical and translational science institutes, colleagues, and webinars.  Additionally, invitations to participate were included in publications such as IRB Advisor, and several Facebook sites including those for CDC, APHA, and JME.

Questions:  Participants were asked a series of questions in the following categories:

  1. Socio-demographics
  2. Conducting research with minority populations
  3. Recruiting minorities into research
  4. Retaining minorities in research
  5. The informed consent process
  6. The Institutional Review Board (IRB)
  7. Working with Community Advisory Boards
  8. Community involvement in research

Questions were a combination of yes/no, select from a list, Likert-scale, and open-ended.

2.  In-depth telephone interviews with researchers

General Overview: The purpose of this study was to conduct telephone interviews with a sample of researchers to determine best practices for recruitment and engagement of racial and ethnic minorities onto research.  This specific aim was accomplished through a series of semi-structured interviews with researchers (N=31) with known success in engaging minority populations in research.  Interviews were conducted by ICF MACRO, Inc. beginning in June 2010.  This was a purposive, convenience sample.  Participants were selected by the following methods:

  • Identified through the NIH RePORTer (formerly CRISP) database
  • Word of mouth referral from BT PIs and Co-Is
  • Reviews of literature in the area of successful recruitment of minority participants

Questions: The interview protocol for these semi-structured interviews was developed from a combination of literature review, team knowledge, and pilot testing (n=6).  In the end, the protocol included 21 questions (not including probes) and covered domains including:

  1. Experience conducting research
  2. Strategies used to build partnerships
  3. Strategies used to recruit & retain minority participants
  4. Challenges encountered in the recruitment & retention of participants
  5. Overall perspective toward engaging minorities in research

Each interview took 33 to 82 minutes to complete.

3.  National telephone survey with African Americans and Latinos (Community Survey)

General Overview:  The purpose of this study was to identify the level of knowledge of research, research terminology, informed consent procedures, human subjects protections, and trust through a telephone survey with a nationally representative sample of racial and ethnic minority adults.  The survey was conducted  June-December 2010 with African American and Hispanic adults (n=2455).  Participants were randomly selected based on telephone exchanges associated with geographic areas of high concentrations of African Americans and Latinos.  To identify the appropriate exchanges, directory-listed telephone numbers were mapped and assigned to a specific geographic location (such as census block group, census tract, or zip code), and those exchanges with an estimated concentration of African Americans and Latinos of at least 40% were used.

Questions:  Community respondents were asked a series of questions in the following categories:

  1. Medical Care
  2. Risk Perception
  3. Trust in Research
  4. Willingness to Participate in Research
  5. Experiences of Discrimination
  6. Human Subjects Protection
  7. Informed Consent
  8. Knowledge, attitudes, and beliefs
  9. Social Support
  10. Religious Involvement
  11. Socio-Demographics

Questions were a combination of yes/no, select from a list, Likert scale, and open-ended.

One of the main goals set forth by the Building Trust project was to create training and educational programs designed to increase the participation of minorities in public health research by empowering them to become informed decision-makers and to strengthen the capacity of researchers and community members to work effectively with each other.

Our team has developed three unique education programs designed to achieve this goal.  Enhancing Minority Engagement in Research is a facilitator-led program designed to enable minority community members to engage with health and medical research and to make informed decisions about participating in research.  Becoming a Self-Reflective Researcher: Successfully Engaging Minority Communities is also facilitator-led, and is designed to strengthen the capacity of researchers, health professionals and IRB members to effectively recruit and retain minority participants in researchers.  Building Trust between Minority and Researchers Online is a web-based, interactive adaptation of Enhancing Minority Engagement in Research, and can serve as a resource for both community members and researchers with their community partners.  

We have also adapted select components from both curricula into a web-based, interactive platform, referred to as Building Trust Online.

Enhancing Minority Engagement in Research

This curriculum is designed for use in minority communities, particularly those who experience significant health disparities.  This program will help participants understand how research can improve public health and eliminate health disparities.  The goals of the program are to enable participants to engage with health and medical research in their communities and to make informed decisions about participating in research.  Ideally, two facilitators will lead this interactive, five-module program in groups of 10-20 participants.  Potential audiences include community advisory boards, civic groups, faith communities, YMCAs/YWCAs, tribal groups, and other interested in learning more about participating in research.

Some of the unique features of this program are: 1) it is not tailored to any specific disease, condition, or research project.  It is designed to be general in nature, and thus applicable across a wide range of audiences; 2) participants learn how to read and evaluate health news stories; 3) participants learn how make their own informed choices about whether to participate in research rather than just being encouraged to participate; and 4) attendees learn ways to become involved with research and researchers other than participating in a study.

Becoming a Self-Reflective Researcher: Successfully Engaging Minority Communities

This curriculum is designed for use by researchers, research staff, IRB members, and health professionals to strengthen their capacity to effectively recruit and retain minority participants in research.  Through seven interactive modules, participants will respond to trigger films, discuss complex ethical issues, and practice skills for enhancing recruitment, retention, informed consent, and the development of community partnerships.  This facilitator-led program can be used in settings such as academic health centers, health sciences schools, research centers, and government agencies.

Unique features of this program include: 1) a formative exploration of how past research abuses contribute to a legacy of mistrust today; 2) tools useful for opening the dialogue about sensitive topics such as race, racism and discrimination; 3)  information on how and why to build community relationships; 4) an extensive look at how to reform the informed consent process into a conversation rather than just a requirement; 5) identifying and practicing the skills and knowledge required to effectively recruit and retain minorities in research.  Additionally, one module of the program is dedicated to analyzing ethically complex research cases to explore how missteps, exploitations, and abuse can occur even when all protocols and guidelines are followed.

Building Trust between Minorities and Researchers Online: An Interactive Web-Based Educational Program

This online resource is designed for use by community members, for researchers and their community partners, by educators as part of a course curriculum, and by health professionals and students.  Throughout the three-unit program, users receive information about health disparities and the fundamentals of health research, how to make an informed decision about participating in a research study, and ways to become involved with research or researchers.  The program includes unique interactive exercises, provocative video clips, stimulating discussion questions, a searchable multimedia resource center, and useful downloads to make the site engaging as well as informative.  It is designed for use by individuals or for groups exploring the issues together.

The Building Trust Online program is freely accessible to everyone at www.buildingtrustumd.org.

Though the formal grant period of the project has ended, the M-CHE’s commitment to Building Trust remains.  We continue to analyze our data and publish the results in peer-reviewed journals and present the findings at public health meetings and events. 

Additionally, results from these research studies helped inform the content and development of our two facilitator-led Building Trust Educational Programs.  These educational programs have been offered to a number of audiences across the country, and we continue to make plans to offer it in new venues. Additionally, we are pleased to offer an online adaptation of our curriculum, available at www.buildingtrustumd.org.

Finally, we continue to seek new funding opportunities to further explore ways to foster the development of trust and enduring relationships between minority communities and researchers to bring the best health to all Americans.

2018 Building Trust Workshop

The Building Trust between Minorities and Researchers (BT) Workshop Becoming a Self-Reflective Researcher: Successfully Engaging Minority Communities took place from June 27- 28, 2018 at the University of Maryland, College Park

The BT Workshop was designed to strengthen the capacity of investigators, recruitment staff and other research personnel to work effectively with minority communities. Over a period of two days, participants completed seven interactive and engaging modules. At the end of the workshop, participants were equipped with a practical set of skills for building relationships with minority communities and recruiting and retaining minority and health disparity populations in their research.

Other Events

Principal Investigators:

Sandra Crouse Quinn, PhD
Professor, Family Science
Associate Dean for Public Health Initiatives, School of Public Health
Senior Associate Director, Maryland Center for Health Equity

301.405.8825
scquinn@umd.edu

Sandra Crouse Quinn, PhD is the Associate Dean for Public Health Initiatives, Professor in the Department of Family Science, and Senior Associate Director of the Center for Health Equity at the School of Public Health, University of Maryland at College Park.   She is the Principal Investigator on Building Trust between Minorities and Researchers: A Bioethics Research Infrastructure Initiative funded by the National Institute for Minority Health and Health Disparities (NIMHD) and the Office of the Director, NIH.  She is also a co-Principal Investigator on the Research Center of Excellence in Minority Health Disparities, also funded by NIMHD, NIH.  She has worked for more than twenty years on addressing the legacy of the US Public Health Service Syphilis Study at Tuskegee.  Dr. Quinn received her doctoral degree in Health Education at the University of Maryland.  Prior to her doctoral work, she worked in substance abuse and mental health treatment programs in two local health departments.

Stephen B. Thomas, PhD
Professor
Director, Maryland Center for Health Equity

301. 405.8859
sbt@umd.edu 

Stephen B. Thomas, PhD, is professor of Health Services Administration in the School of Public Health and Director of the University of Maryland Center for Health Equity at the University of Maryland in College Park. One of the nation's leading scholars in the effort to eliminate racial and ethnic health disparities, Dr. Thomas has applied his expertise to address a variety of conditions from which minorities generally face far poorer outcomes, including cardiovascular disease, diabetes, obesity and HIV/AIDS.

He is the principal investigator of the Research Center of Excellence on Minority Health Disparities, funded by the NIH-National Institute on Minority Health and Health Disparities. He is also principal investigator, with Dr. Sandra Quinn, of the NIH National Bioethics Infrastructure Initiative: Building Trust Between Minorities and Researchers awarded in 2009.

Co-Investigators

David Barnard, PhD, JD
Professor of Medicine and Law
Director, Center for Bioethics and Health Law
University of Pittsburgh

3708 Fifth Avenue, Suite 300
Pittsburgh, PA 15213

Phone: (412) 647-5701
Fax: (412) 647-5877
barnard@pitt.edu 

David Barnard, PhD, is a Professor of Medicine and Law at the University of Pittsburgh, where he is appointed in the Department of Medicine, the Law School, and the Center for Bioethics and Health Law. He is a member of the core faculty in the Global Health Track for the Internal Medicine Residency Program at the School of Medicine. At the School of Law, he is a faculty advisor for the Global Health and Human Rights Track in the Health Law Certificate Program.

James Butler III, DrPH, MEd
Assistant Professor
Department of Behavioral and Community Health

(301) 405-0757
jbutler9@umd.edu

James Butler III, DrPH, MEd is an Assistant Professor in the Department of Behavioral and Community Health and is an Associate Director of the Maryland Center for Health Equity. Dr. Butler has a DrPH in Health Services Administration from the University of Pittsburgh Graduate School of Public Health and master of education degree in Community Health Education from Temple University. He completed a postdoctoral fellowship in preventive medicine and public health at the University of Kansas School of Medicine. His research interests are tobacco control and prevention and the social and environmental influences on smoking. His research incorporates the individual, social structure and environmental influences in eliminating tobacco-related health disparities. To eliminate these disparities, he believes it is imperative to build ongoing and permanent relationships with community members and to design and conduct effective interventions where the community participates fully in all aspects of the research process.

Major Research Interests

  • Tobacco Control and Prevention
  • The Social and Environmental Influences on Cigarette Smoking
  • Health Disparities Research
  • Community-based Participatory Research

Craig S. Fryer, DrPH, MPH

Assistant Professor, Department of Behavioral and Community Health
Associate Director, Maryland Center for Health Equity

(301) 405-0818
csfryer@umd.edu 

Craig S. Fryer, DrPH, MPH is an Assistant Professor in the Department of Behavioral and Community Health and holds a leadership position in the newly established Center for Health Equity in the School of Public Health. He received his DrPH in Sociomedical Sciences from the Mailman School of Public Health, Columbia University. Trained as behavioral scientist, Dr. Fryer utilizes mixed methods research to examine the sociocultural context of health and health disparities, with a concentration in community-engaged research. His work focuses on racial and ethnic health disparities in substance use and dependence, specifically tobacco and marijuana use among urban youth and young adult populations. Collateral research endeavors include: qualitative methods; behavioral intervention research; HIV/AIDS and STI prevention; and the recruitment and retention of underrepresented communities into research.

Major Research Interests

  • Adolescent Health
  • Mixed Methods Research
  • Health Disparities Research
  • Community-based Participatory Research

Mary A.Garza, PhD, MPH
Assistant Professor, SPH Department of Behaivioral and Community Health

(301) 405-0766
magarza@umd.edu

Mary A.Garza, PhD, MPH is an Assistant Professor in the Department of Behavioral and Community Health and she will have a leadership role in the newly established Center for Health Equity at the University of Maryland. Dr. Garza received her MPH from the School of Public Health at San Diego State University with an emphasis in health education and health promotion. She received her PhD in Health Policy and Management with a focus in Social and Behavioral Sciences from the Bloomberg School of Public Health, Johns Hopkins University where she also completed a post-doctoral fellowship in Cancer Epidemiology.

Dr. Garza's research activities embrace the full spectrum of the intervention research process-from planning, developing, implementing, and evaluating, to dissemination of research findings - using a community-based participatory research approach. She has a strong interest in health disparities research, including understanding the interplay of psychosocial, behavioral, and neighborhood-level factors associated with health behavior; specifically, the factors related to sustained compliance with cancer screening. Dr. Garza's research interests also include the role and influence of religion and spirituality on health outcomes.

Research Interests

  • Community-based participatory research
  • Health disparities
  • Religion and spirituality on health outcomes
  • Planning, developing, implementing, and evaluating, to dissemination of research findings

Dr. Kevin H. Kim
Associate Professor, Research Methodology Program
Department of Psychology in Education, University of Pittsburgh School of Education

5918 Wesley W. Posvar Hall
Pittsburgh, PA 15260

(412) 624-7272
khkim@pitt.edu

Dr. Kevin H. Kim is an Associate Professor of the Research Methodology program in the School of Education at the University of Pittsburgh.  Dr. Kim is interested in developing new statistical methods to be used in education, behavioral and social sciences. His research interests include but are not limited to structural equation modeling, multivariate statistics, multilevel modeling, and Asian American Mental Health.  Dr. Kim earned his PhD in Measurement and Psychometrics from the Psychology Department at University of California at Los Angeles.

Christopher Ryan, PhD, CIP
Professor of Psychiatry Director, University of Pittsburgh Institutional Review Board
Western Psychiatric Institute and Clinic


3811 O'Hara Street
Pittsburgh, PA 15213

(412) 246-5392
ryancm@upmc.edu

Christopher Ryan, PhD, is Professor of Psychiatry at the University of Pittsburgh School of Medicine, and also Professor of Psychology, Health & Community Systems, and Clinical and Translational Science. His research focuses on the neuropsychological correlates and consequences of medical illnesses, particularly diabetes mellitus. Currently he serves as Director of the University's Institutional Review Board and is Co-Director of the Regulatory Knowledge and Support Core of the University's Clinical and Translational Science Institute.

Staff

Meleah Himber, MEd
Curriculum Developer, Building Trust between Minorities and Researchers
University of Pittsburgh, Center for Bioethics & Health Law


Suite 300 Medical Arts Building
3708 Fifth Ave
Pittsburgh, PA 15213

(412) 647-5789
mhimber@pitt.edu

Deyana Lewis
Pre-Doctoral Student, Building Trust between Minorities and Researchers
University of Pittsburgh, Center for Bioethics & Health Law


Suite 300 Medical Arts Building
3708 Fifth Ave
Pittsburgh, PA 15213


ddl8@pitt.edu

Public Responsibility in Medicine and Research (PRIM&R)
Public Responsibility in Medicine and Research (PRIM&R) is dedicated to advancing the highest ethical standards in the conduct of research. Since 1974, PRIM&R has served the full array of individuals and organizations involved in biomedical, social science, behavioral, and educational research. PRIM&R is committed to building a strong and diverse community of individuals and institutions concerned with advancing the highest standards in the conduct of research.

ICF Macro
ICF Macro, an ICF International Company, is based in the Washington, DC area and maintains offices across the United States. ICF Macro is a professional services firm focused on research and evaluation, management consulting, information technology, and social marketing communications. To deliver on the promise of research-based solutions, ICF Macro has nurtured high quality research and evaluation capabilities, coupled with advisory and implementation competencies in consulting, training, and information technology. The company also has in-depth social marketing and communications design and implementation capabilities.

WPXI (NBC affiliate in Pittsburgh)
WPXI is the NBC television affi liate based in Pittsburgh, Pennsylvania. WPXI has produced multiple programs on the campaign to address health disparities in Pittsburgh. WPXI, owned by Cox Communications with a national reach of television and cable stations, will work with us to fi lm two thirty minute segments on participation in research that will be broadcast on their channel and cable stations. They will also fi lm our case simulations on informed consent for our use, provide the video components for dissemination through PRIM&R, NIH and our partners, and create an interactive web component focused on minority participation in research.

Office of the Director, National Institutes of Health (NIH)
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people's health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. Composed of 27 Institutes and Centers, the NIH provides leadership and financial support to researchers in every state and throughout the world.

For over a century, the National Institutes of Health has played an important role in improving the health of the nation. The NIH traces its roots to 1887 with the creation of the Laboratory of Hygiene at the Marine Hospital in Staten Island, NY.

The NIH is an agency of the U.S. Department of Health and Human Services. With the headquarters in Bethesda, Maryland, the NIH has more than 18,000 employees on the main campus and at satellite sites across the country.

With the support of the American people, the NIH annually invests over $28 billion in medical research. More than 83% of the NIH's funding is awarded through almost 50,000 competitive grants to more than 325,000 researchers at over 3,000 universities, medical schools, and other research institutions in every state and around the world. About 10% of the NIH's budget supports projects conducted by nearly 6,000 scientists in its own laboratories, most of which are on the NIH campus in Bethesda, Maryland.

National Institute on Minority Health and Health Disparity (NIMHD)
The NIMHD envisions an America in which all populations will have an equal opportunity to live long, healthy and productive lives.

The mission of the National Institute on Minority Health and Health Disparity (NIMHD) is to promote minority health and to lead, coordinate, support, and assess the NIH effort to reduce and ultimately eliminate health disparities. In this effort NIMHD will conduct and support basic, clinical, social, and behavioral research, promote research infrastructure and training, foster emerging programs, disseminate information, and reach out to minority and other health disparity communities.

American Recovery and Reinvestment Act (ARRA)
On Feb. 13, 2009, Congress passed the American Recovery and Reinvestment Act of 2009 at the urging of President Obama, who signed it into law four days later. A direct response to the economic crisis, the Recovery Act has three immediate goals:

  • Create new jobs and save existing ones
  • Spur economic activity and invest in long-term growth
  • Foster unprecedented levels of accountability and transparency in government spending

The Recovery Act intends to achieve those goals by:

  • Providing $288 billion in tax cuts and benefits for millions of working families and businesses
  • Increasing federal funds for education and health care as well as entitlement programs (such as extending unemployment benefits) by $224 billion
  • Making $275 billion available for federal contracts, grants and loans
  • Requiring recipients of Recovery funds to report quarterly on how they are using the money. All the data is posted on Recovery.gov so the public can track the Recovery funds.

Other Completed Research Projects

Principal Investigator: Susan Passmore, PhD

This project sought to explore factors that impact breast cancer (BC) screening behaviors among African American women specifically in Prince George’s County. The goal of this study was to delineate specific methods to effectively promote screening in the county. As a whole, women in Prince George’s County tend to be better educated, have medical insurance and have higher incomes than their counterparts elsewhere in the country. Thus, this study was structured to focus on issues (perceptions of risk, knowledge of BC, family environment) most relevant to our priority population. Another goal was to focus specifically on avenues to screening rather than barriers which suited our desire to develop actionable results.

For this project we implemented a qualitative design to explore BC screening beliefs and behaviors in the county among three types of groups:

  1. African American women living in Prince George’s County (4 focus groups),
  2. Community health navigators working in the county (1 focus group), and
  3. Community leaders and stakeholders in the county (1 focus group)

Preliminary findings from the initial four focus groups with the African American women were presented at the two subsequent groups.

Women’s groups included 26 participants with an age range of 42-64 and a median age of 52.5.  Women were recruited from Doctor’s Community Hospital records. We specifically sought women with some experience with screenings to explore pathways to screening. Participants all had received at least one mammogram in the previous 5 years but only 15% reported that they have a mammogram every year.

The navigators’ group consisted of six participants employed as health care navigators in Prince George’s County area hospitals. The community leaders’ group was attended by approximately 20 participants who were stakeholders in the community. They included representatives from several community-based organizations serving African American women, healthcare providers, local government, Prince George’s County Health Department, and the faith community.

Principal Investigator: Sandra Crouse Quinn, PhD

Funded by the US Food and Drug Administration through the University of Maryland Center for Excellence in Regulatory Science and Innovation

Overview: Successful inclusion of racial and ethnic minorities in research that leads to the development of FDA-regulated drugs and devices is critical to ensuring that such products, when approved, are effective and safe for all populations. To reinforce this goal, the 2012 Food and Drug Administration Safety and Innovation Act placed new demands on industry and the FDA to ensure that applications for drug or device approval provide data on the inclusion of racial and ethnic minorities in the trials on which the applications are based. Understanding the regulations and their implementation and the extent to which industry, in collaboration with the FDA, can meet these demands is of particular importance to the FDA Office of Minority Health. These efforts are also consistent with the University of Maryland Center for Excellence in Regulatory Science and Innovation, (M-CERSI): to foster the development of regulatory science, which includes developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA regulated products. This project employs a social and behavioral science approach to advance our understanding of the current status of minority inclusion in industry research that results in applications for drug or device approvals. Additionally, the project will draw upon our existing curriculum, ‘Becoming a Self-Reflective Researcher: Successfully Engaging Minority Communities’ and use results from the data collection portion of this project to tailor that training.

Specific Aims:

Aim 1: Prepare a review of existing literature and FDA reports pertinent to minority inclusion in industry-sponsored and FDA-related trials

Aim 2: Conduct key informant interviews with FDA staff, industry investigators, and clinical research organizations to understand and document current practices, and facilitators and barriers to successful inclusion of minorities in regulated trials

Aim 3:  Tailor curriculum modules, as necessary, from the training program, ‘Becoming a Self-Reflective Researcher: Successfully Engaging Minority Communities’, based on results of aims 1 and 2.

 

Principal Investigator: Charles F. Reynolds, III, MD

Funded by Grant no. P60 MD000207 (Stephen B. Thomas, PhD, PI, Sandra C. Quinn, co PI)

Overview: Major depression in later life is common, especially in primary care settings, where the six month prevalence is 6-10%. It undermines treatment adherence and amplifies the disability associated with co-existing medical (e.g., hypertension and diabetes) and psychosocial (e.g., bereavement) problems. It is associated with high rates of morbidity and mortality. Because treatment is only partially effective, reflecting both social inequalities in outcomes of depression-treatment and particularly difficult mental health-care disparities affecting older African Americans, preventing depression in later life is an important public health priority.

The purpose of this study is to help establish whether the Problem-Solving Therapy for Primary Care (PST-PC), which is tailored to address specific risk factors for depression (e.g., insomnia, bereavement, disability related to medical illness, and isolation) and which has been shown to be acceptable to older African American patients in primary care, is a useful strategy for indicated preventive intervention of major depression in black and white people aged 50 and older, thereby overcoming mental health care disparities and improving care.

Specific Aims: A target of 306 adults  (153 black and 153 white) aged 50 and older who are already symptomatic but not clinically depressed will be recruited to participate in a randomized trial designed to test the following hypotheses related to the study of "indicated preventive intervention":

Hypothesis 1: The use of Problem-Solving Therapy for Primary Care (PST-PC) will be superior to an attention-only, supportive control condition (providing education in health dietary practices: DIET) in lowering the incidence of major depressive episodes over two years.

Hypothesis 2: Over a two-year period of follow up, PST-PC (relative to DIET) will lower levels of depressive symptoms and improve health-related quality of life.

 

 

 

Visit the Prince George’s County Public Health Impact Assessment website for more information.

The Prince George’s County Public Health Impact Assessment was a study conducted at the University of Maryland School of Public Health to assess the potential public health impact of a new healthcare system for the county.  The school was asked to conduct the study to provide input into the design of the new healthcare delivery system.

Among the specific aims of the overall project, which was conducted by an interdisciplinary team of senior researchers in the School of Public Health, was to gain a deeper understanding of the healthcare needs of Prince George’s County residents.  To accomplish this goal, an M-CHE team led by Sandra Crouse Quinn conducted a telephone survey of county residents.  1000 county residents completed the 20-minute survey, during which they were asked about:

  • Their health and well-being
  • Their healthcare behaviors and experiences
  • Their perceptions of healthcare available in Prince George’s County, and attitudes towards county hospitals
  • The healthcare needs of their family and the county

Results from the survey were incorporated into a comprehensive report to help inform planners, county officials, health care representatives, stakeholders, and other parties on how to develop a healthcare system that incorporates the views and perspectives of the people with the most to gain.

Additional analysis of the data is ongoing.

 

Principal Investigator on Supplement:  Sandra Crouse Quinn

Funded by the US Centers for Disease Control and Prevention (1 PO1 TP000304-02, M. Potter, PI, overall grant)

Overview:  This study included two national surveys in 2009 and 2010 to examine critical issues on vaccine acceptance and uptake; EUA acceptance; disparities in H1N1 exposure, susceptibility and treatment; trust in government and spokespersons; perceived susceptibility, severity and self-efficacy; participation in preventive behaviors; use of information sources including social media.  It was a unique opportunity to examine these issues in real time, and follow changes in public attitudes and willingness to accept public health recommendations in a longitudinal manner.

Specific Aims:

Aim 1: Explore the attitudes toward the use of drugs and vaccines in a pandemic emergency, including willingness to take new drugs or vaccines under an Emergency Use Authorization

Aim 2: Examine empirically disparities in exposure, susceptibility, and access to treatment that may place minority or other populations who already experience health disparities at higher risk during a pandemic

Aim 3: Explore attitudes toward and psychosocial factors associated with support for government actions to mitigate the pandemic

Aim 4: Examine psychosocial factors, trust in governmental and public health officials, and use of social media