Celia B. Fisher - US grants

9310458 Fisher This two year project will develop, implement and evaluate an ethics education curriculum in introductory psychology. The curriculum will provide the students with knowledge and skills which can help them identify ethical issues in human subjects research, consider moral ambiguities which arise within various experimental contexts and generate resolutions sensitive to alternative ethical approaches to specific research designs. Classwork wiill expose students to cases illustrating research methodologies of increasing ethical complexity, in major areas of scientific inquiry in the field of psychology. The case studies will provide students with experience in evaluating the applicability of scientific norms and the Ethical Principles of the American Psychological Association to a broad range of research problems. During the first year of funding, instructional materials and evaluation techniques will be developed and piloted, followed by a 2-day summer faculty workshop. During the second year, the ethics education curriculum will be incorporated into introductory psychology courses at Fordham and Loyola Universities. Evaluation of the project will focus on faculty and student satisfaction with the clarity, difficulty level, and relevance of the curriculum as well as knowledge and skills in ethical reasoning gained by students. ***

US scientists are increasingly aware of public distrust about research participation following some abuses, most notably the Tuskegee study which failed to appropriately inform and provide treatment for African American men with syphilis. This project will assess the strength and impact of the `Tuskegee effect` on the attitudes of African American and European American parents and youth regarding social science research and associated ethical issues. A major goal of this project is to enhance community trust in the scientific enterprise by gathering information that can improve approaches to informed consent for research conducted with adolescents at-risk for health compromising behaviors, juvenile delinquency, and academic failure. A two-pronged methodology will draw upon community perspectives and incorporate both qualitative and quantitative techniques that can document common and unique dimensions of ethical attitudes in different ethnic groups. Ultimately it will empower individuals in ways that improve ethical procedures. Qualitative data will be collected through focus groups on parents' and adolescents' opinions on (a) trust and suspicion of social science research; (b) the perceived value and potential cost of adolescent risk research to individuals and communities, and (b) attitudes toward different ethical arguments on requiring and waiving guardian consent. Building on the qualitative data, the PI will create culturally valid questionnaires to quantify significant aspects of parent and adolescent responses to ethical issues in informed consent procedures for adolescent risk research. Focus groups for community input at the outset and throughout the project will insure that the issues raised in the qualitative portion of the project reflect community concerns, that the terminology and format of the quantitative instruments are appropriate for the participants, and that conclusions drawn from the study are culturally valid. Project results will be disseminated through scholarly publications, meetings with IRB members, and newsletters reaching both scientists and African and European American community members. At the end of the second year a Community Forum held at Fordham University will engage the original participants, their community leaders, and scholars from diverse ethnic backgrounds in open dialogue about how to improve ethics-in-science practices and how to increase ethnic minority interest in social science research and sensitivity to both its promise and risks. The community forum will provide an opportunity for African American and European American clergy, teachers, parents and youth to work in partnership with developmental scientists to create socially meaningful and ethically responsible guidelines for social science research. It will provide the basis of a Guidebook for Informed Consent Procedures for Ethnic Minority Adolescent Risk Research to be distributed to developmental scientists, IRB members, ethnic minority scholars, and community members.

The stated objectives of this research are to assess and develop procedures to enhance the capacity of adults with mild and moderate mental retardation (MR) to provide informed consent for therapeutic research, and to exert their rights to assent or dissent when surrogate consent is obtained. The project will have two phases, with the first designed to examine the understanding of basic elements of psychotropic treatment including the purpose and nature of the research, risks and benefits, voluntary nature of the participation, and right to withdraw without penalty. The project will also examine comprehension of the consent elements (e.g., goals, role of a scientist, nature of placebo conditions, etc). Consent capacity will also be evaluated within the four psycho-legal standards outlined by Appelbaum and Grisso (1988). In phase 1, persons with mild, moderate and "typical;" intelligence will be respond to a hypothetical vignette describing research utilizing a randomized control trial of a new medication to reduce aggressive behavior. In phase 2, the authors will use data generated from phase 1 to develop and evaluate three formats designed to improve the consent capacity of individuals with mild and moderate MR: 1) a picture book format, 2) a video format, and 3) a supported decision-making format. A significant other is also chosen by the subjects to aid in them during the three format presentations.

[unreadable] DESCRIPTION (provided by applicant): Fordham University, Office of Student Affairs in partnership with the Center for Ethics Education proposes to fortify its current alcohol prevention efforts through a multi-faceted program aimed at increasing enforcement of university drinking rules, countering resident drinking norms, and decreasing student resident drinking. In previous years Fordham has developed strong programs addressing individual student drinking problems and off-campus community outreach, two of the constituencies identified in the NIAAA 3-in-1 Framework. In response to a recent campus crises involving freshman resident drinking, Fordham developed a 4-pronged strategy aimed at NIAAA's 3rd constituency: University drinking & related disciplinary policies aimed at the student population as a whole. The Fordham Resident Alcohol Prevent Program (RAPP) drawing upon preliminary evidence of efficacy for NIAAA Tier 2 and Tier 3 interventions will introduce (a) an intensive parental notification policy including appointment of a new Assistant Director of Alcohol Education and Parent Liaison; (b) an Ethics and College Drinking training program for RDs/RAs to increase enforcement of and communication about the rationales for university alcohol policies; (c) peer education through a Sophomore-to-Freshman Stop Campus Drinking Fair; and (d) faculty-freshman dinner discussions to frame drinking policies within Fordham's university-wide mission to transform students into citizens who embrace the values of personal and social responsibility. Over a 3-year period the project will use a cross-sectional longitudinal intervention-comparison residence design to measure predicted effects of the RAPP including (1) decreases in student alcohol expectances and Residential Life recorded and student serf-reported alcohol and alcohol related violations; (2) increases in student college adjustment and situational confidence; and (3) increased interactions among parents, students and the Liaison for alcohol prevention. [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): Over the past 20 years a consensus has developed that the responsible conduct of research (RCR) is vital for the continued health of the scientific enterprise and its stakeholders-the federal government, scientific disciplines, individual researchers, institutions, graduate trainees, and the public (NAS, 1995; PHS, 2000). RCR encompasses adherence to the rules, regulations, norms and practices of science. Within universities the values of science are directly transmitted to graduate students through their research mentors and indirectly through the rules, procedures, and general RCR climate of the departmental program in which they are enrolled. There are over 63,000 current members of the American Psychological Association with Ph.D.s that required science training and approximately 1,000 new Ph.D.s enter the field each year. Like other sciences, the direct contributions of psychological research to public health and welfare have increased heightening its public visibility especially in cases of scientific misconduct. Despite the fact that research psychologists are uniquely trained to develop psychometrically valid instruments to understand and evaluate RCR training, there has been no examination of the role of mentorship and departmental climate on the socialization of graduates students in the responsible conduct of psychological research. The broad goal of this 2-year project is to develop and validate web-based self-report instruments to understand how graduate students are socialized in the responsible conduct of psychological research involving human subjects. Drawing upon the small but growing theoretical and empirical data base on RCR in general and ethical standards for psychological research in particular this 2-year project will develop and validate instruments measuring 2 constructs hypothesized to influenced student RCR acquisition: RCR Mentoring In Psychology and the RCR Psychology Department Climate. An instrument to measure Psychology Students' Perceived RCR Preparedness will also be developed. After reliability and validity has been established the instruments will be used to test the theory-based prediction that RCR mentoring and RCR department climate function individually and jointly to influence psychology graduate students' confidence in their ability to independently apply core RCR principles in their science careers. The broad long-term goal of this project is to provide psychometrically validated measures of RCR mentoring, RCR institutional climate, and students' perceived RCR competencies for use by psychology departments in self-studies designed to improve science integrity education and that other disciplines can begin to adapt to their own training needs. [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): Investigators studying illicit drug use and related HIV risk face unique ethical challenges. Intoxication, long term drug use, or advanced stages of HIV/AIDS can impair consent capacity. Involvement in criminal activities to purchase drugs and diagnosis of HIV/AIDS make participants especially vulnerable to breaches in confidentiality that may result in criminal prosecution, social stigmatization, or loss of employment. The need for money to purchase drugs or ethnic and economic health disparities may heighten susceptibility to coercion from cash or treatment compensation for research participation. Participants in RCT designs may suffer withdrawal symptoms during detoxification or side effects when experimental treatments interact with street drugs. Dissemination of research results may further stigmatize or sustain societal prejudices against historically oppressed groups. Through focus groups, in-depth interviews, and structured interview surveys, this research aims to explore the hopes, values, and fears that multiply vulnerable illicit drug users bring to research ethics practices. This collaborative project uniting the strengths of the Fordham University Center for Ethics Education and the community based substance abuse and HIV/AIDS experience of the Hispanic Health Council, will examine in both depth and breath the attitudes of street drug users towards research risks and benefits, informed consent, confidentiality, and use of incentives in research on the epidemiology, social correlates, and treatments for drug abuse and HIV related risks. How gender and ethnicity influence these attitudes will also be examined. Long-term goals of this project are to identify ethical concerns among economically disadvantaged, ethnically diverse illicit street drug users that will inform and enhance drug use and HIV risk research in ways that reflect the values and merit the trust of participants. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): Federal initiatives to address health disparities in community-based addiction intervention research, has encouraged the employment of community members, called "research extenders" (REs), as recruiters and data gatherers to form the essential collaborative link between the investigator and target population. When REs play a role in translational research, the values, experiences and problems they share with marginalized addicted community members can affect research integrity in both positive and negative ways. In 2004, the Office of Research Integrity (ORI) cited 3 cases of RE's involved in fabrication and falsification of data;however studies on research integrity have not focused on this unique set of research workers. The broad and long term goals of this application is to strengthen the research integrity of community-based addiction trials, help investigative teams maximize RE potential and mitigate risks to research integrity, and provide a tool that can be used to assess the efficacy of RE research integrity training programs. Specific Aim 1 of this project is to provide a qualitative knowledge base to enhance understanding of the linkages between REs'shared community attitudes toward addiction research ethics and their commitment to research integrity. Aim 1 will be achieved through the implementation of focus groups conducted with REs who are involved in addiction research in New York City, Philadelphia, Hartford, New Haven and Newark DE. Focus group discussion will be stimulated by a video created with the assistance of a community advisory board (CAB) and using professional actors, that illustrates in detail the different facets of placebo-controlled randomized addiction trials. Content analysis will provide a rich base of information for identifying linkages among addiction trial domains, shared community beliefs and RE motives that influence commitment to research integrity. Specific Aim 2 is to construct and psychometrically validate an instrument, the Addiction Research Integrity Scale-Research Extenders (ARIS-RE) that can assess multiple components of beliefs and motives that may facilitate or impede the integrity of RE recruitment and data collection. Subscale items representing beliefs and motives specific to different addiction research domains will be drawn from RE statements identified as best representing themes in the content analysis of the focus groups. After piloting and CAB feedback, a large sample of REs will complete the ARIS-RE. Psychometric properties of the scale will be evaluated through an iterative process of item analysis, exploratory factor analysis, and internal reliability followed by correlations between ARIS-RE subscales and standardized measures of medical research trust, health care distrust, and addiction beliefs to confirm construct validity. Recently ORI published a statement alerting investigators that regulations governing human subjects protections pertain to all who are involved in PHS research. This proposal seeks to generate information and tools that can assist ORI and principal investigators to provide REs with the training and skills they need to meet standards of research integrity in community-based addiction trials. PUBLIC HEALTH RELEVANCE (provided by applicant): Federal health disparity initiatives to achieve equity in community-based addiction treatment research have increased employment of indigenous research extenders (REs) as recruiters, data gatherers, and peer interviewers. While they help to form the essential collaborative link between addiction scientists and marginalized populations, recently the Office of Research Integrity (ORI) has uncovered scientific misconduct involving REs. The proposed study is an important step toward understanding and measuring the ethics-related beliefs and motivation facilitating and impeding the RE's contribution to addiction trials.

DESCRIPTION (provided by applicant): This application seeks funding for the HIV Prevention Research Ethics Training Program. The program addresses the urgent need for HIV investigators with the knowledge and skills to identify and address ethical issues in HIV prevention research, ethically engage participants and communities in the construction and evaluation of population and culturally sensitive research protections, and generate empirical data to inform HIV prevention science ethical procedures and policies. Through an intensive summer institute, mentoring and financial assistance, and a communications networking platform the program offers research ethics education and mentoring to social, behavioral, medical and public health early career scientists with demonstrated expertise in HIV prevention research and the capacity to initiate innovative programs of research that focus on the conduct, improvement and evaluation of population sensitive HIV prevention research ethical procedures. The program's aims are to: (1) increase trainees' knowledge of and capacity to address key ethical issues in HIV prevention research; (2) increase trainees' capacity to ethically engage participants and communities in the construction of participant protections that reflect the values and merit the trust of all stakeholders in HIV prevention research.; (3) increase trainees' capacity to conduct research that will generate data to inform HIV prevention research practices and policies; and (4) create and sustain an information and communication network for trainees, faculty and others in the field for enhancing ethical knowledge, ethical dialogue and future professional collaborations in HIV prevention research ethics. The 5-year grant will include 4 cohorts of 6 trainees each (N = 24). Each trainee will commit to 2 years of training. The program includes: (a) a structured intensive summer institute for trainees in their 1st year; (b) a 2-year individually mentored and financially supported research pilot project on an ethical issue in HIV prevention research; (c) an advanced summer seminar for trainees in their 2nd year focused on data analysis, professional and community dissemination of their mentored research project, and grant writing incorporating the mentored project as a pilot study for a grant supplement or new grant; (d) access to web-based platform for HIV prevention ethics resources and collegial exchange; and (e) participation in a mini-conference on HIV prevention research ethics for all trainees in the 5th year of the grant. Mentoring will be conducted in person during the summer institutes and via electronic media during the year. The summer institute will be held at Fordham University's Center for Ethics Education, NYC. The Center will have primary responsibility for all aspects of the training program. The program has outstanding ethnically diverse, gender balanced and multidisciplinary faculty with experience in the conduct and ethics evaluation of national and international HIV prevention research. Travel, housing, meals and training materials will be fully covered by the training program.

DESCRIPTION (provided by applicant): Young men who have sex with men (MSM) and transgender women are at alarmingly high risk for HIV, and the risk among women who have sex with women and transgender men is estimated to be at least as high as that of heterosexuals. However, there are no empirically recommended behavioral or biomedical HIV prevention programs for lesbian, gay, bisexual, and transgender youth (LGBTY) under the age of 18 despite this clear evidence of need. A major reason for the absence of HIV prevention programs in this population is the challenge of initiating research on LGBTY under age 18. There is a lack of consensus among investigators and their IRBs about appropriate ethical procedures for protecting LGBTY's research rights and welfare. And, without empirical data to guide their decisions, IRBs must often rely on subjective judgments that can lead to over- or under-estimation of the magnitude and probability of risks of LGBTY participation in HIV prevention research. Consequently, many investigators have excluded LGBTY under 18 in HIV prevention research because of anticipated or actual difficulties obtaining IRB approval. This unfortunate exclusion prevents LGBTY from participating in research that has the potential to determine the safety, efficacy, and effectiveness of HIV behavioral or biomedical preventive interventions that are developmentally appropriate for this population. The overarching goal of the current proposal is to inform evidence-based decision making by investigators and IRBs alike regarding the responsible design and conduct of HIV prevention research involving LGBTY. We propose to address this knowledge gap with three specific aims: (1) To inform ethically responsible decision making and IRB application of relevant federal regulations ( 46.102i; 46.111.a) to the evaluation of psychological, social and informational risk-benefits of LGBTY involvement in HIV prevention research. Using focus groups and surveys we will generate empirical data on LGBTY's appraisals of the magnitude and probability of the risks and anticipated benefits of recruitment strategies, risk behavior surveys, HIV/STI and drug use testing, and biomedical prevention trial participation. (2) To inform ethically responsible decisio making and IRB application of regulations permitting waivers of guardian permission ( 46.116d and 46.408c) for LGBTY participation in HIV prevention research. Using focus groups and surveys we will generate empirical data on LGBTY's appraisals of whether guardian permission is or is not a practical or a reasonable requirement for their participation in studies involvig risk behavior surveys, HIV/STI and drug use testing, and biomedical prevention trials. We will explore if these appraisals differ by youth characteristics (e.g., degree of outness, HIV risk). (3): To inform ethically responsible decision making and IRB application of regulations on youth capacity to consent ( 46.116d and 46.408c) for LGBTY participation in biomedical HIV prevention trials. Using a hypothetical HIV prevention trial, we will generate empirical data on the consent preparedness of LGBT youths' ages 14 - 17 compared to LGBT youth with adult legal status (18 - 20 years).

? DESCRIPTION (provided by applicant): The evolving nature of the HIV/AIDS pandemic, dynamic shifts in drug use patterns, criminalization of drug use and other HIV risk behaviors, along with the use of new technologies and other rapid advances in treatment and prevention create continuously changing ethical challenges for HIV research involving people who abuse drugs. NIH has recently called for research programs at all levels to include face-to-face instruction in RCR. However, few programs provide such training and to date the NIDA funded (DA031608) Fordham University HIV and Drug Abuse Prevention Research Training Institute (RETI) is the only program to provide early career clinical scientists with knowledge of and ability to generate empirical data that can enhance HIV/drug abuse research ethics practices and policies. This 5-year renewal will sustain and expand upon RETI's success. The long-term objectives of the RETI are to produce a new generation of clinical scientists with the skills to address the health and human rights needs of drug using populations and to meet the global need for empirical and educational resources to inform HIV/drug abuse research ethics practices and policies. These objectives will be met through the following specific aims: To 1: increase early career clinical scientists' knowledge of and capacity to address key ethical issues in HIV/drug abuse prevention research; 2: increase early career clinical scientists' capacity to engage communities in the construction of HIV/drug abuse participant protections; 3: increase early career clinical scientists' capacity to conduct empirical research on HIV/drug abuse prevention research ethics practices/policies; 4: create and sustain a global information network for enhancing ethical knowledge and evidence-based ethics practices/policies for HIV/drug abuse prevention research ethics; and 5: provide online global resources to facilitate the ability of faculty in other graduate and post-graduate training units to mentor and teach HIV/drug abuse prevention research ethics. To achieve these aims the program will: (1) recruit highly qualified ethnically diverse clinical scientists from multiple disciplines and national and international settings; (2) update the 2-year intensive on-site curriculum to include a new innovative focus on emerging ethical issues in HIV prevention research designs that incorporate addiction treatment and harm reduction strategies; (3) provide experiential training in community engagement in the design and dissemination of HIV/drug abuse research; (4) provide year-round mentoring and financial support for trainees to design, conduct and disseminate population-sensitive empirical studies to inform HIV/drug abuse prevention research ethics policies and practices; (5) expand RETI on-line public resources including an extensive HIV/drug abuse research ethics bibliography, Ethics Scales and Measures Resources page, and Ethics & Society blog; and (6) create downloadable webinars, podcasts, video lectures, and educational modules for use by faculty and supervisors in other research units.

PROJECT SUMMARY The global HIV/AIDS pandemic, shifts in drug use patterns, and advances in intervention research designs, all create new ethical challenges for studies at the intersection of HIV and drug abuse. To date, there is a paucity of well-qualified investigators trained to conduct scientifically rigorous studies to inform policies directed at meeting these challenges. The goal of this renewal is to advance the contributions of the Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute (RETI), the only program of its kind, to meet this need. The broad long-term objectives of the RETI are to train a new generation of scientists who will conduct robust and unbiased designs to inform research ethics practices sensitive to the unique needs of individuals with and at-risk for HIV and substance abuse and to extend the program's global impact through online scientific and pedagogical resources. These objectives are met through the following aims. Aim 1: To increase early career clinical scientists' capacity to conduct rigorous and reproducible empirical research on HIV and drug abuse prevention research ethics practices and policies. Ethical decisions by investigators and IRBs/RECs are often guided by subjective interpretations of broadly worded regulations and guidelines. Empirical data on ethics practices and policies is thus needed to better inform these decisions. Aim 1 will address this need through the RETI mentored research project (MRP), a multi-year funded research experience in which trainees receive intensive supervised experience designing, implementing, analyzing and disseminating an original study on HIV and drug abuse research ethics. The MRP will be conducted in conjunction with the annual RETI Summer Institute that will build trainee competencies in the unique conceptual frameworks and research designs for conducting studies on research ethics. Aim 1 will also be achieved through career development activities designed to enhance publication and grant writing skills and to disseminate trainees' work through a new public webinar series. Aim 2: To increase early career clinical scientists' capacity to engage communities in the construction of HIV and drug abuse participant protections. Although community advisory boards (CABs) are now commonplace in HIV and drug abuse research, few programs teach trainees how to involve appropriate stakeholders in the development of the study design and the procedures to protect participant rights and welfare. This has often led to limited empowerment of prospective participants as collaborative partners. Aim 2 will be achieved through Summer Institute seminars on methods to engage prospective participants in ethics-relevant dialogue and inclusion of community advisory boards at the design and interpretation stages of the mentored research project. Aim 3: To create and sustain a global information network for enhancing ethical knowledge and evidence-based ethics practices, policies and pedagogy for HIV and drug abuse prevention research ethics. Aim 3 will be achieved through expansion of RETI's global online HIV and drug abuse research ethics scientific and pedagogical resources. As a new feature, the RETI will promote transformative partnerships between investigators and communities by creating Community Access to Research Ethics (CARE), a social media platform specifically tailored to bring research ethics science to communities and populations represented in HIV and drug abuse research.