AAMC Funded Projects for RCR
Ambulatory Pediatric Association
The Ambulatory Pediatric Association (APA) will initiate several activities to promote research integrity. APA will hold a workshop on conflict of interest in pediatric research at the Annual Meeting of the Pediatric Academic Societies in May 2003. Additionally, it will convene a meeting to develop a draft code of research ethics for general pediatrics. Thirdly, the APA will evaluate both the workshop on conflict of interest in pediatric research, and the development of a code of research ethics to determine if they lead to a change in general pediatricians' knowledge levels regarding certain areas crucial to research integrity.
American Psychiatric Institute for Research and Education/American Psychiatric Association
The American Psychiatric Institute for Research and Education (APIRE) will develop a comprehensive research ethics curriculum for psychiatric researchers using a variety of educational approaches. The curriculum will address researcher education across a continuum of the research enterprise from initial study design and choice of methodology to the publication and dissemination of research findings. The APIRE curriculum will build a "psychiatry-specific curriculum appropriate to a variety of audiences and delivery settings."
American Thoracic Society
The American Thoracic Society (ATS) will develop ethical and legal guidelines for critical care research through a three-phase process. Initially, this process will involve the development of draft position papers by clinical investigators, ethicists, and legal scholars as a first step in the development of guidelines. This will be followed by a discussion of the position papers at a workshop in the fall of 2003. The third phase of the process will be directed toward the preparation of formal guidelines for clinical research integrity involving critically ill subjects, and the dissemination of the guidelines nationally and internationally through professional societies' publications. The ATS project team will also evaluate the impact of the guidelines on research and practice.
Association of Academic Physiatrists
The Association of Academic Physiatrists will convene a half-day pre-conference workshop at the annual meeting of the Association of Academic Physiatrists (AAP) in March 2003 to increase awareness among academic physiatrists about ethical issues in basic research involving human subjects. Topics to be addressed include mentoring, publication practices, research misconduct, conflicts of interest and commitment, design and methodological issues, cultural competency, and proposal review considerations.
Alliance of Independent Academic Medical Centers
The Alliance of Independent Academic Medical Centers will present a one and a half-day 2003 symposium titled, An Ethical Framework for Managing Clinical Trials in the Independent Academic Medical Center featuring presentations on RCR education in clinical research. The symposium will be directed to chief medical officers, directors of research, and vice-presidents of academic affairs. Following conference discussions, a draft set of best practices will be developed, and distributed for comment through the Alliance's listserv.
American College of Medical Genetics
The American College of Medical Genetics (ACMG) will engage in a multiple-step process focused on defining and communicating responsible conduct of research and ethical guidelines for the genetic disease intervention clinical research community. An ACMG Steering Committee will generate a series of workshops to develop a clinical trials training program with a focus on responsible conduct of research and ethics including the design of educational materials. The ACMG training program will be offered in late 2004. Evaluative results from the training will be utilized for programmatic improvement. Final training course materials will be made available through the ACMG web site. The ACMG will publish any new guidelines or educational materials in appropriate journals for its research audience.
American Educational Research Association
The American Educational Research Association will conduct a 6-hour session, Assessing Research Integrity in Education in Science and the Professions, during its 2004 AERA meeting in San Diego, California. The focus of the program will be to engage AERA members to "study issues related to integrity in scientific research and to focus specifically on how to assess research integrity in graduate and professions education." AERA's program will include a moderated forum, as well as an additional working session on assessing research integrity. Written summaries of these sessions will be used to develop assessment strategies for faculty and student use, and will be disseminated through the AERA's web site.
American Psychiatric Institute for Research and Education/American Psychiatric Association
Following the development of a model responsible conduct of research and ethics curriculum for psychiatric researchers (previously funded by an AAMC/ORI contract), the American Psychiatric Institute for Research and Education (APIRE) and American Psychiatric Association (APA) will disseminate and evaluate the curriculum. The APIRE/APA will pilot the model curriculum for psychiatric researchers during two full-day workshops, and in two trainings for young APA investigators. APIRE/APA will evaluate the curriculum at multiple points in time on a variety of measures including: (1) knowledge and skills acquired by the participants, (2) quality ratings for the training overall, (3) congruence between training goals and deliverables, and (4) impact on participants' research over time. Following a review of the evaluations, an analysis will be prepared and discussed by APIRE members, and reported to the AAMC.
American Society for Bioethics and Humanities
An American Society for Bioethics and Humanities (ASBH) working group will lead an assessment initiative, Promoting the Responsible Conduct of Clinical Research, with its members to determine best practices with respect to policy and education in promoting clinical RCR. ASBH members engaged in this project will utilize a web-based survey to assess its members' consensus on best practices in these areas. Following the compilation of the survey results, a draft document on best practices will be developed during a 1-day workshop convened by the working group. The draft document will then be posted on the ASBH web site for additional review and comment. Following the consideration of members' input, the final document will be made available on the ASBH web site, and will be submitted for peer reviewed publication, and to the AAMC and ASBH for inclusion in their respective annual meetings.
Association of Academic Health Sciences Libraries
The Association of Academic Health Sciences Libraries (AAHSL) will develop Responsible Literature Searching for Research: A Self-Paced Interactive Educational Program, an instructional tool to teach researchers "the fundamentals of responsible literature searching for research practice." An Advisory Committee of experienced medical reference librarians will be appointed to recommend content, and test questions, during the development of the interactive program. The web-based programmatic content will include 10 chapters with accompanying quizzes to test proficiency. Included in the 10 chapters are "Literature Searching for Adverse Events," and "Keeping Current Using PubMed Cubby, OVID Autoalerts, Web of Science, and other current awareness services." The interactive program will be promoted through AAHSL established contacts, and AAMC institutions, and will be made freely available to academic health sciences libraries and medical centers.
Association of Academic Physiatrists
The Association of Academic Physiatrists (AAP) will provide 14 hours of instruction on Ethical Elements of Responsible Rehabilitation Research over 3 days in conjunction with the AAP's annual meeting in the spring of 2004. AAP's course will utilize case studies involving research integrity and responsible research with human subjects. Some of the topics to be addressed during the course include mentoring, publication practices, conflict of interest and commitment, difficult design issues, and cultural competency. Following the annual meeting, the AAP project team and AAP Research Committee will prepare several educational materials including an AAP white paper on the "Elements of Responsible Research," and a guidebook of case studies and commentaries suitable for use as an RCR teaching tool for training residents and young faculty. The guidebook will be published as a supplement in The American Journal of Physical Medicine & Rehabilitation.
Association of Chairpersons of Departments of Physiology
A 4-hour Mini-Conference in RCR for Department Chairpersons will be presented at the 2003 ACDP annual meeting. The purpose of the mini-conference is to assist physiology chairpersons in improving RCR instruction within their departments and institutions. The ACDP program includes presentations and workshops on several RCR core areas (i.e., collaborative science, data issues, and research misconduct). The mini-conference participants will also focus on a discussion on the goals of RCR instruction.
Association of Professors of Medicine
The Association of Professors of Medicine will hold a plenary session on Conducting Responsible Research: What Chairs Should Know during its winter meeting, February 25-28, 2004. The session will feature a panel of experts from various professions and with varied perspectives (i.e., medical school, medical journal, biomedical industry, and legal) leading a discussion on research integrity with emphasis on Conflicts of Interest and Human Subjects Protections. Dissemination of the APM's plenary discussions on Research Integrity will be presented in The American Journal of Medicine.
North American Association for the Study of Obesity
The North American Association for the Study of Obesity will organize a session, Promoting Research Integrity in Obesity Research: What are the Issues? What are Some Solutions? The 2-hour session will be held during the association's annual meeting, October 11-15, 2003. Session organizers have planned for a synopsis of the conference to be published in Obesity Research. Also, an inter-association work group will be established "to use the conference as a basis for developing best practices" for obesity researchers.
Society for Academic Emergency Medicine
The Society for Academic Emergency Medicine will present a 1-day workshop, A Course in Responsible Research, to be held May 15, 2004, one day prior to its annual meeting in Orlando, Florida. Topics to be included in the workshop are: Human Subjects Protection, Care and Use of Animals in Research, Authorship, Conflicts of Interest, Publication Bias, Use and Abuse of Statistics, Publication Rights and Data Ownership, Retracted Data, the Responsibilities of a Mentor, and Scientific Misconduct. Evaluation immediately following the workshop, as well as evaluation after a year are planned to assess the impact of the workshop on research and publication practice. Results are to be published on the society's web site, and submitted to the journal, Academic Emergency Medicine.
American Occupational Therapy Association
The American Occupational Therapy Foundation (AOTF), in partnership with the American Occupational Therapy Association (AOTA), will develop a Responsible Conduct of Research (RCR) case-based curriculum expressly targeted to master and doctoral occupational therapy students. Promoting Research Integrity in the Next Generation of Occupational Therapy Researchers will be designed to actively engage graduate students in occupational therapy specific research dilemmas and issues across the range of ages, populations, and settings involved in OT research. The curriculum will be designed to improve beginning occupational therapy researchers understanding of RCR issues, and strengthen their ability to prevent and handle future RCR problems.
Gerontological Society of America
The Gerontological Society of America (GSA) will develop a Guidebook for Multidisciplinary Clinical Geriatric Research to improve the quality and integrity of clinical research with elderly populations. The Guidebook will include 8 major sections written by well-known clinical researchers, and an appendix of supplemental materials including practical examples of responses to various regulatory requirements. The Guidebook will be evaluated by participants at two workshops on responsible and ethical research with elderly populations that will be held in conjunction with major conferences and through a random survey of clinical researchers who have requested the Guidebook. The Guidebook will be available through the GSA website.
Research and Assessment Corporation for Counseling
The Research and Assessment Corporation for Counseling (RACC), a non-profit affiliate of the National Board for Certified Counselors, Inc., will develop a DVD instructional module designed specifically for researchers in the counseling field. Utilizing the expertise of specialists in ethics and research integrity, the RACC will develop a series of videotaped scenarios with researchers facing a variety of ethical and RCR dilemmas. The RACC will pilot test the scenarios with trainees, and evaluate their knowledge of appropriate courses of action.
Society for Academic Emergency Medicine
The Society for Academic Emergency Medicine (AEM) will publish a special edition of Academic Emergency Medicine in November 2005 on the proceedings and recommendations of a consensus conference on research integrity issues that will be held in conjunction with its 2005 annual meeting. The AEM seeks to (1) raise awareness of research integrity issues in emergency medicine, (2) summarize existing knowledge on research integrity issues in emergency medical research, (3) identify knowledge gaps, and (4) establish a research agenda to improve research integrity in emergency medicine.
Society of Teachers of Family Medicine
The Society of Teachers of Family Medicine (STM) in collaboration with the North American Primary Care Research Group (NAPCRG) will develop recommendations on subject and researchers protection in participatory, educational, and network research. The recommendations will be developed during the fall 2004 NAPCRG meeting and discussed during the spring 2005 STFM annual meeting. The recommendations will be published in leading journals in the discipline.
AcademyHealth will develop two complementary activities. The first, the Journal Editors Project, includes the development of a disclosure statement for adoption by health services research journal editors. The statement, to be completed by manuscript authors, would ensure transparency of relationships that could be perceived as a conflict of interest. AcademyHealth will encourage journal editors to adopt the statement as a requirement of manuscript submission. The second activity, the Curriculum Project, includes the development of case studies designed as educational tools to bring the Guidelines to a real world context. The proposed activities are designed to encourage the use of the Guidelines as a tool to foster an environment of consistently ethical behavior and to build consensus regarding the proper management of conflicts of interest in health services research.
American Academy of Family Physicians
The American Academy of Family Physicians will complete a qualitative study to examine the personal and institutional approaches taken in the conflict resolution process. They will investigate conflicts of interest declared by individuals whose educational (CME) presentations include their own research results. AAFP will identify 30 CME presentations with potential conflicts of interest (CoI) and undertake a three component investigation: 1) peer-review of CME application, 2) monitoring of the presentation, and 3) open-ended interviews with 20 presenters. Data will be analyzed qualitatively. The study team will then discuss the apparent success or failure of CoI and ethical conduct of research for each case. Finally, we will develop scenarios from the cases that will help illustrate how CoI enters into the research process as well as successful and inappropriate forms of resolution. These scenarios will be disseminated through a variety of current AAFP meetings including the Annual Leadership Forum, the Scientific Assembly, the Annual North American Primary Care Research Group meeting and the Convocation of Practices and Networks hosted by the AAFP National Research Network.
American College of Physicians
The American College of Physicians (ACP) will develop and implement a long term formal RCR education and training program related to practice-based research for doctors of internal medicine and its subspecialties, as well as internal medicine students, residents and fellows. In addition, the ACP will implement an ongoing RCR member support structure within its Center for Ethics and Professionalism. Training will be provided at national and local chapter meetings and through the ACP web site and publications.
American College of Rheumatology/Association of Rheumatology Health Professionals
The Association of Rheumatology Health Professionals (ARHP) will develop and conduct a 90-minute Responsible Conduct of Research (RCR) workshop at its 2005 Annual Scientific Meeting. The workshop's audience will include ARHP members and physicians attending the American College of Rheumatology (ACR) Annual Scientific Meeting, which runs parallel to the ARHP's. The workshop participants will analyze data management cases, discuss dilemmas and actions that led to them, and develop strategies to avoid or ethically resolve data management problems. The workshop will emphasize practical guidelines that ensure integrity in quantitative and qualitative clinical and community research.
American Society for Clinical Pharmacology and Therapeutics
The American Society for Clinical Pharmacology and Therapeutics will conduct a workshop at its 2005 annual meeting on Corporate Influence in Research that will provide an overview of how drug industry sponsorship affects clinical trials, researchers, and their recommendations. Dissemination of program presentations and materials are planned through print, DVD, and publication submissions.
American Speech-Language-Hearing Association
The American Speech-Language-Hearing Association will convene a 2-day summit meeting to identify and prioritize the major issues, challenges, and knowledge gaps facing the communication science and disorders (CSD) research community relative to publication practices, responsible authorship, manuscript content and the peer review process and to formulate and prioritize a set of recommendations to develop, enhance, and evaluate resource materials in the aforementioned areas of RCR. The desired outcome of the planned project is to develop and disseminate instructional products that foster RCR, related to the review, reporting, and dissemination of research findings to the segment of ASHA membership.
Association of Academic Physiatrists
The Association of Academic Physiatrists (AAP), and the American Congress of Rehabilitation Medicine (ACRM), a multidisciplinary organization of rehabilitation researchers, will collaborate to develop training resources on RCR suitable for an interdisciplinary audience of rehabilitation researchers. The goal is to develop a set of training resources that focuses particularly on the elements of RCR that are specific to rehabilitation research, while placing them in the larger context of a general framework on RCR. Experts from a variety of disciplines will develop content in several formats, appropriate to the topic, including text, slide presentations, videotape/DVD presentations and web casting. This content will be previewed at the 2006 annual meeting of the ACRM, with critical feedback provided by specially scheduled focus groups and discussion forums. The expected outcome will be the increased availability of a consistent training RCR curriculum; an increased knowledge of RCR issues; and the ability to have a set of core materials that can be further enhanced overtime as the field of PM&R matures.
Association of Anatomy, Cell Biology and Neurobiology Chairs
The Association of Anatomy, Cell Biology and Neurobiology Chairs will hold a round-table discussion on the RCR at its 2006 annual meeting. AACBN expects that this will launch an annual session on RCR at every subsequent meeting. The entire proceedings of the meeting will be published in Experimental Biology and Medicine.
The Endocrine Society will develop a one-day workshop on Enhancing Integrity in Clinical Research in association with its 2005 annual meeting. This workshop will become an integral part of the educational offerings of the society, at its annual meeting as well as other venues, including collaborative presentations at meetings of related societies. The workshop will produce web-based and hard copy materials that will be made widely available to extend the benefits of the workshop far beyond its actual participants.
Public Health Leadership Society
The Public Health Leadership Society (PHLS) will address the needs of public health professionals for guidelines and education on the ethics of public health research, particularly focusing on ways to distinguish and clarify the perplexing differences between public health practice and human subjects research. The project will draw on the Principles of the Ethical Practice of Public Health (Code of Ethics), drafted and disseminated by PHLS members and recently adopted or endorsed by nine public health associations. The PHLS, through its Ethics Committee and Ethics Program Director, will feature a planning workshop to bring together public health professionals in the field, including leaders from other relevant national public health associations that have either adopted or endorsed the Code, with experts in research ethics and public health ethics.
Society for Academic Continuing Medical Education
This project will develop and pilot test a computerized, skills-based educational program for health professionals who obtain informed consent from patients to participate in clinical research. The project has three components: 1) Needs assessment: Focused interviews with research subjects who have given consent to participate in clinical research to qualitatively identify the problematic issues in the consent process from the participants' perspective. 2) Educational intervention: Develop a multimedia computerized educational program that provides the necessary skills for an informed consent dialogue, and deliver this to researchers associated with a Medical College who recruit patients into studies. 3) Evaluation: participants in the intervention will evaluate process issues, and the usefulness of the intervention; this subjective data will be gathered by questionnaire. A pilot study of the effectiveness of this educational program will be conducted, again using interviews with research participants, as outlined in component 1. Once completed, SACME will seek further funding to conduct a randomized trial to determine whether this intervention results in higher standards of informed consent. SACME anticipates that this program may become an integral part of health professional education, and promote research integrity.
Society of Research Subject Advocates
The Society of Research Subject Advocates will develop a comprehensive Orientation and Development Workshop for research subject advocates (RSAs) as part of its annual meeting held in conjunction with the General Clinical Research Centers annual meeting. The training workshop is designed to (1) emphasize their pivotal roles in establishing and safeguarding research integrity in their institutions, (2) convey an understanding of and basic competence in execution of the RSA role, (3) provide strategies, techniques, tools and best practices to accomplish research integrity goals, and (4) provide an introduction to mentors for RSAs.
Federation of American Societies for Experimental Biology
Addressing conflicts of interest is an essential component of the responsible conduct of research. The proposed activities will serve to improve the management of conflicts of interest in biomedical research. FASEB developed a set of guiding principles for investigators to address challenges as a result of financial relationships with industry. FASEB is poised to expand this work by convening a coalition of major stakeholders to manage the next phase. Over the course of one year, this coalition will develop and implement activities to achieve two major goals: 1) raise awareness of conflict of interest issues on the part of investigators and 2) develop more standard practices for conflicts of interest management in biomedical research. Proposed activities include developing tools for investigators and laboratories and developing a model conflict of interest disclosure form. Outcomes from this project include increased awareness about conflicts of interest by investigators and trainees, enhanced stewardship of funds for research, and improving the partnering between academia and industry for the public good.
American Society of Hematology
The ASH Clinical Research Training Institute (CRTI) is a major new initiative designed to respond to the need for a well-trained cadre of clinical researchers who have the skills, knowledge, and network needed to succeed in clinical research. The CRTI consists of a summer week-long workshop, a December meeting in conjunction with the ASH annual meeting, and a follow-up meeting in the spring at ASH headquarters. Throughout the training sessions, the responsible conduct of research is emphasized, both with specific didactic material as well as personal experiences of senior investigators. Throughout the ASH CRTI, the Society will work to ensure that trainees are taught the required clinical research methods to foster the responsible conduct of research (RCR).
American College of Rheumatology/Association of Rheumatology Health Professionals
American College of Rheumatology/Association of Rheumatology Health Professionals will develop and present a RCR workshop at its 2006 annual scientific meeting. The proposed workshop will increase awareness of the ethical issues accompanying the dissemination of research and promote responsible publication and presentation of rheumatic research. This workshop will fill a self-identified gap in RCR knowledge and skills of ARHP members. The evaluative data will provide directions for future education about RCR topics in rheumatology.
Council on Social Work Education
The Council on Social Work Education (CSWE) will develop and implement a Responsible Conduct of Research (RCR) symposium, during the Spring 2006 CSWE Annual Program Meeting, to evaluate and promote research integrity within the field of social work. The symposium will initiate broad-based development in policy and practice of social work education in the responsible conduct of research in its 624 accredited undergraduate and graduate programs. RCR has not been the focus of systematic attention in social work. Training and mentoring the next generation of social work leaders to analyze and change social work education and curricula will institutionalize RCR within social work education. Goals for the project are: (1) enlist 50-60 social work faculty researchers, junior faculty, MFP fellows, and Hartford fellows and scholars in development of goals for integration of research integrity throughout the field; (2) initiate discussion in the field of social work on the RCR; and (3) produce a research integrity policy statement and action plan for dissemination and long-term follow-up. The results of the meeting, including a draft policy statement for research integrity, will be published in The Journal of Social Work Education and other publications through the CSWE publications program. Ten participants from the symposium will be brought to CSWE for a follow-up policy development meeting in June. CSWE will longitudinally evaluate the impact of the symposium on research policy and practice through an annual census of social work programs.
American College of Neuropsychopharmacology
The American College of Neuropsychopharmacology proposes to codify its relationship with the pharmaceutical industry in such a way that ensures transparency, protects scientific integrity, and helps to bolster public confidence in the scientific research enterprise. Having been a pioneer in establishing the requirement that its members affirm their commitment to its “Principles of Professional Conduct” annually, ACNP plans to establish a similar code of conduct for its supporting corporations. The proposal is a plan to engage the ACNP leadership and supporting corporations in a process to: 1) More clearly define the roles and responsibilities of ACNP corporate supporting members; 2) Develop a code of conduct for ACNP supporting corporations; 3) Engage the commitment of industry participants in that Code of Conduct; and, 4) Offer this Code of Conduct as a model for other academic societies.
Society of Research Subject Advocates of the GCRCs
Society of Research Subject Advocates of the General Clinical Research Centers (GCRCs) proposes to sponsor an Orientation and Research Integrity Workshop featuring eight nationally prominent speakers addressing themes of 1) Informed Consent; 2) Mediating Disputes in Research, 3) Issues in Genetic Research: and 4) Innovation in Research Subject Protection. The goals of the workshop are to: 1) emphasize to new Research Subject Advocates (RSAs) their pivotal role in establishing and safeguarding research integrity, 2) convey understanding of and basic competence in execution of the RSA role; 3) provide strategies, techniques and advanced tools to accomplish research integrity goals, 4) enhance and expand RSA expertise, and 5) provide new and ongoing mentoring within the RSA community. In addition to didactic lectures, interactive sessions, workshops, and panel discussions provided. Expertise is drawn from experienced RSAs, and from outside speakers invited for their expertise. The proposed workshop fits into a continuum of annual professional development for RSAs in research integrity.
Society of University Surgeons
The overall goal of this project is to develop consensus guidelines for the responsible development, testing, and application of surgical innovations, and broadly disseminate the guidelines to institutionalize them in surgical training and practice. Over the past 15 years, rapidly advancing technology has led to many innovations in surgical practice. A critical issue surrounding surgical innovation is that the line between subtle modifications of practice (“tinkering”), and research requiring formal protocol development and Institutional Review Board oversight, can be blurry. The development and application of innovations has been poorly regulated, due in part to the considerable ambiguity that surrounds the issue. To date, there has been little effort from within the surgical community to address this. However, the current climate of intense public scrutiny of medical practice, and an emphasis on patient safety and integrity in research, demands clarity and consistency in this area. The specific goals of the project are to: 1) convene a panel of surgeons and expert stakeholders to develop consensus guidelines for the application of surgical innovations; 2) develop related educational materials for surgeons in training and practice; and 3) publish the consensus guidelines in major general surgical and surgical subspecialty journals, and further disseminate the guidelines and educational materials broadly through print and Web-based media. The consensus guidelines will address all of the nine core components of responsible conduct of research (RCR) and target surgical trainees as well as practicing surgeons. It is expected that this will bring clarity to the issue and mainstream acceptance to the concept. It is further hoped that by introducing RCR during surgical training it will become part of the culture of surgical practice. The SUS will measure the adoption of guidelines by surveying its membership and auditing surgical journals for compliance in innovation publications.
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