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Clinical research training in CAM for minorities at an HBCU.

Abstract

Morgan State University (MSU) is one of two universities nationwide (the other being Florida International University) which have been awarded Institutional Research Training (T-32) grants by the NIH--National Center for Complementary and Alternative Medicine (NCCAM) to train minority researchers and practitioners approaches for conducting scientific research in Complementary and Alternative Medicine (CAM). Morgan State aims to establish a Center for Research Training in Complementary and Alternative Medicine (CRTCAM) at the University. To accomplish this MSU is teaming with Johns Hopkins University and the Traditional Acupuncture Institute--School of Philosophy and Healing In Action (TAI-SOPHIA) Institute in Columbia, Maryland. Our overall goal is to recruit individuals from underrepresented minority population groups and train them in the performance of high quality research to better answer fundamental and clinical questions regarding the practice and utilization, as well as the safety and efficacy of CAM in the United States.

Background

Compelling evidence indicates that racial and ethnic minorities suffer from increasing disparities in the incidence, prevalence, mortality and morbidity of diseases. These disparities include shorter overall life expectancy, higher rates of cardiovascular disease, cancer, infant mortality, birth defects, asthma, diabetes, stroke, sexually transmitted diseases, and mental disorders, etc. (NIH, 2000b). Nationally, more and more Americans--as many as 42 percent according to one recent estimate--are using Complementary and Alternative Medicine (CAM) approaches for their health care needs. Between 1990 and 1997, the number of Americans using CAM increased by 38 percent from 60 million to 83 million. (NIH, 2000c) But, good systematic data on CAM use among racial and ethnic minorities in the U.S. was lacking (Eisenberg, 1993; NIH, 2000c). Results of a study by the Consumer Healthcare Products Association, the trade association that represents U.S. manufacturers and distributors of over-the-counter medicine and dietary supplements, show that 59 percent of Americans are more likely to treat their own health conditions than they were a year ago. Also, 73 percent would rather treat themselves at home than see a physician. African Americans and Hispanic Americans showed the highest level of interest in becoming more familiar with alternative medicines in the future, and were over-sampled in the study to insure that findings for these two groups were projectable (Consumer Healthcare Products Association, 2001).

Today, African-, Hispanic-, and Native-American physicians are a crucial source of care for the nation's underserved communities (AAMC, 2001). With the current health disparities, and the projection that racial and ethnic minorities will increase nationally from 28 percent in 1998 to nearly 40 percent in 2030, (NIH, 2000b), there is a serious need for more racial and ethnic minorities in the health professions. A related concern is that racial and ethnic groups make up about 25 percent of the U.S. population, but only about 10 percent of health professionals (DHHS, 2000). In 1994, the Institute of Medicine (IOM) called for vigorous efforts to increase the ethnic and racial diversity in health professions (Lewin, 1994). In its recent report on health disparities in America, the Institute of Medicine restated its call for increases in the number of racial and ethnic minorities in various health care professions (IOM, 2002).

To effectively address the broad range of various diseases that affect Americans, there is a need for more minority scientists in biomedical, clinical, behavioral, and health services research (U.S. Senate, 2000). This cadre of researchers must include a diverse community of "alternative medicine" researchers as well. Unfortunately, there are often limited opportunities for racial and ethnic minorities to receive training in CAM research due to a lack of resources at their home institutions, a lack of opportunities to develop the research skills via both didactic training and interactions with a critical mass of CAM research scientists, and a lack of state-of-the-art technology relevant to CAM. The National Center for Complementary and Alternative Medicine (NCCAM) was established at the National Institutes of Health (NIH) in 1998 by Congress to stimulate, develop, and support research on CAM to benefit the public (NIH, 2000a). NCCAM grouped CAM modalities into the following five major domains: alternative medical systems, mind-body interventions, biologically-based treatments, manipulative and body-based methods, and energy therapies (NIH, 2000b).

On March 8, 2000, President Clinton established the White House Commission on Complementary and Alternative Medicine Policy. Through the Secretary of Health and Human Services, the Commission was to provide a report to the President with recommendations for assuring that public policy maximizes the benefits of CAM to the American people. Training and research are two of the focus areas of need identified for the Commission's deliberations (White House, 2000). In September 2000, NCCAM established the first natural medicine center for minorities. The grant of nearly $8 million was awarded to Maharishi University of Management to study the effectiveness of alternative medical approaches for treatment and prevention of cardiovascular disease in African Americans and other high-risk groups (Natural Healthline News, 2000). The Johns Hopkins Center for Cancer Complementary Medicine, funded in October 2000, has two research projects to study the effects of CAM therapies on prostate cancer and breast cancer in ethnic and racial minorities (NIH, 2000e).

Beginning in September 2001, NCCAM-NIH funded two minority clinical research training grants in CAM--one at Morgan State University, in Baltimore, Maryland; the other at Florida International University. By awarding the Institutional Clinical Research Training grant to Morgan State, the NCCAM has awarded one of its first minority clinical training grants to an historically black college or university (HBCU). The overall goal of Morgan State University and our collaborating institutions (Johns Hopkins University and TAI-SOPHIA Institute of Columbia, Maryland) is to recruit individuals from under-represented minority population groups and train them in the performance of high quality research to better answer fundamental and clinical questions regarding the practice and utilization of CAM.

Program Direction

The leadership and administration of the new CAM Research Training Program at Morgan State includes the Principal Investigator/Program Director; Co-Principal Investigator and Associate Program Directors; National External Advisory Board; Internal Advisory Board; Program Steering Committee, and Admissions Committee. Emmanuel A. Taylor, M.Sc, Dr.P.H., Associate Professor of Public Health at Morgan State University is the Principal Investigator (P.I.) and Program Director (P.D.). In this role, Dr. Taylor is responsible for the overall conduct and direction of the CAM Research Training program, as well as the selection and appointment of trainees. Gail Geller, Sc.D., Associate Professor at the Johns Hopkins School of Medicine and the Bloomberg School of Public Health, serves as a Co- Principal Investigator and as one of the principal linkages to the Johns Hopkins University. Robert Duggan, M.Acu., M.A., President of the TAI-SOPHIA Institute, functions as Associate Director for specific aspects of our proposed CAM research training program that will be implemented at the Institute in Columbia, Maryland. Mr. Duggan has practiced traditional acupuncture since 1973.

Program Faculty

The Program Faculty was purposely appointed to be multi-disciplinary in order to provide the necessary research strength for adequate training of the research fellows in the various domains of Complementary and Alternative Medicine (CAM). The faculty, which was drawn from the collaborating institutions, provides a broad base of expertise in scientific research--from basic research to patient-oriented, and population-based epidemiological research. Faculty members have diverse expertise in CAM interventions, clinical trials, social epidemiology, health services research, statistics and methodology, bio-ethics, and health policy analysis Because the development of strong mentoring relationships is essential to the success of the trainees and the program, all trainees will be matched with a faculty advisor, who will function as the trainee's mentor based on their area of research interest

Design of the Training Program and CAM Focus

The Training Program at Morgan State is designed to develop a pipeline of minority students who are interested in pursuing research careers in CAM related fields. To this end, the program will target two cadres of minority students: 1) pre-doctoral students, and 2) post-doctoral trainees. Some of the pre-doctoral students currently enrolled in health-professional schools (e.g., medical, nursing, Pharm.D. programs, etc.) may be selected for short-term full-time training positions. The program admission committee will endeavor to select a mixture of trainees both from health professions and appropriate disciplinary backgrounds with existing CAM knowledge and expertise (without formal research training) and those with demonstrated research training in conventional biomedical science and public health (but without previous training in CAM). This approach will create an environment for cross-fertilization of ideas and methodologies between committed CAM research scientists and others with orientations to conventional biomedical science. This program design provides opportunities for the trainees to develop the research skills necessary for scientific investigation of CAM through both didactic training and interactions with a critical mass of CAM research scientists. The program will use an educational model of early trainee exposure to faculty role models and research projects, to complement didactic-oriented training.

Integration of CAM into Existing Curricula

All trainees will be required to take a course on ethical issues in the conduct of health/biomedical research. Trainees must satisfy the requirements for their respective curriculum track. In addition, a common core curriculum emphasizing fundamental training in areas related to CAM research will be developed and required of all trainees. The core CAM curriculum will be readily integrated into the doctoral program of all pre-doctoral trainees in the CAM program. Trainees will be required to participate in CAM related research seminar series at the collaborating institutions. The research seminars will give the trainees an opportunity to present the conceptualization, design, and content of their research for review and critique. A seminar series focusing on Research in CAM, for example, will be developed and rotated among the three-institutions.

Research Topical Areas

Pre-doctoral as well as post-doctoral trainees must select research topical areas that are relevant for the mission of NCCAM and the NIH. Research topical areas may include: the epidemiology of CAM use among various racial and ethnic population groups in the United States; what types of CAM modalities are used for what health conditions; the efficacy of CAM modalities; safety and human subjects protection in CAM research; what aspects of CAM are complementary with mainstream medicine; what aspects of CAM can be integrated into mainstream medicine; and, how ready are mainstream physicians to accepting CAM practitioners.

Training Facilities, Environment and Resources

Collectively, Morgan State University, Johns Hopkins Schools of Medicine, Public Health, and Nursing, and the TAI-SOPHIA Institute provide more than adequate facilities and resources to support a research training program in CAM. By having the only doctoral program in public health located at a historically black college or university (HBCU) in the United States, Morgan State is uniquely qualified to develop a meritorious research training program for pre-and post-doctoral trainees who are interested in CAM. By teaming with Johns Hopkins and the TAI-SOPHIA Institute in this CAM research training program, Morgan State is seeking to broaden its leadership role in helping reduce, if not eliminate, the disparities in health status in this nation.

Clearly, the collaborating institutions provide an array of clinical, educational, and public health facilities on and off campus; access to patient populations in the Northeast region of the country as well as the general community in the Baltimore/Maryland, DC metropolitan areas. The location of the program in Baltimore, Maryland gives the trainees access to the National Library of Medicine (NLM), and the considerable resources and facilities of the National Institutes of Health (NIH) and other federal facilities. Trainees also have access to the Maryland State, Baltimore City, and several suburban and county health departments.

Recruitment of Trainees

In the spirit of creating a pipeline for minority students interested in pursuing research careers in CAM related fields, the collaborating institutions will jointly recruit prospective trainees for the Program. It is agreed that this is a truly mutually beneficial partnership. The three institutions have naturally complementary educational and research domains--Johns Hopkins is world-renowned for its clinical and research expertise; the TAI-SOPHIA Institute is a national leader in acupuncture and other ancient healing arts; and Morgan State has the only doctoral program in public health practice at an HBCU. We have been able to identify a number of pre-doctoral students in the DrPH program at Morgan as prospective candidates for the CAM training program. A number of minority students in CAM training at TAI-SOPHIA have also expressed interest in enrolling in the DrPH program at Morgan.

Eligibility and Qualification Requirements

Applicants to this training program must be citizens of the United States, non-citizen nationals, or persons lawfully admitted to the United States for permanent residence (evident by possession of a currently valid alien registration card I-551) at the time of appointment. They must also be enrolled in a post-baccalaureate degree program in relevant biomedical or behavioral science field at Morgan State University. Since this is a research training program for minority researchers, prospective trainees must be from racial and ethnic groups that have been shown to be under-represented in health-related research nationally. These groups include African Americans, Hispanics, American Indians, Alaska Natives, Native Hawaiians, and Pacific Islanders.

Pre-doctoral Trainees In addition to the general eligibility requirements described above, pre-doctoral trainees must be enrolled in an academic program at Morgan State leading to a research doctorate relevant to CAM (e.g., PhD, ScD, or DrPH), or a combined research and clinical degree. Pre-doctoral applicants must have made a strong commitment to complete a doctoral degree or equivalent in a bio-medical or behavioral science relevant to CAM. Students currently enrolled in health-professions programs who wish to postpone their professional studies in order to engage in full-time research training may receive appointment to this training program.

Post-doctoral Trainees Prior to beginning the traineeship is this program, in addition to the general requirements, post-doctoral trainees must have earned a doctorate degree from an accredited domestic or foreign institution. Research training at the post-doctoral level may be part of a research degree program, but must emphasize specialized training which meet CAM research priorities in the biomedical, behavioral, or clinical sciences. Post-doctoral trainees will be required to engage in at least 2 years of research, research training, or comparable activities beginning at the time of appointment to this program. We expect the duration of post-doctoral research training to be 3 years, since the duration of training is strongly correlated with post-training research activities. (And, we will be tracking the post-training research activities of our former trainees).

Short-term Health Professional Trainees Eligibility for short-term, full-time, pre-doctoral research training positions in the proposed program will require that the students be currently enrolled and in good standing, and must have completed at least one quarter or semester, in a program leading to a clinical doctorate prior to participation in the program. Within schools of pharmacy, only individuals who are candidates for the Pharm. D. degree will be eligible for short-term training positions. Such appointments may only last 2-3 months, on a full-time basis during the summer or other "off-quarter" periods.

Selection Process

All applicants (pre-doc or post-doc) will be required to submit a complete application for appointment in the program, including recent graduate record examination (GRE) result or equivalent, official transcripts of college and graduate work, and at least three letters of recommendation. The Admissions Committee will review each complete application, and those deemed appropriate will be chosen for interviews. A final selection will be offered appointment based on the quality of their work, recommendations and interviews, as well as their interest and commitment to a research career in CAM. Candidates will have the opportunity to visit the training sites prior to starting their training. A rating form will be developed to standardize the selection process. In addition, all post-doctoral candidates will present their prior research work in a seminar setting. All trainees will be required to pursue their research training on a full-time basis.

Instruction in the Responsible Conduct of Research

All trainees in the Morgan State program are required to complete a course and attend series of seminars on the ethical issues in the responsible conduct of research. These include seminars on topics such as informed consent, privacy and confidentiality, beneficence, individual autonomy, scientific integrity, conflict of interest, allocation of scarce resources, and justice as well as a required course on Bioethical issues in Public Health and Health Care. These seminars and coursework allow multiple opportunities for presentation and discussion of specific cases raising ethical and moral principles, as well as any such consideration in the research proposed by trainees. Ethical aspects of research are also part of the curriculum in several other required courses. Trainees are required to include a section on ethical concerns in their research proposals and theses

Human Subjects Protection

As an HBCU, Morgan State University is deeply committed to the equitable treatment, safety, and protection of all individuals who may choose to participate in any current or future CAM research. Given the history and experience of African Americans in clinical trials in the United States, Morgan State will position itself as "gate keeper" and participant observer in any current, planned and/or proposed CAM research. All protocols in development will be reviewed and approved by the IRB prior to recruitment of human subjects into any research projects. The Principal Investigator (PI) will promptly notify NIH-NCCAM of any violations and take appropriate actions to rectify any improprieties.

Conclusion

This program in the clinical training of minority researchers in CAM is a commendable first step by NIH-NCCAM to broaden the involvement of minority populations in its clinical research and training program. The NIH, however, must continue to be encouraged to fund additional training sites across the country. Existing literature suggest that Americans will continue to use the dual systems of medical care at an increasing rate. It is critical that scientific research be conducted by properly trained researchers. They must identify what aspects of the so-called "alternative medicine" are complementary and could be integrated into "conventional" clinical practice in the United States. The patients will continue to avail themselves of whatever it takes to feel better, it is incumbent upon healthcare providers on both sides of the CAM debate to work together for more effective patient care while ensuring human safety.

References

Association of American Medical Colleges. http://www.aamc.org/about/progemph/diverse/affirm.htm., 2001.

Council on Graduate Medical Education. Twelfth Report: Minorities in Medicine. U.S. Department of Health and Human Services. Rockville, MD, 1998.

Department of Health and Human Services. Healthy People 2010. Washington, DC: Government Printing Office, November, 2000.

Department of Health and Mental Hygiene. Maryland Health Improvement Plan. Baltimore, MD: August, 2000.

Eisenberg, D. M. "Unconventional Medicine in the United States: Prevalence, Costs, and Pattern of Use," N Engl J Med 1993;328:246-52.

Eisenberg, D. M. "Trends in Alternative Medicine Use in the United States: 1990-1997," JAMA 1998;280:1569-1575.

Health Resources and Services Administration. "Community Health Status Report: Baltimore, MD," Department of Health and Human Services, Rockville, MD, July 2000.

Lewin, M., Rice, B (eds.) Balancing the Scales of Opportunity: Ensuring Racial and Ethnic Diversity in the Health Professions. Institute of Medicine, National Academy Press, Washington, DC, 1994.

National Institutes of Health, National Center for Complementary and Alternative Medicine, http://nccam.nih.gov/nccam/an/general, 2000.

National Institutes of Health, National Center for Complementary and Alternative Medicine, http://nccam.nih.gov/nccam/fcp/classify, 2000a.

National Institutes of Health. "NIH Strategic Research Plan to Reduce and Ultimately Eliminate Health Disparities." National Institutes of Health, Bethesda, MD, October 2000b.

National Institutes of Health. (NIH) "Epidemiological Studies of CAM in Racial and Ethnic Minority Populations: Project Concept Review." National Center for Complementary and alternative Medicine, Bethesda, MD, October 2000c.

Emmanuel A. Taylor, Morgan State University, MD Lanardo Moody, Morgan State University, MD David Levine, Johns Hopkins School of Medicine, MD Gail Geller, Johns Hopkins School of Medicine, MD Robert Duggan, TAI-SOPHIA Institute, MD

Taylor, MSc., DrPH, is Associate Professor and Director, Center for Research Training in CAM; Moody, MA, is Doctoral Candidate, Morgan State University Public Health Program; Levine, MD, Associate Professor and Geller, ScD, Associate Professor, are with the Johns Hopkins School of Medicine and the Bloomberg School of Public Health; Duggan, MA, MAc, is President of the TAI-SOPHIA Institute.
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Author:Duggan, Robert
Publication:Academic Exchange Quarterly
Date:Sep 22, 2002
Words:3348
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