The ICs reported many excellent activities aimed at fostering public trust. A careful reading of the PT Inventory suggests that while some have been developed and are appropriate for a particular Institute, others may be exportable or adaptable across the NIH. The following compilation is not intended as a list of best pniractices, but rather as a guide for IC staff who may be interested in expanding or modifying programs designed to enhance communication and collaboration with the public.
For purposes of this report, the "publics" are defined as:
Health Careers Education - Lifeworks (Office of Science Education, OD)
This program is an excellent starting point for members of the public interested in scientific or health-related careers. It includes aptitude and interest inventories, education and salary information, and profiles of persons working in many fields. It could easily be tailored to the interests and needs of a particular institute or center.
Contact: Bruce Fuchs, Director, 301-402-5225
Public Education Campaigns
Many ICs conduct extensive public education campaigns. Most are readily accessible from the IC websites; links are given for the selected examples cited below.
Town Hall Meetings
Several ICs use Town Hall Meetings to inform and gather input on research priorities and issues.
Health Fairs and Screenings
Health Fairs and screenings are a feature of the outreach efforts of many ICs.
Traveling exhibits include:
NEI: The Eye Site [a.k.a. VISION] (http://www.nei.nih.gov/nehep/)
NHLBI: The Heart Truth (http://www.nhlbi.nih.gov/health/hearttruth/index.htm)
NHGRI, with Pfizer: Genome: The Secret to How Life Works (http://genome.pfizer.com/)
NIMH's Brain: The World Inside Your Head
Targeted Outreach Programs
Outreach efforts to particular communities represent an important effort to reach populations with whom communication is difficult, or among whom risk factors are high. Selected examples include:
- NICHD offers SIDS outreach to African Americans and American Indian groups. NICHD co-hosted three summit meetings with AKA, WIN, and the Coalition of 100 Black Women addressing SIDS risk reduction in African American communities in Detroit, Tuskegee, and Los Angeles. Audiences included lay people, public health professionals, faith-based organizations and others.
Contact: Lisa Kaeser, 301-496-0536
- Several ICs conduct outreach programs for Alaska Natives focusing on health issues of greatest concern to this population, including diabetes and its ocular complications, alcohol abuse and related problems, cardiovascular disease, and cancer.
Contacts: www.ndep.nih.gov, http://www.nei.nih.gov/nehep/programs/diabeticeyedisease/, http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-04-023.html, http://pubs.niaaa.nih.gov/publications/aa55.htm, http://www3.cancer.gov/rrp/CDRP/
- NIHSeniorHealth.gov, sponsored by NIA and NLM, is a website with large print, audio option and a booklet, Making Your Web Site Senior Friendly: a Checklist. Changes in memory, text comprehension, information processing speed and vision can interfere with older adults' use of computers, but research indicates older adults can effectively use computers if information is provided in a senior-friendly manner. NIH extensively tested NIHSeniorHealth with adults age 60 to 88 to ensure that it is easy for them to see, understand and navigate. Each health topic includes general background information, open-captioned videos, quizzes and frequently asked questions (FAQs). New topics are added to the site on a regular basis.
- Cancer Bulletin, launched in January 2004, is weekly electronic publication to provide useful, timely info to the cancer community about NCI, its programs, and policies. It includes updates on various aspects of cancer and allows the reader to access past issues. NCCAM Update, an e-bulletin, is offered in several formats and includes updates on science, employment opportunities, Congressional activities, and more.
Programs for the General Public
The "Medicine for the Public" lecture series was created by the NIH Clinical Center in 1978. It is a series of lectures on disease topics by NIH scientists. It was developed as a means of reaching out to the general public with information on clinical research and to make people aware of what NIH does and how it contributes to the public health of the nation. It aims to convey complex medical and scientific information to non-scientists. The series has been popular from the start and often draws overflow crowds. It was the first outreach program that drew the community to the NIH campus. More than 200 "Medicine for the Public" lectures have been delivered. It remains one of the most popular outreach programs at NIH. It is free and open to the public. There are typically 200-400 attendees per lecture.
Clinical Trial Participants
Information for current and potential participants in clinical trials goes beyond the provision of recruitment materials. ICs may invite the input of participants in clinical research programs, promote advocacy on behalf of participants, or expand the descriptions of specific trials to include more in-depth discussion of methodology and the need for clinical trials.
The NCI created the CARRA--Consumer Advocates in Research and Related Activities--program to draw upon the experience of people affected by cancer to represent the views of cancer survivors and family members in NCI's daily activities. The goal is to recruit consumer advocates to form a "ready and waiting" group of people who are available to participate in a wide range of NCI activities. Most often members participate in the peer review process to help evaluate cancer research grants and review cancer patient education materials. CARRA members represent many different cancer types, age groups, and ethnic groups from across the nation. NICHD is currently adapting this model for a "mini-CARRA" to include public members in review and other activities.
Contacts: Jane Jacobs, Program Manager (NCI), 301-451-3393
Lisa Kaeser, Senior Analyst (NICHD), 301-496-0536
Research Participant Advocacy
Several ICs have institutionalized the concept of advocacy for clinical research participants. Selected examples follow:
- In early 2001, NCRR began funding the position of the Research Subject Advocate (RSA) at each of the General Clinical Research Centers (GCRCs). The RSA assists GCRC investigators, nurses, and staff in the safe and ethical conduct of GCRC studies and represents the interests of research participants on GCRCs. Most RSAs are physicians; some are nurses, pharmacists, or biomedical ethicists.
- Participants in NIAMS intramural research studies are assigned a Health Liaison who serves as an escort and, when necessary, an advocate for the patient.
- NHLBI currently supports a trial of pediatric hydroxyurea in sickle cell anemia in infants and children up to age 2 (BABY HUG.) The trial seeks to extend findings about the benefits of this drug in older children. Its design includes a requirement for a special patient advocate at each enrolling site to help decide if participating in the trial is truly in the best interests of the child.
Contact: Duane Bonds, 301-435-0055
Information for Participants
The primary source of information about ongoing trials is the NIH-supported site www.ClinicalTrials.gov, and a link to it is featured on many IC websites. Several ICs provide educational materials for trial participants ranging from descriptions of specific trials to information about trial design and factors for potential participants to consider. Examples include:
- NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN) is composed of university drug abuse researchers and community treatment providers working together to test science-based treatments in community settings. This CTN infrastructure, established in 1999, has grown to include 17 research centers covering 27 states. Educational programs about clinical trials have been conducted in 117 community treatment programs (CTPs) to community members, providers and practitioners across the country.
- NCI's Clinical Trials Education series is designed for cancer patients, health professionals, and the general public. It consists of 13 different educational materials (books, booklets, slides, videos) that can be ordered separately or viewed online.
- NIAID's Equal Access Project is targeted to minority populations to help educate them about clinical trials and encourage their participation.
- Other examples of innovative educational materials include NIMH's Participants' Guide, NCCAM's website information, and PowerPoint presentations available from NIDCR.
Ongoing Community Relationships
Long-term trials and longitudinal studies often involve ongoing relationships with communities and clinical trial participants. Examples include NHLBI's Framingham and Jackson studies and the Women's Health Initiative.
http://www.nhlbi.nih.gov/about/framingham/index.html http://jhs.jsums.edu/jhsinfo http://www.nhlbi.nih.gov/whi/index.html
Other Innovative Approaches
Research Advocacy Community
A number of coalitions have formed around IC activities involving patient and research advocates, professional organizations, and philanthropists. Such groups can support efforts in health promotion and disease prevention, increase public interest in specific studies, and form partnerships encompassing an IC's entire program. In addition, most ICs and other components-including the Council of Public Representatives-have electronic newsletters, listservs, or options displayed on their websites to sign up for electronic updates.
- NINDS spearheaded the Brain Attack Coalition in the late 1990s when the advantages of rapid treatment of stroke became clear. Professional, voluntary, and government groups look to the Coalition as a source of information for recommended guidelines, clinical pathways, and the latest research developments.
- NIAAA's Leadership to Keep Children Alcohol Free brings together Governors' spouses, Federal agencies, and public and private organizations to prevent the use of alcohol by children age 9 to 15. It is the only national effort that focuses on alcohol us in this age group. The initiative was founded by the NIAAA and the Robert Wood Johnson foundation, and has been joined by additional Federal sponsors.
- The Outreach Partnership Program is a nationwide initiative of the NIMH with support from NIDA and SAMHSA's Center for Mental Health Services (CMHS.) The purpose of the program is to enlist national and state organizations in partnerships to help bridge the gap between research and clinical practice by disseminating the latest scientific findings, informing the public about mental disorders, alcoholism, and drug addiction, and reducing the stigma and discrimination associated with these illnesses. The program strives to increase public awareness about the importance of basic and clinical research in improving treatments for, and ultimately curing, mental illnesses and addiction disorders through advancing knowledge about the brain and behavior.
- Several ICs have offered variants of "NIH 101" to advocacy groups. These overviews of how grants are reviewed and funding decisions are made can be tailored to the audience at hand, including the general public and the external research community as well as the research advocacy community. The concept is now being broadened to cover other topics of interest, such institutional animal care and use committees. Most of the information-often tailored to an IC's constituency-can be found on the OER or CSR home page or on individual IC pages.
External Scientific Community
OER and CSR have developed a wealth of useful information for the external scientific community and made it available on their websites. Several ICs have linked to this information (e.g., NCI), or tailored it to their grantee and applicant communities (e.g., NIAID.) Training in grantsmanship and peer review is useful for the research advocacy community as well, and dovetails with the "NIH 101" efforts described above. Staff of CSR and most ICs conduct live training sessions at professional societies as well, often targeted to potential minority applicants.
- NIMH and the New York Academy of Medicine sponsored a meeting, "Ethical Issues Pertaining to Research in the Aftermath of Disaster" January 13-14, 2003. The attendees included 37 mental health professionals, trauma researchers, public health officials, ethicists, Institutional Review Board (IRB) representatives, as well as family members and first responder representatives from the Oklahoma City and World Trade Center disasters. The purpose of the meeting was to examine evidence concerning the impact of research on trauma-exposed participants, review the applicable ethical principles and policies concerning protection of human subjects, and offer guidance to investigators, IRBs, public health and local officials, and others interested in assuring that research in the aftermath of a disaster is conducted in a safe and ethical manner.
- Inclusion of public members on site review teams (NCI's CARRA and NICHD counterpart) can educate investigators about important public perspectives and concerns. See information on NCI and NICHD programs under "Clinical Trial Participants," above.
- The NIAMS annual extramural retreat includes non-NIH researchers and other members of the public.
Contact: Dr. Janet S. Austin, Director, Office of Communications and Public Liaison, NIAMS (301) 496-8190
Assisting Investigators and Applicants
Several ICs have developed improved informed consent documents, reference materials, and procedures to assist grantee investigators and applicants.
- ORWH's "Outreach Notebook for the Inclusion, Recruitment, and Retention of Women and Minority Subjects in Clinical Research" is a comprehensive primer explaining the scientific rationale and policy basis for diverse and inclusive populations in clinical research. It includes practical suggestions for inclusion, recruitment, and retention of women and minority participants in clinical trials and studies.
- NIAID's Stem Cell Transplantation for Autoimmune Diseases program is developing a video to accompany the written informed consent that will explain the tests and procedures that will be performed while participating in the clinical trial.
NEI requires that trial-specific informed consent documents be submitted prior to the initial review.
Contact: Lore' Ann McNichol, Ph.D. 301-451-2020.
- In 1999 the National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), convened a day-long working group on "Communicating Informed Consent to Individuals Who Are Deaf or Hard-of-Hearing," in Bethesda, Maryland. The purposes of the meeting were: (1) to clarify issues of informed consent; (2) to develop guidelines for use by scientists who are recruiting deaf or hard of hearing individuals to participate in clinical research; (3) to highlight materials for the scientific community to use in facilitating clear communication between deaf or hard-of-hearing research volunteers and scientific investigators in clinical research. Based on those recommendations, NIDCD has prepared a brochure to improve understanding of informed consent among deaf and hard-of-hearing individuals.
Minority Outreach Programs
Outreach to minority students and researchers is an important component of many institute programs. As the principal NIH supporter of research training, NIGMS provides a range of outreach efforts aimed at enhancing the diversity of the research workforce:
- Frequent staff presentations at national meetings about training in general and to recruit underrepresented minority students into biomedical and behavioral science careers.
- NIGMS web site contains considerable information on research and training opportunities for underrepresented minority students and for students in general.
Contact: http://www.nigms.nih.gov/minority/, http://www.nigms.nih.gov/training/
- NIGMS brochure on Minority Opportunities in Research Programs
- Since an important part of the NIGMS mission includes increasing the number of minority students who pursue careers in the biomedical and behavioral sciences, activities relevant to career development are sponsoring the Annual Biomedical Research Conference for Minority Students (ABRCMS) national meeting and supporting meetings of the Society for the Advancement of Chicanos and Native Americans in Science (SACNAS). Both meetings have strong components of career information.
- NINR maintains an online free research training course (with CEU's) titled: Research Training: Preparing Nurse Scientists. A second level course for intermediate researchers is in its first year and is presented at regional research conferences by NINR staff and key investigators in the region. It will eventually be online also. NINR staff present at regional research meetings and the Office of Science Policy and Public Liaison provides brochures and other printed and audiovisual materials for the meetings. Career information is also available on the NINR website.
Requiring community participation and engagement in certain types of research projects is a strategy employed by several institutes.
Summer-long programs for college and high school students also provide an opportunity for young people to experience the research environment first-hand and to receive academic and career information from mentors and colleagues. Other offerings focus on enhancing the research skills of current and potential investigators.
- NCI offers an online course on "Incorporating Clinical Trials Into Your Practice." Clinical Trials are critical to understanding both the causes of cancer and how best to treat the disease. Cancer care and oncology clinical practices have been significantly advanced because of clinical trials. Yet, fewer than 3% of adult cancer patients participate in clinical trials. This course is intended to emphasize the importance of cancer clinical trials and provide practical information and guidance to health care professionals contemplating referring patients to, or conducting, clinical trials. It will bring to the forefront some of the challenges clinical trials investigators face when attempting to incorporate clinical trials into their practice, and will address solutions for meeting those challenges.
- A Summer Genetics Institute hosted by NINR has included 102 graduates since its inception in 2000. This eight week course is designed to provide a foundation in molecular genetics for use in clinical practice and the research laboratory. Basic concepts and principles of genetics are covered in the lecture component. The laboratory component focuses on techniques integral to current molecular genetics. Tutorials, utilizing a case-based approach, are used to integrate the concepts and principles of genetics with laboratory experiments that are designed to provide an understanding of genetic testing, detection of genetic disease, how to understand the strengths and limitations of genetic approaches and how to use the information clinically to counsel individuals and families. Ethical, legal and clinical practice issues and perspectives, and the role of the nurse in the area of genetics are also addressed in a seminar format.
Contact: Melinda Tinkle 301-402-7889;
- A partnership of the NIH, the Foundation for the National Institutes of Health, and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) hosts a Biomedical Engineering Summer Internship Program (BESIP) at the NIH. This ten week summer program, formerly sponsored by the Whitaker Foundation, allows undergraduate biomedical engineering students to participate, under the mentorship of world class scientists in cutting edge biomedical research projects in NIH laboratories.
- NHGRI's Office of the Director's Education and Community Involvement Branch is currently working on a DVD project featuring career opportunities in genomics. It will be an interactive, user-friendly tool (for computer or television use) to inspire high school and college students to pursue careers related to genomics, exposing students to the large variety of fields that overlap with genomics, including law, politics, art, education, alternative medicine, psychology, and agriculture.
- NIA offers a "Summer Institute on Aging Research." This one-week training initiative, done in partnership with the National Center for Minority Health and Health Disparities (formerly the Office of Research on Minority Health), is highly competitive and supports training experiences for scientists at the beginning stages of a research career in aging. Minority applicants are highly recruited to participate in this initiative.
Internal Scientific Community
Research conducted in the intramural programs is subject to the same policies and guidelines as research funded by grants and contracts. NIH intramural investigators work with participants and communities throughout the U.S. and the world, as well as nearby areas. In addition to the resources outlined above, the ICs offer programs tailored to the needs of their investigators and the participants and communities involved. Examples include:
- The NIEHS IRB offers regular training to its members. Training is conducted by the Ethics Officer or by a subject matter expert on the IRB. Training is typically scheduled when there is an issue suggesting a need for it. IRB members are encouraged to attend relevant meetings at local institutions as well as meetings of national organizations focusing on research ethics or other issues of public trust. The NIEHS IRB hosted a one-day workshop for colleagues at other research organizations in Research Triangle Park on September 23, 2005.
Contact: Dr. Marian Johnson-Thompson, 919-541-4265
- NCI has developed a class on Human Subjects Protections Education for Researchers. This free, web-based course presents information about the rights and welfare of human participants in research. The two-hour tutorial is designed for those involved in conducting research involving human participants. It is also available to extramural scientists and satisfies the NIH human subjects training requirement for obtaining Federal Funds.
- The intramural program of the NCI is one of the largest centers for cancer research in the world, with over 300 Principal Investigators and 900 Postdoctoral Fellows. Over 50% of the postdoctoral fellows come from foreign countries, with varying cultural backgrounds. The Cultural Sensitivity Training (CST) course examines differences in language, and both verbal and non-verbal communication, styles, and expression of emotion.
This was conducted in 2004 but enrollment was insufficient in 2005.