National Institute on Drug Abuse Policy on Hiv Education, Counseling, Testing, and Treatment for Research Subjects

Notice Number: NOT-DA-07-013

Key Dates
Release Date: February 22, 2007

Issued by
National Institute on Drug Abuse (NIDA), ( http://www.nida.nih.gov )

PURPOSE  

In 1995, the National Institute on Drug Abuse (NIDA) established a policy intended to reduce drug abuse-related transmission of HIV in its study populations. The policy encouraged NIDA-funded researchers to make HIV-risk reduction counseling and testing available to subjects at high risk for acquiring or transmitting HIV. In recognition of concerns about other infectious agents and their linkages with both drug abuse and HIV, in 2001 the 1995 policy was revised ( http://grants.nih.gov/grants/guide/notice-files/not95-154.html ) to include hepatitis B (HBV), hepatitis C (HCV), tuberculosis, sexually transmitted diseases (STDs), and other infectious agents in addition to HIV (http:// grants.nih.gov/grants/guide/ notice-files/NOT-DA-01-001.html) . Since the 2001 policy there have been significant advances in rapid HIV testing and in effective treatments for HIV. CDC estimates that one quarter of the persons living with HIV in the U.S. do not know that they are infected. Those unaware of their HIV-positive status have a greater risk of transmitting HIV. They are also unlikely to receive treatment early in their disease; many will not learn their serostatus until they receive a diagnosis of AIDS. Mounting evidence suggests that starting antiviral therapy earlier is more likely to lead to normalized CD4 counts and virologic suppression and slower disease progression. In addition, the nature and prevalence of infectious and other co-morbid diseases linked to both HIV and drug abuse is consistently evolving, and varies significantly in different settings (domestic and international).   In light of these advances and in recognition that opportunities for appropriate education, referrals, counseling, testing, and treatment will vary with the characteristics of populations studied, research design, and research context, this Notice revises the 2001 policy. NIDA's policy is that NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally.   As a public health research institute, NIDA believes that researchers share the responsibility for preventing the acquisition and transmission of HIV and helping individuals to find treatment for drug abuse and its comorbid conditions. Educating, facilitating testing for research subjects, and helping to link research subjects with HIV treatment in research related or local health care facilities is the most efficient way to increase identification and treatment of HIV and drug abuse related infectious and other co-morbid diseases. Where facilities do exist and where appropriate to the research, investigators are encouraged to offer educational materials, testing, and treatment for other infectious diseases. Special consideration should be given to providing educational materials focused on the prevention, testing, and treatment for other infectious diseases (e.g. HBV and HCV) that are common among drug abusers. Referral to HBV and other available vaccinations should be included in prevention efforts. Investigators funded by NIDA to conduct research in community outreach settings, clinics, hospitals, drug treatment programs, or other clinical settings who have contact with research subjects at risk for acquisition or transmission of HIV are strongly encouraged to provide education, counseling, and information on how to obtain treatment to those individuals. This policy covers NIDA sponsored studies in which persons, who are being screened as potential subjects are tested for HIV, whether or not they later meet study inclusion criteria. Investigators should consider appropriate referrals to testing and treatment services if they are not available at the on-site location.  

At minimum, education in a verbal format or easy-to-read materials on drug abuse and HIV/AIDS should be available to research subjects when the study (e.g., surveys, ethnographic or field studies) is not based in or directly affiliated with a counseling, testing or treatment facility. In general, investigators conducting research in clinical or laboratory settings that provide diagnostic, treatment, or other health or social services over a period of time will be more likely than other investigators to have the resources to provide or refer subjects to HIV counseling, testing and treatment. To the extent feasible, investigators in such settings are expected to provide subjects with such services or referrals.

In keeping with NIH's authority to conduct research, 42 U.S.C. §284(b)(1 ), NIDA funds are not to be used to support testing, counseling and treatment services for HIV that are outside the scope of the NIDA sponsored research design. It is, however, important that research subjects who are at risk for HIV receive such services. Therefore, investigators are strongly encouraged to seek and identify alternative sources of funding for the provision of appropriate diagnostic and therapeutic services for their research subjects.

Educational and counseling materials developed by NIDA ( http://www.nida.nih.gov/infofacts/DrugAbuse.html ), the Centers for Disease Control and Prevention (CDC) ( www.cdc.gov/hiv/HIVinfo.htm ), the Substance Abuse and Mental Health Services Administration ( http://www.samhsa.gov/Matrix/matrix_HIV.aspx ), and the National Institute of Allergy and Infectious Diseases (NIAID) ( http://www.niaid.nih.gov/publications/aids.htm ) are available for use by interested parties, grantees, and contractors. Appropriate educational materials (manuals, brochures, and posters) may also be obtained by calling or writing the National Clearinghouse for Alcohol and Drug Information (1-800-729-6686) and AIDSInfo www.aidsinfo.nih.gov ; 1-800-HIV-0440 (1-800-448-0440) . The CDC WEB site also provides links to HIV testing sites.   NIDA grantees should provide in all Progress and Final Reports submitted to the Agency a rationale and description of the services provided or their efforts to link subjects to appropriate services provided under this policy. Instructions for Progress Reports are provided at http://grants.nih.gov/grants/funding/2590/2590.htm and http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-06-058.html .  

Additional information regarding this policy can be found in a document entitled “ Rationale for Modifications to the 2001 National Institute on Drug Abuse Policy on Counseling and Testing for HIV/AIDS and other Infectious Diseases” at http://www.nida.nih.gov/about/organization/arp/arp-pa&rfa.htm .

Inquiries

For additional information on this policy, contact:  

AIDS Research Program
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd.
Rm. 5274, MSC 9581
Bethesda , MD 20892
Telephone: 301-443-1470
Email: le30q@nih.gov


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