Source: https://www.niaaa.nih.gov/about-niaaa/our-work/advisory-council/agenda-minutes/advisory-council-meeting-minutes/minutes-fourth
Timestamp: 2018-09-25 22:31:36
Document Index: 368493492

Matched Legal Cases: ['art 2', 'art 46', 'art 46', 'art 46', 'art 2', 'art 2']

Minutes of the Fourth Joint Meeting of the National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National Cancer Advisory Board | National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Minutes of the Fourth Joint Meeting of the National Advisory Council on Alcohol Abuse and Alcoholism, National Advisory Council on Drug Abuse, and National Cancer Advisory Board
Minutes of the Fourth Joint Meeting of the
Deborah Watkins Bruner, R.N., Ph.D
NIDA, Director, Division of Extramural Research: Susan B. Weiss, Ph.D.
NIDA Senior Staff: Joellen M. Austin, M.P. Aff., M.S.M.; Carlos Blanco, M.D., Ph.D.; Cheryl Boyce, Ph.D.; Kevin Conway, Ph.D.; Dave Daubert; Gaya Dowling, Ph.D.; Roger Little, Ph.D.; Ivan Montoya, M.D.; Joni Rutter, Ph.D.; Phil Skolnick, Ph.D., D.Sc.; Jack Stein, Ph.D.; Mark Swieter, Ph.D.; Betty Tai, Ph.D.
NIAAA Senior Staff: Vicki Buckley, M.B.A; Ralph Hingson, D.Sc.; Robert Huebner, Ph.D.; Gary Murray, Ph.D.; Antonio Noronha, Ph.D.; Kenneth Warren, Ph.D.
NCI Senior Staff: Robert Croyle, Ph.D.; Michele Bloch, M.D., Ph.D.; Glen Morgan, Ph.D.
Dr. George Koob began his presentation with a review of NIAAA’s goals and activities, including the obtaining of FDA approval of more medications for alcohol use disorder (AUD); implementation of effective behavioral treatments for AUD; implementation of effective prevention strategies for adolescent drinking; implementation of effective prevention strategies for drinking during pregnancy; development of effective treatments for fetal alcohol spectrum disorders (FASD); elimination of alcohol-related HIV pathology; development of effective treatments for alcoholic liver disease; appropriate treatment of co-morbidities associated with AUD; successful recruitment of young investigators to the alcohol field; elimination of disparities in the alcohol field; and equal pay for women and minorities in the alcohol field.
Integrated Neuroscience Initiatives on Alcoholism Consortium (INIA). This consortium is a merger of the INIA Stress and INIA Neuroimmune consortia. INIA Stress’ s goal is to elucidate adaptations to chronic alcohol in corticolimbic and corticostriatal brain circuitry and to understand synaptic mechanisms that underlie altered response to stress, which in turn can facilitate the transition from moderate/controlled drinking to excessive and habitual drinking. INIA-Neuroimmune’s goal is to identify the genomic, cellular, and behavioral neuroadaptations related to excessive alcohol consumption, focusing on the importance of neuroimmune and inflammatory signaling systems in promoting and maintaining excessive drinking; and to use this information to determine & test medication(s) in the treatment of an AUD.
Surgeon General’s Report on Substance Use, Addiction, and Health: NIAAA and NIDA have played major roles in the development of the first Surgeon General’s Report on Substance Use, Addiction, and Health, to be released in 2016. The report will present the state-of-the-science on alcohol and other substance misuse from the perspectives of neurobiology, prevention, treatment, recovery, and delivery of care. It will provide a comprehensive review of the research literature on alcohol, drugs, and health; outline potential future directions; and educate, encourage, and call upon all Americans to take action.
Publications: An NIAAA priority is to educate and inform health care professionals and the public about the effects of alcohol and treatment options. Publications are available on the NIAAA website.
Discussion: Mr. Robert Rancourt noted the central role that alcohol and drug use plays in the criminal justice system and the scarcity of resources to address the issue. He asked if NIAAA had established protocols for early intervention/treatment within the justice system and if it had reached out to the judiciary to share them. Dr. Koob responded that NIAAA has not yet done so, but the issue has been raised in Council discussions and he expects it will be part of the NIAAA strategic plan. Dr. Volkow explained that NIDA has a research network in the judicial system, which is now focused on juvenile offenders. This could provide an infrastructure for disseminating information. Dr. Arun Sanyal pointed out the critical need to translate basic research into implementation in the field. Dr. Koob said NIAAA is working with other government agencies, such as the Substance Abuse and Mental Health Services Administration (SAMHSA), the Office of National Drug Control Policy (ONDCP), and the Center for Disease Control (CDC) to accomplish this goal.
Dr. Laura Bierut noted that she sits on the Big Data to Knowledge (BD2K) Council and wondered how the Institutes are thinking about their interaction with BD2K. Dr. Volkow responded that the ABCD and the Precision Medicine Initiative provide opportunities for the ICs to contribute. Dr. Koob stated that Dr. Philip Bourne, NIH Associate Director for Data Science, has been reaching out to the ICs on this topic, and NIAAA is actively working on these issues. Dr. Croyle noted greater interaction between the ICs and BD2K can be anticipated; a broader challenge 10-15 years out is integration of NIH data with the data systems of healthcare organizations outside the government.
42 CFR & Precision Medicine
Sensitive data and vulnerable populations are critical to include in the long-range implementation of the PMI Cohort Program since NIH is seeking a nationally representative dataset. If the technological infrastructure for the PMI Cohort Program is built without considering all possible use cases, it may be difficult to retrofit the system to include vulnerable populations later leading to a biased data set. This has the potential to exacerbate health disparities.
There is a complicated regulatory framework that must be addressed. Federal and state regulations on health information privacy and research pose challenges for inclusion of substance use disorder (SUD) treatment data (42 CFR Part 2); specialty mental health treatment data (laws vary by state); incarcerated populations (45 CFR Part 46, Subpart C); children and adolescents (45 CFR Part 46, Subpart D); and people who are decisionally impaired (45 CFR Part 46). Three PMI Cohort Program workgroups are addressing these issues, including one on sensitive data and vulnerable populations, chaired by Dr. Boyle; one on addressing state laws; and one on policy issues related to PMI.
PMI needs to start by addressing the current regulations; however, it should also follow the new ones so they can adapt quickly when needed. The Advisory Committee to the Director (ACD) Proposal Registry for PMI is a hub and spoke model with the hub being core data and the spokes addressing more specialized information. In this hybrid data model, different levels of access based on data needs and security capabilities will be determined by a resource access subcommittee. Under the current rule patient consent would be required to contribute information to the registry and an additional consent would be required to send personally identifiable substance use disorder treatment information to any researchers not named in the original consent. Under the proposed rule the PMI registry would be a lawful holder of the Part 2 data and could make the determination to share the data with a qualified researcher as discussed above.
The implications of the regulations governing specific special populations, i.e., the incarcerated, adolescents, and the decisionally impaired, are currently being considered as well. There are IRB requirements about addressing the needs of those populations, so NIH needs to address these use cases within the context of the PMI Cohort Program. How the regulations are ultimately interpreted with be important.
Dr. Bierut stated that the field needs to change its thinking because everything needs protection, e.g., HIV status, pregnancy. Mental health is no different from any of those; behavioral health is part of health in general. The separation in general creates stigma, lack of research, etc. Dr. Boyle noted that behavioral health is different because of criminal and civic concerns, e.g., the data an individual gives to his or her doctor can’t be used against the individual criminal case, by employers, in child custody decisions, etc. HIPAA doesn’t provide that. It would be good to have one central set of standards that governs all sensitive health data so that organizations can implement one process to address them all and health information technology can be designed to address the single standard instead of having to meet various standards across states. In addition, legislation that would protect patient reported information would go a long way, e.g., anything people tell their doctor can’t be used against them.
Discussion: Dr. Eberwine inquired about how the Common Rule deals with metadata regarding biospecimens. Mr. Paine replied that it doesn’t treat such data separately. What matters is if the data is identifiable or not. If it’s not identifiable, then there are no new requirements. Judge Flies-Away noted that some tribal organizations have their own IRBs and their own regulations about data sharing.
In addition, beginning in 2016, a common review panel will be established for NIAAA and NIDA institutional National Research Service Award (NRSA) applications. This strategy should increase the pool of reviewers, broaden their expertise, and address reviewer bias against trainees studying other IC’s priority areas. It should also communicate to the research community that NIDA and NIAAA leadership support training that is broad and inclusive of multiple substances. This will not replace Institute-specific training programs, which remain important to both Institutes, especially in certain topic areas (e.g., alcohol-related liver disease). It will be implemented by an NIAAA/NIDA working group.
Note that this will not apply to NCI training applications, because there are few that are specifically focused in this area.
Dr. Bierut inquired if the study has considered providing feedback to the parents as an incentive to continue. Dr. Dowling responded that clinical information would not be provided to parents. One site plans to give out t-shirts with the participant’s brain scan on the front. Dr. Volkow commented that the study needs to be mindful of not discriminating or creating stigma, e.g., for a child whose development is delayed.
Dr. Auerbach asked about the message given to potential participants about why they should participate. In the context of earlier discussion regarding CFR Part 2, how does consent work with a child and parents together? Whose consent is more important? Dr. Dowling said their elevator speech is that this is a national study of brain development and the opportunity to contribute to a body of knowledge that can help children develop in the future. NIH and study investigators think people are attracted to the brain images. There are a lot of issues around informed consent. Dr. Murray, who sits on the bioethics and medical advisory group, stated that both parent consent and child assent are required. As children get older, they will also have to give consent.