7.1 NAMI’s Support
(7.1.1) Neuroscience research, behavioral research, pharmaceutical research, clinical research, as well as service system research are some of the initiatives supported by NAMI. To this end, NAMI calls upon Congress and the Executive Branch to focus more attention on research, treatment, education, and rehabilitation related to serious mental illnesses and to appropriate funds sufficient to make that promise a reality. NAMI supports both effectiveness and efficacy based research, focusing on severe and persistent mental illnesses, especially those with markedburdens of disease. NAMI expects the rigor and pace of the field of services research to be equal to that of biomedical research.
(7.1.2) Given the role culture plays in all aspects of mental health, it is imperative to focus more attention on culture specific mental health and substance use research. The National Institutes of Health (NIH) and its National Institute of Mental Health (NIMH) must increase funding for culturally specific mental health research, specifically in reference to persons of different ages and of varying cultures, racial, religious, ethnic, sexual orientation, gender, gender identity, and disability, including persons who are deaf and hearing impaired, and those for whom English is not the primary language. Particular attention must be given to areas such as epidemiology, psychopharmacology, diagnosis and assessment, prevention, evidence based practices, disparities, and cultural competence.
(7.1.3) Given the importance of evidence-based, promising and emerging practices in the current climate of mental health care, NAMI calls for the inclusion of diverse stakeholders in the development and testing of evidence-based practices (EBPs). To ensure quality of care for diverse communities, cultural competence must be defined and required for EBPs, and it should be incorporated into the development and implementation of existing and emerging EBPs.
The process of developing and credentialing EBPs needs to be modified to be inclusive of diverse communities and culturally competent community based practices. The process of implementing EBPs in these communities and with these specific populations must be supported with resources, including resources to document and test community based practices
7.2 Standards for Protecting the Well-being of Individuals Participating in Research
(7.2.1) NAMI accepts the critical necessity for research using human subjects, acknowledges the important contribution of persons who become human subjects, and affirms that all such research should be conducted in accordance with the highest medical, ethical, and scientific standards.
(7.2.2) National standards to govern voluntary consent, comprehensive exchange of information, and related protections of persons with cognitive impairments who become research subjects must be developed and they must include the interests of persons who become human subjects, families, and other caregivers.
(7.2.3) Participants in research and their involved family members must be fully and continuously informed, orally and in writing, about all aspects of the research throughout the process. Research investigators must provide information in a clear, accessible manner to ensure that participants and their involved families fully understand the nature, risks, and benefits of the research.
(7.2.4) The consent protocol must provide clear and understandable information that is linguistically appropriate on an individual basis for each participant and the participant’s family members. The consent protocol must provide information about the purposes and scale of the research, what is hoped to be learned, prospects for success, and potential benefits and risks to the individual (including options for treatment other than participation in research, since research is not the same as treatment). The consent protocol should also contain information about the function of the institutional review board (IRB), the identity of the IRB administrator, the address and telephone number of the IRB administrator and other information, as appropriate. The consent protocol and information for the subject and his/her family members should include a procedure for responding to medical and psychiatric emergencies. Research protocols should develop and implement a concrete plan to address these emergencies.
(7.2.5) Whenever consent is given by someone other than the research participant, the participant and involved family members must receive information on the same basis as the person actually giving consent.
(7.2.6) Research participants should be carefully evaluated before and throughout the research for their capacity to comprehend information and their capacity to consent to continued participation in the research. The determination of competence shall be made by someone other than the principal investigator or others involved in the research. Except for research protocols approved by the institutional review board (IRB) as minimal risk, whenever it is determined that the subject is not able to continue to provide consent, consent to continue participation in the research shall be sought from families or others legally entrusted to act in the participant's best interests.
(7.2.7) Research participants should be encouraged to develop psychiatric advance directives prior to beginning their participation in research protocols, indicating their research and treatment preferences should they become incapacitated at any point during their participation.
(7.2.8) Institutional review boards that regularly review research proposals for serious mental illnesses must include public participants who are consumers and family members who have direct and personal experience with serious mental illnesses.
(7.2.9) Members of IRBs approving research on individuals with serious mental illnesses must receive specialized training about serious mental illnesses and other cognitive impairments and the needs of individuals who experience these disorders. Persons with serious mental illnesses and members of their families must be integrally involved in the development, provision, and evaluation of this training.
(7.2.10) Without penalty, a research participant must be free to withdraw consent at any time, with or without a stated reason. Any time a participant terminates participation, regardless of the reason, investigators will make every effort to ensure that linkages to appropriate services occur with follow-up to assist that participant to establish contact with appropriate service providers and/or care-givers in a timely manner. If a participant disappears or terminates his or her continued consent, the investigator shall contact his or her family or others designated to receive notification and information.
(7.2.11) When participation by an individual in a research protocol is completed, participants and/or their families are entitled to be informed of results as soon as this information is available, to have the opportunity to receive feedback concerning their individual participation in the protocol, to critique the protocol, and to provide input concerning possible additional research.
(7.2.12) All participants in research protocols involving the assessment of new medications will be provided with opportunities by the investigator for a trial on the medication being studied, so long as other research on the new medication has demonstrated potential safety and efficacy.
(7.2.13) All individuals who have benefited from the administration of experimental medications in research will be provided continual access to the medication by the investigator without cost until a source of third-party payment is found or until the medication is approved for use.
7.3 Biomedical Research
(7.3.1) NAMI strongly encourages the donation of human organs and other tissue for transplant, research, and education, and the donation of tissue samples to developing gene banks. NAMI recognizes the severe shortage for research purposes of postmortem human brain tissue of persons who were afflicted with serious mental illnesses and members of their immediate families. All brain and tissue samples donated should be accompanied by appropriate clinical records.
(7.3.2) NAMI believes that the careful, responsible use of animals is indispensable in research on serious mental illnesses. At the same time, NAMI advocates the use of non-animal systems whenever feasible and urges researchers to observe the traditional, compassionate standards of animal experimentation; and to comply fully with the Federal Animal Welfare Act.
7.4 Psychopharmacological Research
(7.4.1) NAMI supports making psychopharmacological research a priority, given its impact on persons with serious mental illness and their families. Psychopharmacological research must include research on the efficacy of medications on populations of varying ages, genders, and varying racial and ethnic backgrounds.
(7.4.2) With Board review, NAMI may support legislation to place reasonable caps on product liability awards to encourage greater research and development.
7. 5 Disclosure of Potential Conflicts of Interest
(7.5.1) In order to maintain trust in the research endeavor, any situations that may create the appearance of a conflict of interest should be disclosed to potential participants in research. The source of funding for the research should always be disclosed.
(7.5.2) Examples of other required disclosures include:
- Investigators or institutions holding relevant stock or patent rights, serving as a paid advisor to the sponsor, or receiving direct or indirect honoraria from the sponsor for speaking about the class of products;
- Payments contingent on the number of subjects entering and/or completing the study, including payments made to recruiting firms or individuals;
- Investigators who also serve as the primary clinician (in which case the clinician/investigator should offer the opportunity of having an independent clinician involved in significant decisions.)
- Other individuals involved in the research or funding review process must disclose any vested interests they have in the research.