In all cases, when in doubt, ask them for their assistance. Be sure to check in with your research protections office to see whether they leave the determination in the hands of the investigator or require a formal determination be made by their office. Information limited to a stakeholder’s professional role will not typically bump them into a ‘human subject’ but information like gender, race, and exact length of tenure within their current role, may.įederal regulations do not speak to who has the authority to make the above determinations, though your local institution may. When gathering characteristics of the stakeholders themselves, it may sometimes be only this information that pushes the activity into the category of ‘human subjects research’ and so investigators should consider whether/how much demographic information is useful for their study purposes. Is there another, more general, way to get at the information you are seeking? When gathering information about the main subject matter, think about how the questions are posed – “How do you feel about…”, “What is your opinion of…” tend towards a ‘human subject’ categorization. This includes not only information about the main subject matter, but any demographic information that the investigator would like to collect about the stakeholders themselves. Whether a stakeholder is considered a human subject depends on the type(s) of information the investigator is seeking to obtain. (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” 45 CFR §46.102(e) (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens or Human subject is defined as “a living individual about whom an investigator (whether professional or student) conducting research: Otherwise, consider the definition of human subject. If the activity does not meet the definition of research, there is no need for further evaluation – it is not human subjects research and does not require IRB oversight. That said, it is not unusual for stakeholder activities to be considered research. Of note, the expectation of publication does not, in and of itself, make something research. It is often the last part of the definition that requires the most thought. Research is defined as “ A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” 45 CFR §46.102(i) To be considered “human subjects research,” the activity should fit the regulatory definitions of both ‘research’ and ‘human subjects’. This also requires up-front investigation, assessment, and piloting of translated materials. We would also encourage PIs to think about linguistic/dialect differences in the communities of patients for whom they need translation and be thoughtful about drafting materials that are easy to understand and consider both people living with dementia (PLWD) and their care partners as readers of these materials. PIs may also want to include team members who can provide translation services “in-house” to keep costs down if budgets are limited. Because rates can fluctuate from region to region, we suggest using local reputable and healthcare-specific translation services that have contracts with hospitals, clinics, and/or nursing homes that serve patients with Alzheimer’s disease and related dementias (ADRD) and their care partners. The Health Equity Team would encourage principal investigators (PIs) to engage in up-front investigating and request quotes from translation services in the local area to get an idea of costs for the budget. NIA IMPACT Collaboratory Transforming Dementia Care
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