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. 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. PIs may also want to include team members who can provide translation services “in-house” to keep costs down if budgets are limited. 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. This also requires up-front investigation, assessment, and piloting of translated materials.

Topic: Stakeholder Engagement

The short answer is, it depends.  To be considered “human subjects research,” the activity should fit the regulatory definitions of both ‘research’ and ‘human subjects’.

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)

It is often the last part of the definition that requires the most thought.  Of note, the expectation of publication does not, in and of itself, make something research. That said, it is not unusual for stakeholder activities to be considered research.

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.  Otherwise, consider the definition of human subject.

Human subject is defined as “a living individual about whom [emphasis added] an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” 45 CFR §46.102(e)

Whether a stakeholder is considered a human subject depends on the type(s) of information the investigator is seeking to obtain.  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. 

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.  Is there another, more general, way to get at the information you are seeking?

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.  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.

Federal regulations do not speak to who has the authority to make the above determinations, though your local institution may.  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.  In all cases, when in doubt, ask them for their assistance.

Whether or not stakeholder activity is considered human subjects research, investigators should always make sure they are asking for the most limited amount of information that they need, and that they have procedures in place to maintain confidentiality and privacy to the extent possible.

Based on my experience, incentives vary from one organization to another and from the culture of one group of health professionals to another.  I typically ask the early adopters, key stakeholders or persons involved, what do they need and what would be helpful to them.  I then develop incentives based on their responses.  In other words there isn’t one incentive that works across the board.  Some of the incentives that have been stated previously by stakeholders are the following:  sponsored breakfast or lunch; opportunities for expert advice; participation in staff meetings to help address complex issues; travel support; possibility for select individuals to engage in a poster or presentation.  

Every health organization is facing a crisis including extreme staff shortages – so understanding what incentives are needed for what problem is also important – it may be staff are just simply too overwhelmed and can’t put anything else on their plate.  Also, we recently encountered in a PACE program we are working on that front line staff who are supposed to implement the evidence based program we are integrating into that setting all had different understandings of the demands of what we were asking – so we participated in a staff meeting to show how the program could help them, address the workload question directly and provided a brief checklist of what we were asking of them – which was actually quite minimal.

Response from Implementation Core Members:

• Raffle or offer certificate for dinner for two ($150.00)
• Raffle Chromebooks
• One clinical site wanted a subscription to a journal for a year
• Sponsored breakfast or lunch
• Opportunities for expert advice
• Participation in staff meetings to help address complex issues
• Travel support 
• Possibility for select individuals to engage in a poster or presentation
• Preparation for and participation in Magnet site visit (research focus) 
• Providing materials for gero nurse certification (purchasing materials)
• Assistance with site newsletters, presentations to Board on research activity 
• Activity supplies for patients/residents 
• Publicity and certificates they can display
• Ask them - what would they/their staff find motivating?
• Look at financial assistance that is at a level to covers some type of service or membership they would normally need to pay (eg. Membership in state association);
• Support one or two staff to participate in some type of training or certificate program for professional development"