Table 3.

Recruitment, Consent, and Protocol-Related Strategies with Exemplar Participant Quotes and Sample Strategies

Strategy focus	Strategy categories	Exemplar participant quotes	Sample strategies
Recruitment and consent strategies	Consent to contact: Strategies for accessing the population through the use of intermediaries or opt-out/opt-in system	“We approached their nurse before we approached the patient to see if there was any reason why they felt like this was not a good time or a good situation to approach the patient from their perspective as a clinician” P023C “We initially would get information from the hospice staff. They would talk to patients and families, get their consent to give us information, consent to contact, and then we would follow up. Then one hospice said, ‘Why don't we kind of turn that around and we will inform the patient that we are participating with you in this study, and we will ask them to sign the form if they are not okay with us giving you information.’ So it actually worked very well.” N057J	(a) Establish partnerships with clinicians to assist in verifying participant eligibility and appropriateness for study. (b) Obtain consent to contact through clinical or community partners (allows potential participants to opt out or opt in without interacting with researcher. (c) Prepare letter of introduction that will be sent to potential participants by clinical or community partners indicating their support of the study that also clarifies right to refuse participation but does not imply participant should participate.
	Initial Contact: Approaches to establishing a relationship with potential participants before inviting participation.	“When I contacted subjects about participating, I sent them a letter explaining the study and I sent them an opt-out card. When I didn't hear back within a certain amount of time, I called them on the telephone and gave them a lot of information about what I would be expecting and also, you know, when they would ask, How have other people done with this? Sort of just walked them through what other people's experiences had been without obviously divulging any personal information.” P009S “The turnaround time was crucial. From the time that I got the phone call that someone was interested, I called them back within 48 hours, and I was in their home as soon as they would allow it.” N003J	(a) Use caring and sensitive language in materials. (b) Set time frame for contact with sensitivity to potential participant's situation. (c) Provide opt-out postcard or phone number to call to opt out with initial letter of information. (d) Share experiences of other participants when describing study. (e) Be prepared to respond quickly to interest in participation. (f) Promise participant that data collection will be stopped if they appear tired or upset.
	Consent process and forms: Strategies related to the process of obtaining consent including the use of surrogates and the approach to ensuring informed consent.	“Patients consented for themselves whenever possible, and then if they were not able to consent and not able to understand what was happening at the time, we needed to go to surrogate consent.” P002C “I repeat things at least twice, verbally and then in writing, and I actually read the consent even though the person says, “Oh yes, I want to do it.” I always have a story explaining to them whey I want to read them the formal document. I purposely read every word and try not at all to give the impression of being rushed.” I007S	(a) Request waiver of informed consent or waver of documentation of informed consent when appropriate to minimize what is asked of participants. (b) Provide alternate forms of consent form that are readable and simplified to supplement (but not replace) the IRB-required version. (c) Read consent form out loud, slowly, to help ensure participants fully understand and have time to process information. (d) Provide examples of the most sensitive study questions in the consent form so participants who agree to participate more fully understand nature of study.
	Decisional capacity: Approaches to assessing the capacity to consent to participation and identifying appropriate surrogates.	“And initially we also had a requirement in there that there was ‘no noted cognitive impairment’ for consenting to the study, but we modified that so that we can enroll hospice patients who are no longer able to provide an informed consent, but can assent to the study itself.” N013J “We used the [IRB] screening tool, so we were prepared to deal with capacity issues to make informed consent. We had a whole piece on assent as well. If we decided that there was someone that wanted to participate, but we were questioning their capacity to give informed consent, we had the whole assent piece in place.” N033S	(a) Assess decisional capacity at time of enrollment if population is anticipated to be impaired. (b) Proactively establish standards and procedures for proxy consent, witness consent, and assent with IRB.
Protocol related strategies	Approaching a Potentially Sensitive Topic: Strategies to gently approach a delicate topic.	“We were at great pains to make sure the interviews were all done in ways that were very sensitive and we used language that gave people an opportunity to not answer or [indicate that certain topics did not apply to them] – all those kinds of things.” N069J “We are very careful in the way that we word our consent form and our questionnaires to try and make it clear that individual patients and families may find that some of these questions don't apply to them, and to sort of give them that psychological out or psychological protection if this is stressful for them.” N013J	(a) Use “may not apply” qualifiers to give participants a psychological “out” in consent form and interview. (b) Use broad, open-ended questions that expand focus and allow participant to decide what aspects of question are applicable to their situation. (c) Be sensitive and responsive to cues of discomfort or hesitation. (d) Back away from or skip sensitive questions if responses to preliminary questions suggest discomfort or a lack of awareness.
	Use of language: Selecting language to avoid inadvertently disclosing prognosis or other information that participants may not already know, or may choose not to recognize. Includes recruitment, consent, and data collection documents or speech.	“We are very cautious to kind of tread lightly and ask questions in a way that does not presuppose that they are aware of their prognosis.” N064S “We never talk about end of life in our studies. We talk about serious illness.” N069J	(a) Avoid charged terms including terminal, death, dying, and end of life. (b) Use terms such as advanced illness, critically ill, seriously ill, palliative care, or life-limiting disease. (c) Use language employed by participant and follow their lead on what terms are acceptable. (d) Avoid language that conveys or discloses prognostic information.
	Working with clinicians: Strategies that include working with clinicians as consultants, screeners, or to address physical or emotional symptoms identified during the study.	“We work closely with the oncologist. We get a list from them of the patients who meet criteria, and then we ask them if there are any specific patients that they feel might be harmed by us approaching them. Actually, they will often have helpful information. They might say, you know, ‘This person is so ill – I don't think they are going to make it [through] the whole study.’ Or they may give us a heads up that this is a very fragile patient who uses a lot of denial and even if approached to be involved in a study like this will freak out or something like that.” N006S “Any symptoms rated as severe– and we used a four, none, mild, moderate, severe Likert scale for assessing severity of symptoms– by the patient would be reported to the patient's primary nurse and documented in the medical record, and that was acceptable to the study section and to the IRB.” N047C	(a) Before approaching patients, seek input from clinicians about whether they are well enough to participate or if the approach should be on another day (or not at all). (b) Let participants know distressing physical or emotional symptoms will be reported to treating clinicians. (c) Pass clinical questions on to team or encourage participant to follow up with clinicians. (d) Do not interfere with clinical care.
	Flexible methods: A strategy that involves modifying data collection procedures to accommodate participant's physical, emotional, or other needs.	“So, that's part of what we have been working with, is creating it so it is still rigorous in trying to get at the same issues, but being flexible to recognize this is not a pharmaceutical trial and that 72 hours is not nearly as important as making sure that somebody will talk to you.” N013J “One of them had an experience on a telephone call where the patient was really very, very short of breath, having a very difficult time getting through the interview, and part of what we had done to adjust for any of those kinds of things was to say we can stop at any point. We can call back and finish the interview later today. We can call tomorrow. I mean we were very flexible in how we presented the interview.” N033S	(a) Track and avoid holidays, birthdays, death anniversary. (b) Anticipate need to reschedule or prematurely end data collection based on participant's needs. (c) Check in frequently during data collection and stop if participant fatigued or upset. (d) Compensate regardless of whether participant completed surveys/interview. (e) Minimize number, length, and complexity of survey instruments and interviews. (f) Allow participants to talk as long as they need. (g) Drop surveys or data collection time-points to minimize burden. (h) Conduct data collection at location most convenient to participant. (i) Conduct data collection by phone or in person depending on participant preferences. (j) Let participant control who is in the room (especially if a patient).
	Backup protocols: Plans that address situations where the participant identifies or appears to be experiencing physical, emotional, or spiritual harm. Formalized as part of the study protocol.	“We have a procedure for, if we upset anybody, they can get counseling resources. If there are any red flags, if somebody expresses during the intervention that they are thinking of suicide, we have a procedure to handle that. That's all well spelled out. We have a plan in place for all of the studies like this that could upset somebody or where we could learn something about them.” P006C “We tell them in the consent form that if you tell us about untreated symptoms or severe distress, we will let your treatment providers know. No one has ever objected.” N064S	(a) Develop guidelines regarding participant behavior, comments, or scores on measure that serve as triggers for enacting backup plan. (b) Train data collectors how to respond if participant is distressed or at risk of self-harm. (c) Create backup plan to detect underlying, preexisting problem or issues related to data collection. (d) Use data safety and monitoring plans to identify at-risk participants. (e) Develop contingency plans to include referrals or direct contact with mental health or psychiatric services.
	Research staff strategies: Ways to support the research staff who engage in challenging, emotionally laden work during the study.	“We have had conference calls devoted solely to the research staff talking about what it is like emotionally to work with this patient population that are moderated or led by our social workers…. If you want to have a sustainable, retainable, standardized research staff, you have to address this, just as we do on clinical teams. We think about burnout. We talk about it. We talk about self-care. You have to do the same with research team.” N047C “Whenever [the research assistant] has any concerns or whenever they just need to process – that is another thing. That's a big one for me and anyone working on this: Do they know what they are getting into before they start working on the study? So [my] providing support in that way is a big thing.” N042J	(a) Hire more than one research assistant to do data collection to ensure peer support is available. (b) Ensure resources are readily available for research staff who may require support, including access to team members with appropriate background to provide support. (c) Screen staff carefully and hire individuals with relevant expertise, familiarity with population, and ability to think on their feet. (d) Provide in-depth training to staff to prepare for work with population. (e) Regularly and deliberately provide emotional support to research staff to help process the difficult work and manage feelings about population through planned team meetings and the use of professional counselors.