Academic journal article IRB: Ethics & Human Research

The Many Ways of Saying Yes and No: Reflections on the Research Coordinator's Role in Recruiting Research Participants and Obtaining Informed Consent

Academic journal article IRB: Ethics & Human Research

The Many Ways of Saying Yes and No: Reflections on the Research Coordinator's Role in Recruiting Research Participants and Obtaining Informed Consent

Article excerpt

It is now common to read in the clinical research literature that informed consent is more than the act of signing a consent form--rather, it is a process that extends throughout the research subject's clinical trial experience. (1) Various studies have examined different formats for providing information to individuals recruited to participate in research, e.g., shorter consent forms, video presentations, and interactive computer programs. (2) However, the interaction between the person soliciting consent and the prospective participant has not been addressed. The person who seeks consent is often the research coordinator, and his or her role may also include recruiting individuals to enroll in the research study. To perform these roles, the research coordinator must make countless practical decisions that shape the recruitment encounter and the informed consent process.

What follows is a qualitative report of and reflections on a research coordinator's (IH) experiences over a three-year period recruiting research participants for two minimal risk studies: a study of the quality of care for adult inpatients on a general medicine service (QOC study) and a genetic study of children and adults with cystic fibrosis (CF study). We focus on two interlocking issues: the various types of agreement and refusal from individuals recruited to participate in the studies and the role that consent documents play in the interaction between prospective subjects and the research coordinator during the consent process.

Table 1 compares the two studies with regard to 1) the procedure and location of the studies, 2) the participants' ethnicity, age, and experience with health care, 3) the participation rate of individuals recruited, and 4) the absolute number of individuals who agreed to participate. In the QOC study, the inpatients recruited were mostly from a variety of racial/ethnic groups; many were members of lower socioeconomic groups, and most did not have a primary care physician. The study involved a questionnaire, a chart review, and a follow-up interview after discharge. In the CF study, the population recruited reflected the ethnicities of patients with CF, i.e., primarily non-Hispanic Caucasians of varying socioeconomic class; all of the patients had extensive experience in the health care system and in the hospital where the study was located, and each had not only a primary care physician but an identified subspecialty physician for CF care. This study involved a questionnaire and a blood sample for genetic analysis.

The Many Ways of Saying Yes and No

Although in principle the decision to decline or accept an invitation to participate in research should be based on a reasoned appreciation of the possible benefits and burdens of the study, little is known about how potential subjects arrive at this decision. While approaching hundreds of individuals for the QOC and CF studies, IH encountered a variety of responses that highlighted the complexity of those decisional processes. In the vast majority of interactions, consent was given to participate. However, two dialogues that sometimes occurred between the research coordinator and individuals being recruited to participate illustrate some of the practical challenges that research coordinators face in trying to enroll individuals in research studies: the "quick no dialogue," in which patients immediately decline to participate when they hear the word research, and the "partial yes/not now dialogue," in which patients seemed to consent to participate but hesitated during aspects of the consent process or asked the research coordinator to return later.

* The Quick No.

Research Coordinator: "Hello, I'm a research coordinator here at the hospital working on a research study. Would you like to hear about the study?"

Patient: "No, thanks."

While it is clear in this situation that these individuals should not be approached again to participate in the study at hand, it is not clear how the research coordinator should interpret the present refusal for purposes of recruiting these individuals for other studies. …

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