Respondent Burden in Clinical Research

Case Presentation and Introduction

Mrs. C. is a 32-year-old female diagnosed with melanoma and metastasis to the liver. She has been suffering from moderate, self-described annoying pain in the abdominal region almost constantly for the past several weeks and self-medicating with Ibuprofen, which provides some relief. She also reports episodes of nausea and difficulty sleeping most nights. She arrives in the late afternoon at a regional medical research facility to enroll in a clinical trial for experimental surgery and chemotherapy in the morning. She indicates to a staff nurse her sense of concern and worry about the impending surgery as well as her prognosis. Upon arrival, the attending surgeon and anesthesiologist approached her to obtain consent for participation in the clinical trial. By enrolling in the trial, she becomes eligible for participation in several other trials, including transfusion related research and health related quality of life (HRQOL) outcomes assessment. Appointments throughout the afternoon and early evening and consuming at least several hours of Mrs. C's time consist of pre-assessment lab work, a preoperative history and physical, bowel prep, and other activities related to the various clinical trial protocols. Mrs. C. verbalizes that she is physically and emotionally exhausted from the pace of the admission and enrollment processes. That night she has difficulty sleeping and develops a severe migraine, making her eligible for a clinical trial associated with migraines. Over a period of several hours, Mrs. C. gives informed consent to participate in four different clinical trials, each with differing degrees of risk and associated burden.

Although the field of bioethics has not clearly identified or articulated the problem of respondent burden in clinical trials, the ethical concern that underlies the concept has been acknowledged periodically in health services research. For example, health care providers are sometimes reluctant to allow clinical researchers to approach their patients for inclusion in clinical trials because they perceive the research to be distressing or overly burdensome for their patients.^[1] Clinicians' desire to diminish "burden" to symptom-laden patients has also been identified as a factor that contributes to recruitment barriers in palliative care and end-of-life studies.^[2] This notion of patient "distress" or "burden" related to participation in clinical research is comparable to what social scientists and survey methodologists have previously identified as "respondent burden." This phenomenon also needs to be addressed in the area of clinical research.

The Office of Management and Budget (OMB) used the term respondent burden when it introduced efforts to reduce the number and frequency of federal requests for information and to minimize both the time and effort required of survey respondents in order to maximize response rates or research participation.^[3] Bradburn further explicated this concept in health survey research, where he defined it as a subjective phenomenon that may be related to four differing factors: interview length; effort requirement on the part of the respondent; the sensitivity of the questions being asked and the stress they may engender; and the frequency of participating in interviews.^[4] Yet to date, no one has directly addressed the issue of respondent burden in cases in which the subject population is seriously ill, the subject's participation is requested in multiple, ongoing studies, and where the research is clinically based, rather than limited to survey participation. Given the nature of human subjects research in clinical medicine, there is an obvious, pressing need to explore the issue of respondent burden, to understand its frequency and severity, and to create safeguards to minimize it.

Following Bradburn, we define respondent burden in the clinical research context as a subjective phenomenon that describes the perception by the subject of the psychological, physical, and/or economic hardships associated with participation in the research process. Respondent burden may vary in intensity and degree, depending upon the risk level of the research, the procedures that the research entails, and the individual subject's condition, prognosis, mental state, and support systems. Returning to our case, the potential for respondent burden is easy to identify: Mrs. C., who is already suffering from pain and symptoms related to her disease, may be particularly burdened by being asked to commit limited physical and emotional energy to the demands of participating in multiple studies and clinical trials.

IRB. 2005;27(4):17-20. © 2005 The Hastings Center

Disclaimer: The opinions expressed are the authors' own. They do not reflect any position or policy of the U.S. National Institutes of Health, Public Health Service, or Department of Health and Human Services.

Cite this: Respondent Burden in Clinical Research - Medscape - Jul 01, 2005.