Anesth Analg 2004;99:1272
© 2004 International Anesthesia Research Society
doi: 10.1213/01.ANE.0000133963.71995.75
LETTERS TO THE EDITOR
Proper Consent for Clinical Anesthesia Research May Be Difficult to Obtain on the Day of Surgery
Mitchel B. Sosis, MD PhD
Board Certified Anesthesiologist, Lafayette Hill, PA, mitchelsosis@hotmail.com
To the Editor:
I read with interest the recent report by Brull et al. (1) on the "comfort" of patients consenting to participate in clinical anesthesia research studies on the day of surgery. In this retrospective survey, conducted by mail, the authors enrolled patients who had previously been involved in one of six studies. According to the authors, the studies had negligible or minimal risk to the patients, however, they provided scant details about the studies.
The results of the investigation of Brull et al. may summarized in part as follows: By their own report, 20% of patients did not understand the purpose of the clinical anesthesia trial for which they consented. Twenty-four percent of patients did not understand the consent form, and 29% did not understand the studies’ risks and benefits. Twenty-one percent felt anxious at the time of consent, and 26% felt obligated or pressured to participate in the trial. Thirteen percent were not aware that their participation was voluntary, and 20% did not realize that they could withdraw at any time without consequences. Seven percent felt that their participation in the study put them a risk. Complications listed by the patients included prolonged numbness, pain, and urinary retention.
The results listed above appear to be at odds with the authors’ conclusions: "Our study suggests that patient recruitment and consent for negligible- or minimal-risk clinical anesthesia trials is appropriate on the day of surgery." Indeed, just the opposite conclusion seems more tenable.
It has been shown that patients’ participation in a research study is usually without benefit to patients and may actually place them at risk. Moreover, a patient’s ability to understand a consent form may be limited, and they may feel coerced to participate in a study especially if the health care professional who is rendering their care is also the investigator (2). In the context of their recruitment for clinical research, it is important that the rights of patients are protected and their informed consent to participate must be assured. The study of Brull et al. shows that this may be difficult to accomplish on the same day as a patient’s surgery.
References
- Brull R, McCartney CJL, Chan VWS, et al. Are patients comfortable consenting to clinical anesthesia research trials on the day of surgery? Anesth Analg 2004; 98: 1106–10.[Abstract/Free Full Text]
- Treschan TA, Scheck T, Kober A, et al. The influence of protocol pain and risk on patients’ willingness to consent for clinical studies: randomized trail. Anesth Analg 2003; 96: 498–506.[Abstract/Free Full Text]
Response
Colin J. L. McCartney, MBChB FRCA,
Richard Brull, MD FRCPC,
Vincent Chan, MD FRCPC, and
Frances Chung, MB FRCPC
Department of Anesthesia, Toronto Western Hospital, Toronto, Canada
In Response:
We thank Dr. Sosis for his interest and comments. The results of our study clearly indicate that the majority of patients were comfortable with the informed consent process, and we maintain our conclusion that it is appropriate to obtain informed consent for negligible or minimal risk clinical anesthesia trials on the same day as surgery.
Although informed consent can be obtained prior to the day of surgery, Treschan et al. (1) demonstrated that 14% of consenting patients did not understand painful risks involved despite the consent process occurring on the day before surgery. Earlier recruitment may not, therefore, translate into better understanding.
However, as we indicated in our study, further prospective research is needed to more accurately determine concerns that may arise as a result of obtaining consent on the same day as surgery. In addition, we need to identify better methods of finding and educating those patients who feel less comfortable but still feel compelled to take part in a study.
Reference
- Treschan TA, Scheck T, Kober A, et al. The influence of protocol pain and risk on patients’ willingness to consent for clinical studies: a randomized trial. Anesth Analg 2003; 96: 498–506.
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