Brienza Ashley M, Sylvester Raeanne, Ryan Christopher M, Repine Melissa, DiFiore Sara, Barone Jean, Callaway Clifton W
Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.
Human Research Protection Program, University of California at San Francisco, San Francisco, CA.
Acad Emerg Med. 2016 Jul;23(7):772-5. doi: 10.1111/acem.12969. Epub 2016 Jun 18.
Exception from informed consent (EFIC) for research in emergency settings requires investigators to notify enrolled subjects, family members, or legally authorized representatives about inclusion in the study. We examined the success rate of a notification strategy including mail services for subjects enrolled in EFIC trials.
We describe notification attempts for subjects in three out-of-hospital cardiac arrest clinical trials in both urban and rural areas around Pittsburgh, Pennsylvania, between the years 2000 and 2014. We examined the time required to notify subjects and the success of contacting subjects or their representatives when notified in person (if alive), by mail (if alive and unable to reach in person), or by mail (if the subject was deceased). We characterized comments received from subjects or their representatives as positive, neutral, or negative.
We attempted notification on a total of 1,912 subjects, 1,762 by mail, and 163 in person. Of these, 1,767 (92%) notification forms were successfully delivered, and 431 (24%) were signed and returned. Only 16 subjects or representatives (0.91%) requested to withdraw from the study. In-person notifications were more likely to be signed than mailed notifications (69% vs. 20%; p < 0.001). A total of 3.2% of recipients contacted investigators by phone or letter in response to notifications, but only five recipients expressed negative attitudes toward the trial. Ninety percent of subjects were notified within 35 days of the incident. Time to notification was shorter for in person (median = 5 days, interquartile range [IQR] = 2 to 10 days) than for deceased and mailed (11 days, IQR = 8 to 14 days) or alive and mailed (20 days, IQR = 14 to 29 days).
It is possible to successfully notify recipients of enrollment in a study using EFIC over 90% of the time within 35 days, although only 24% of recipients will sign and return a form. Fewer than 1% of subjects withdraw from the study, and fewer than 5% contact investigators, usually for neutral reasons.
紧急情况下研究的知情同意豁免（EFIC）要求研究者将受试者纳入研究一事通知已登记的受试者、家庭成员或法定授权代表。我们考察了一种通知策略的成功率，该策略包括为参与EFIC试验的受试者提供邮件服务。
我们描述了2000年至2014年间在宾夕法尼亚州匹兹堡市周边城乡地区开展的三项院外心脏骤停临床试验中针对受试者的通知尝试。我们考察了通知受试者所需的时间，以及当面通知（如果受试者还活着）、邮寄通知（如果受试者还活着但无法当面联系到）或邮寄通知（如果受试者已死亡）时联系受试者或其代表的成功率。我们将从受试者或其代表那里收到的反馈分为正面、中性或负面。
我们总共尝试通知了1912名受试者，其中1762名通过邮件通知，163名当面通知。其中，1767份（92%）通知表成功送达，431份（24%）已签署并返还。只有16名受试者或代表（0.91%）要求退出研究。当面通知比邮寄通知更有可能获得签署（69%对20%；p<0.001）。共有3.2%的收件人在收到通知后通过电话或信件联系了研究者，但只有五名收件人对试验表达了负面态度。90%的受试者在事件发生后35天内得到了通知。当面通知的时间更短（中位数=5天，四分位间距[IQR]=2至10天），而对于已死亡和邮寄通知的受试者（11天，IQR=8至14天）或活着且通过邮寄通知的受试者（20天，IQR=14至29天）来说，时间更长。
使用EFIC在35天内超过90%的时间成功通知研究受试者是有可能的，尽管只有24%的收件人会签署并返还表格。不到1%的受试者退出研究，不到5%的受试者联系研究者，通常是出于中性原因。
