Ethics/original research
Local Media Influence on Opting Out From an Exception From Informed Consent Trial

Presented as an abstract at the Society for Academic Emergency Medicine annual meeting in May 2008, Washington, DC.
https://doi.org/10.1016/j.annemergmed.2009.05.028Get rights and content

Study objective

News media are used for community education and notification in exception from informed consent clinical trials, yet their effectiveness as an added safeguard in such research remains unknown. We assessed the number of callers requesting opt-out bracelets after each local media report and described the errors and content within each media report.

Methods

We undertook a descriptive analysis of local media trial coverage (newspaper, television, radio, and Web log) and opt-out requests during a 41-month period at a single site participating in an exception from informed consent out-of-hospital trial. Two nontrial investigators independently assessed 41 content-based media variables (including background, trial information, graphics, errors, publication information, and assessment) with a standardized, semiqualitative data collection tool. Major errors were considered serious misrepresentation of the trial purpose or protocol, whereas minor errors included misinformation unlikely to mislead the lay reader about the trial. We plotted the temporal relationship between opt-out bracelet requests and media reports. Descriptive information about the news sources and the trial coverage are presented.

Results

We collected 39 trial-related media reports (33 newspaper, 1 television, 1 radio, and 4 blogs). There were 13 errors in 9 (23%) publications, 7 of which were major and 6 minor. Of 384 requests for 710 bracelets, 310 requests (80%) occurred within 4 days after trial media coverage. Graphic timeline representation of the data suggested a close association between media reports about the trial and requests for opt-out bracelets.

Conclusion

According to results from a single site, local media coverage for an exception from informed consent clinical trial had a substantial portion of errors and appeared closely associated with opt-out requests.

Introduction

Media have been shown to influence public opinion about medical research.1, 2, 3, 4, 5, 6 Several case reports indicate that news media can sway public opinion about health-related controversies7, 8 and media coverage increased public interest about a phase 1 pharmaceutical trial.9 For emergency care research conducted under exception from informed consent regulations, investigators use media to educate the community and to facilitate required public notification.10, 11 However, previous studies have found that only 5% to 8% of the population was aware of an exception from informed consent project ongoing in their community.12, 13

Because research subjects cannot consent before enrollment in exception from informed consent trials, many institutional review boards require investigators to offer a mechanism for individuals to prospectively opt out (though this is not required by federal regulations). The opportunity to opt out depends on awareness that the trial is ongoing, which, at our site, was primarily accomplished through local media coverage. For a member of the community, the decision to opt out hinges on knowing that the trial is ongoing, fearing enrollment in the trial, and having the contact information to reach investigators. It is possible that some element of what people read or hear in media reports triggers a reaction strong enough to drive requests to opt out of the trial, though it is also possible that simply knowing about the trial (regardless of the language used) prompts community objection.

Investigators designing exception from informed consent trials frequently use the media to educate and notify the community about such trials, yet there are few objective data about how such media may influence public behavior. It is possible that the timing, content, and accuracy of trial information conveyed through news media influence public perception about these trials, plus individual behavior (eg, the desire to opt out). Data about whether the media may influence public behavior and the accuracy of media reports about exception from informed consent trials may help guide investigators in communicating with the media.

In this study, we evaluate local media coverage of an exception from informed consent trial and seek to characterize the media reporting of the study and its temporal relation to requests to opt out of the trial.

Section snippets

Study Design

This was a qualitative analysis of all local media coverage for an exception from informed consent out-of-hospital trial at one clinical research site during a 41-month period (September 1, 2004, through January 31, 2008). This period covered the creation of the multisite research consortium (described below), clinical trial design, and community consultation and public notification phases, as well as the first 12 months of trial enrollment. Data collection for this study was stopped after the

Results

A total of 39 local media reports were collected during the 41-month period, including 33 (85%) newspapers or newsletters, 4 (10%) Web logs, 1 (3%) television broadcast that aired twice on local news, and 1 (3%) radio announcement that aired 5 times. One additional television report was aired but excluded because no copy was available. Length of media reports ranged from 183 to 2,197 words (median 498).

Most (90%) of the articles mentioned that an exception from informed consent would be used in

Limitations

These findings are limited to a single site participating in a multisite research consortium. Consequently, results are based on a modest sample size of local media articles and bracelet requests. In addition, media coverage is frequently triggered by sentinel articles that are picked up by other media outlets, suggesting correlation (clustering) between certain media reports. Such clustering of articles may have also affected opt-out bracelet requests, a possibility that is suggested by the

Discussion

Our results suggest that the content and timing of media reports for an exception from informed consent trial are associated with requests to opt out of the trial. The findings also demonstrate inaccuracies in such media coverage. Previous research examining health and medicine, as reported in the popular press, has documented a tension between science and news media.1, 7, 17, 18, 19, 20, 21 Specific to research, one author observed the presence of negative media statements and attitudes

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    Supervising editor: Kathy J. Rinnert, MD, MPH

    Author contributions: MJN, NMD, TS, DZ, and CDN participated in study design. LH was responsible for media communication from trial investigators. DG was in charge of opt-out bracelet distribution and community interaction. MJN and NMD were data abstractors, and TS mediated. MJN and CDN performed the statistical analyses. TS, MD, and CDN are local investigators in the Resuscitation Outcomes Consortium. All authors participated in article planning and writing and approved the final article. MJN and CDN had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. MJN takes responsibility for the paper as a whole.

    Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article that might create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. This publication was made possible with support from the following sources: Oregon Clinical and Translational Research Institute (#UL1 RR024140, the National Center for Research Resources, a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research); and the Resuscitation Outcomes Consortium (ROC) Training Grant (#U01/HL-04-001, National Heart, Lung, and Blood Institute), and the ROC cooperative grants. The ROC is supported by a series of cooperative agreements to 10 regional clinical centers and 1 data coordinating center (5U01 HL077863, HL077881, HL077871 HL077872, HL077866, HL077908, HL077867, HL077885, HL077885, HL077863) from the National Heart, Lung, and Blood Institute, in partnership with the National Institute of Neurological Disorders and Stroke, US Army Medical Research and Material Command, the Canadian Institutes of Health Research-Institute of Circulatory and Respiratory Health, Defence Research and Development Canada, the Heart and Stroke Foundation of Canada, and the American Heart Association. The ROC Publications Committee reviewed and approved this manuscript.

    Publication date: Available online August 13, 2009.

    Reprints not available from the authors.

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