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Researchers to Benefit from Customizable Patient EHR Data Consent

Most patients may prefer a customizable e-consent form to allow EHR data use in research.

Source: Thinkstock

By Kate Monica

- A new JAMIA study found many patients have an interest in interactive electronic consent (e-consent) applications and want more detailed information about EHR data use in clinical research.

Harle et al. conducted a series of 42 think-aloud interviews with 32 patients. Researchers coded and analyzed interview transcripts using a modified grounded theory approach and identified themes related to patient preferences, reservations, and mixed attitudes about e-consent.

Researchers concluded that e-consent applications could be designed to ensure patients receive the information they need when providing consent for the use of health information in research. They also offered a potential electronic approach to meet the new Common Rule requirement mandating consent documents include a concise and focused presentation of key information followed by further details.

“Understanding how to provide information to patients during consent for research use of EHR data is particularly important in light of recent updates to the US Federal Policy for the Protection of Human Subjects (Common Rule),” researchers noted.

The revised Common Rule takes effect in 2018. In addition to requiring a concise and focused presentation of key information in an effort to reduce the unnecessary length and complexity of consent forms, the updated rule also gives institutions the option to obtain broad consent from patients to use individually identifiable health information in future research.

“Using broad consent will be an alternative that investigators can choose in lieu of other options, such as using de-identified information, seeking institutional review board (IRB) waivers of consent, or obtaining study-specific consent,” wrote researchers.

Broad consent will appeal to both researchers and patients. The consent method enables healthcare organizations to implement institutional processes to attain consent from many patients simultaneously. Patients will benefit by gaining insight into the ways their information will be used, as well as by reducing the number of times they will be asked to provide consent.

In light of the Common Agreement and other showings of support for the use of EHR data in clinical research, researchers also investigated best practices for obtaining broad consent without placing unnecessary burden on researchers and clinical staff.

Researchers received mixed results about which consent format most patients preferred, with some patients showing an interest in utilizing e-consent and others wary about straying from the traditional paper form.

Ultimately, study participants that preferred e-consent over providing consent through a traditional paper format often cited the many advantages of the modern electronic format, as well as the general cultural shift toward digitization in healthcare.

Other participants reported e-consent forms were more concise, easier to read, and more accessible than the paper version.

“I like how it’s broken up so it’s easier to read,” a respondent stated. “It’s less intimidating upon first glance than a packet of paper.” 

As part of the study, researchers separated respondents into two groups — high-information-seeking respondents and low-information-seeking respondents.

High-information-seeking respondents commonly reported an interest in knowing more about the potential risks of consenting to share information contained in EHRs for research purposes, as well as an interest in being notified if health information is compromised.

“Some participants commented specifically on the notion of broad consent and wanted to know more about the extent and duration of their control over their personal information,” observed researchers.

However, patients categorized as low-information-seeking respondents were content with the amount of information given by the primary consent form.

Regardless of categorization, most respondents reported being comforted by information indicative of researcher or institutional expertise, the presence of safeguards around health data, and prohibitions against the sharing of information with pharmaceutical companies.

Given the variety of responses among survey participants about the preferred ways for researchers and clinical staff to request consent, researchers determined allowing patients to customize their consent experience was likely the best option.

“At the same time, this study suggests a need to support people who have reservations about electronic consent platforms as well as the importance of communicating information about administrative processes and safeguards that protect personal health information when used in research,” recommended researchers.

A customizable e-consent form would meet the needs of both patients that are interested in learning more about the ways EHR data will be used and those content with a limited, concise amount of information related to EHR data use. 



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