Review ArticleThe Changing Face of Clinical Trials

Informed Consent

Listing of authors.
  • Christine Grady, R.N., Ph.D.,
  • Steven R. Cummings, M.D.,
  • Michael C. Rowbotham, Thou.D.,
  • Michael V. McConnell, M.D., M.S.E.E.,
  • Euan A. Ashley, F.R.C.P., D.Phil.,
  • and Gagandeep Kang, M.D., Ph.D.

Introduction

This multipart review provides an overview of innovative approaches to improving and expanding the informed consent process for researchers and participants, along with curt essays covering specific areas of innovation.

The Changing Face up of Informed Consent

Christine Grady, R.N., Ph.D.

In the classic interaction in which informed consent is obtained for enquiry, an investigator presents the potential participant with information regarding a new therapeutic, diagnostic, or prophylactic intervention and so asks the participant to read and sign a detailed written consent document. This traditional prototype is becoming outdated. Informed consent, which is ethically essential in most clinical research, respects persons' rights to determine whether participation in the enquiry is compatible with their interests, including their interests in protection from exploitation and impairment.1,two In the process of informed consent, participants are given an opportunity to understand relevant data most research participation and to make a voluntary choice.iii Required by ethical guidelines and regulations unless explicitly waived by institutional review boards,4-seven informed consent is thus a means of protecting the rights and welfare of participants while they contribute to the advocacy of noesis.

Over the past 50 years, the informed consent process has get increasingly regulated and standardized, while the challenges remain persistent and difficult to overcome.8 Consent forms are increasingly long and complicated, obscuring of import details, and are often designed to serve the interests of institutions and sponsors. Data show that participants often have a limited agreement of written report information even when they have signed a consent grade.8 Technological advances driving changes in research methods and information practices have influenced how nosotros think almost informed consent for research, which raises the possibility of new approaches to informed consent and innovative options for obtaining it.

Changing Inquiry Methods

Unprecedented opportunities to reply of import clinical inquiry questions are available through the assay of massive amounts of information ("big" data) in commercial, wellness care, research, and government databases, in social media and mobile devices, and in growing collections of biologic specimens and clinical and genomic information. Data are clustered quickly and easily, sometimes through passive technologies such every bit location-based mobile devices, through registries, or through systems of electronic health records or data and biospecimens collected for other purposes. Innovative studies are existence developed that are conducted entirely through the Cyberspace, as described below by Cummings and Rowbotham, or through the use of smartphone apps, equally described below by McConnell and Ashley. Such inquiry allows "access" to participants remotely without the constraints of fourth dimension or location. Powerful technologies enable information mining and analytics, as well as the integration of data from multiple sources.

Is the classic written informed consent process and document appropriate for these inquiry paradigms? The level of risk to participants is depression and is unremarkably idea to be primarily advisory,ix which differs from the risks associated with traditional interventional clinical research; the researcher–participant relationship as well differs. Some argue that although informed consent allows participants to make up one's mind well-nigh acceptable risks, information technology may be unnecessary for enquiry that involves the mining of large data sets or the analysis of deidentified biospecimens, because risks are low, especially equally compared with the risks of inquiry on previously untested treatments. In improver, deidentification and privacy protections further attenuate any private informational gamble.10,11 Moreover, at that place is concern that requiring consent for low-risk research of this type could impede or make infeasible otherwise valuable research or could issue in selection bias — that is, a situation in which persons who are willing to consent differ fundamentally from those who are not willing, thus jeopardizing the science.12,13

In the commercial market place, people use social media and mobile devices and contribute their data to large databases in innumerable ways, and they may be unaware of the multiple entities gathering and storing their data for future use. Persons are sometimes notified in general terms nearly various uses of their data, all the same "[r]esearchers are rarely in a user'south imagined audience."fourteen Reactions to certain research studies, such as the Facebook emotion experiment or OkCupid research,15-17 as well every bit empirical data, such every bit that gathered in association with Twitter's population-level depression monitoring,18 provide testify that some people feel strongly nigh being asked and may not consent to certain research uses.19

Research with biospecimens may pose risks that are different from those posed by inquiry with either actively or passively gathered data, yet public and private researchers oftentimes apply deidentified clinical biospecimens without consent.12 Requiring consent for the use of such samples could result in smaller, more highly selective pools of participant samples, which may impede publicly beneficial research or limit its validity. The debate almost the need for and form of informed consent for inquiry with stored biospecimens was revived by contempo international discussions and proposed changes to the U.Due south. Common Rule (changes that were not ultimately accepted) that would accept required written consent for all research use of biospecimens.20,21 Even those who favor requiring consent for biospecimen inquiry disagree most whether consent should exist broad for a wide range of time to come possible research or specific for each utilize, 1-time or ongoing, and opt-in or opt-out.22-27

Other emerging clinical research paradigms, including pragmatic trials and learning wellness care systems — that is, systems in which interventions that are within the scope of standard exercise are tested and information are gathered passively in an attempt to ameliorate outcomes — have too provoked argue virtually appropriate methods of informed consent.28-31 Although more similar to the prototypical clinical trial, some of these studies pose low research risks, are more similar to quality-improvement studies than to interventional clinical research, and depend on collective participation for scientific validity. Features of some of these trials arguably permit less formal consent procedures, maybe notification with opt-out and, in some cases, fifty-fifty waiver.31

In survey after survey, all the same, people study that they adopt to be asked and given a option nearly research even if there is trivial risk to them.27,32-39 The challenge is finding applied, nononerous ways to respect persons' choices that have minimal negative effects on the scientific discipline. Information technology may provide new opportunities to implement informed consent with minimal intrusion.

Changing Information Technologies and Practices

Digital technology has transformed how people communicate, learn, and work; information is increasingly acquired and communicated online or through mobile devices. Club is gradually condign paperless, and information is constantly at our fingertips. Health information is stored in electronic health records. Small tablet computers and smart phones are multiplying 5 times faster than the global population.40 Technological and societal changes in information practices nowadays fresh opportunities for innovative implementation of informed consent. Apps, tablets, video, interactive computers, robots, personal digital assistants, mobile phones and smartphones, and wearable engineering could help to modernize, alter, and improve methods of informed consent. Technologies allow broad standardization and easy updating of information, ready use of creative graphics, the means for remote interactive discussions, and documentation of the procedure. Investigators tin can use technologies to provide information, interact with participants, answer questions, and assess understanding on an ongoing basis. Bachelor consent tool kits featuring visual interactive approaches aim to make informed consent more than participant-centered and less focused on signing legal documents.41 Other tool kits allow researchers to create apps for medical enquiry and include customizable visual consent templates.42 Technologies allow for methods of informed consent that are modern, green, interactive, and dynamic.43-46

Tabular array 1. Table one. Components and Challenges of Informed Consent with Traditional Paper Forms and Electronic Methods.

Forth with providing opportunities, adoption of digital and electronic methods of consent requires deliberation, evidence, and recognition of challenges (Table 1). Investigators and oversight bodies must still determine the advisable content for disclosure. Replacing long, complex, technical written forms with long, circuitous, technical or legalistic electronic information pages would not represent progress. Indeed, very few persons read click-through agreements, a mutual notice-and-consent characteristic of computer and mobile device utilize, before clicking "agree."48,49 Clicking an agreement box without engaging with the data would exist the equivalent of signing a consent form without reading it. This approach to consent would probably do more than to protect investigators and sponsors than to inform participants. Of import additional challenges in digital consent interactions include verifying that the people who are consenting take the capacity to consent and are who they say they are (authentication). If informed consent aims to provide information that participants tin use to brand decisions, promoting informed consent will crave the creative utilise of electronic technologies that are simple, easy to utilise, and in widespread and mutual use. The interactions demand to exist cursory, engaging, informative about risks and benefits in a mode that users tin can easily appreciate, and equipped with methods for authentication, equally discussed below past Cummings and Rowbotham. Such approaches to obtaining consent could besides reduce worries well-nigh possible selection bias.

Information technologies enable new ways of presenting information and transferring some control to participants even in inquiry in which investigators and participants never encounter, yet they exercise non resolve questions related to the necessity or adequacy of informed consent. As described beneath by Kang, regulations in Republic of india require consent interactions to be videotaped in order to raise accountability, with the promise of improving the consent procedure and ensuring its adequacy.

Informed consent as a process that serves to respect autonomous choices and protect people from risks is not "ane size fits all" and should be tailored to context. One-on-one interactive informed consent with detailed information about the purpose of a written report as well as about its risks, benefits, and alternatives is necessary for high-stakes gene-transfer inquiry, for example; however, in my view, it is unnecessary for studies that involve deidentified aggregate clinical information. For the latter, educating the public and notifying persons whose data will be used might sufficiently show respect without impeding the science.

Wide dialogue and empirical research should inform decisions well-nigh adopting new methods of obtaining informed consent and tailoring models of consent to changing research paradigms. Inquiry is needed to examine whether and when whatever progress made through low take chances–high reward inquiry outweighs other issues, including the upstanding reasons behind obtaining prototypical informed consent. Researchers should also investigate public views nigh informed consent for the utilize of big data and electronic consent methods, as well equally methods promoting engagement with and comprehension of digital written report information, methods of authentication and capacity cess as office of digital consent, and the extent to which there is selection bias in inquiry in which digital consent technologies are used. The upstanding goals of informed consent and the importance of considering research context should guide u.s. equally we digest technology into inquiry and the informed consent process and develop artistic and effective evidence-based practices.

From the Department of Bioethics, National Institutes of Health Clinical Heart, National Institutes of Health, Bethesda, Medico. Address reprint requests to Dr. Grady at the Section of Bioethics, National Institutes of Health Clinical Middle, National Institutes of Health, Bldg. 10, 1C118 Bethesda, MD 20892, or at [email protected].

The views expressed are those of the author and practice not necessarily reverberate those of the Clinical Heart, the National Institutes of Health, or the Section of Wellness and Human being Services.

I give thanks Frank Miller, Dave Wendler, and Carl Runge for their helpful comments.

Electronic Informed Consent and Cyberspace-Based Trials

Steven R. Cummings, M.D. and Michael C. Rowbotham, M.D.

Informed consent for a research written report brings to heed a paper document with a handwritten signature completed at a clinical inquiry site. Notwithstanding, the paper, ink, and clinical site are not necessary. Sufficient information to enable a participant to make an informed conclusion tin be provided electronically, either on-site (when the investigator and the participant are at the same location) or remotely.50

Informed consent past means of electronic devices (e-consent) often includes multimedia, such as graphics or video, virtually essential study features that may increase agreement of the study, particularly for people with a low educational level or express literacy51-53; for instance, the ADAPTABLE trial (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness; ClinicalTrials.gov number, NCT02697916) — a very large pragmatic trial comparison two doses of aspirin — includes a video overview of what the study is almost and what participation involves (https://adaptablepatient.com/en/prescreen/watch-video).51-53 Due east-consent includes a display of the official document, only the certificate can be enhanced with popular-up definitions of unfamiliar terms and links to additional information or an audio version. Born quizzes appraise comprehension and correct misunderstandings of key trial features; an instance of an due east-consent knowledge review questionnaire is shown at world wide web.youtube.com/lookout man?v=HtLuqJdYuoQ.54 A participant must exist given the opportunity to have questions answered during the informed consent process through a phone call, real-time video, or electronic messaging, and the discussion may exist guided by review of a participant's errors. Most studies have shown that participants' retrieve of key facts about a written report is better with the utilize of east-consent with these interactive features than with paper forms.55-58 Participants and staff usually prefer due east-consent over informed consent on paper.56,57,59

Participants can sign electronically using passwords known only to the participant or using a fingertip on a mobile device.50 When e-consent is performed remotely, the identity of the person who is giving the consent can be confirmed in 1 of several means, such as digital signature, username and password, or biometrics.50 Participants receive a copy of the completed eastward-consent form, which can be provided electronically.50 Signed e-consent records are stored securely (due east.g., encrypted to protect privacy, with audit trails to rails any changes).50

E-consent is also used currently for the enrollment of participants in biobanks.58,lx-62 The e-consent organisation tin can link a participant's consent electronically to all aliquots obtained from that participant; equally a effect, changes in a participant'south informed consent for assaying a specimen are updated instantaneously, and participants can also track how their specimens are used. The due east-consent process for an entire study can be tracked centrally to obtain data on time spent on steps in the grade, queries of unfamiliar terms, and errors on quizzes, and these data can be used to better the e-consent process.57 Amendments to forms can exist distributed immediately to all clinical sites.

East-consent has disadvantages. Videos and quizzes add time to reading the consent form.55-58 Initial development of an eastward-consent process tin can be plush, but reuse of templates can salvage money in subsequent studies. Although due east-consent has been accustomed by cardinal institutional review boards in the United States, launching a multisite trial tin be challenging because local institutional review boards may be unfamiliar with e-consent or may want unique modifications. For international trials, countries may accept unlike requirements for e-consent.

Internet-Based Clinical Trials

Freeing the informed consent process from physical clinical sites enables trials of drugs or supplements to exist conducted entirely through the Internet. Trials conducted entirely through the Internet have several potential advantages over clinic-based trials.63 Instead of recruiting patients from split clinical sites with express catchment areas, one center could attain all potentially eligible people who have Internet access; recruitment could be performed through online advertisements and social media campaigns, and with advisable permissions, patients may receive e-mail messages with links to a study website. Since there are no face-to-face visits, the identity of potential participants can be confirmed by other ways, such as online identity verification services, transmission of images of regime-issued identification cards, or biometrics; participants can so utilise passwords or fingerprints to sign into their accounts, which minimizes the chance of duplicate enrollment or fraudulent participation under multiple identities.62

Cyberspace-based clinical trials also have potential disadvantages. Trials that require specialized assessments and treatments in clinical settings cannot exist performed completely through the Net. To overcome this problem, mobile research nurses can make home visits to depict blood, carry tests (due east.g., electrocardiography), perform assessments guided past video with a study physician, and verify identity.64,65 Equally is the instance in standard trials, adverse events may be reported past telephone, electronic mail, or text to the central staff or written report clinicians, who record the adverse event data and, if appropriate, give advice or refer the participant to emergency care or follow-upwardly with their physicians.

Treatments can be sent to participants through secure overnight commitment with signature confirmation of receipt; unused treatments tin be returned by the aforementioned method. Participants tin also be instructed to ship an e-mail message that includes the number on the bottle to admit receipt of the treatment. If necessary, mobile enquiry nurses can also deliver medications and administer some types of parenteral drugs during a home visit. The Nutrient and Drug Administration has allowed sending approved but not investigational treatments directly to participants.66 State laws may require that the written report treatments, including placebo, exist prescribed past a physician licensed in that state.

Published examples of Internet-based trials include a simple (i.e., fewer steps for the participants and fewer exclusions) trial of nutraceuticals for indisposition and anxiety, in which 391 participants from 45 states were enrolled and underwent randomization over an viii-week period,67 and a trial of omega-3 fat acids for autism, in which 57 children from 28 states were enrolled and underwent randomization over a 6-week period.68 In contrast, a complex clinical trial that was conducted under an investigational new drug application for a urinary incontinence treatment used a protocol that mimicked previous clinic-based trials.66 The online screening, informed consent, and data collection systems worked well. However, the protocol required multiple steps that included laboratory tests and 24-hour urine collections; consequently, less than one% of women who entered the screening procedure continued to randomization.66 The same Adaptable study is beingness conducted entirely through the Net, with the utilise of electronic medical records to recruit participants and ascertain finish points (http://theaspirinstudy.org).

The Time to come

We believe that freeing informed consent and clinical trials from the fetters of paper forms and physical clinical sites has the potential to ameliorate the informed consent process, expand participation, and reduce the costs of trials. E-consent and Net-based trials should besides be studied with the goals of improving their performance and increasing the conviction of patients, investigators, and regulatory authorities in these new methods.69

From the California Pacific Medical Center Research Found (S.R.C., M.C.R.), the San Francisco Analogous Center (Southward.R.C.), and the Departments of Medicine, Epidemiology, and Biostatistics, University of California, San Francisco (S.R.C.) — all in San Francisco. Accost reprint requests to Dr. Cummings at the San Francisco Coordinating Center, Mission Hall, Box #0560, 550 16th St., 2nd Fl., San Francisco, CA 94143, or at [e-mail protected].

Mobile Wellness Research — App-Based Trials and Informed Consent

Michael V. McConnell, M.D., Chiliad.S.E.Eastward. and Euan A. Ashley, F.R.C.P., D.Phil.

The use of smartphones to conduct wellness research allows investigators to accomplish a large population, including participants who may not exist in shut proximity to a research center. Mobile device subscriptions in the world now exceed the earth population (>seven billion), and smartphones account for 75% of all mobile phones sold.70-72 Almost half the population in the developing world has a mobile device, with the largest growth in mobile device utilize in India, Africa, and Asia-Pacific, and mobile access worldwide now exceeds desktop access to the Internet. Thus, "apps" (i.e., software programs designed to run on smartphones) are the natural evolution in facilitating clinical and population health research.

Advantages and Challenges of App-Based Inquiry

App-based enquiry has multiple additional advantages. Principal among them is that all or nigh of the research study can be conducted through the smartphone — from obtaining informed consent to collecting data. A powerful feature of smartphones is that they now comprise multiple sensors, such every bit accelerometers, global positioning organisation receivers, cameras, and microphones, which tin can be used for passive or active drove of data (e.g., the half-dozen-minute walk test)73 without requiring a person to visit a facility for testing. Indeed, the ability to collect information on a more frequent and continuous basis in a more real-world environs with a device people take with them throughout the twenty-four hour period may expand the wealth of research data and the potential for insights. The smartphone has besides go a hub for importing and aggregating a broad range of health data, such as data from other apps, wear devices (e.g., fettle trackers and smartwatches), and continued medical devices. Furthermore, the majority of smartphone users go on their device with them throughout the 24-hour interval and interact with it multiple times per 60 minutes,74 which offers opportunities for more interactive enquiry, such equally reporting and tracking symptoms or testing behavioral interventions.

Conversely, conducting health inquiry and obtaining informed consent on smartphones raise several unique challenges and limitations. The most important limitation is that in that location is no face-to-face confirmation of identity. For example, it is possible that one person could sign in to confirm identity and some other could behave the device. Therefore, app-based research is virtually suitable for low-risk studies in which electronic informed consent (eastward-consent) is appropriate (discussed by Cummings and Rowbotham above). The smaller screen size of smartphones adds a considerable challenge to the e-consent process in that multiple consent screens are required to review all the key consent components. Even so, the interactive nature and multimedia capabilities of mobile phones provide potential advantages over the standard procedure of obtaining informed consent. These advantages include graphics and animation, explanatory audio and video clips, links to boosted information, and interactive quizzes to ensure understanding.

Although smartphone use and familiarity with mobile engineering science are growing, they are certainly not evenly distributed beyond populations. This uneven distribution can cause selection bias with respect to which participants are able to download the app and complete the informed consent process and study tasks. Fifty-fifty more of an upstanding challenge is the disability of segments of the population to participate in smartphone-based research studies because of issues related to access or cost of smartphones or data connectivity.

Some other key challenge with respect to app-based research and informed consent is data security and privacy.75 Modern smartphones have security features that exceed those of about computers, because they are enabled with biometric identification (e.g., fingerprint) for admission, as well as data encryption. The mobile phone identification number and global positioning system location involve specific risks to privacy that should be safeguarded. International apply and travel raise boosted issues, because most countries accept their own regulations regarding health data crossing borders; therefore, the language used in the consent process should be clear about who has access to the research study app and how the app can or cannot be used when the person is traveling internationally.

Introduction of App-Based Inquiry Studies

Figure ane. Figure 1. Informed Consent Process in ResearchKit.

The major introduction of app-based research studies occurred in March 2015 with the launch of v institutional review board–approved study apps that were created with ResearchKit (http://researchkit.org) on the Apple tree iOS platform; the study apps, which have been described previously,76 include MyHeart Counts (cardiovascular illness), mPower (Parkinson's disease), GlucoSuccess (type 2 diabetes), Asthma Health (asthma), and Share the Journey (breast cancer). MyHeart Counts enrolled more than than x,000 participants in the commencement 24 hours, and the total enrollment in all five studies in the beginning 7 months was more than than lxx,000 participants. The open-source ResearchKit platform is a software toolkit to enable building apps for smartphone-based medical enquiry. ResearchKit includes an e-consent process (Figure 1),77 with a visual consent catamenia (run into the Video) equanimous of animated screens of consent elements, links to "learn more," and a full consent form for review. In improver, the participant is given a screen to review and "opt-in" to allow access to each element of health or demographic data through the smartphone and a screen to choose whether the data can exist shared with researchers worldwide. MyHeart Counts updated its informed consent process to enable enrollment outside the Us and, forth with other ResearchKit-based studies, has added a consent module to incorporate personal genomic data.78 ResearchKit was initially limited to iPhone users, but similar software tools (e.g., ResearchStack [http://researchstack.org]) take at present been made available for app-based informed consent and research on the Android operating arrangement,79 a organization that runs on more than lxxx% of smartphones worldwide.72

Initial information from the MyHeart Counts written report showed both the challenges and the potential of app-based research.eighty The population that provided consent was predominately young (median historic period, 36 years) and male (82%), and although the nearly 5000 participants who completed the 6-minute-walk test at the end of 7 days was the largest such cohort reported, information technology represented only 10% of participants who provided consent. On the other hand, a cluster analysis of activity data in more 20,000 participants yielded distinct activity patterns that correlated with cardiovascular wellness status as reported past the participants, especially more frequent transitions from an inactive to an active state. These findings will need prospective, longitudinal evaluation.

The Future

The growth in mobile access and device use heralds greater power to conduct both personalized and population health research.81 Using mobile devices, people tin participate and contribute their data to enquiry more easily, and researchers can take broader access to populations likewise as deeper admission to individual activities. The wealth of "big information" that tin come from this research offers the potential for new insights into health and disease.82 Indeed, the Precision Medicine Initiative launched by former President Barack Obama aims to leverage this potential by including mobile devices equally office of its "phenotyping technologies" and empowering patient-centered research83,84; this initiative uses novel approaches to enrollment, informed consent, and engagement in its plan to recruit more than than 1 1000000 volunteers in the All of Us inquiry program.85 Federal agencies are actively updating their approaches to research and mobile devices with guidance on e-consent, mobile medical applications, and low-chance devices.86-89 In that location is clearly a need — and an opportunity — to written report and better app-based informed consent processes every bit experience and technologies advance.90 The overarching goal is to provide the enquiry community of participants and researchers with ameliorate tools to enhance medical enquiry in the 21st century.

From the Partition of Cardiovascular Medicine, Stanford University School of Medicine, Stanford (M.Five.M., Due east.A.A.), and Verily Life Sciences, Due south San Francisco (Thousand.V.G.) — both in California. Address reprint requests to Dr. McConnell at the Sectionalisation of Cardiovascular Medicine, Stanford Academy Schoolhouse of Medicine, 300 Pasteur Dr., Stanford, CA 94305, or at [email protected].

Video Informed Consent

Gagandeep Kang, M.D., Ph.D.

In 2013, the Indian Supreme Court ruled on a case that highlighted the fact that patients enrolled in clinical trials had niggling or no understanding that they were participating in a inquiry trial or of the nature of the trial; in the ruling, information technology was recommended that the informed consent process be recorded on video. During the previous year, widely reported issues with consent and participation had resulted in Supreme Courtroom rulings that delayed or cancelled many clinical trials in India, including several that were supported by the National Institutes of Health.91

Afterwards the turmoil that followed the initial rulings of the Supreme Court, which threatened to stop all clinical trials in India unless college standards were established, the directive regarding video recording of the informed consent process offered a path to permitting experimental studies involving patients to resume. Because it was a new requirement for clinical trials and researchers had no previous experience with the process, there was footling clarity, much ambiguity, and intense discussion amid researchers regarding the execution and standardization of processes.92 A 10-page guidance document issued past the Cardinal Drugs Standard Control Arrangement (CDSCO, the equivalent of the U.S. Food and Drug Administration) in early 2014 provided instructions well-nigh the data to be given to participants, included the requirement that the faces and voices of participants and investigators or designees should exist conspicuously recorded, emphasized confidentiality, and stated that recordings were to be archived for a minimum of v years.93 After much experimentation and discussion in the by 2 years in Bharat, in that location accept been several lessons learned and standard operating procedures developed,94 but clarity is still needed with regard to both process and some ethical issues.

Setting upward video recording of the consent procedure in a busy clinical surroundings is not simple. It requires a serenity room that is large plenty to accommodate at least four people: the prospective trial participant; the investigator or designee; a witness, in case the participant is illiterate; and a videographer, who despite existence able to use minor, loftier-resolution cameras notwithstanding needs to accept sufficient distance from those being recorded to record two or three people going through the consent documents, the discussion, and the initialing and signatures. In the case of children being recruited, the room also needs to be big plenty accommodate additional family members. The requirement of oral consent for the recording and of the provision of initial information, followed by the discussion and the recording of the process of informed consent, results in multiple sessions for some studies, especially when the participants need time for give-and-take with their families. (An example of video consent is available with the full text of this article at NEJM.org.)

Each recording has to be reviewed for quality, which results in more than demands on the time of the study team and the need for backup equipment, since any poor recordings or equipment breakdowns will require obtaining consent again or atomic number 82 to substantial delays in recruitment. Digital storage is not expensive in relation to the costs of clinical trials, but there is every bit yet no specific guidance on the acceptability of location (due east.k., cloud storage) or the demand for backup storage, level of encryption, and access.

Although the practical difficulties take solutions, two ethical issues need consideration. The directives require that only participants who consent to video recording may participate in a clinical trial. This may event in a lack of participation for religious, cultural, or social reasons that lead to a reluctance to be recorded on video, even though the potential participant understands the benefits and risks and would similar to enroll in the study. Minor studies have indicated that patients worry nearly the confidentiality of video recording, particularly when they have cancer or stigmatizing diseases. In a report in southern Republic of india involving 150 participants, upwardly to a third, specially women and younger persons, said that they would refuse to participate in a report because of the recording.95 My ain experience has been that video recording does result in some eligible persons refusing to become further, but the likelihood of refusal can be decreased with careful explanations from the investigative team in hospitals. Another approach that works well in customs-based trials is the encouragement of discussion of the process with participants enrolled in other studies who accept agreed to draw their experiences when asked by the investigators. Despite these approaches, deprival of participation because of a refusal to be recorded goes against the principle of justice; the opportunity to share in the benefits and risks of research should exist offered to all eligible persons. In an subpoena issued by the CDSCO in August 2015, the issue was partly addressed by permitting only audio recording for trials related to human immunodeficiency virus and leprosy.

A second unresolved issue is that of confidentiality: there is no clarity with regard to the command the participant has over the process. Opt-out clauses can ensure that biologic samples are destroyed later on the original purpose of study is completed, just for video records there is no information on who can view the video — within the research team, within the institution, among members of the institutional review board, among regulatory or legal authorities — and whether the participant has the right to deny a viewing of the video to any of these authorities and at what time during or after the written report.

Overall, video recording of informed consent has the laudable purpose of ensuring better conduct of the process of informed consent and should decrease the conduct of trials in which participants are insufficiently informed and practice non understand the purpose and the risks and benefits of research. It requires planning, new processes, and substantial resources, but it is feasible if the resource are available.

The unresolved bug of processes for ensuring confidentiality and for addressing participation in trials when persons may non want to be recorded need attending and word. There is no empirical show every bit nonetheless that the goals of truly informed consent are being met through the process of video recording, and there is no mensurate of the proportion of persons or communities who decline participation because of their unwillingness to be recorded. The price, complexity, and level of preparation required for video recording also hateful that in certain emergency intendance and public health settings, it will not be possible to test interventions, given the logistic constraints. Overall, although the goal is to protect vulnerable populations, the costs in terms of resource and opportunities require regulatory regime to carefully consider the populations, settings, and study designs that truly do good from the requirement for video recording of consent.

From the Partition of Gastrointestinal Sciences, Christian Medical Higher, Vellore, Bharat. Address reprint requests to Dr. Kang at the Division of Gastrointestinal Sciences, Christian Medical College, Ida Scudder Rd., Vellore, TN, 632004 India, or at [electronic mail protected].

Funding and Disclosures

Disclosure forms provided past the authors are available with the full text of this article at NEJM.org.

Supplementary Material

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