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Audio-visual recording of ''informed consent'' in India: Step towards ''understood consent'' Aman Goyal Clin Trials 2014 11: 605 DOI: 10.1177/1740774514542621 The online version of this article can be found at: http://ctj.sagepub.com/content/11/5/605
Published by: http://www.sagepublications.com
On behalf of:
The Society for Clinical Trials
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CLINICAL TRIALS
Letter to the Editor
Audio-visual recording of ‘‘informed consent’’ in India: Step towards ‘‘understood consent’’ The informed consent process is considered to be lynchpin of clinical research. However, in practice, it has been observed to be one of the weakest links in whole clinical trial process. The patient often participates in the trial without fully understanding its implications.1 This particularly holds true for a developing country like India, where the patient may be especially vulnerable due to poverty, illiteracy, ignorance, or other factors. Due to paucity of time with the investigator and poor oversight mechanisms by the regulator, on many instances, lapses have been reported in informed consent procedure.2,3 To address this issue and on the directives of Supreme Court of India, the government has directed mandatory audio-visual recording of the informed consent for clinical trials in the country.4 Furthermore, the Central Drugs Standard Control Organization has recently issued a guidance document of draft guidelines concerning mandatory audio-visual recording of the informed consent process for all clinical trials, which is among a series of steps taken to reinforce clinical trial regulations in India.5 Obtaining consent based on a true understanding of what participation in the trial will entail for the participant is a major challenge. The informed consent document in global clinical trials is often a translated version of a form used in other countries without many adaptations for the local population.1 The document may contain medical jargon translated into local language that does not convey the intended meaning, making its understanding even more difficult for the participant. With the introduction of audio-visual recording of the consent process, there is a stronger incentive for the investigator to explain comprehensively in understandable language the risks and benefits to the potential trial participant. To ensure that the implications of participation are properly understood by the participant, a checklist of key questions regarding participation in the study may be asked prior to signing the consent. Such verbal feedback will increase comprehension and will provide the participant with an opportunity to clarify any doubts or apprehensions about the study. A checklist may be voluntarily included in consent procedure by the investigators in order to ensure truly ‘‘informed’’ participation in the trial, although this is not mentioned by the new guidelines.
Clinical Trials 2014, Vol. 11(5) 605–606 Ó The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1740774514542621 ctj.sagepub.com
The implementation of audio-visual recording cannot be contested, despite some of the concerns being raised regarding confidentiality issues, cost, infrastructure, socio-cultural issues and others.6 These concerns can be addressed with meticulously drafted procedures and suitable oversight by the regulatory authority. The new guidelines assume even more importance in the light of recently issued guidelines on compensation for clinical trial–related injury in India, and will act as a future legal safeguard for the investigator and sponsor.7 Mandatory audio-visual recording is a welcome step that will benefit all the stakeholders—sponsor, investigator and trial participant—and will go a long way towards achieving the ultimate goal of ‘‘understood consent.’’ Aman Goyal Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India Corresponding author: Aman Goyal, Department of Pharmacology, All India Institute of Medical Sciences, New Delhi 110029, India. Email: [email protected] Declaration of conflicting interests No potential conflict of interest to declare.
Funding None to declare.
References 1. Bhutta ZA. Beyond informed consent. Bull World Health Organ 2004; 82: 771–777. 2. Rajalakshmi TK. Criminal trials. Frontline, 28 January–10 February 2012, http://www.frontline.in/static/html/fl2902/ stories/20120210290203300.htm (accessed 23 May 2014). 3. Shetty P. Vaccine trial’s ethics criticized. Nature 2011; 474: 427–428. 4. Shankar R. Health ministry makes audio-visual recording of informed consent mandatory for trials. Pharmabiz.com, 22 November 2013, http://www.pharmabiz.com/News Details.aspx?aid=78887&sid=1 (accessed 23 May 2014).
Downloaded from ctj.sagepub.com at SEIR on November 13, 2014
606
Clinical Trials 11(5)
5. Draft guidelines on audio-visual recording of informed consent process in clinical trial. New Delhi, India: Central Drugs Standard Control Organization, 2014, http:// www.cdsco.nic.in/writereaddata/Guidance_for_AV%20Recording_09.January.14.pdf (accessed 14 May 2014).
6. Kulkarni NG, Dalal JJ and Kulkarni TN. Audio-video recording of informed consent process: boon or bane. Perspect Clin Res 2014; 5: 6–10. 7. Choudhury K and Ghooi R. New rules for clinical trialrelated injury and compensation. Indian J Med Ethics 2013; 10: 197–200.
Downloaded from ctj.sagepub.com at SEIR on November 13, 2014
Audio-visual recording of ''informed consent'' in India: Step towards ''understood consent'' Aman Goyal Clin Trials 2014 11: 605 DOI: 10.1177/1740774514542621 The online version of this article can be found at: http://ctj.sagepub.com/content/11/5/605
Published by: http://www.sagepublications.com
On behalf of:
The Society for Clinical Trials
Additional services and information for Clinical Trials can be found at: Email Alerts: http://ctj.sagepub.com/cgi/alerts Subscriptions: http://ctj.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav
>> Version of Record - Sep 4, 2014 What is This?
Downloaded from ctj.sagepub.com at SEIR on November 13, 2014
CLINICAL TRIALS
Letter to the Editor
Audio-visual recording of ‘‘informed consent’’ in India: Step towards ‘‘understood consent’’ The informed consent process is considered to be lynchpin of clinical research. However, in practice, it has been observed to be one of the weakest links in whole clinical trial process. The patient often participates in the trial without fully understanding its implications.1 This particularly holds true for a developing country like India, where the patient may be especially vulnerable due to poverty, illiteracy, ignorance, or other factors. Due to paucity of time with the investigator and poor oversight mechanisms by the regulator, on many instances, lapses have been reported in informed consent procedure.2,3 To address this issue and on the directives of Supreme Court of India, the government has directed mandatory audio-visual recording of the informed consent for clinical trials in the country.4 Furthermore, the Central Drugs Standard Control Organization has recently issued a guidance document of draft guidelines concerning mandatory audio-visual recording of the informed consent process for all clinical trials, which is among a series of steps taken to reinforce clinical trial regulations in India.5 Obtaining consent based on a true understanding of what participation in the trial will entail for the participant is a major challenge. The informed consent document in global clinical trials is often a translated version of a form used in other countries without many adaptations for the local population.1 The document may contain medical jargon translated into local language that does not convey the intended meaning, making its understanding even more difficult for the participant. With the introduction of audio-visual recording of the consent process, there is a stronger incentive for the investigator to explain comprehensively in understandable language the risks and benefits to the potential trial participant. To ensure that the implications of participation are properly understood by the participant, a checklist of key questions regarding participation in the study may be asked prior to signing the consent. Such verbal feedback will increase comprehension and will provide the participant with an opportunity to clarify any doubts or apprehensions about the study. A checklist may be voluntarily included in consent procedure by the investigators in order to ensure truly ‘‘informed’’ participation in the trial, although this is not mentioned by the new guidelines.
Clinical Trials 2014, Vol. 11(5) 605–606 Ó The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/1740774514542621 ctj.sagepub.com
The implementation of audio-visual recording cannot be contested, despite some of the concerns being raised regarding confidentiality issues, cost, infrastructure, socio-cultural issues and others.6 These concerns can be addressed with meticulously drafted procedures and suitable oversight by the regulatory authority. The new guidelines assume even more importance in the light of recently issued guidelines on compensation for clinical trial–related injury in India, and will act as a future legal safeguard for the investigator and sponsor.7 Mandatory audio-visual recording is a welcome step that will benefit all the stakeholders—sponsor, investigator and trial participant—and will go a long way towards achieving the ultimate goal of ‘‘understood consent.’’ Aman Goyal Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India Corresponding author: Aman Goyal, Department of Pharmacology, All India Institute of Medical Sciences, New Delhi 110029, India. Email: [email protected] Declaration of conflicting interests No potential conflict of interest to declare.
Funding None to declare.
References 1. Bhutta ZA. Beyond informed consent. Bull World Health Organ 2004; 82: 771–777. 2. Rajalakshmi TK. Criminal trials. Frontline, 28 January–10 February 2012, http://www.frontline.in/static/html/fl2902/ stories/20120210290203300.htm (accessed 23 May 2014). 3. Shetty P. Vaccine trial’s ethics criticized. Nature 2011; 474: 427–428. 4. Shankar R. Health ministry makes audio-visual recording of informed consent mandatory for trials. Pharmabiz.com, 22 November 2013, http://www.pharmabiz.com/News Details.aspx?aid=78887&sid=1 (accessed 23 May 2014).
Downloaded from ctj.sagepub.com at SEIR on November 13, 2014
606
Clinical Trials 11(5)
5. Draft guidelines on audio-visual recording of informed consent process in clinical trial. New Delhi, India: Central Drugs Standard Control Organization, 2014, http:// www.cdsco.nic.in/writereaddata/Guidance_for_AV%20Recording_09.January.14.pdf (accessed 14 May 2014).
6. Kulkarni NG, Dalal JJ and Kulkarni TN. Audio-video recording of informed consent process: boon or bane. Perspect Clin Res 2014; 5: 6–10. 7. Choudhury K and Ghooi R. New rules for clinical trialrelated injury and compensation. Indian J Med Ethics 2013; 10: 197–200.
Downloaded from ctj.sagepub.com at SEIR on November 13, 2014
