PERSPECTIVE
Mandating audio-video recording of informed consent: are we right in enforcing this?
There is greater need to deliberate on the types of clinical studies where audio visual recording should be made mandatory
In India, these concerns have led regulators to mandate audio-video (AV) recording of informed consent in addition to the requirement of obtaining written consent from the participating subjects. It is also required to preserve the AV recording of the informed consent adhering to principles of confidentiality. This is applicable to the new subjects to be enrolled in all clinical trials including Global Clinical Trials (3). Every time regulators see an ethical lapse, more regulations are created. And now, with mandating of AV recording of informed consent process, the time has come to deliberate, if we have gone too far? In affirmative, this act will definitely impart greater degree of transparency in conduct of clinical trials for example those involving minors. It will ensure that participant in trial is informed completely, his participation is voluntary and his queries are addressed duly. However, on the negative note, the haste with which the AV recording of informed consent is implemented is not justified. It opens the
794
room for greater debate related various issues of participants’ confidentiality and operational management. AV recording of the participants is source of potentially sensitive information which in absence of clear guidance on information security management may be tampered with and will be minefield of potential abuse. Further, directive and guidance provided for the same does not elaborate on steps that need to be taken in case religious and socio-cultural reasons hinder patient from providing AV consent (3). The patients suffering from sexually transmitted diseases and acquired immune deficiency syndrome may not be willing to provide AV consent to trial participation. Similar would be the case with diseases associated with social stigma e.g. leprosy. Clearly, patient’s refusal in such cases may impact the trial recruitment (4). Also, implementing the directives with immediate effect entails greater stress on the trial infrastructure and logistics support in terms of procuring the equipments, investing in training the staff and costs of administering, storing and maintaining AV records which may further delay ongoing trials and greatly increase the trial expenditure. Further, as the directive is applicable to ‘all clinical studies’, various field trials and observational studies that are generally uncontrolled will face operational issues as implementing AV consent process in such settings has practical limitations. There is no doubt that the process of informed consent upholds the patient autonomy to participate in the trial. However, the process, amount of regulations, documentation and oversight should not be so complex that it starts burdening the participants and investigators. Further, implementing such regulation should be provided with some window time so that necessary arrangements are made to comply with the regulations. Also, stringently following existing laws may go a long way in ensuring transparent conduct of clinical trials. Although, AV recording of informed consent may be suitable for
Medicines are the result of experimentation carried out in animals and humans. However, there are numerous instances in the history of medicine where humans were subjected to undue risks and abuses, requiring regulations for their safety. Idea of informed consent has found its presence in medical literature from the times of Hippocratic Oath propagating principles of ‘. . .never do harm to anyone’ and physician directed care of patients. This was revived in post-world war II era in the form of Nuremberg code and the declaration of Helsinki in response to various debilitating experimentations done on prisoners in concentration camps and elsewhere. Complete information and voluntary participation forms the ethical tenets of these acts and the same has been reflected in various guidelines enacted worldwide, which are sufficient to make sure that patient consent is obtained in fair and just manner (1). Despite this, there have been undesirable lapses in the conduct of clinical trials. This situation worsens, when intentional lapses in conduct of trial hamper the ability of socially and economically disadvantaged communities in developing countries to make free and informed decision (2).
ª 2014 John Wiley & Sons Ltd Int J Clin Pract, July 2014, 68, 7, 794–795. doi: 10.1111/ijcp.12441
Perspective
studies for interventions that have potential to cause serious risk to patient, or those involving minors, its administration to all types of clinical trials may seriously thwart the pace of drug development and the goal of affordable medicines for all. Clearly, best practices are those that aid patients in making fair decision to participate in clinical trial by effectively understanding its pros and cons.
References 1 Nirmal B, Sacchidanand SA. Informed consent in dermatology: what’s known and what’s new? Indian J Dermatol Venereol Leprol 2014; 80: 58–61. 2 Pare Toe L, Ravinetto RM, Dierickx S et al. Could the decision of trial participation precede the informed consent process? Evidence from Burkina Faso PLoS ONE 2013; 8: e80800. 3 CDSCO. Draft guidelines on audio-visual recording of informed consent process in clinical trial. http:// www.cdsco.nic.in/writereaddata/Guidance_for_AV%
ª 2014 John Wiley & Sons Ltd Int J Clin Pract, July 2014, 68, 7, 794–795
A. R. Agrawal, R. P. Joshi, V. Shah SIRO Clinpharm, DIL Premises, Thane, India Correspondence to: Dr Ashish R. Agrawal, SIRO Clinpharm, DIL Premises, 2nd Floor, Swami Vivekananda Road, Near Tatwagyan Vidyapeeth, Ghodbunder Road, Thane (W) 400 610, India Tel.: +91 22 2584 8041 Fax: +91 22 2584 8281 Emails: [email protected], [email protected]
20Recording_09.January.14.pdf. (accessed February 05, 2014). 4 Kulkarni N, Dalal JJ, Kulkarni TN. Audio-video recording of informed consent process: boon or bane. Perspect Clin Res 2014; 5: 6–10.
Author contributions All authors contributed equally to this work.
Disclosure None.
Acknowledgement None to declare.
Paper received March 2014, accepted March 2014
795
Mandating audio-video recording of informed consent: are we right in enforcing this?
There is greater need to deliberate on the types of clinical studies where audio visual recording should be made mandatory
In India, these concerns have led regulators to mandate audio-video (AV) recording of informed consent in addition to the requirement of obtaining written consent from the participating subjects. It is also required to preserve the AV recording of the informed consent adhering to principles of confidentiality. This is applicable to the new subjects to be enrolled in all clinical trials including Global Clinical Trials (3). Every time regulators see an ethical lapse, more regulations are created. And now, with mandating of AV recording of informed consent process, the time has come to deliberate, if we have gone too far? In affirmative, this act will definitely impart greater degree of transparency in conduct of clinical trials for example those involving minors. It will ensure that participant in trial is informed completely, his participation is voluntary and his queries are addressed duly. However, on the negative note, the haste with which the AV recording of informed consent is implemented is not justified. It opens the
794
room for greater debate related various issues of participants’ confidentiality and operational management. AV recording of the participants is source of potentially sensitive information which in absence of clear guidance on information security management may be tampered with and will be minefield of potential abuse. Further, directive and guidance provided for the same does not elaborate on steps that need to be taken in case religious and socio-cultural reasons hinder patient from providing AV consent (3). The patients suffering from sexually transmitted diseases and acquired immune deficiency syndrome may not be willing to provide AV consent to trial participation. Similar would be the case with diseases associated with social stigma e.g. leprosy. Clearly, patient’s refusal in such cases may impact the trial recruitment (4). Also, implementing the directives with immediate effect entails greater stress on the trial infrastructure and logistics support in terms of procuring the equipments, investing in training the staff and costs of administering, storing and maintaining AV records which may further delay ongoing trials and greatly increase the trial expenditure. Further, as the directive is applicable to ‘all clinical studies’, various field trials and observational studies that are generally uncontrolled will face operational issues as implementing AV consent process in such settings has practical limitations. There is no doubt that the process of informed consent upholds the patient autonomy to participate in the trial. However, the process, amount of regulations, documentation and oversight should not be so complex that it starts burdening the participants and investigators. Further, implementing such regulation should be provided with some window time so that necessary arrangements are made to comply with the regulations. Also, stringently following existing laws may go a long way in ensuring transparent conduct of clinical trials. Although, AV recording of informed consent may be suitable for
Medicines are the result of experimentation carried out in animals and humans. However, there are numerous instances in the history of medicine where humans were subjected to undue risks and abuses, requiring regulations for their safety. Idea of informed consent has found its presence in medical literature from the times of Hippocratic Oath propagating principles of ‘. . .never do harm to anyone’ and physician directed care of patients. This was revived in post-world war II era in the form of Nuremberg code and the declaration of Helsinki in response to various debilitating experimentations done on prisoners in concentration camps and elsewhere. Complete information and voluntary participation forms the ethical tenets of these acts and the same has been reflected in various guidelines enacted worldwide, which are sufficient to make sure that patient consent is obtained in fair and just manner (1). Despite this, there have been undesirable lapses in the conduct of clinical trials. This situation worsens, when intentional lapses in conduct of trial hamper the ability of socially and economically disadvantaged communities in developing countries to make free and informed decision (2).
ª 2014 John Wiley & Sons Ltd Int J Clin Pract, July 2014, 68, 7, 794–795. doi: 10.1111/ijcp.12441
Perspective
studies for interventions that have potential to cause serious risk to patient, or those involving minors, its administration to all types of clinical trials may seriously thwart the pace of drug development and the goal of affordable medicines for all. Clearly, best practices are those that aid patients in making fair decision to participate in clinical trial by effectively understanding its pros and cons.
References 1 Nirmal B, Sacchidanand SA. Informed consent in dermatology: what’s known and what’s new? Indian J Dermatol Venereol Leprol 2014; 80: 58–61. 2 Pare Toe L, Ravinetto RM, Dierickx S et al. Could the decision of trial participation precede the informed consent process? Evidence from Burkina Faso PLoS ONE 2013; 8: e80800. 3 CDSCO. Draft guidelines on audio-visual recording of informed consent process in clinical trial. http:// www.cdsco.nic.in/writereaddata/Guidance_for_AV%
ª 2014 John Wiley & Sons Ltd Int J Clin Pract, July 2014, 68, 7, 794–795
A. R. Agrawal, R. P. Joshi, V. Shah SIRO Clinpharm, DIL Premises, Thane, India Correspondence to: Dr Ashish R. Agrawal, SIRO Clinpharm, DIL Premises, 2nd Floor, Swami Vivekananda Road, Near Tatwagyan Vidyapeeth, Ghodbunder Road, Thane (W) 400 610, India Tel.: +91 22 2584 8041 Fax: +91 22 2584 8281 Emails: [email protected], [email protected]
20Recording_09.January.14.pdf. (accessed February 05, 2014). 4 Kulkarni N, Dalal JJ, Kulkarni TN. Audio-video recording of informed consent process: boon or bane. Perspect Clin Res 2014; 5: 6–10.
Author contributions All authors contributed equally to this work.
Disclosure None.
Acknowledgement None to declare.
Paper received March 2014, accepted March 2014
795
