|Year : 2014 | Volume
| Issue : 2 | Page : 113-116
Standard operating procedure for audio visual recording of informed consent: An initiative to facilitate regulatory compliance
PM Parikh1, K Prabhash2, KB Govind3, R Digumarti4, S Pandit5, I Banerjee6, R Biyani7, A Deshmukh8, D Doval9, GS Bhattacharyya10, S Gupta11
1 SAARC Federation of Oncology, Mumbai, India
2 Indian Cooperative Oncology Network, Mumbai, India
3 Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bengaluru, Karnataka, India
4 Tata Cancer Hospital, Visakhapatnam, Andhra Pradesh, India
5 Department of Finance, Sydenham Institute of Management Studies, Research and Entrepreneurship Education, Mumbai, India
6 Academy of Clinical Excellence, Mumbai, India
7 Founder Trustee, Highway Infinite, Pune, Maharashtra, India
8 Department of Political Science, Chetana College, Mumbai, India
9 Department of Research, RGCI, New Delhi, India
10 Department of Medical Oncology, Fortis Hospital, Kolkata, West Bengal, India
11 Tata Memorial Center, Mumbai, India
|Date of Web Publication||7-Aug-2014|
P M Parikh
SAARC Federation of Oncology, Mumbai
Source of Support: None, Conflict of Interest: None
The office of the Drugs Controller General (India) vide order dated 19 th November 2013 has made audio visual (AV) recording of the informed consent mandatory for the conduct of all clinical trials in India. We therefore developed a standard operating procedure (SOP) to ensure that this is performed in compliance with the regulatory requirements, internationally accepted ethical standards and that the recording is stored as well as archived in an appropriate manner. The SOP was developed keeping in mind all relevant orders, regulations, laws and guidelines and have been made available online. Since, we are faced with unique legal and regulatory requirements that are unprecedented globally, this SOP will allow the AV recording of the informed consent to be performed, archived and retrieved to demonstrate ethical, legal and regulatory compliance. We also compared this to the draft guidelines for AV recording dated 9 th January 2014 developed by Central Drugs Standard Control Organization. Our future efforts will include regular testing, feedback and update of the SOP.
Keywords: Checklist, clinical trials, confidentiality, ethics, Supreme Court India
|How to cite this article:|
Parikh P M, Prabhash K, Govind K B, Digumarti R, Pandit S, Banerjee I, Biyani R, Deshmukh A, Doval D, Bhattacharyya G S, Gupta S. Standard operating procedure for audio visual recording of informed consent: An initiative to facilitate regulatory compliance. Indian J Cancer 2014;51:113-6
|How to cite this URL:|
Parikh P M, Prabhash K, Govind K B, Digumarti R, Pandit S, Banerjee I, Biyani R, Deshmukh A, Doval D, Bhattacharyya G S, Gupta S. Standard operating procedure for audio visual recording of informed consent: An initiative to facilitate regulatory compliance. Indian J Cancer [serial online] 2014 [cited 2020 Jul 2];51:113-6. Available from: http://www.indianjcancer.com/text.asp?2014/51/2/113/138158
| » Introduction|| |
In the recent past, there have been a number of controversies regarding the conduct of clinical trials in India.  Clinical trials have also been brought in the limelight of public attention because of litigation in the Supreme Court of India alleging that some of them have been conducted under questionable circumstances and in a manner that did not protect the patient's rights. Specifically allegations have been made about the adequacy of the informed consent process.  The Hon'ble Supreme Court of India paid special attention to these concerns and passed an order dated 21 st October 2013 regarding the same.  Consequently, the Drugs Controller General (India) [DCG (I)] passed an order dated 19 th November 2013 making the audio visual (AV) recording of the informed consent mandatory including the preservation and archival of the AV recording while adhering to the principles of confidentiality.  However, the technical specifications for the same have not been specified. We therefore decided to develop a standard operating procedure (SOP) with the objective of ensuring that the AV recording of the informed consent process is performed in compliance with the ethical guidelines and regulatory requirements as well as that the recording is stored, archived and retrieved in a failsafe manner. This would help document that the subjects had voluntarily agreed to participate in the clinical trial after they had understood the details of the study as well as their rights and obligations.
| » Materials and Methods|| |
The authors first evaluated following orders, rules, regulations and guidelines - Order of Director General of Health Services, Ministry of Health and Family Welfare, Office of DCG (I), F.No. GCT/20/SC/Clin./2013 DCGI dated 19 th November 2013, Schedule Y (January 2005) of Drugs and Cosmetics Act and its amendments, Ethical Guidelines for Biomedical Research on Human Participants, Indian Council for Medical Research, Government of India 2006, International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines: May 1996 and GCP for Clinical Research in India 2001. ,,,, The SOP for the AV recording was then developed to ensure compliance with all of them using a time tested and well-established checklist.  The scope was limited to the digital documentation of the informed consent process and not meant to replace the written informed consent. The SOP was to be applicable to the principal investigator, co-investigator(s) and all other medically qualified trial personnel authorized by the principal investigator for obtaining the informed consent. The draft SOP was circulated among peers, their feedback obtained and then modified as applicable. The SOP was also tested for ease of implementation and completeness in a mock AV recording of a hypothetical informed consent process. The SOP was then made available free online for wider dissemination and utility (http://www.OncologyGoldStandard.com).  We also compared our SOP to the draft guidelines for AV recording dated 9 th January 2014 developed by Central Drugs Standard Control Organization (CDSCO). 
| » Results|| |
The SOP for AV recording of informed consent in India for regulatory compliance: 
The resultant SOP is a 13 page document with 7 sections that contains details of the procedure, where it is applicable, specifics of what equipment, personnel and environment is required for the recording (full document available free at http://wwwOncologyGoldStandard.com). Variations for five circumstances were outlined based on whether the potential participant was literate or not, whether the consent was being administered in a language common to the parties concerned or not and whether a legally acceptable representative was necessary or not. The SOP also contains details for storage and archival in a manner that will maintain confidentiality/privacy as well as allow access for authorized individuals. This SOP has been adapted by at least two ethics committees as part of the official procedures at their respective institutions. A checklist was prepared to ensure that the AV recording documented that the written consent process was informed; voluntary and impartial [Table 1].
|Table 1: Checklist for documenting completion of the informed consent process in the AV recording|
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It is not appropriate to compare guidelines to SOPs. Guidelines give a general direction and SOPs help in meticulous implementation so that no item required/mandatory is missed out. Hence these two are usually complementary to each other. In this instance this refers to the draft guidelines developed by CDSCO and the SOPs developed by ICON Trust and Oncology Gold Standard. , There is a crucial need to ensure that these two match the requirements of the regulatory and legal orders - only then will they allow smooth compliance. [Table 2] comments on the salient features of these two.
|Table 2: Salient features of the CDSCO draft guidelines and the SOP prepared by ICON trust and oncology gold standard|
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| » Discussion|| |
SOP is a terminology applicable to a variety of sectors including health care. For medical research, ICH defines of the performance of a specific function".  Thus, they allow an inexperienced individual to repeatedly apply the same process and document it without missing any step. Such SOPs are also mandatory to be eligible for international quality standard (e.g. International Organization for Standardization 9001) certification.  They also form the backbone of compliance and the basis for training of involved personnel.
In this case, we are faced with unique legal and regulatory requirements that are unprecedented globally. This makes it important that this SOP was developed with great attention and that it's careful implementation is encouraged widely and rapidly.  Only then can the AV recording of the informed consent be performed, archived and retrieved to demonstrate ethical, legal and regulatory compliance in a manner that is systematic, simple and complete. Keeping in mind that poor implementation can have serious consequences; we have deliberately stayed away from some details that were considered as unnecessary.
While our SOP solely recommends digital media, other older methodologies can also be used (film/cine-recording or tape/analogue recording). We do not recommend either of these for obvious reasons. We also remain cognizant of the fact that digital recording may throw up new challenges. Although digital files can be corrupted, we live in the era where full length movies are created digitally. Would it be possible that a digitally created file can bring to life an AV recording of an informed consent process that never happened (a la Life of Pi)? As technology advances, entire class of instrumentation and software can become redundant, forcing costly upgradation. It is also important to realize that cloud computing and storage is not always secure and hacking could compromise the privacy/confidentiality of the information [Table 3].
|Table 3: Steps to ensure privacy and confidentiality for the AV recording|
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Based on operational application, feedback from those using the SOPs, change in work practices and development of new technology, SOPs require to be updated from time to time. We intend to do this proactively and are in the process of developing a strategy and proforma in different languages for the same.
The world is eagerly watching India's experiments in legislation to protect clinical trial participants. We envisage that our SOPs will help in taking the guesswork out of the legal and regulatory compliance of AV recording of the consent process. At the same time, we point out that the ICH-GCP defines IC as a process which is different (and much wider) than the event of capturing the process of obtaining a participant's willingness as an AV recording.
| » References|| |
|1.||Mudur G. India plans to audit clinical trials. BMJ 2005;331:1044. |
|2.||Sanmukhani J, Tripathi CB. Ethics in clinical research: The Indian perspective. Indian J Pharm Sci 2011;73:125-30. |
|3.||Available from: http://www.supremecourtofindia.nic.in/notice_circular.htm. [Last accessed on 2013 Dec 10].4.Available from: http://www.cdsco.nic.in/order.pdf. [Last accessed on 2013 Dec 10]. |
|4.||Available from: http://www.cdsco.nic.in/order.pdf. [Last accessed on 2013 Dec 10]. |
|5.||Available from: http://www.dbtbiosafety.nic.in/act/schedule_y.pdf. [Last accessed on 2013 Dec 10]. |
|6.||Available from: http://www.icmr.nic.in/ethical_guidelines.pdf. [Last accessed on 2013 Dec 10]. |
|7.||Available from: http://www.ich.org/products/guidelines.html. [Last accessed on 2013 Dec 10]. |
|8.||Available from: http://www.cdsco.nic.in/html/GCP.htm. [Last accessed on 2013 Dec 10]. |
|9.||Available from:http://www.m.wikihow.com/Write-a-Standard-Operating-Procedure. [Last accessed on 2013 Dec 10]. |
|10.||Available from: http://www.oncologygoldstandard.com. [Last accessed on 2014 Jan 4]. |
|11.||Available from: http://www.cdsco.nic.in/order.pdf. [Last accessed on 2014 Jan 14]. |
|12.||Available from: http://www.iso.org/iso/iso_catalogue/management_standards/quality_management/iso_9001_2008/iso_9000. [Last accessed on 2013 Dec 10]. |
|13.||Satyanarayana K, Sharma A, Parikh P, Vijayan VK, Sahu DK, Nayak BK, et al. Statement on publishing clinical trials in Indian biomedical journals. Indian J Cancer 2008;45: 39-40. |
[Table 1], [Table 2], [Table 3]