Advantages and challenges of AV recording in clinical trials

In the last couple of years in India, concerns have been raised by the public and the Parliament about the lack of ethical oversight and recruitment of vulnerable subjects into clinical trials without undertaking proper informed consent, which is a legal, as well as ethical requirement of research in human beings.

Even though it is mandatory under Schedule Y of the Drugs and Cosmetics Rules 1945 to obtain a freely given informed, written consent from study subject before he/ she is enrolled in a clinical trial, in the absence of audio/video proof, there have been complaints about misuse of this provision by the pharma companies and CROs who are engaged in clinical trials. There were reports that many a time the informed consent was taken from the participating subjects without informing them about the pros and cons of the trial.

It is the duty of the investigators to adequately inform the trial subjects about the essential elements of the study and that of the drug to be administered. The trial subjects should be made fully aware that the drug is a new drug and it is being administered for the first time; its therapeutic efficacy and adverse effects have not yet been well documented. The research subject should also give his consent stating that he has understood the information provided by the investigator with respect to the study and his participation in the trial is voluntary. Incidentally, the informed consent which should truly mean ‘understood consent’ has been found lacking in the later and in spirit at many occasions. In our opinion, the word informed consent should be replaced by ‘understood consent’.

Some important factors that compromise the quality of the informed consent process are poorly comprehensible language in the participant information sheet, its erratic translation in vernacular language, partial disclosure of information, lackadaisical back translations and inadequate time provided to the prospective participant to take a truly informed decision.

Various ethical issues concerning conduct of clinical trials, including informed consent process, has drawn the attention of the print and electronic media. Health sector NGOs have been at the forefront of raising this sensitive issue.

In the case writ petition (W.P.) (C) No. 33/2012 of Swasthya Adhikar Manch, Indore & Anr Vs. Ministry of Health and Family Welfare &Ors. with WP(C) No. 779/2012 regarding clinical trials, the Supreme Court has passed an order dated 21.10.2013. As per the said order, with respect to five global clinical trials for which approval was given by CDSCO after 01.01.2013 till 31.08.2013, before the clinical trials are conducted, appropriate provision shall be made or administrative direction shall be issued which ensures that audio- visual recording of the informed consent process of the participants is done and the documentation is preserved, adhering to the principles of confidentiality.

In light of the above order by the Supreme court, CDSCO vide F. No. GCT/20/SC/Clin./2013 DCG1 dated 19.11.2013 issued direction that in all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual (AV) recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent is required while adhering to the principles of confidentiality.

To facilitate and guide the implementation of draft notification, the SC’s order and its own office order, CDSCO issued ‘Draft guidelines on audio-visual recording of informed consent process in clinical trial’ dated Jan 9, 2014. This document provides guidelines to stakeholders on audio-visual recording of informed consent process in clinical trial as per the above direction.

Advantages of the AV recording of the informed consent of clinical trial:

• This gives emphasis on both the process as well as content of consent recording. It ensures that the participant has consented to participate in the trial after due deliberation.
• There will be more transparency of the informed consent process ensuring that it has actually taken place and the process has been done in a fair and unbiased manner.
• It proves that all the components of the informed consent have been covered.
• It safeguards stakeholders. It ensures that all the pertinent information has been provided by the investigator and there will be irrefutable evidence that the information has been passed in case of any dispute in future, especially in the case of vulnerable groups such as illiterate persons, pregnant women, children, elderly, tribal population and mentally challenged persons.
• Electronic data will occupy less space for storage and will be durable.
• Will increase confidence of trial participant and society at large in the entire clinical trial activity.

Challenges of AV recording of informed consent process in clinical trials

• Infrastructure and personnel/AV recording sites: There are 650 plus ethics committees (overseeing at least as many trial sites) in the country. Many trial sites may not have sufficient infrastructure such as a dedicated room with no background noise for AV recording. A designated videographer may also not be there. Personnel with basic knowledge and skills of recording need to be permitted to undertake AV recording after adequate competence training has been given to them.
• Time: Informed consent is not an event, it is a process which may sometime take several hours spread over many days. Participant may come back with some questions after consulting his/her family members and therefore informed consent process may be interrupted in between.
• In some situations, urgency of the enrolment may not permit the video recording e.g. trial of drugs for stroke, for post head injury intervention etc. There should be some provision for granting relaxation of AV recording by the EC on a case-to-case basis, provided adequate rationale is available for the same.
• Reluctance of prospective participants to undergo video recording: India is a country with diverse social, cultural and religious background. Some participants such as those belonging to rural areas, ladies practicing purdah or ghunghat may be reluctant to get videographed. Participants suffering from some specific diseases such as Hep C, HIV, leprosy, TB may hesitate to subject themselves to AV recording due to the attached/perceived social stigma.
• Videography, while ensuring robustness of the informed consent process, may act as a deterrent and prevent some participants from discussing certain sensitive issues (such as contraception) over camera.
• Legally authorised representatives (LAR) of participants such as those of minors, illiterate persons, suffering from psychiatric illnesses will also need to be included in videography.
• Data storage and risk of tampering: While electronic storage of data offers advantages in terms of longer shelf life and lesser space requirements, it also poses certain challenges. This data can be copied or deleted easily by anyone.

The issue of AV recording of informed consent process has been widely debated by all stakeholders involved in clinical research in India.

The Indian Society for Clinical Research (ISCR), an association of professionals involved in clinical trials, said that lack of guidance and direction on operational and logistical issues of managing the AV recording process like the kind of equipment to be used, the quality aspects of AV recordings and where and how information should be stored could leave room for ambiguity and inconsistencies in execution thereby defeating the very purpose of these guidelines and instructions.

More clarity is required on the following issues:

1. How to protect and maintain confidentiality of patients in an AV context and what processes need to be followed in instances where, for religious and socio-cultural reasons, patients might not want to be videographed?
2. Who bears the overall responsibility of AV recording, if and how should the ethics committee monitor the AV process and what is the broad purpose of doing AV recording?
3. Should the participants be provided with a copy of the recordings as this can increase participant confidence in the informed consent process and the study itself?
4. Is re-recording needed for protocol amendments requiring reconsent? In some situation the protocol may be amended because of addition of any investigational procedure, deletion of some investigation, change in rescue medication and also altered risk assessment in view of the recent information. Will the re-consenting in such cases need to be done on AV recording. Though logically yes, but some believe it is a minor change and AV recording can be avoided considering the logistics involved.
5. Is editing of the AV recording permitted? AV recording often require editing for making it crisp, short and relevant. However, editing may have the risk of accidental or intentional deletion of a strategically important component of the consenting process. For e.g. the participant may be asking whether any adverse event is associated with the intervention or not. This may be answered in the negative to ensure the person’s participation and then that part of the video may be edited out. This may be disastrous for interventions such as cardiac stents, anti-coagulants etc. On the other hand, if editing is not allowed, then does the EC or any other authority such as CDSCO have the expertise and the time to analyse whether editing has been done or not.
6. If the AV recording is not edited then the duration of the video may be too long.

It is imperative that clear guidelines be formulated to specify the following:

1. The device to be used for recording – in the notification it has only been mentioned that sufficient quality of video and audio should be ensured. Though some mobile phones may be equipped with a good quality camera, can they be used? With mobiles there is a confidentiality issue, since mobile phones are more susceptible to inadvertent transfer of data.
2. Specific protocols to be followed for identifying, archiving (password protection), access control (to the PI, or sponsor or the EC) and creating secure backups for the AV recordings.
3. To ensure the standards required, it is desirable to specify minimum standards such as megapixels, distance between the camera and participant etc

AV recording of clinical trial consenting will undoubtedly help reassure the regulatory authority and the community about the practice of clinical trial standards and ethics in letter and spirit thereby re-establishing society’s faith in clinical research. But, due to grey areas and challenges in execution of mandated AV recording, there is a case of revising the issue of AV recording

There is a need to look at the following alternatives:

• Restriction of AV recording of informed consent process to only those trials which include participants from the vulnerable population or to trials in specific disease conditions.
• E-Consent may be an alternate solution. We may soon have a technology in place for e-Consent by using iPads. There is already a solution available internationally.

The decreased confidence of the public and Parliament in the informed consent process in India resulted in a corrective step in the form of AV recording of informed consent of all trials. Evidence and logic-based deliberations are required for correcting the largely perceived over correction.