Lights, camera, action! Starring Investigator and trial participants….
Back in November 2013, following a number of scandals in India involving revelations that vulnerable patients were being recruited into unethical clinical trials without proper informed consent, a supreme court order demanded that mechanisms be put in place to address these worrying ethical issues. This resulted in the CDSCO (Central Drugs Standard Control Organization) issuing a direction requiring an interesting and some would say challenging, new procedure in the recruitment and consent process.
The direction from the Drugs Controller India [1], which is aimed at all sponsors, investigators, institutes/organizations and other stakeholders involved in clinical trials went (in part) as follows: “In all clinical trials, in addition to obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, including the procedure of providing information to the subject & his/her understanding on such consent is required to be done while adhering to the principles of confidentiality”. This was to apply to all local and global clinical trials.
This move was understandably greeted with some consternation and scepticism about the practicality of this potentially burdensome additional requirement. However, as the immediate consequence of the Supreme Court’s reaction to the scandals was that the number of new clinical trials dropped dramatically (data from the Indian Government show that the number of trial applications/approved studies fell from 480/253 in 2012 to 207/73 in 2013) strong regulatory intervention was necessary to try and restore some confidence in the ethics and integrity of Indian clinical trials as far as sponsors and regulatory agencies, non-governmental organizations and the public were concerned.
Some initial guidance on the requirements was provided for clarification and, indeed, to achieve a degree of standardization to deliver quality suitable for audit.
The strict guidance outlined key aspects of required procedures: Basic requirements for the AV recording (equipment, surroundings etc); documentation and approval requirements; the process of A-V recording consent (with initial consent being required for the recording as well as covering, and ensuring understanding of, all the required points – including foreseeable risks or discomforts that might have been missing from poorly obtained consent with overstated benefits); points to consider (such as testing the equipment, reaffirming consent to recording, clear facial identification of participants, ensuring no interruptions etc.); storage of recordings (pen drive, CD/DVD, security, archiving etc.). Guidance also states that it is the Investigator’s responsibility to adhere to the principles of confidentiality; AV recording should be treated as written medical records in terms of confidentiality, removal from the site and access by patients as mentioned in ICMR (Indian Council of Medical Research) & Indian GCP. With digital recording, safeguards regarding electronic transmission are as important as the safeguarding of the physical location of the recording, they point out. Other guidance topics include access to A-V records (e.g. controlling this and maintaining confidentiality); video re-consenting as necessary during the trial; requirements for special populations (video recording of the usual consent from independent witnesses or legally acceptable representatives). Roles & Responsibilities are covered – with the PI also having overall responsibility for identifying and training the site staff and AV recording of consent process etc. [2]
If fully and successfully applied, adopting these procedures should clearly improve the reliability, transparency and quality of conducting the informed consent process to internationally recognized standards and be welcomed at an ethical level but at the same time its introduction will surely have placed extra challenges on sponsors and investigators to apply them as required. These challenges, at best, put pressure on potential recruitment numbers at sites and at worst prevent some potential investigators taking part in trials at all.
Firstly, there is the infrastructure at study sites to consider in making AV recording at the sites possible – suitable rooms for the recordings in a quiet environment and the equipment itself – and this will incur some additional consent costs to the budget, especially as the recordings (and storage/archiving) applies to all patients being consented, including screen failures. A little extra time is also need to set up and conduct each process.
There is also the question of culture and preferences of potential participants, which may prevent proper recording according to necessary guidelines; feelings of intrusion or any discomfort at being ‘on camera’ may simply result in refusal to participate – with an obvious negative impact upon recruitment. One also has to remember that consent is a ‘process’ not a simple ‘event’ and recording this can produce more work at the site. A potential language barrier may also exist, particularly for external monitors, meaning a careful more restrictive choice of personnel for this task is necessary.
Note that for consent of ‘special populations’ of patients (e.g. illiterate patients, those not able to consent for themselves) any necessary witnesses, representatives or guardians are also involved as participants in the recordings and so their willingness (and consent) to the process must also be established.
Any ‘re-consenting’ required after amendments also creates extra work and potential dilemma – for example, what to do if a participant refuses further video recording yet wishes to continue in the trial?
Further, there is an extra, but obviously important, dimension to video consent – that of interpretation of ‘body language’, both of the patient/representatives and of the investigator / study staff. Although assessing degree of willingness on behalf of the patient or possible coercion on behalf of the investigator is the principal benefit not apparent with a simple signature, it puts the extra onus on monitors and auditors to understand and interpret the scenario and, in some cases, perhaps even feeling confident to question the purported freely given nature of the consent. Training of these personnel in this and other aspects of video-consent is also an important consideration requiring extra time and expertise.
Extra care would be necessary to protect the confidentiality and integrity of the additional personal information and identity of patients on behalf of the investigator (camera, pen drives, SD cards etc.) and particularly the sponsor’s personnel who have access to, and review, the videos. Tampering with the video record – inappropriate editing down, for instance – is something sponsors and regulators should also be on their guard about, although one trusts that this would be a rare occurrence.
In part two on this topic we shall consider how this requirement has been received and how, in practice, it may have affected the conduct of clinical trials in India.
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