|Year : 2014 | Volume
| Issue : 1 | Page : 6-10
Audio-video recording of informed consent process: Boon or bane
Niranjan G Kulkarni1, Jeroze J Dalal1, Tejashree N Kulkarni2
1 Clinical Operations, GlaxoSmithKline Pharmaceuticals Limited, Worli, Mumbai, Maharashtra, India
2 Institute of Medical Education Technology and Teachers' Training, MUHS Regional Centre, Civil Hospital, Aundh, Pune, Maharashtra, India
|Date of Web Publication||7-Jan-2014|
Niranjan G Kulkarni
Clinical Team Leader, GlaxoSmithKline Pharmaceuticals Limited, Dr. Annie Besant Road, Worli, Mumbai 400 030, Maharashtra
Source of Support:
, Conflict of Interest: Tejashree N Kulkarni was
working at Department of Infectious Diseases, Maharashtra University
of Health Sciences, Seth Gordhandas Sunderdas Medical College and
King Edward Memorial Hospital, Mumbai, Maharashtra, India when this
article was submitted.
| Abstract|| |
The Drugs Technical Advisory Board has recommended inclusion of audio-video (AV) recording of the informed consent process while conducting clinical trials in India. It is included as draft rule in the gazette of India notification dated 7 th June 2013. This will soon become a law. There are many anticipated advantages of AV recording like reliability, transparency, and improvement in quality of conduct of informed consent process. However, at the same time the industry will need to address challenges in infrastructure, maintaining confidentiality, cost implication, and so on. AV recording will help reassure the government and community about standards maintained by the industry/institute while conducting informed consent process, thereby increasing society's faith in clinical research.
Keywords: Audio-video recording, AV recording, clinical trials, informed consent
|How to cite this article:|
Kulkarni NG, Dalal JJ, Kulkarni TN. Audio-video recording of informed consent process: Boon or bane. Perspect Clin Res 2014;5:6-10
| Introduction|| |
In recent years, there has been substantial debate about the ethics of research in developing countries. The quality of informed consent process is identified as one of the issues.  India's clinical trials system has come under intense scrutiny after a series of scandals involving alleged malpractices which have sparked widespread public protests. Concerns have been raised about the lack of ethical oversight, and there have also been allegations that vulnerable patients are routinely recruited to clinical trials without proper informed consent.
In a survey questionnaire served to 29 investigators in India, very few investigators (18%) felt that all their patients in studies were "truly autonomous."  It may be because of mainly cultural dependence on family, physicians, and community, irrespective of education.
With this background, it was not a surprise that central government in consultation with Drugs Technical Advisory Board (DTAB), Central Drug Standard Control Organization vide the Gazette of India notification dated 7 th June 2013 proposed to make draft rule that audio-video (AV) recording of the informed consent process of individual participant by an investigator including procedure of providing information to the subject and his understanding on such consent shall be maintained by the investigator for record while conducting clinical trials in India.  Once the Ministry makes the necessary amendments in this regard, the AV recording of informed consent will become mandatory in India.
A video tape recording of the consent interview is also recommended by United States Food and Drug Administration in case of illiterate participants who can understand and comprehend spoken English but are physically unable to talk or write.  As per Indian Council of Medical Research Ethical Guidelines, in case of sensitive nature of the project or when participants cannot sign or give thumb impression AV methods could be adopted with prior consent and adequate precaution to ensure confidentiality. In addition, Ethics committee (EC) approval is required for such procedures. 
This article enlists the anticipated advantages and foreseeable challenges in the process of implementing AV recording of informed consent process.
| Anticipated Advantages|| |
Safeguarding the stakeholders
Though the intention of the DTAB is safeguarding the rights, safety, and well-being of the participants enrolled in clinical trials. AV recording will actually play a major role in safeguarding all stakeholders involved in a clinical trial, not just the patients. The investigator will be able to demonstrate that all relevant information was provided to the potential participant before he/she understood and voluntarily agreed to take part in the clinical study. The EC can use this as a tool to oversee the consent process at the site and direct the investigator in case of any shortcomings in the process. In case of any dispute/litigation, the sponsor will have some solid evidence to support that adequate measures were taken to obtain consent appropriately rather than simply rely on the signed informed consent form (ICF) and the documented narrative.
Simplification of the consent process
In the absence of AV recording of the consent process, the monitors rely on the documentation of informed consent narrative to reconstruct informed consent process. The sites are often advised and trained to write a detailed informed consent narrative, which can run into pages. The expectation of documentation from the site has grown over time and will continue to increase. The emphasis needs to be shifted from laborious documentation of mechanical aspects of research process to assuring true comprehension and voluntary participation. The efforts will be worth the time and cost involved, as it will strengthen the research effort through recruitment and retention of participants who better understand their roles and responsibilities in the study and thus can adhere to protocol.  The AV recording mandate will ensure that conduct is given more importance over mere documentation of whole process.
Some sponsors, to safeguard themselves, make it mandatory for the participant to sign each page of the ICF, which means that the participant has to sign around 20-25 times to indicate that he/she agrees to be a part of clinical trial. If AV recording is used, the number of signatures per ICF could reduce dramatically. This will help the patient a lot because signing a single ICF multiple times is a cumbersome process for patients suffering from major illnesses.
As per good clinical practice, the participant should be given the signed and dated copy of the informed consent document.  One of the reasons is that this document helps the participants to refer to the details of the trial anytime. However, trial participants may not recollect all the answers provided by the physician to their doubts. If a copy of the informed consent AV recording is given to the participants, they can access the discussion with the investigator anytime, provided they have access to the required technology to be able to view this recording. This can be of special importance in case of illiterate participants or those who have a limited understanding of medical terminologies.
Lack of transparency is a reason for the public to be suspicious of industry's intentions.  The AV recording of the informed consent will increase the transparency of the informed consent process in clinical trials, this will in-turn increase the confidence of the society in the ethical conduct of clinical research in India, which is currently a pressing concern. As per amendments to Indian Evidence Act, 1872 (1 of 1872) the definition of ''evidence'' has been changed to include electronic records (Section 3(a) of the Evidence Act) produced for the inspection of the court. Also the definition of ''Admission'' has been amended to include statement in electronic form in addition to oral or documentary form. As per the Information Technology (IT) Act, 2000 ''electronic records'' means data, record or data generated, image or sound stored, received or sent in an electronic form or microfilm or computer-generated microfiche.  Hence in case of any allegation by the subject, AV recording could be used as evidence in the court of law provided prescribed process is followed for recording and maintaining the records.
Also name of the nominees and the income status can be confirmed with the recordings, which may help reduce likelihood of misinterpretation (example false claims) in the compensation process.
Improvement in conduct of informed consent process
Introduction of the AV recording could take the informed consent process to higher standards than those followed today. Since the process will be recorded, the investigator will have greater accountability to ensure that the participants truly understand the clinical trial before enrollment. This will ultimately help increase society's confidence in clinical trials because the person conducting the process will ensure all essential elements of informed consent document are discussed and any doubts/concerns raised by the participant/participant's legally acceptable representative (LAR) are satisfactorily addressed. It will also expose the investigators who are not following the informed consent process properly. This will help India have a different standard over and above International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) countries.
Improvement in informed consent documents
The task of conveying the concept of research and basic scientific terms (blinding, confidentiality, randomization, and others) to a scientifically naοve population is a major challenge of informed consent process.  AV recording may enable researchers to identify areas poorly grasped by the potential research participants. This information can be used for further simplifying the informed consent documents/counseling.
Confirmation of informed decision
After delivering all information, to complete the cycle of communication, it is important to assess how far the message has reached the participant.  AV recording can help confirm the understanding, if the researcher asks the participant to demonstrate their understanding of information conveyed to them. If this is achieved, it would be fair to assume that AV recording has helped the participant to take an informed decision.
| Foreseeable Challenges|| |
Infrastructure is a main point of discussion when anybody tries to think of implementation of AV recording of the informed consent discussion. Not many government-funded clinical trial sites have appropriate infrastructure required to make AV recording at the sites possible. If we think of infrastructure, a minimum requirement would be separate room for consent with minimum background noise and equipment to record the consent process, which could be a simple camera. In the absence of any regulatory specifications about the type of recording, for example what all should be seen in the recording full/half face, side view, rear view, and so on further clarity is required on what is expected and acceptable. Consideration should be given for patients who are immobile, as there may be need for a movable set-up to record their consent.
Indian culture has tradition of ladies using ghunghat (a veil or headscarf worn by South Asian women to cover their head and often their face) and burkhas (enveloping outer garment worn by women in some Islamic traditions to cover their bodies when in public) especially in rural India. In rural parts of the country, women avoid eye contact with men. If we are now asking these individuals to give consent on camera, it will be a time-consuming process for the site staff. Patients who are uncomfortable will simply refuse and this may impact recruitment adversely.
Dilemma regarding ongoing research participants
It is assumed that this mandate will not only be applied for the consent process at the beginning of study participation but also for each and every amendment applicable for the study. It is yet to be determined what happens to the participants who refuse video recording of their consent discussion, if they are already on study medication for ongoing studies. Will these participants be withdrawn from the study drug only because they refuse to be video recorded and is it ethical to do so, when they were not informed about this requirement at a time when they decided to participate in the study?
Recording of a "process"; not an "event"
Informed consent is a process and not an event. The investigator may counsel the patient or resolve the patient's doubts as and when these are asked, which may be through a telephone call, during outpatient departments or through subinvestigator(s). So recording informed consent at one stretch seems to be a difficult task and recording each small consultation on camera may not be practically possible. However, it is definitely going to take more time for the investigator to obtain consent from each participant with this method. Also before the start of the informed consent process, the participant will have to consent for AV recording. This will significantly increase the volume of the work at the site.
In addition, who is responsible for recording the consent process is questionable. Is it the site staff or a third party professional, in case of the latter, subject confidentiality would be at stake. Another option worth considering will be automatic recording with self timer which would engage only the concerned parties.
Willingness to discuss ailment over camera
In India, patients may not be comfortable discussing about their disease in front of the camera especially in cases of sexually transmitted diseases, acquired immune deficiency syndrome, and so on patients with depression and mania may be suspicious and may have to be dealt with carefully. The patient may be worried about social stigma associated with diseases such as leprosy or tuberculosis. The investigator will have to reassure the patient about the confidentiality maintained by the site and sponsors who are end users of the data. This may lead to fewer patients opting for clinical trials and subsequently recruitment delays.
Interpretation of behavior on camera
It seems to be a big problem how the body language or the facial expressions of the participant or the investigator providing information are interpreted, since it is very subjective. It may seem that the participant is coerced to take part in the trial based on his/her body language or vice versa.
Confidentiality at stake
With personally identifiable information being collected, the responsibility of handling this sensitive information with utmost care increases multifold. The investigators will have to strengthen the governance at the site to ensure that there is no theft or misuse of the confidential discussion available on record. The investigator will have to assure the participants by explaining what this information will be used for and how it will be stored.
From the sponsor's perspective it is monitor's responsibility to verify that source documents and other trial records are accurate, complete, and appropriately maintained. Once AV recording becomes a regulatory requirement in India, the monitor would be required to review the IC process and bring any deficiencies to the notice of investigator. The monitor will have to take all reasonable precautions within the applicable regulatory framework to maintain confidentiality of subjects' identity and ensure that these recordings are maintained under secured access. Extensive training will have to be imparted to the monitor to fulfill this responsibility.
In case of audits and inspections, it will become challenging for auditor/inspector to confirm if the process was adequately performed since he or she may not familiar with the language used and may need a translator.
The cost implication of recording consent process for each and every informed consent discussion cannot be undermined. The activity has a potential to shoot the clinical trial budget significantly. Consider in a study with large sample size and high screen failure rate, each and every informed consent discussion will have to be recorded, irrespective of whether the participant agrees or refuses to consent at the end of the discussion. In addition, the records of all participants who have consented but screen failed due to any inclusion and exclusion criteria will have to be archived, which adds to the cost.
AV recording of the consent process in studies enrolling patients treated in emergency conditions and critical cases will be a problem. In addition, for the illiterate patients, the impartial witness and for participants not able to consent for themselves a LAR will have to be included in the recording. The assent from the minor will also have to be captured in the recording.
Risk of tampering the records
The ICFs are maintained with original signatures and though tampering the signed document is possible, it is quite difficult and may be relatively easier to detect. However with advances in technology, tampering of the AV recording may become easier and difficult to detect. Hence, ensuring controlled access and robust IT policies (including an audit trail) will be required in order to be in place to avoid any misuse of the records. How long would this information be stored for and what happens at the end of a trial would need to be defined and discussed with the regulators.
| Conclusion|| |
AV recording of the consent process will definitely help to record the actual consent process, but ascertaining that the participant has voluntarily consented still remains debatable. Also until expectations of regulators from the AV recording are crystal clear, the records may work as double-edged sword for the investigators and sponsors, because AV recordings once made becomes an irreversible process and mistakes made by the investigator would be difficult to be corrected and can be misused. However, in the current scenario, it is our highest priority to reassure the government and community at large about standards adopted by the industry and AV recording would be a very positive step ahead to build trust and confidence in the clinical research industry.
| Disclaimer|| |
The views expressed in this article are those of the authors and do not necessarily reflect views of the company.
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