Indian Journal of Dental Research

LETTER TO EDITOR
Year
: 2015  |  Volume : 26  |  Issue : 3  |  Page : 333--335

Audio-visual recording of obtaining informed consent: Mandatory for clinical trials


S Gowri1, S Kannan2,  
1 Department of Oral Health, National Univesity, Suva, Fiji
2 Department of Health Sciences, National Univesity, Suva, Fiji

Correspondence Address:
S Kannan
Department of Health Sciences, National Univesity, Suva
Fiji




How to cite this article:
Gowri S, Kannan S. Audio-visual recording of obtaining informed consent: Mandatory for clinical trials.Indian J Dent Res 2015;26:333-335


How to cite this URL:
Gowri S, Kannan S. Audio-visual recording of obtaining informed consent: Mandatory for clinical trials. Indian J Dent Res [serial online] 2015 [cited 2020 Dec 5 ];26:333-335
Available from: https://www.ijdr.in/text.asp?2015/26/3/333/162887


Full Text

Sir,

Obtaining informed consent from study participants is the hallmark of any ethical clinical research, the exception being, where a waiver of consent can be granted. The International Conference on Harmonization Guideline for good clinical practice[1] defines informed consent as a process by which a participant or his/her legal representative voluntarily confirms their willingness to participate in a particular trial/study after having been informed about all aspects of the trial that are relevant to the participant's decision to participate. Usually informed consent has to be documented by means of a written, signed, and dated informed consent form and a patient information sheet. The three essential principles of this procedure include: (1) Providing all the necessary information about the study, (2) ensuring the research participant has understood the relevant information, and (3) documenting his/her voluntary decision to participate or not.[2],[3] The ethical obligation of an investigator in any clinical research is to ensure that these principles are being adhered to.

Approximately, 36% of the patients in India were found to be illiterate in 2011,[4] and studies[5],[6] have shown that the informed consent documents were too complex for the study participants in India to understand. Despite various approaches described to improve the participants' understanding of clinical research,[7] a recent study from Pune[8] has shown that almost 62% of the study participants have not understood the study-related risks and illiterate subjects have almost two times odds of lower consent comprehension. As regards to dental research in India, although there is no data regarding how the participants were informed during a clinical research, studies from the West[9],[10] have shown similar results as the above-mentioned medical literature. In response to a public interest litigation filed by a nongovernmental organization in Indore, in October 2013, the Honorable Supreme Court of India has made audio-visual recording of the informed consent process mandatory and has indicated this should be done for five new clinical trials that have been approved between January and August 2013. Following this directive, the Office of Drugs Controller General (India) (DCG [I]) issued an order on November 19, 2013 stating that written informed consent with audio-visual recording of the informed consent process of each trial participant including the procedure of providing information to the participant and documenting his/her understanding on such consent, is required for all clinical trials, the principles of confidentiality should be observed, and such recording and related documentation should be preserved.[11]

This order as issued has several shortcomings. The order is unclear in whether or not clinical studies that do not fall under the purview of DCG (I) require audio-visual recording of the informed consent process. If the participant refuses to be videotaped but still wishes to be enrolled in the study, then should he/she be enrolled or not? Is it ethical not to enroll a participant who has actually understood all the essential aspects of the study and is willing to participate? additionally patients with stigmatized diseases such as HIV infection, or those who are mentally challenged, may not accept to be videotaped. The order does not mention how to conduct audio-video recording of the informed consent process in these vulnerable participants. Other considerations include: Creating an adequate infrastructure with sound-proof materials so the voice of both the investigator and research participant can be captured clearly; a camera with good resolution and a sufficient memory in place; measures for non-editable date and time on the video; storing the recordings on a CD/pen drive/hard disk with password protection so the recordings may be preserved for adequate duration as specified by the drug regulatory authority (ranging anywhere between 5 and 15 years after the trial completion); and creating a standardized operating procedure at the investigation site for performing the consent process; all these will add to the clinical trial budget. Although a potential participant should be included only after ensuring that he has understood all the aspects of the study and his/her consent is voluntary, the audio-visual recording is very cumbersome and time-consuming for a clinical study that does not carry a great risk. Instead, we suggest that this recording may be considered on a case-to-case basis. There are slightly over 100 clinical trials registered in the clinical trial registry of India pertaining to dentistry.[12] Dentists who are involved in conducting clinical trials should be aware of this new order.

References

1Guideline for Good Clinical Practice E6 (R1). ICH Harmonized Tripartite Guideline. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf. [Last cited on 2013 Nov 25].
2The Process of Informed Consent. Association of Clinical Research Professionals. Available from: http://www.acrpnet.org/pdf/ACRPWhitePaperTheProcessofInformedConsent.pdf. [Last cited on 2013 Nov 25].
3Bhutta ZA. Beyond informed consent. Bull World Health Organ 2004;82:771-7.
4Literacy and Level of Education. Available from: http://www.censusindia.gov.in/Census_And_You/literacy_and_level_of_education.aspx. [Last cited on 2013 Nov 25].
5Gitanjali B, Raveendran R, Pandian DG, Sujindra S. Recruitment of subjects for clinical trials after informed consent: Does gender and educational status make a difference? J Postgrad Med 2003;49:109-13.
6Jhanwar VG, Bishnoi RJ. Comprehensibility of translated informed consent documents used in clinical research in psychiatry. Indian J Psychol Med 2010;32:7-12.
7Shafiq N, Malhotra S. Clinical research: Comprehension of the patient information leaflet and the consent form. J Postgrad Med Educ Res 2012;46:122-5.
8Joglekar NS, Deshpande SS, Sahay S, Ghate MV, Bollinger RC, Mehendale SM. Correlates of lower comprehension of informed consent among participants enrolled in a cohort study in Pune, India. Int Health 2013;5:64-71.
9Taiwo OO, Kass N. Post-consent assessment of dental subjects' understanding of informed consent in oral health research in Nigeria. BMC Med Ethics 2009;10:11.
10Butterworth M. How informed is informed consent? Br Dent J 2002;193:217.
11Order. Directorate General of Health Services, Ministry of Health and Family Welfare, Office of Drugs Controller General (India). Available from: http://www.cdsco.nic.in/Office%20Order%20dated%2019.11.2013.pdf. [Last cited on 2013 Nov 25].
12Clinical Trial Registry of India. Available from: http://www.ctri.nic.in/Clinicaltrials/login.php. [Last cited on 2013 Nov 25].