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Elements for AV Informed Consent Process for Clinical Trials

Audio video consent Guidelines

  • Shekhar Goyal, Indra Bhadu, Akhil Kapoor

Abstract:

Clinical research rules require that each adult volunteer must agree to participate in a scientific trial after given the consent. As per the schedule Y, in every trials, a readily given, enlightened, written consent, free from any physical, internal or economic details. After highlight the order of the Hon'ble Supreme court, CDSCO dated 19 Nov. 2013 has passed that all scientific studies should be audio video recording of the prepared consent process along with written consent of every trial subject. Sound video recording consent is another best device intended to improve the quality of ICF. An music video recording consent of the informed consent process will protect both the themes and the researchers. AV consent will also are a guard for industry as well as researchers for future litigations, press and socialist fake claims. This informative article highlights the music video recording consent elements techniques according to present guidelines.

Keywords: AV process, Clinical studies, consent, Elements, audio video

Introduction:

Voluntary involvement in research strengthens honest conduct, making a comprehensive; knowledgeable consent documents a crucial element of research. Once and for all specialized medical practice (GCP) essential elements of informed consent process and documents should be contained.

However, there are still instances where in fact the process is not properly conducted intentionally or scheduled to ignorance and things were found to get poor understanding of information provided or incompetent individuals were recruited. There are some issues is going on when review enroll vulnerable subjects, illiterate individuals or those who have no idea understandable terminology or investigator don't know the local terminology.

Indian regulatory authority has taken the demanding decision to increase the confidentiality, safety of human things, and the transparency of the professional medical research. CDSCO given the gazette of India notification dated 7th June 2013 suggested to help make the draft rule that sound - video (AV) saving of the educated consent process of individual members by an investigator. Final decision has been used by Supreme Court docket, CDSCO vide F. No. GCT/20/ SC/Clin. /2013/ DCGI dated 19 Nov. 2013 has released the directions that in all clinical trials in addition to the requirement of obtaining written prepared consent, audio-video (AV) saving of the informed consent procedure for each participant trial content, including the method of providing information to the topics and his/her understanding on such consent is required to be achieved while sticking with the concepts of confidentiality. Such audio video tracking and related paperwork would be maintained by site at least 5 calendar year.

A training video tape tracking of the consent interview is also suggested by USA Food and Drug Administration (US FDA) in case of illiterate participants who is able to understand and comprehend spoken English but are physically unable to discuss or write. This guide is applicable for many Indian as well as global clinical trials which can be conducted in India.

Elements of Informed consent Process (AV ICF Process):

Every participant/ patient before participant in the study, Principal Investigator must have provide the individual or group display in presence of witness or LAR in a understandable terminology or local dialect without using much more technological words to the patients in a proper manner. PI should describe the following required Elements for AV consenting:

  • Topic of the study and aspires & purpose of the study
  • Study period with scheduler & amount of participants
  • Protocol design, selection criteria & timelines with follow up & investigation list
  • Foreseeable Risk & benefits associated with the study with discomfort
  • Alternative treatment source and procedures
  • Data confidentiality & accessible details
  • PI & study team contact details
  • Aware about AE & SAE & SAE medical management & compensation details in case of:
  • Seriousness of illness
  • If Death
  • Statement that participant is voluntary in the study and agree for AV consenting
  • About prorate payment
  • Subject obligations (confirming of new finding, any AEs and Drawback from the study anytime, regular follow up, previous results)

In circumstance patient unconscious or mental illness/ struggling to give up to date consent process then previously listed information should be provided to the legal acceptable representative (LAR). In case the subject matter or LAR both are illiterate then use the impartial witness should be there during the sound video recording ICF process.

All the marketing communications between investigator and patient / LAR should be documented in proper way without any restriction in audio tracks video tutorial process. AV consent should be taken at disruption free room. Investigator resolves all query produced by patient and patient LAR through the audio video tutorial consent. ICF copy also directed at the subjects for deeply been through, from then on process should be began with the elements and finished with sign/ thumb impression in proper section by subject matter/ LAR, impartial witness and investigator.

Previously without AV process, consent had been used written format, but after strict law to tighten up the regulatory construction around clinical trials & same recorded should be in the proper execution of audio video which one saved by site / investigator for every single participant trials content.

Protocol of AV recording:

At the initial of the consent process, investigator will identify the patients/LAR (in case impartial witness (IW) required then IW occurrence is necessary during the process). Investigator communicate to the individual, his /her understandable dialect otherwise interpreter request inter- communication. All elements things should be communicate through the informed consent treatment & Last affirmation of the subject and certify that he is in complete understanding of the study and all the concerns are clarified. Patient Identification proof also noted. Audio video have adequate capacity to capture the cosmetic details of subject, LAR, IW (if any), investigator during the consent process with no hurdle in peaceful place. This consent should be taken by orally before video recording. This consent method retained as source documents or further record purpose.

Merits:

Saves investigators from future litigations:

Audio video consent process should be safeguarding of the participants subjects in specialized medical tests. AV process also protect to investigator and show that all relevant information was provided to the topics after that topics agreed to take part in the study. In case there is any issue or dispute, the sponsor will have sturdy evidence to aid that adequate steps were taken up to obtain consent instead of simply written enlightened consent form.

Provides transparency

Audio video consent process should improve the transparency ration of the enlightened consent process in professional medical trials; it will enhance the confidence degree of the clinical trial societies and institutions.

AV recording could be used as an information in the judge of legislation provided & written process is adopted for recording and keeping the records. Which might helpful to reduce the false cases in the compensation process of SAEs.

Protects vulnerable topics from risk

After taking AV consent process prone themes and illiterate subject matter have protected and the ones subjects who aren't understandable medical terminologies. AV consent patient & investigator tracking and investigator clarify the each & every components of the analysis. So vulnerable things and illiterate subject know about the analysis & study methods.

Simply and advanced ICF process:

In previously, screen focus on ICF documents and make out the narratives to reconstruct the ICF process often. The expectation of the paperwork and detailed narrative languages continuous increase for the website & make issues.

Current process will be recorded for patient as well as investigator to ensure that before participant the professional medical trials, participant find out about the trial and all elements of the study are reviewed and questions and queries lifted by individuals/ LAR are settled. It will highlight those researchers who aren't following the up to date consent process properly.

Demerit:

Additional step and responsibility to do this work:

Audio video recording process can be an additional step for site. The investigator may counsel or take care of the all concerns and uncertainties. Investigator will get his more time to obtain knowledgeable consent process from each participant through AV consent process. This may enhance the amount of work at the website such as recording, storage, perform the videography etc.

Maintain the confidentiality and long term storage

Investigator and study team should be keep confidentiality of sound training video consent process, AV data cannot utilized or open by any alternative party or sponsor / CRO. It will be utilized by regulatory body or EC in case there is evidence or Moral issues.

Indian Culture:

Indian has traditional culture especially in rural India. Indian women's wear ghungat or burkas to protect his mind & face to avoid eyeball contact with men. When investigator or site personnel goes for audio tracks video recording consent then it will be frustrating and uncomfortable. Subjects who are not want to show her face, she refused to provide her consent which may affect the recruitment of the analysis & bias.

Language barrier

Indian has 26 types of dialects speak away from different locations. When inspections or auditor want to removed the audio video recording process then it will be become problematic for auditor or inspector to learn the procedure was effectively performed or not? Because he or she not familiar with the language.

Unconscious & serious ill patients

Some studies are related to earnestly sick patients or unconscious patients; if so AV taking of the consent process to enroll the things will be a large issue.

Cost burden:

This process has a significantly increased the professional medical trial budget. In a study with large test size and high display screen failure rate, each and every consent should be audio video documented or stored, if the participants consent or refuse the consent at the end of the talk. This can be increase up the price & unnecessary insert.

Conclusion:

Audio video tracking and elements of the consent process would be beneficial to investigators to consider AV consent in proper way. Best indicate transparent the data which is effective to regulatory body.

References:

  1. CDSCO, Directorate Basic of Health Services, Ministry of Health & Family welfare, Govt. of India; "Draft suggestions on Audio Aesthetic recording of Prepared consent Process in Clinical trial" published in CDSCO website dated on dated 9 Jan 2014.
  2. Niranjan G. K. , Sound video taking of enlightened consent process: benefit or bane. Perspectives in Clinical research; Jan- March 2014; Vol. 5 concern 1.
  3. US FDA guide to Informed Consent: Information Sheet available form: http://www. fda. gov/regulatoryinformation/guidances/ucm126431. htm [Previous accessed on 2013 Sep 14].
  4. Ghooi R. B. , Ensuring that informed consent is absolutely an informed consent: Role of Videography. Perspectives in Clinical research; Jan- March 2014; Vol. 5 concern 1.
  5. The Gazette of India. Ministry of Health and Welfare, Notifications, New Delhi, 7th June 2013 G. S. R. 364 (E). Available from http:// www. cdsco. nic. in /GSR%20364EJune13. pdf [Last accessed on 2013 Sep 23]
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