Informed consent process ensures the individual’s autonomy, to voluntarily participate in a trial. This process comprises of three components, which are:
- Providing relevant and necessary information about the trial to the participants,
- Ensuring that this information is understood / comprehended by them,
- Assuring their voluntary participation.
Information that is to be provided to participants for a regulatory clinical trial, must be approved by the Ethics Committees and furnished to the Licensing Authority (i.e., CDSCO). For academic trials, only the EC(s) approval is required. These approvals must be sought before the initiation of the trial. The documents that must be submitted to the EC(s) and/or CDSCO are:
- Participant Information Sheet (PIS),
- Informed Consent Form (ICF),
- Assent Form (in case study population is between 7-18 years of age),
- And, any other written information to be provided to the participants (for example, participant diaries which are to be provided to a participant after recruitment).
- Translations of the above mentioned documents into the local language (wherever applicable). Translation of ICD must be done by an expert in the language. The languages in which the translations must be done, will be guided by the study population and requirements of the EC. The translations should comply (as closely as possible) to the ICD written in English, meet the site-specific requirements, and comply with the applicable regulatory guidelines. For submission to the EC, certificate of translation, and back translation to English might be required.
Researchers are recommended to keep the following points in mind, while developing the informed consent documents:
- Documents are meant to provide all trial related information to a prospective participant or their guardian or legal representative.
- Should be brief, concise, clear, not coercive or unduly persuasive or influencing content.
- Written in non-technical terms and simple understandable language. However, care should be taken that the information provided is scientifically accurate, and socially and culturally sensitive.
- Written in English and local or vernacular languages of the participant.
- The document must detail the risks that can be anticipated and explain that the consent is voluntary and the participant has the right to withdraw consent for participation at any time point during the study period.
- Explain that information obtained about them in the course of the trial will be confidential and used solely for the purposes of this study. It should also explain measures to ensure confidentiality.
- Adequate time should be given to the potential participants to read the information, discuss with their family, and seek clarification, before deciding to enrol in the trial.
- If the participant and/or the guardian cannot read and write, then this information can be read to them in the presence of a literate, impartial witness. If the participant voluntarily agrees to participate in the trial, they can give their thumb impression and the witness can then sign the ICD on behalf of the participant or the guardian (if consent is given).
- After obtaining consent from the participant, the investigator (or researcher administering consent) must ensure that the participant is provided with a copy of the PIS and a signed ICF. If the participant is unwilling to take the documents, then, this should be recorded.
- The investigator should also retain the original PIS and signed ICF, as per the regulatory requirements. These documents should be appropriately archived after the completion of the trial.
- For pediatric population: if the trial is planned for a pediatric population, then, the consent from the guardian must be obtained. The ICDs should include assent forms, if the participant is aged between 7 and 18 years. Assent Forms explain the proposed trial in a simple language, which ensures that the child understands the request to voluntarily participate in the trial. The child’s agreement to participate in the trial is referred to as assent.
- Biological samples: if the proposed trial involves storage of samples and/or tissues for future use, then, consent for storage must be taken and documented. The ICD must provide details of sample type that will be stored, storage methods and period of storage. It should also reiterate confidentiality, and disposal of unused samples at the end of the proposed period of storage. The ICD should also state that the participant is the owner of their samples, and that the Principal Investigator is the custodian of these samples. The participants should also be asked whether they would like to receive the results.
Table 3 of the Third Schedule (page 215) of the New Drugs and Clinical Trail Rules, 2019 and Section 5 of the National Ethical Guidelines for Biomedical and Health Research involving Human Participants (2017), provide checklists and a format for developing ICDs. The following templates may be used for developing ICD for a trial:
- Checklist of essential elements to be included in ICD as per Table 3 of the Third Schedule (page 215) of the New Drugs and Clinical Trial Rules, 2019
- Template for ICF, developed as per the guidance available in the Table 3 of the Third Schedule (page 215) of the New Drugs and Clinical Trial Rules, 2019.
- Checklist of essential and additional elements to be included in ICD, as per the National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017.
References and Further Reading
- New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 03.04.2019).
- Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
- National Ethical Guidelines for Biomedical and Health Research involving Human Participants, Indian Council of Medical Research, 2017, available online (last accessed on 26.02.2019).
- ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9th November 2016, available online (last accessed on 26.02.2019).