- PIS, ICF and Assent: What Each Document Does
- Elements of the Participant Information Sheet
- Writing the Informed Consent Form
- Children, LAR and Participants Who Cannot Read
- Vernacular Translation and Back-Translation
- Audio-Visual Consent: When Does It Apply?
- Common Mistakes and How to Fix Them
- Getting Help with Your Consent Documents
- FAQs
The Participant Information Sheet (PIS) and Informed Consent Form (ICF) are the documents your participants actually read. The IEC reads them closely for that reason, and they are one of the most common reasons a thesis file comes back with queries. A protocol can be scientifically perfect and still be held up because the information sheet is written in textbook English, leaves out compensation, or has a Hindi version that says something different from the English one.
This guide walks you through what each document is for, the elements the ICMR National Ethical Guidelines (2017) expect, a consent statement template, assent for children, translation and back-translation, when audio-visual recording of consent applies, and the mistakes that cause most IEC queries. Your IEC will usually have its own template; use it, and treat this as a checklist for filling it well.
1PIS, ICF and Assent: What Each Document Does
- Participant Information Sheet (PIS): explains the study in plain language so a person can decide whether to take part. The participant keeps a copy.
- Informed Consent Form (ICF): a short document in which the participant confirms, statement by statement, that they have understood the information and agree to take part. It carries signatures or thumb impressions and dates.
- Assent form: for children (and others who cannot give legal consent but can understand), a simpler document recording their own agreement, used alongside consent from a parent or legally acceptable representative (LAR).
Remember that consent is a process, not a signature. ICMR guidance describes it as a conversation in which the participant has time to ask questions and decide freely. The forms only document that the process happened. The underlying principles are discussed in our post on ethical standards in medical research.
2Elements of the Participant Information Sheet
The ICMR 2017 guidelines list the information a prospective participant should receive. Not every element applies to every study, but your PIS should address each one or deliberately leave it out because it is not relevant. A practical checklist:
| Element | What to write (in plain language) |
|---|---|
| Study title and investigators | A simple title, your name, guide's name, department and institution |
| Purpose | Why the study is being done, in one or two sentences |
| Why the person is invited | For example, "because you have been diagnosed with type 2 diabetes" |
| Voluntary participation | Taking part is their choice; refusing will not affect their treatment |
| Procedures and duration | What will be done, how many visits, how long each takes, total duration of involvement |
| Research vs routine care | Which tests or procedures are only for the study |
| Risks and discomforts | Realistic, specific risks (pain of venepuncture, time burden, side effects), not "no risk" |
| Benefits | Direct benefit if any; otherwise say there may be no direct benefit, but results may help others |
| Alternatives | For interventional studies, the treatment options available if they do not take part |
| Confidentiality | How identity will be protected, who can see records (including the IEC and, where applicable, regulators) |
| Costs and payments | Whether study tests are free, and any reimbursement for travel or time |
| Research-related injury | Free treatment for research-related injury and how compensation will be handled, as per institutional and regulatory requirements |
| Right to withdraw | They may withdraw at any time without giving a reason and without penalty |
| Samples and future use | If samples are stored, for how long, and whether they may be used for future research (with separate consent) |
| Contacts | Your phone number and that of the IEC Member Secretary for questions about rights |
Use "you" and short sentences. Replace "venepuncture" with "a small amount of blood (about two teaspoons) will be taken from a vein in your arm". Replace "randomised" with "a process like tossing a coin will decide which treatment you receive". Read it aloud; if it sounds like a textbook, rewrite it.
3Writing the Informed Consent Form
The ICF is usually one page of numbered statements, each with a box the participant initials or ticks. A typical set, which you should adapt to your IEC's template:
- I confirm that I have read (or had read to me) and understood the information sheet dated ______ (version ___) for the above study, and have had the opportunity to ask questions.
- I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected.
- I understand that the investigators, the Ethics Committee and regulatory authorities (where applicable) may look at my records, and I agree to this access. My identity will not be revealed in any report or publication.
- I agree to the use of my data for this study and its publication without my identity being disclosed.
- (If applicable) I agree / do not agree to my samples being stored for future research, subject to Ethics Committee approval.
- I agree to take part in the above study.
Below the statements, provide lines for the participant's name, signature or thumb impression and date; the LAR's details if applicable; an impartial witness where the participant cannot read; and the name, signature and date of the person obtaining consent. Each participant should get a copy of the PIS and the signed ICF.
If your CRF assigns a participant code, put the same code on the ICF so they can be matched later; our CRF and proforma guide explains coding.
4Children, LAR and Participants Who Cannot Read
Assent for children
For research in children, the ICMR guidelines require consent from a parent or legal guardian, and assent from the child when the child is old enough to understand. The way assent is obtained depends on age and maturity: younger children are usually given a simple oral explanation, and older children a short written assent form. Check the exact age bands and format your IEC follows. An assent form should be short, use pictures or very simple words for younger children, and say clearly that they can say no.
Legally acceptable representative (LAR)
When an adult cannot consent (for example, an unconscious patient in the ICU or a person with severe cognitive impairment), consent may be taken from an LAR as defined in the guidelines and institutional policy. Explain in your protocol why such participants must be included, and how you will seek the participant's own consent if they regain capacity.
Participants who cannot read or write
Read the PIS aloud in the participant's language, record their thumb impression, and have an impartial literate witness (not a member of the study team) sign that the information was explained accurately and consent was given freely.
If you are using existing records and cannot contact participants, you may request a waiver of consent. Only the IEC can grant it, and you must justify why the study is not practicable without the waiver, why the risk is minimal, and how confidentiality will be protected.
5Vernacular Translation and Back-Translation
Your PIS, ICF and assent forms must be available in the language(s) your participants actually speak. In most Indian hospitals that means English plus at least one regional language, sometimes two. A reliable workflow:
- Finalise the English version first. Translating a draft that will change means translating twice.
- Forward translation: a person fluent in the target language translates into everyday spoken language, not literary or overly formal language.
- Back-translation: a second person, who has not seen the English original, translates the vernacular version back into English.
- Compare: you and your guide compare the back-translation with the original and fix differences in meaning.
- Certify: many IECs ask for a translation certificate stating that the versions are equivalent. Use your IEC's format.
Do not rely on machine translation alone. It often produces words patients do not use and can change meaning, especially for risks and voluntary participation. When the English version is amended, every translated version must be updated and resubmitted too.
6Audio-Visual Consent: When Does It Apply?
Many residents ask whether they must video-record consent. Indian regulations for clinical trials of new drugs, now set out in the New Drugs and Clinical Trials Rules, 2019, require audio-video recording of the informed consent process in specific situations, notably for vulnerable participants in trials of new chemical entities or new molecular entities, with audio recording for certain other categories. These provisions are aimed at regulated clinical trials.
Most thesis studies, such as observational studies, diagnostic accuracy studies, or comparisons of drugs already approved and used within their approved indications, are not regulated clinical trials of new drugs, and audio-visual recording is usually not required for them. However:
- If your thesis involves a new drug, a new indication, or a regulated trial, check the regulatory requirements with your IEC before starting.
- Some IECs ask for audio-visual consent in additional situations as institutional policy.
- If recording is required, the PIS must say so and the recording must be stored securely and confidentially.
If you are unsure whether audio-visual consent applies, ask your IEC to state its decision in the approval letter. A written decision protects you at thesis submission and at publication.
7Common Mistakes and How to Fix Them
| Mistake | Fix |
|---|---|
| Writing "there is no risk" | Describe the real, minor risks: discomfort, time, privacy, side effects |
| Promising benefit ("you will be cured") | State only realistic benefits; say there may be none |
| Copying the protocol abstract into the PIS | Rewrite in plain language from scratch |
| Missing IEC contact details | Add the Member Secretary's name and phone number |
| No mention of research-related injury | Add free treatment and compensation statements as per policy |
| Different sample size or duration from the protocol | Check every number against the protocol before submission |
| Translation without back-translation | Follow the forward, back-translation and certification steps |
| Consent taken by a person with undue influence | Where possible, avoid the treating doctor pressuring the patient; give time to decide |
| Not giving participants a copy | Give a copy of the PIS and signed ICF to every participant |
| No version number or date | Add version and date in the footer of every page |
Submit the PIS and ICF together with the rest of your file; the full list of documents is in our guide to IEC approval for an MD/MS thesis.
8Getting Help with Your Consent Documents
Well-written consent documents save a round of IEC queries and, more importantly, give your participants a fair chance to decide. If you would like your PIS, ICF and assent forms reviewed for completeness, plain language and consistency with your protocol, the PubMedico team can help. Reach us on WhatsApp at +91 78787 33004.
❓ Frequently Asked Questions
Quick answers to common questions on this topic
Most IECs expect two parts: an information sheet the participant keeps, and a consent form with statements and signatures. Some institutions combine them into one document with clearly separated sections. Follow your IEC's template, and make sure the participant receives a copy of both the information and the signed consent.
Usually yes. Consent must be in a language the participant understands well, and in most Indian hospitals many patients are more comfortable in their regional language. IECs commonly ask for English plus the main local language(s), with back-translation. Offer the version the participant chooses and record which language was used.
Generally not for observational or routine-care studies. Indian rules for clinical trials of new drugs require audio-video recording of consent in specific situations, mainly for vulnerable participants in trials of new chemical or molecular entities. If your study involves a new drug or a regulated trial, or your IEC has its own policy, ask the IEC to confirm in writing.
ICMR guidance asks for assent from children once they are old enough to understand, alongside parental consent, with oral assent for younger children and written assent for older ones. IECs specify the exact age bands and formats they follow, so check your committee's template and include an age-appropriate assent form in your submission.
Often yes, since the resident is usually the investigator, but take care that patients do not feel pressured because their doctor is asking. Explain clearly that refusal will not affect their care, give time to decide, and follow any IEC rule about who may obtain consent. For vulnerable groups, an independent person may be preferred.
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