# Participant Information Sheet and Consent Form: [Study short title]

> Template for the participant information sheet and consent form of a
> research study with human participants, written for a clinical trial
> and adaptable to other health research. The content checklist follows
> the informed consent section of ICH E6(R3) Good Clinical Practice
> (section 2.8, adopted 6 January 2025), the US Common Rule at 45 CFR
> 46.116 and, for the EU, the Clinical Trials Regulation (EU) No 536/2014
> and the GDPR (Article 9 for health data). Replace every `[bracketed]`
> value and every row marked *Example*. This is a documentation format,
> not legal or medical advice: your research ethics committee (REC) or
> institutional review board (IRB) must approve the final wording, and
> its templates and local law take precedence. Check the current official
> texts and ask a qualified professional.

<!--
Guidance: How to use this template
- The document has three parts. Part A is the information sheet the
  participant keeps. Part B is the consent form they sign. Part C is the
  research team's checklist, which is not given to participants.
- Write Part A for the participant, not for the committee: short
  sentences, everyday words, "you" and "we", no unexplained abbreviations.
  Many committees ask for a reading age of about 12 to 14 years; check
  yours.
- Put the key information first (section A1). The US Common Rule requires
  a concise and focused key information summary at the start, and ICH
  E6(R3) asks for information that is clear, concise and no longer than
  needed.
- Never include wording that waives, or appears to waive, a participant's
  legal rights or releases anyone from liability for negligence (45 CFR
  46.116(a)(6), ICH E6(R3) 2.8.4).
- Use your institution's template if it has one; it may require fixed
  wording on insurance, data protection or injury compensation. Fill this
  template's checklist (Part C) against it.
- Rows marked *Example* describe the fictional FERN-01 study of a
  fictional study medicine (FR-201) for long-term sleep problems,
  sponsored by the fictional Fernhollow Research Institute. Delete them
  when you fill your own.
-->

## Document control

<!-- Guidance: Every version of the consent materials must be approved before use, and the version number and date must appear in the footer of every page given to participants. Record which version each participant signed. -->

| Field | Value |
|---|---|
| Document ID | [ICF-001] |
| Study title | [Full title as approved] |
| Study short title or acronym | [ACRONYM] |
| Protocol number and version | [Protocol number, v2.0, YYYY-MM-DD] |
| Registration | [Registry name and number, for example EU CT number, ISRCTN or NCT] |
| Sponsor | [Sponsor organisation] |
| Ethics approval | [REC or IRB name, reference number, date of approval] |
| Population version | [Adult participant / parent or guardian / legally acceptable representative / young person assent] |
| Language and translation | [Language; translation certified on YYYY-MM-DD] |
| Version | [1.0] |
| Status | [Draft / Submitted to REC or IRB / Approved for use / Superseded] |
| Owner | [@chief-investigator] |
| Approvers | [@sponsor-representative], [@data-protection-officer], [REC or IRB] |
| Last updated | YYYY-MM-DD |
| Classification | [Public once approved] |

### Approvals

| Role | Name | Decision | Date |
|---|---|---|---|
| Chief or principal investigator | [@name] | [Approved] | YYYY-MM-DD |
| Sponsor representative | [@name] | [Approved] | YYYY-MM-DD |
| Data protection officer | [@name] | [Reviewed] | YYYY-MM-DD |
| Research ethics committee or IRB | [Committee name] | [Favourable opinion / approval, reference] | YYYY-MM-DD |

### Revision history

| Version | Date | Author | Change summary | Re-consent needed? |
|---|---|---|---|---|
| 1.0 | YYYY-MM-DD | [@name] | First approved version | Not applicable |
| 1.1 | YYYY-MM-DD | [@name] | *Example:* New information on next-day drowsiness added to section A6, marked as new | Yes, all participants still on study medicine |

## Contents

<!-- Guidance: Keep this list for the team. In the printed participant version, a short contents box at the start of Part A helps readers find sections. -->

1. [Part A: Participant information sheet](#part-a-participant-information-sheet)
2. [Part B: Consent form](#part-b-consent-form)
3. [Part C: Research team checklist](#part-c-research-team-checklist)
4. [Glossary and references](#glossary-and-references)

## Part A: Participant information sheet

<!-- Guidance: This part is for the participant to read and keep. Use the headings as questions, as participants scan for the answer they need. Replace the example text with plain-language text about your study. -->

**Study title:** [Full title]
**Short title:** [ACRONYM]
**Sponsor:** [Sponsor]
**Study doctor:** [Name, site, telephone]
**Version:** [1.0], [YYYY-MM-DD]

We are inviting you to take part in a research study. Before you
decide, please read this information and talk about it with others if
you wish. Ask us about anything that is not clear. Taking part is your
choice.

### A1. Key information

<!-- Guidance: Five to eight short points covering the facts most likely to help someone decide: that this is research and voluntary, the purpose, how long it lasts and what is involved, the main risks and possible benefits, and the alternatives. Fit it on one page. -->

| Question | Short answer |
|---|---|
| Is this research? | Yes. *Example:* We are testing whether a new medicine, FR-201, helps adults sleep better. It is not yet approved for this use. |
| Do I have to take part? | No. Your care will not change if you say no or stop later. |
| What would I do? | *Example:* Take one capsule each night for 12 weeks, keep a short sleep diary and come to 4 clinic visits. |
| Will I get the new medicine? | *Example:* Maybe. A computer decides by chance. You have a 1 in 2 chance of getting FR-201 and a 1 in 2 chance of getting a dummy capsule (placebo). |
| What are the main risks? | *Example:* Drowsiness the next morning, headache and dizziness. Do not drive if you feel drowsy. |
| Could it help me? | *Example:* It might improve your sleep, but we do not know. You may not benefit. |
| What else could I do? | *Example:* Your usual treatment, sleep therapy or other medicines your doctor can discuss with you. |

### A2. Why is this study being done?

[Explain the condition, the question the study asks and why it matters,
in two or three short paragraphs.]

### A3. Why have I been invited, and how many people will take part?

[Explain why the person is eligible.] *Example:* You have been invited
because you have had trouble sleeping for at least 3 months. About 240
adults at 8 hospitals will take part.

### A4. Do I have to take part?

<!-- Guidance: State clearly that participation is voluntary, that refusing or stopping has no penalty or loss of benefits the person is otherwise entitled to, and that their usual care continues. -->

No. It is up to you. If you decide to take part, you can stop at any
time without giving a reason. Saying no or stopping will not affect the
care you receive now or in the future. [If the study doctor is also the
person's usual doctor, say how you avoid pressure, for example another
team member takes consent.]

### A5. What will happen to me if I take part?

<!-- Guidance: Describe each visit and procedure, which parts are experimental, the chance of each group, what is expected of the participant and how long it all lasts. A table or timeline is easier to follow than text. -->

*Example:* Your part in the study lasts about 14 weeks.

| Visit | When | What happens | Time |
|---|---|---|---|
| Screening | Week 0 | Questions about your health, blood test, pregnancy test if relevant | 90 minutes |
| Start | Week 1 | Random allocation, first capsules, sleep diary explained | 60 minutes |
| Check-in | Weeks 4 and 8 | Questions, side-effect check, blood test at week 8 | 45 minutes each |
| End of treatment | Week 13 | Last capsules returned, questionnaires | 60 minutes |
| Follow-up call | Week 14 | Telephone call about side effects | 15 minutes |

**What we ask of you:** [For example take the capsule each night, keep
the diary, avoid alcohol on study nights, tell us about any new medicine
and any pregnancy.]

**Which parts are research:** [For example the study medicine, the extra
blood tests and the questionnaires; all other care is routine.]

### A6. What are the possible risks, side effects and burdens?

<!-- Guidance: List reasonably foreseeable risks with how often they happen, plus burdens such as time, travel and discomfort. Include risks to an embryo, foetus or breastfed infant where relevant, and say there may be risks not yet known. Mark new information clearly in a revised version. -->

| Risk or burden | How often | What we do about it |
|---|---|---|
| *Example:* Next-morning drowsiness | About 1 in 10 people in earlier studies | Do not drive or use machines if drowsy; tell the study team |
| *Example:* Headache | About 1 in 20 | Simple pain relief allowed; tell the study team |
| *Example:* Bruising from blood tests | Common | Trained staff take blood |
| Unknown risks | Not known | We will tell you promptly about any new information |
| Pregnancy and breastfeeding | [Risk known or unknown] | [Contraception requirements, what happens if pregnancy occurs] |

### A7. What are the possible benefits?

[Describe possible benefits honestly. If there is no intended benefit to
the participant, say so plainly.]

### A8. What other options do I have?

[Describe alternative treatments or procedures and their main benefits
and risks, or say that the person can simply continue usual care.]

### A9. What happens when the study ends or if I stop early?

<!-- Guidance: Explain what happens after the study (access to the study medicine, return to usual care), how a person stops, the follow-up offered after stopping, what happens to data and samples already collected, and when the study doctor or sponsor might stop someone's participation. -->

| Situation | What happens |
|---|---|
| Study ends as planned | *Example:* You return to your usual care. FR-201 will not be available after the study. |
| You stop taking the capsules | *Example:* We would like to keep seeing you for safety checks, if you agree. |
| You leave the study completely | [What happens to data and samples already collected, in line with the law and section A11] |
| The study doctor stops your participation | [For example for safety, if you need a medicine that is not allowed, or if the sponsor stops the study] |

### A10. Costs, payments and injury

<!-- Guidance: Describe any expenses the participant may have, payments or reimbursement (and if they are prorated for partial participation), and what compensation or treatment is available if they are harmed by taking part. Insurance and indemnity wording is often fixed by the sponsor or by law: use the approved text. -->

| Topic | Detail |
|---|---|
| Costs to you | [None / describe] |
| Expenses paid | *Example:* Travel costs up to [amount] per visit, on receipts |
| Payment for your time | *Example:* [Amount] per completed visit, paid even if you stop early for visits completed |
| If you are harmed | [Approved text on treatment and compensation for research injury, insurance or indemnity, and whom to contact] |

### A11. How will my information be used and protected?

<!-- Guidance: Explain what is collected, who sees it, where it is stored, for how long, whether it leaves the country, and the participant's rights. In the EU and UK, data protection law requires specific transparency information (GDPR Articles 13 and 14). Consent to take part in research is not automatically the legal basis for processing data; your data protection officer decides the legal basis. -->

| Topic | Detail |
|---|---|
| What we collect | *Example:* Name and contact details (kept at the hospital only), health information, questionnaire answers, blood results |
| Coding | Your study data carry a code, not your name. Only the site team can link the code to you. |
| Who can see your records | [Study team; monitors and auditors for the sponsor; regulators; the ethics committee, to check the study is done properly] |
| Where it is stored and for how long | [Location; retention period required by law or the sponsor] |
| Transfers | [Countries outside your own, and safeguards] |
| Legal basis (EU and UK) | [As decided by the data protection officer, for example a task in the public interest and scientific research, rather than consent] |
| Your rights | [Access, correction, objection, complaint to the supervisory authority; limits that apply to research data] |
| Data controller and contact | [Organisation, data protection officer contact] |
| Registration and results | [The study is registered on a public database. Results will be published without your name.] |

### A12. Samples and future research

[Describe what samples are taken, where they go and what happens to them
after the study. State whether identifiers may be removed and the
samples or data used or shared for future research without asking you
again, or that they will not be. Say whether samples could lead to
commercial profit and whether you would share in it, and whether whole
genome or exome sequencing may be done. Offer optional consent for
future use as a separate box in Part B.]

### A13. Results and new information

[Say whether and how general study results and, where appropriate,
individual results (including what treatment you received) will be
shared, and that you will be told promptly about new information that
may affect your willingness to continue.]

### A14. Who is organising, funding and reviewing the study?

[Sponsor, funder, any payment to the study team or site, conflicts of
interest, and the committee that reviewed and approved the study.]

### A15. Who can I contact?

| For | Contact |
|---|---|
| Questions about the study | [Name, role, telephone, email] |
| Your rights as a participant | [Independent contact, for example the ethics committee or patient advice service] |
| If you think you have been harmed | [24-hour telephone number] |
| Complaints | [Process and contact] |
| Data protection | [Data protection officer] |

## Part B: Consent form

<!-- Guidance: One page if possible. Each statement is initialled by the participant, not ticked by staff. Optional items are separate and the person can take part without agreeing to them. Signatures can be handwritten or electronic where the law and committee allow; the person must get a copy of the signed form and of any later updates. -->

**Study:** [Short title], **Participant ID:** [code],
**Information sheet version:** [1.0, YYYY-MM-DD]

Please initial each box you agree with.

| No. | Statement | Initials |
|---|---|---|
| 1 | I have read the information sheet, version [x], dated [YYYY-MM-DD], had time to think about it and had my questions answered. | [ ] |
| 2 | I understand that taking part is voluntary and I can stop at any time without giving a reason and without my care or legal rights being affected. | [ ] |
| 3 | I understand that people named in the information sheet may look at my medical and study records to check the study is done properly, and I give permission for this. | [ ] |
| 4 | I agree to my study information being used as described in the information sheet. | [ ] |
| 5 | I agree that my family doctor can be told I am taking part. | [ ] |
| 6 | I agree to take part in this study. | [ ] |

**Optional items** (you can take part without agreeing):

| No. | Statement | Yes | No |
|---|---|---|---|
| 7 | I agree that my samples can be stored and used for future research as described in section A12. | [ ] | [ ] |
| 8 | I agree to be contacted about future studies. | [ ] | [ ] |
| 9 | I would like to receive a summary of the results. | [ ] | [ ] |

| Person | Name | Signature | Date | Time |
|---|---|---|---|---|
| Participant | [Name] | | YYYY-MM-DD | [hh:mm] |
| Person taking consent | [Name, role] | | YYYY-MM-DD | [hh:mm] |
| Impartial witness (if the participant cannot read) | [Name] | | YYYY-MM-DD | [hh:mm] |

### B1. Legally acceptable representative

<!-- Guidance: Use only where the committee has approved enrolment of people who cannot consent for themselves, and the law defines who may act. The representative gives consent on the basis of what the person would want. Inform the participant as far as they can understand, and seek their own consent if capacity returns. -->

| Field | Detail |
|---|---|
| Representative name and relationship | [Name, relationship] |
| Basis for acting | [Legal basis, as defined by local law] |
| Signature and date | [Signature], YYYY-MM-DD |

### B2. Assent of a child or young person

<!-- Guidance: Write a separate age-appropriate assent form, with pictures where helpful, for each age band the committee requires. Plan how to seek the young person's own consent if they reach the age of legal consent during the study. -->

[Short assent statement in age-appropriate words; space for the young
person to write their name; parent or guardian consent on a separate
form.]

### B3. Remote and electronic consent

[If allowed: how identity is checked, how the discussion takes place,
how signatures are captured and how the copy is delivered. Offer a paper
option to people who prefer it.]

## Part C: Research team checklist

<!-- Guidance: Use this checklist when drafting and before submitting to the committee. Each row maps one topic to where it appears in Part A and to the source texts. Clause references are to the texts named in the header; check the current consolidated versions, as rules change and local law adds requirements. -->

This checklist maps each topic to the information sheet and to the
source requirements. "ICH" refers to ICH E6(R3) section 2.8.10; "US"
refers to 45 CFR 46.116 (paragraph (b) basic elements, (c) additional
elements).

| ID | Topic | Part A section | ICH E6(R3) 2.8.10 | 45 CFR 46.116 | Done |
|---|---|---|---|---|---|
| ICF-01 | Research, purpose, experimental aspects | A1, A2, A5 | (a), (b) | (b)(1) | [ ] |
| ICF-02 | Investigational product and chance of each group | A1, A5 | (c) | (b)(1) | [ ] |
| ICF-03 | Procedures, including invasive ones, and what is expected | A5 | (d), (e) | (b)(1) | [ ] |
| ICF-04 | Expected duration of participation | A1, A5 | (t) | (b)(1) | [ ] |
| ICF-05 | Foreseeable risks and inconveniences, including to embryo, foetus or nursing infant | A6 | (f) | (b)(2), (c)(1) | [ ] |
| ICF-06 | Expected benefits, or that none are intended | A7 | (g) | (b)(3) | [ ] |
| ICF-07 | Alternatives and their benefits and risks | A8 | (h) | (b)(4) | [ ] |
| ICF-08 | Injury compensation and treatment | A10 | (i) | (b)(6) | [ ] |
| ICF-09 | Payments, prorated where applicable | A10 | (j) | Not listed | [ ] |
| ICF-10 | Expenses to the participant | A10 | (k) | (c)(3) | [ ] |
| ICF-11 | Voluntary, no penalty for refusing or withdrawing | A4 | (l) | (b)(8) | [ ] |
| ICF-12 | Follow-up after stopping and consequences of withdrawal | A9 | (m) | (c)(4) | [ ] |
| ICF-13 | Data handling, including after withdrawal | A9, A11 | (n) | (b)(5) | [ ] |
| ICF-14 | Direct access to records by monitors, auditors, regulators, committee | A11 | (o) | Not listed | [ ] |
| ICF-15 | Confidentiality, publication without identity, registration | A11 | (p) | (b)(5) | [ ] |
| ICF-16 | New information shared promptly | A13 | (q) | (c)(5) | [ ] |
| ICF-17 | Contacts for questions, rights and injury | A15 | (r) | (b)(7) | [ ] |
| ICF-18 | Circumstances for ending participation | A9 | (s) | (c)(2) | [ ] |
| ICF-19 | Approximate number of participants | A3 | (u) | (c)(6) | [ ] |
| ICF-20 | Results and actual treatment made available | A13 | (v) | (c)(8) | [ ] |
| ICF-21 | Future use of identifiable data or samples | A12 | Not listed | (b)(9) | [ ] |
| ICF-22 | Commercial profit from samples | A12 | Not listed | (c)(7) | [ ] |
| ICF-23 | Whole genome or exome sequencing | A12 | Not listed | (c)(9) | [ ] |
| ICF-24 | Key information summary at the start | A1 | 2.8.1(b) clarity | (a)(5) | [ ] |
| ICF-25 | No exculpatory language | Whole document | 2.8.4 | (a)(6) | [ ] |

### C1. Process requirements

<!-- Guidance: The form is only part of consent. Committees and inspectors look at the process: time to decide, who took consent, how understanding was checked and how it was recorded. -->

| ID | Requirement | Source (paraphrased) | How we meet it |
|---|---|---|---|
| PRC-01 | Committee approval of the materials and process before use | ICH E6(R3) 2.8.1(a) | [Reference] |
| PRC-02 | Ample time to decide and questions answered | ICH E6(R3) 2.8.6; 45 CFR 46.116(a)(2) | *Example:* At least 24 hours between information and consent, unless the person asks to decide sooner |
| PRC-03 | No coercion or undue influence | ICH E6(R3) 2.8.3; 45 CFR 46.116(a)(2) | [Who takes consent, payment level reviewed by committee] |
| PRC-04 | Consent taken by the investigator or delegated, trained staff | ICH E6(R3) 2.8.5 | [Delegation log] |
| PRC-05 | Signed and dated before any study procedure | ICH E6(R3) 2.8.7 | [Note in medical record] |
| PRC-06 | Impartial witness when the person cannot read | ICH E6(R3) 2.8.9 | [Process] |
| PRC-07 | Copy of the signed form and later updates given | ICH E6(R3) 2.8.11 | [Paper or electronic copy] |
| PRC-08 | New information assessed for re-consent, revised materials approved first | ICH E6(R3) 2.8.2 | [Process and log] |
| PRC-09 | Emergency enrolment only under approved measures | ICH E6(R3) 2.8.8 | [Not applicable / describe] |
| PRC-10 | Identity checked in person or remotely | ICH E6(R3) 2.8.1(e) | [Method] |

### C2. Jurisdiction notes (dated examples)

<!-- Guidance: These rows are dated examples for the EU, UK and US, checked on 2026-10-30. They are not complete, other countries have their own rules, and texts change. Confirm with your committee, sponsor and data protection officer. -->

| Jurisdiction | Text | Point to check |
|---|---|---|
| International | ICH E6(R3) Guideline for Good Clinical Practice, adopted 6 January 2025 | Section 2.8 on informed consent; regional implementation dates differ |
| International | WMA Declaration of Helsinki, as amended in October 2024 | Paragraphs 25 to 32 on free and informed consent |
| EU | Clinical Trials Regulation (EU) No 536/2014, applicable since 31 January 2022 | Chapter V (Articles 28 to 35) on protection of subjects and informed consent, including minors and incapacitated subjects |
| EU | GDPR (EU) 2016/679, Article 9 | Health and genetic data are special categories; processing needs an Article 9(2) condition, such as explicit consent or scientific research under Union or Member State law with safeguards |
| EU | EDPB Opinion 3/2019 on the interplay between the CTR and the GDPR, adopted 23 January 2019 | Consent to take part in a trial is separate from the GDPR legal basis for processing data |
| UK | Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (SI 2025/538), in force 28 April 2026 | Check current HRA and MHRA guidance on consent for trials of medicines |
| US | 45 CFR 46.116 (revised Common Rule) | Key information first, basic and additional elements, broad consent (d), waiver or alteration (f), posting of one consent form for federally funded trials (h) |
| US | 21 CFR Part 50 (FDA) | Applies to FDA-regulated investigations; elements overlap with but are not identical to the Common Rule |

## Glossary and references

<!-- Guidance: Add terms your committee expects defined in the participant version. Keep the participant glossary in plain words. -->

Terms and sources used in this template.

| Term | Meaning |
|---|---|
| Assent | A child's or young person's agreement to take part, alongside a parent's consent |
| IRB, REC | Institutional review board (US term) and research ethics committee: the committee that reviews and approves research with people |
| Key information | Short summary of the facts most likely to help a person decide, placed at the start |
| Legally acceptable representative | Person allowed by law to consent on behalf of someone who cannot consent |
| Placebo | A dummy treatment that looks like the study medicine but contains no active ingredient |
| Randomisation | Allocation to a study group by chance |
| Re-consent | Asking a participant to confirm consent after important new information |

| Reference | Version or date | Link |
|---|---|---|
| ICH E6(R3) Guideline for Good Clinical Practice | Final, adopted 6 January 2025 | https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf |
| 45 CFR 46.116, general requirements for informed consent | Current eCFR text, checked 2026-10-30 | https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.116 |
| WMA Declaration of Helsinki | October 2024 | https://www.wma.net/policies-post/wma-declaration-of-helsinki/ |
| Regulation (EU) No 536/2014 on clinical trials | Applicable since 31 January 2022 | https://eur-lex.europa.eu/eli/reg/2014/536/oj |
| Regulation (EU) 2016/679 (GDPR), Article 9 | Consolidated text | https://eur-lex.europa.eu/eli/reg/2016/679/oj |
| EDPB Opinion 3/2019 | 23 January 2019 | https://www.edpb.europa.eu/our-work-tools/our-documents/opinion-art-70/opinion-32019-concerning-questions-and-answers_en |
| UK clinical trials legislation | SI 2025/538, in force 28 April 2026 | https://www.gov.uk/government/collections/clinical-trials-for-medicines |

Related templates in this collection: science/trial-protocol,
science/research-ethics-application, science/case-report-form,
science/data-management-plan, compliance/dpia and, for lighter user
research consent, design/research-consent-form.

## Standard and licence note

Based on ICH E6(R3) Guideline for Good Clinical Practice (section 2.8,
adopted 6 January 2025), the US Common Rule at 45 CFR 46.116, the WMA
Declaration of Helsinki (2024), Regulation (EU) No 536/2014 and
Regulation (EU) 2016/679, all checked on 2026-10-30. The requirements
are paraphrased in original text and referenced by section and paragraph
number; no official wording is reproduced. This is a documentation
format, not legal or medical advice: follow your research ethics
committee or IRB, your sponsor and local law, check the current official
texts and consult a qualified professional. Template licence: MIT.