Participant Information Sheet and Consent Form Template

Research participant information sheet and consent form: key information, visits, risks, data protection, consent, ICH E6(R3) and 45 CFR 46.116 checklist

Наукові дослідженняПовнийICH E6(R3) 2.8 (2025); 45 CFR 46.116; GDPR Art. 9informed consent formОновлено 29 жовт. 2026 р.

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Як використовувати: Use it when preparing consent materials for a clinical trial or other health research before ethics review. Fill the key information summary and the visit table first, then check every row of Part C against your committee's template. The main pitfall is unapproved wording changes or language that appears to waive participants' rights.

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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.

Document control

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Status	[Draft / Submitted to REC or IRB / Approved for use / Superseded]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

Part A: Participant information sheet
Part B: Consent form
Part C: Research team checklist
Glossary and references

Part A: Participant information sheet

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

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?

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?

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?

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?

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

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?

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

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	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

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

[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

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

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)

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

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.

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