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Medical Research Consent Form

A completed clinical research consent recording information, optional samples, risks, confidentiality, withdrawal and no effect on NHS care.

Jurisdiction: England and Wales - completed fictional worked example

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An editable Microsoft Word version is available from the interactive page.

Important: This sample provides general legal information only and is not legal advice. Check the law, prescribed forms and signing requirements that apply to your exact jurisdiction and circumstances before use.

# MEDICAL RESEARCH CONSENT FORM

Date: 20 May 2029

Parties: Dr Leah Morgan, North Trent NHS Foundation Trust and Oliver James Reed

## 1. Parties and purpose

Oliver James Reed of 7 Beech Avenue, Nottingham NG5 3RP is invited to join the fictional RESTORE-LUNG observational study led by Dr Leah Morgan at North Trent NHS Foundation Trust. The study examines recovery data after asthma admissions; it is not a promise of treatment, diagnosis or personal medical benefit, and Oliver may decline without giving a reason.

## 2. Scope, price and subject

After an explanation and time for questions, Oliver consents to one baseline interview, review of relevant NHS records for five years, and two follow-up questionnaires over 18 months. A blood sample for the optional biomarker sub-study is not required for the main study; Oliver has separately ticked consent for that sample and may decline it without losing the core study option.

## 3. Operating duties

The foreseeable burden is approximately 45 minutes per visit, minor bruising from the optional blood draw and possible discomfort when discussing illness. No experimental medicine is administered. The research team will explain any new information affecting continued participation, and Oliver should seek urgent clinical help through ordinary NHS routes rather than waiting for the study team.

## 4. Compliance, records and controls

The Trust processes identifiable information under UK GDPR and the Data Protection Act 2018 for a task in the public interest and scientific research safeguards. The study code is used in analysis; the key is restricted to authorised staff. Results may be published in aggregate without identifying Oliver. Confidentiality has limits where safeguarding, serious risk, law or a regulator requires disclosure.

## 5. Term, ending and remedies

Participation is voluntary and Oliver may withdraw at any time by contacting the research office, without affecting NHS care, benefits, employment or relationship with the Trust. Withdrawal stops new data collection and future contact; data and samples already used or required for research integrity may be retained in coded form, and Oliver may ask what can lawfully be deleted. The Trust will explain any practical limit before acting.

## 6. Liability and reservations

There is no payment, but reasonable travel expenses up to £35 per completed in-person visit may be reimbursed with receipts. The Trust maintains an indemnity arrangement for negligent harm and will explain the NHS complaints and research-ethics routes; compensation is not guaranteed for ordinary study inconvenience. The consent does not waive statutory rights or create a clinical contract.

## 7. Governing law and signatures

Oliver signs the participant sheet and receives a copy; Dr Morgan signs for the research team on 20 May 2029. The study follows its Health Research Authority approval, favourable Research Ethics Committee opinion and applicable clinical governance, UK GDPR and safeguarding requirements. England and Wales law applies, and this form records consent rather than transferring any medical decision-making authority.

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