Informed Consent Best Practices for GP Practices

As GP practices in the UK increasingly participate in clinical research, upholding ethical standards particularly around informed consent is critical. Informed consent safeguards research participant safety and autonomy, ensures regulatory compliance, and maintains public trust. This blog outlines best practices for GP practices looking to transition into research or already participating in clinical research, aligning with UK frameworks such as the UK Policy Framework for Health and Social Care Research and the Mental Capacity Act 2005.

Informed Consent is a formal ‘process’- voluntary agreement by an individual to participate in a medical procedure, clinical trial, or research study, after being fully informed of its purpose, procedures, risks, benefits, alternatives, and their right to withdraw at any time. It ensures the individual’s comprehension of the information and their ability to make an autonomous, uncoerced decision, in line with ethical and legal standards (e.g., Declaration of Helsinki, Good Clinical Practice). It is both a process (ongoing dialogue) and a document (written confirmation).

1. Understand the Legal and Ethical Foundations

Informed consent is both a legal requirement and an ethical obligation under:

UK Policy Framework for Health and Social Care Research
General Data Protection Regulation (GDPR) and Data Protection Act 2018
Health Research Authority (HRA) guidelines.

Ensure all research protocols receive approval from a Research Ethics Committee (REC). The HRA provides templates for participant information sheets (PIS) and consent forms, which must be version-controlled and REC-approved.

2. Invest in Comprehensive Training

Staff involved in research must undergo training in:

Good Clinical Practice (GCP): Focus on consent processes, documentation, and ethical considerations.
Role-playing scenarios: Simulate consent discussions to address complex scenario.
Regulatory updates: Stay informed on changes post-Brexit and evolving HRA/MHRA guidelines.

3. Communicate Clearly and Transparently

Use plain language avoiding medical jargon; the PIS) should be understandable to a 12-year-old.
Provide translations: Offer materials in multiple languages and formats (e.g., braille, audio). General practices can request EC approved PIS/CF for languages prevalent within their community from sponsor.
Encourage questions by allowing participants time to reflect, consult with family or advisors, and seek clarification, ensuring all their questions are answered satisfactorily.
Avoid language that may come across as promotional, overly optimistic about benefits, or dismissive of potential risks.

4. Ensure Voluntary Participation

Avoid coercion: Clearly inform the patient that their decisions regarding participation in the trial—whether before, during, or after—will not affect the individual’s clinical care and they have the right to withdraw at any time during the trial.

Reassure anonymity: Explain how data will be handled in accordance with GDPR to ensure participants’ privacy and confidentiality.

5. Meticulous Documentation – ‘If it is not documented, it didn’t happen’

Print name, sign, and date: Obtain consent either in physical form or electronically (eConsent), ensuring compliance with UK regulatory standards. Provide the patient with a copy of the signed consent form for their records.
Store securely: Retain copies of the consent documentation for at least 20 years following the conclusion of the study, in accordance with HRA guidance or the sponsor’s requirements.
Document thoroughly: Every step of the consenting process must be clearly recorded in the patient’s medical notes. This should include, but is not limited to, the date and time of consent, the version of the Participant Information Sheet (PIS) and Consent Form (CF) used, confirmation that a copy was provided to the patient, and that all questions were answered to their satisfaction.
Signature order: Always ensure the patient signs the consent form first, followed by the consenting investigator.

6. Maintain Ongoing Consent

Consent is an ongoing process, not a one-time event. The investigator must reaffirm consent at each study visit and during follow-ups, with the participant’s response clearly documented. Regularly assess and confirm the participant’s continued willingness to take part in the study.

7. Protect Vulnerable Populations

Special considerations must be taken when obtaining consent from vulnerable groups:

Children: Obtain parental or guardian consent, along with the child’s assent where appropriate, based on their age and understanding.
Adults lacking capacity: Engage a legal guardian or representative in accordance with the Mental Capacity Act 2005.
Non-English speakers: Use certified translators or interpreters to ensure full understanding of the study information.

In cases where individuals are unable to provide informed consent themselves—such as minors or adults with cognitive impairments—a Legally Authorised Representative (LAR) may give consent on their behalf.

An impartial witness may be required in certain situations—such as when the participant or their LAR has decision-making capacity but is unable to read, write, speak, or is visually impaired. The impartial witness should be an adult who is not part of the study team, and preferably not a family member, unless they are a healthcare professional or possess relevant knowledge of research practices. The impartial witness must print their name, sign, and date the consent form at the time the consent process takes place.

8. Internal Quality Control

Real-time review: Ensure that each Informed Consent Form (ICF) is reviewed for accuracy and completeness by a separate member of the study team while the patient is still on site.
Internal reviews: Regularly check for compliance with study protocols. One copy of the signed ICF must be filed in the Investigator Site File (ISF), and another may be filed in the patient’s medical record.

9. Sponsor Monitoring Visit and Inspection/ Audit

Maintain clear, organised, and up-to-date documentation to ensure readiness for inspections by the sponsor during monitoring visits or audit by Research Authority or other oversight bodies.

Robust informed consent practices protect participants, enhance research integrity, and bolster your practice’s reputation. By prioritising training, transparency, and continuous improvement, GP practices can excel as ethical research sites.

*Biopharmaal Consulting specialises in guiding healthcare providers through research setup complexities.