A research study that involves recruitment of participants (whether staff, healthy volunteers or patients) will require the study inclusion/exclusion criteria to be clearly defined in the protocol and REC approved consent documentation (Participant Information Sheets (PIS) and consent forms).
Potential participants will refer to the Patient Information Sheet (PIS) for information on which to make their ‘informed’ decision on whether the research is right for them and the consent form is used to evidence their decision to participate on file.
Informed consent is at the heart of ethical research; the consent process and documentation undergo rigorous ethical review. Noclor strongly recommends that the Chief Investigator refers to the HRA guidance and templates and involve users in the development of the PIS’s and consent forms.
- Responsibilities in participant consent & enrolment
The roles and responsibilities for informed consent and the details of the informed consent process should be clearly defined in the protocol and the REC application (and for clinical trials responsibilities should be clearly delegated on the delegation log). Individuals delegated responsibilities by the Principal Investigator must have appropriate expertise/training evident for the responsibilities that they are delegated.
Enrolled participants must meet the eligibility criteria defined in the protocol. It is not acceptable for participants to be recruited in to a clinical trial where they do not fully the eligibility criteria. These types of events should be reported as protocol violations to Noclor
For CTIMPs, the decision as to whether a participant is eligible for entry into the trial is considered a medical decision and must therefore be made (and evidenced as such) by a medically qualified doctor. The decision should be clearly documented in the medical records or CRF and signed by the medically qualified doctor (as delegated and as they appear on the site delegation log) prior to participant enrolment /randomisation. Noclor recommends that the trial specific data capture tools and study procedures/manual are explicit in this regard (e.g medical doctor’s signature specified on the eligibility assessment CRF).
Participant consent forms should be completed accurately, taken at the time stipulated in the approved protocol and signed off by relevant (responsible) personnel.
- Consent documentation
Consent documentation should always be up to date and available to monitor, audit or inspect at any time. Noclor recommends that sites carry out routine self –monitor checks on their consent forms (check all consent forms are complete and filed).
Completed consent forms should be filed together with the accompanying version of PIS on which the consent was taken in the medical notes with originals placed in the Investigator Site File (ISF). A copy of the consent form and PIS should be given to the participant.
Version control of consent documentation is of paramount importance in a clinical trial, copies of current approved and superseded versions of consent documentation should be retained in the Study/Trial Master File S/TMF (and in the ISF at site) any version changes should be included on the protocol amendment log / document inventory log.
Any non-compliances in the consenting process should be reported to Noclor.
- Re-consent & withdrawal of consent
Informed consent is an ongoing process and over the duration of a study amendments to the protocol, PIS and/or consent forms may be made that may require participants to re-consent. Any requirements for re-consenting participants will be clearly instructed to site by the Chief Investigator.
Participants may also withdraw their consent at any point. In the event that a participant withdraws their consent the Chief Investigator must have systems in place to deal with these events (this should be incorporated in the protocol /data management procedures). The action taken should be according to what consent it being withdrawn (for example is consent being withdrawn from further treatment but participant still consents to follow-up; is consent being withdrawn for GP to be informed or medical notes to be followed up at the end of study or is consent being withdrawn for any data being used).