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Learn about documenting, conducting, and managing informed consent in the medical research setting to uphold ethical practices and patient confidentiality.
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This training session contains information regarding: Documenting consent Conducting informed consent Confidentiality
Documenting Consent Did the respondent grant consent? Was the respondent approached for consent? Did the respondent decline consent? There is an important distinction between those that are approached for consent and decline to participate versus those that are not approached for consent at all. Data concerning ‘consent granted,’‘not approached’ and ‘declined’ are important to capture and are used to help inform the site and coordinating centre of any barriers to consent.
When not to approach for consent There will be instances where a patient and/or family member is eligible to be included in the study based on the entry criteria however, it is not appropriate to approach them for consent to participate. Some examples of situations where this is the case include: • Newly diagnosed patients • Actively dying patients
Newly Diagnosed Patients • Do not enroll a newly diagnosed patient (e.g. new diagnosis of metastatic cancer). • These discussions would be very sensitive in a newly diagnosed patient. • The intent of the study is to speak with those that have an established diagnosis.
Actively Dying Patients • If a patient is in the process of ‘actively dying’ do not approach them or their family members for participation in the study. • This is not the appropriate time to engage in these discussions.
‘Other’ Reasons why not approached for consent: All eligible respondents not approached for consent should be entered into the CRS.
Informed Consent Free and informed consent refers to the dialogue, information sharing and general process through which prospective subjects choose to participate in research involving themselves.
Informed Consent Form (ICF) You must use an ICF that has been reviewed and approved by your local ethics committee You should have 2 versions of the ICF: • Patient version • Family Member version
Consent Procedures • The research site should always adhere to local REB procedures when obtaining informed consent. • Assess the patient/family members competence to consent to research • Review the study details with the patient/family member in a quiet and private location • Fully inform the Patient/Family Member of all pertinent aspects of research, in non-technical language that is easy to understand.
Explain the Study Procedures • Collection information from the patient’s medical record • You will ask them to complete a questionnaire: • ACP • Satisfaction with communication and decision making regarding current and future medical care • Demographics
Ensure the patient/family member fully understands the information • If the Patient/Family Member is showing signs of stress, ask if they would like you to come back at another time. • Ascertain the Patient/Family Member’s willingness to participate. • Consent = Yes = Sign/date ICF • Place original ICF in study files • Copy of ICF in medical chart • Copy of ICF to respondent
Consent is Declined It is important to document the reasons why consent was refused for the patient/family member. If the patient/family member was approached for consent and refused to participate, please indicate the reason using the list below.
Confidentiality refers to prevention of disclosure, to unauthorized individuals, of a Patient/Family Member’s identity and of records that could identify a Patient/Family Member. • Follow your hospital policies • All enrolled patients/family members will be identified with a unique study enrollment number
