Module 3: Informed Consent

This training session contains information regarding: Documenting consent Documenting consent Conducting informed consent Conducting informed consent Confidentiality 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). 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. 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. 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. 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. This is not the appropriate time to engage in these discussions.

‘Other’ Reasons why not approached for consent: PatientFamily Member Discharge soon Can’t hear well/deaf Can’t see well/blind Difficulty speaking At request of health care team At request of family memberAt request of patient >120 hours from hospital admission Newly diagnosed Actively dying Too sickFamily member cognitively impaired Missed patientFamily member not available Other (specify): _____________ All eligible respondents not approached for consent should be entered into the CRS.

Conducting Informed Consent

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 must use an ICF that has been reviewed and approved by your local ethics committee You should have 2 versions of the ICF: You should have 2 versions of the ICF: Patient version Patient version Family Member version Family Member version

Consent Procedures The research site should always adhere to local REB procedures when obtaining informed consent. The research site should always adhere to local REB procedures when obtaining informed consent. Assess the patient/family members competence to consent to research 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 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. 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 Collection information from the patient’s medical record You will ask them to complete a questionnaire: You will ask them to complete a questionnaire: ACP ACP Satisfaction with communication and decision making regarding current and future medical care Satisfaction with communication and decision making regarding current and future medical care Demographics Demographics

Ensure the patient/family member fully understands the information 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. 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. Ascertain the Patient/Family Member’s willingness to participate. Consent = Yes = Sign/date ICF Consent = Yes = Sign/date ICF Place original ICF in study files Place original ICF in study files Copy of ICF in medical chart Copy of ICF in medical chart Copy of ICF to respondent 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. PatientFamily Member Not interested Too upsetting Too tired Too sickCan’t hear well/deaf Discharge soonCan’t see well/blind Can’t hear well/deafOther (specify): ______________ Can’t see well/blind Other (specify): _____________

Consent Scenarios Patient Consent Response Family Member Consent Response Procedures Considerations Yes A separate ICF should be signed by the patient and the family member. YesNo A consent should be signed by the patient. No None NoYes A consent should be signed by the family member.

Confidentiality

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. 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 Follow your hospital policies All enrolled patients/family members will be identified with a unique study enrollment number All enrolled patients/family members will be identified with a unique study enrollment number

Training Module 3 Complete