Module 3: Module 3: Informed Informed ConsentConsent

This training session This training session contains information contains information

regarding:regarding: Documenting consentDocumenting consent Conducting informed consent Conducting informed consent ConfidentialityConfidentiality

Documenting Documenting ConsentConsent

Documenting ConsentDocumenting ConsentDid 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 When not to approach for consentfor 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 Newly Diagnosed PatientsPatients

Do not enroll a newly diagnosed Do not enroll a newly diagnosed patient (e.g. new diagnosis of patient (e.g. new diagnosis of metastatic cancer). metastatic cancer).

These discussions would be very These discussions would be very sensitive in a newly diagnosed sensitive in a newly diagnosed patient. patient.

The intent of the study is to speak The intent of the study is to speak with those that have an established with those that have an established diagnosis. diagnosis.

Actively Dying PatientsActively Dying Patients

If a patient is in the process of If a patient is in the process of ‘‘actively dyingactively dying’’ do do notnot approach approach them or their family members for them or their family members for participation in the study.participation in the study.

This is not the appropriate time to This is not the appropriate time to engage in these discussions.engage in these discussions.

‘‘OtherOther’’ Reasons why not Reasons why not approached for consent:approached for consent:Patient Family MemberDischarge soon Discharge soonCan’t hear well/deaf Can’t hear well/deafCan’t see well/blind Can’t see well/blindDifficulty speaking Difficulty speakingAt request of health care team

At request of health care team

At request of family member At request of patient>120 hours from hospital admission

>120 hours from hospital admission

Newly diagnosed Newly diagnosedActively dying Actively dying

Too sickFamily member cognitively impaired

Missed patientFamily member not available

Other (specify): _____________ Other (specify): _____________All eligible respondents not approached for consent should be entered into the CRS.

Conducting Conducting Informed Informed ConsentConsent

Informed ConsentInformed Consent

Free and informed consent refers Free and informed consent refers to the dialogue, information to the dialogue, information sharing and general process sharing and general process through which prospective through which prospective subjects choose to participate in subjects choose to participate in research involving themselves.research involving themselves.

Informed Consent Form Informed Consent Form (ICF)(ICF)

You must use an ICF that has been You must use an ICF that has been reviewed and approved by your local reviewed and approved by your local ethics committeeethics committee

You should have 2 versions of the You should have 2 versions of the ICF:ICF: Patient versionPatient version Family Member versionFamily Member version

Consent ProceduresConsent Procedures The research site should always adhere The research site should always adhere

to local REB procedures when to local REB procedures when obtaining informed consent.obtaining informed consent.

Assess the patient/family members Assess the patient/family members competence to consent to researchcompetence to consent to research

Review the study details with the Review the study details with the patient/family member in a quiet and patient/family member in a quiet and private locationprivate location

Fully inform the Patient/Family Member of Fully inform the Patient/Family Member of all pertinent aspects of research, in non-all pertinent aspects of research, in non-technical language that is easy to technical language that is easy to understand.understand.

Explain the Study Explain the Study ProceduresProcedures

Collection information from the Collection information from the patient’s medical recordpatient’s medical record

You will ask them to complete a You will ask them to complete a questionnaire:questionnaire: ACPACP Satisfaction with communication and Satisfaction with communication and

decision making regarding current and decision making regarding current and future medical carefuture medical care

DemographicsDemographics

Ensure the patient/family member Ensure the patient/family member fully understands the informationfully understands the information

If the Patient/Family Member is If the Patient/Family Member is showing signs of stress, ask if they showing signs of stress, ask if they would like you to come back at would like you to come back at another time.another time.

Ascertain the Patient/Family Ascertain the Patient/Family Member’s willingness to participate. Member’s willingness to participate.

Consent = Yes = Sign/date ICFConsent = Yes = Sign/date ICF Place original ICF in study filesPlace original ICF in study files Copy of ICF in medical chart Copy of ICF in medical chart Copy of ICF to respondentCopy of ICF to respondent

Consent is DeclinedConsent 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.Patient Family Member

Not interested Not interestedToo upsetting Too upsettingToo tired Too tiredToo sick Can’t hear well/deafDischarge soon Can’t see well/blind

Can’t hear well/deafOther (specify): ______________

Can’t see well/blindOther (specify): _____________

Consent ScenariosConsent ScenariosPatient Consent Response

Family Member Consent Response

Procedures Considerations

Yes YesA separate ICF should be signed by the patient and

the family member.

Yes No A consent should be

signed by the patient.

No No None

No Yes A consent should be signed by the family member.

ConfidentialityConfidentiality

Confidentiality refers to prevention of Confidentiality refers to prevention of disclosure, to unauthorized disclosure, to unauthorized individuals, of a Patient/Family individuals, of a Patient/Family Member’s identity and of records that Member’s identity and of records that could identify a Patient/Family could identify a Patient/Family Member. Member.

Follow your hospital policiesFollow your hospital policies

All enrolled patients/family members All enrolled patients/family members will be identified with a unique study will be identified with a unique study enrollment numberenrollment number

Training Module 3 Training Module 3 CompleteComplete