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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