CRP 104 Leture 4

Question 1

informed consent

Answer 1

a process that begins with the first contatct with a potential participant all the eay to the end of a participant’s invovlement with the CT

Question 2

LAR

Answer 2

legally authorized representative

Question 3

ethically valid ICF components (4)

Answer 3

-disclosure
-understanding
-voluntariness
-competence
-consent in writing, consent process is documented

Question 4

ICF disclosure elements (8)

Answer 4

-basic research/ experimentation info
-subject’s involvement in trial
-risks, benefits, alternatives
-costs and compensation
-voluntary involvement/termintation
-information access and disclosure
-changes in information
-contact information (trial, rights, injury)

Question 5

if participant or representative cannot read

Answer 5

an impartial witness must be present and must sign and date the ICF, along with the participant if they can sign.

Question 6

decisionally impaired

Answer 6

those with diminished capacity for judgment and reasoning due to psychiatric, organic, developmental, ot other disorder that affects cognitive or emotional functions
-dependence on drugs/alcohol, degenerative disease, terminally ill, severe physical diability

Question 7

Assent

Answer 7

minor’s affirmative agreement to participate

Question 8

documentation considerations for ICF

Answer 8

-erros in completing ICF should be corrected in a way that followd GCP and GDP, not obscured, dated and initialied
-time and date formats standardized
-each page of ICF authenticated (initialed) by participant to show understanding
-additional identification process if needed, i.e. checking signatures

Question 9

Documenting consent

Answer 9

-prior to participation ICF is signed and dates by subject, or LAR, AND staff who did the consent discussion
-recieve a copy of this ICF before participating
-subject or LAR to reicve copy of any updates to ICF and amendments to any written information provided

Question 10

Emergency consent

Answer 10

-line of consent: subject, LAR,
-if no one can give consent, Enrollment must follow measures described in the protocol approved by the REB
-need consent for continued participation when able
-need supporting documentation : PI, REB, sponsor approval, ICF, justification, explanation of events

Question 11

Vulnerable populations research requirements

Answer 11

• the research must relate to the cognitive impairment lack of capacity or serious or life-threatening diseases and conditions of vulnerable participants- research is minimal risk more than minimal risk with a prospect of direct benefit or more than minimal risk without a prospect of direct benefit but of importance to the vulnerable population

Question 12

Enrolling vulnerable populations consent considerations

Answer 12

Adequate Provisions for obtaining consent from the participant or participants Lar- weather Ascent of the participant is required and if the plan for a cent is adequate- protocol must have adequate plan for assessment of capacity to consent