CRP 113 Lecture 3

Question 1

Principles of GCP(13)

Answer 1

-conduct trials according to GCP
-weigh risks vs benefits (physical, psychological, privacy, social and economic)
-subject wellbeing exceed science
-adequate info to justify trial
-write sound protocol
-recieve IRB/REB approval
-use qualified physicians
-use qualified and trained support staff
-obtain informed consent
-record info appropriately
-confidentiality and data protection
-handle investigational products appropriately
-quality assurance

Question 2

REB responsibilites

Answer 2

-safeguard the rights, safety, and well-being of all trial participants
-special attention to trials with vulnerable pop
-assess ethical acceptability of CT through foreseeable risks, potential benefits, ethical implications
-evaluate essential docs (protovol, ICF, CVs, ads, IB, payment and compensation, emergency consent methods, etc)
-review CTAs
-document its views and decisions in writing, clearly identify the trial, documents reviewed and dates (approvals, modifications request, disapproval, termination/suspension of prior approval)

Question 3

REB independence

Answer 3

-accoutable to highest body of the institution that established it
-instituitions must respect the authority delegaed to the REB and not override REB decisions on research proposals

Question 4

Quorum

Answer 4

-minimum number of members of a deliberative assembly that is necessary to conduct the business of that group (ie majority of ppl need to be in attentance)

Question 5

REB composition

Answer 5

-greater than 5 ppl
-equal females and males
-at least 2 members knowledgable in research area of CT
-1 member knowledgeable in ethics
-1 member knowledgeable in applicable laws
-1 member independent of institution (community member)
-have written SOPs and guidelines
-decisions made in meetings with quorum in attendance
-can only vote if independent of investigator/sponsor and participated in review process
-non-members with expertice can review but not vote

Question 6

Ethics review process

Answer 6

-Application (submission by researcher, assessed for risk, full board or delegated member review)
-review (submit reviews to Research Ethics, RE communicate review and decision to researcher)
-revisions (submits revised submission if needed, process can continue until approved)
-approval (letter of approal, research can begin)

Question 7

suspension of approval

Answer 7

-patient safety issues
-evidence of gross violations of GCP
-serious breaches of study protocol
-persistent failure to comply with REB regulations

Question 8

needs to be reviewed by REB

Answer 8

-research involving human participants
-research involving humn biological materials, from living or deceased

Question 9

does not need REB approval

Answer 9

-research relies exclusively on public info that is legally assessible and protected by law or publically accessible with no reasonable expectation of privacy
-relies exclusively on secondary anonymous info or biological materials, no generation of identificable info
-QA studies, testing in normal educational requirements, organizational or employee performance studies

Question 10

REB records

Answer 10

-maintain for at least 3 years after trial completed
-REB membership lists, written procedures, meeting minutes, submitted docs, correspondence
-decisions only can be made at announced meetings