Clear Statements
The study involves ___________.
What is research?
Clinically relevant results
What type of results could be disclosed?
The person the participant/parent calls with questions about the study
Who is the PI?
Foreseeable ____ and discomforts
What are risks?
Initial Lines
What was recently removed from the footer of the consent form?
The ____ of the study should be a very simple statement.
What is the purpose of the study?
Commercial Profits
What is a statement indicating if participants will share in these?
Q's regarding research participants' rights
Who is the IRB?
For example, standard of care, other drugs, do nothing
What are alternatives to research participation
One or two parent signature(s)
What has to be stated if Pediatric Risk Level 2
FDA
Who can inspect the records?
For research involving biospecimens, whether the research will or might include ______ .
What is whole genome sequencing?
PI and/or 9-1-1
Who to call in case of a research-related injury?
Participants won't lose any if they withdraw.
What are benefits?
18 years old
When does a minor need to sign an adult consent form?
Participation is ________
What is voluntary?
If removed, their data/samples could be used or shared for future research
What are Identifiers?
Sponsor, IRB, FDA, etc.
Who can review the participants' records?
RRIL
What is Research Related Injury Language?
LAR
Who signs if a person is not competent to provide consent and is allowed by the IRB?
True or False. If a person refuses to participate, they will no longer be treated at Duke.
What is False?
January 2019
When was the Revised Common Rule effective?
24/7 Contact Number
What phone number is required if research involves more than minimal risk?
Compensation and Reimbursement
What is not considered a benefit of research participation?
True or False. The study team decides if they will re-consent at amendment time.
False. This is determined by the IRB and need/no need for re-consent must be stated.