Socra Questions

Question 1

How long must a suspected unexpected serious adverse reaction (SUSAR) be reported to the IRB?

Answer 1

</= 15 Days

Question 2

How long must an unanticipated adverse device effect (UAADE) be reported to the IRB?

Answer 2

</= 10 working days

Question 3

How long must an unexpected fatal/like-threatening AE be reported to the IRB?

Answer 3

< 7 days

Question 4

When is a short form ICF needed?

Answer 4

For subjects whose first language is not English.

Question 5

What are the 10 points of the Nuremberg Code?

Answer 5

1) Required voluntary, informed consent
2) Experiment aims at positive results for society
3) Based on previous knowledge that justifies the experiment
4) Study design avoids unnecessary physical and mental suffering and injuries
5) Not conducted if there is any reason to believe it implies a risk of death of disabling injury
6) Risks< Benefits
7) Preparations and facilites must be provided to protect subjects against risk
8) Staff must be fully trained and qualified
9) Subject must be free to quit at any time
10) Medical staff stop the experiment at any time if they observe continuation would be dangerous

Question 6

When can investigational product be used without consent?

Answer 6

-inability to communicate
-time is not sufficient
-no alternative approved method available that provides an equal or greater likelihood of saving the subject’s life

Question 7

When can wards participate in a study?

Answer 7

-research related to ward status
-conducted in an environment with majority of children are not wards
- advocate has best interest of child during research
- advocate must not be associated with guardian organization, clinical investigation, or the investigator.

Question 8

How long do investigators need to keep current FDFs for?

Answer 8

Before study initiation, during the study, and 1 year after study completion.

Question 9

What is the main purpose of the IRB?

Answer 9

Assure protection of rights, safety, and welfare of human subjects.

Question 10

Who provides the final approval of a study?

Answer 10

IRB

Question 11

IRB must find when approving a study

Answer 11

-Risks are minimized
-selection of subjects is equitable
-ICF follows guidelines
-ICF documented appropriately
-Adequate provisions for monitoring data collected to ensure the safety of subjects
-privacy and confidentiality is protected
-additional safeguard in place to protect vulnerable populations

Question 12

What are significant risk devices?

Answer 12

-Implants with potential serious risks
-used to support or sustain human life
- substantial importance in diagnosing, curing, or treating disease

Question 13

What kind of investigational devices are exempt from Premarket approval requirements? (IDE)

Answer 13

-diagnostic devices that are non-invasive
-for vet or lab use
-custom device not intended for commercial distribution
-distributed prior to May 1976

Question 14

Who must by part of the IRB members?

Answer 14

-males and females
-varied background
-at least 5 members
-1 scientific background

Question 15

When was the Nuremberg Code created?

Answer 15

1947

Question 16

What did the Nuremberg Code established?

Answer 16

1979

Question 17

What does the Belmont report do?

Answer 17

-Establish boundaries between practice and research
-created ethical principles: Respect for persons, Beneficence, and Justice
-ensure applications of informed consent, risk/benefit assessment, and selection of research subjects

Question 18

When was the Declaration of Helsinki established?

Answer 18

1964

Question 19

What is the Declaration of Helsinki?

Answer 19

-developed by World Medical Association
-provides basic principles or medical research
- binds the physician with words, “The health of my patient will be my first consideration”,

Question 20

What are the 8 required elements of an informed consent?

Answer 20

1) Study description-research acknowledgement, purpose,expected duration, procedures, and specify which procedures are experimental
2)Foreseeable risks and discomforts
3) Benefits
4) Alternative procedures/treatments
5) Confidentiality of records
6) Compensation and treatment for injury
7) Contact information
8) Voluntary participation

Question 21

What kind of investigational devices are exempt from premarket approval requirements? (IDE)

Answer 21

-Diagnostic devices that are non-invasive
-for vet or lab use
-custom device not intended for commercial distribution
-distributed prior to May 1976