IRBs

Question 1

According to 45 CFR part 46, is the following IRB exempt:

Research conducted in established or commonly accepted educational settings, involving normal educational practices.

Answer 1

Yes.

Question 2

According to 45 CFR part 46, is the following IRB exempt:
Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior.

Answer 2

Yes UNLESS human subjects provide personally identifiable information or providing such info puts the subjects at criminal or civil liability or damages their reputation.

Question 3

According to 45 CFR part 46, is the following IRB exempt:
Research involving educational tests, surveys, interview procedures, or observation of public behavior of public officials or candidates for public office.

Answer 3

Yes.

Question 4

According to 45 CFR part 46, is the following IRB exempt:
Research involving the collection/study of existing data, documents, records, specimens, etc. where subjects can be identified.

Answer 4

No, only if the subjects can NOT be identified is it exempt.

Question 5

According to 45 CFR part 46, is the following IRB exempt:

Research of public benefit or service programs.

Answer 5

Yes

Question 6

According to 45 CFR part 46, is the following IRB exempt:

Research on taste and food quality evaluation and consumer acceptance studies.

Answer 6

Yes.

Question 7

According to 45 CFR part 46, who has the final say as to whether an activity falls under OHRP regulation?

Answer 7

The Department or Agency heads.

Question 8

True or False. OHRP guidelines can be followed instead of state or local laws or regulations which may be applicable.

Answer 8

False.

Question 9

What is the minimum number of members required for an IRB to exist according to 45 CFR part 46.

Answer 9

Five members with emphasis on diversity of expertise, gender, race, etc. This includes at least one scientific member and one non-scientific member.

Question 10

It is OK for members of an IRB to consist of all one gender.

Answer 10

Every nondiscriminatory effort should be made to ensure this doesn’t happen.

Question 11

It is OK for members of an IRB to consist of all one profession.

Answer 11

No.

Question 12

An IRB consists of all institution professionals and the daughter of one of the institution’s deans as its non-institution member. Is this appropriate?

Answer 12

No. All IRBs must have a non-institutional member who can not be an immediate family member of a person affiliated with the university.

Question 13

Who is required at IRB meeting for research approval?

Answer 13

A majority of members, including at least one non-scientific member.

Question 14

True or False: An IRB has the authority to approve, require modifications in, or disapprove of research activities.

Answer 14

True.

Question 15

True or False. If an IRB gives a decision of disapproval to the investigator has an opportunity to respond in person or in writing?

Answer 15

True.

Question 16

How often does IRB continuing review occur?

Answer 16

No less than once a year.

Question 17

What are the general characteristics of IRB submissions that qualify for expedited review?

Answer 17

They are no more than minimal risk or contain minor changes in previously approved research (of one year or less)

Question 18

Under expedited review, how many IRB members are required in order to approve the research? What about disapprove the research?

Answer 18

Only one member is required to approve the research. However, if the member disapproves it must go through full IRB review in order to be disapproved or require changes.

Question 19

What are the criteria for IRB approval of research?

Answer 19

1. Risk to subjects is minimized
2. Risk are reasonable in relation to anticipated benefits
3. Selection of subjects is equitable
4. Informed consent is gathered from each subject or LAR and properly documented
5. Monitoring plan is in place for subject data
6. Privacy of subject data

Question 20

If an IRB terminates or suspends the approval of research, who is notified?

Answer 20

Investigator, institutional officials and department/agency head.

Question 21

In the IRB meeting minutes, if a vote was taken what must be recorded?

Answer 21

1. Action taken,
2. number of members voting for, against and abstaining,
3. the basis for requiring changes or disapproving research,
4. and a written summary of the discussion.

Question 22

Do copies of all correspondence between the IRB and investigators need to be recorded by the IRB?

Answer 22

Yes.

Question 23

Do the IRB procedures written in detail need be recorded by the IRB?

Answer 23

Yes.

Question 24

Do statements of significant new findings provided to trial subjects need to be recorded by the IRB?

Answer 24

Yes.

Question 25

How long should IRB records be retained?

Answer 25

3 years.

Question 26

According to ICH GCP, an IRB/IEC should safeguard the ____, ____ and ____ of all trial subjects.

Answer 26

Rights, safety and well-being.

Question 27

According to ICH GCP, what documents do IRB/IEC’s need to obtain prior to the study beginning?

Answer 27

• Trial protocol(s) / amendment(s)
• Written informed consent form(s)
• Subject recruitment procedures (e.g., advertisements)
• Written information provided to subjects
• Investigator’s Brochure
• Available safety and compensation information
• Investigator’s current CV

Question 28

What categories of research qualify for expedited IRB review?

Answer 28

• No more than minimal risk or minor changes to approved research
• IND/IDE used for its labeling purposes
• Minimal blood sampling research
• Collection of biological samples that is not invasive
• Collection of routine data from clinical practice (heart rate, bp, etc.)
• Research done on data collected for non-research purposes (e.g. - routine vitals)
• Data from voice, video or digital
• Research on individual or group characteristics
• Previously approved research (continuing review)

Question 29

What is required for research to be approved using non-viable neonates?

Answer 29

• Study must be scientifically appropriate and backed by science
• The participants are fully informed of what might happen to the neonate
• Study team has no say in determining the viability of the viability of the fetus
• Vital functions will not be artificially maintained
• Research doesn’t terminate heartbeat/respiration
• No added risk to neonate
• Objective of the research can’t be obtained another way
• Provides important knowledge which can’t be provided another way
• If no LAR, either parent can consent

Question 30

What is required for research to be approved using neonates with uncertain viability?

Answer 30

• Study must be scientifically appropriate and backed by science
• The participants are fully informed of what might happen to the neonate
• Study team has no say in determining the viability of the viability of the fetus
• Research holds out possibility of improving survival
• Research provides important knowledge and couldn’t be provided any other way
• Either parent or, if not available, LAR can be used for consent

Question 31

What does “nonviable” mean in regards to neonates?

Answer 31

Although the neonate is living, it is not viable.