Chapter 24

Question 1

What are the three primary goals of research ethics committees (RECs) (institutional review boards) (IRBs)?

Answer 1

1) Protect the “human subjects“ who will participate in observational or experimental studies or whose personal information will be examined by researchers
2) Protect researchers by preventing them from engaging in activities that could cause harm
3) Legally protect the researcher’s institution from the liability that could occur as a result of research activities

Question 2

What are the major functions of ethics review boards?

Answer 2

1) Review new and revised research protocols
2) Approve or disapprove of those protocols
3) Ensure that informed consent is documented (if required)
4)  Conduct continuing review of long-term research projects

Question 3

What do IRBs maintain to verify the achievement of their goals?

Answer 3

Careful records of their procedures and membership.

Question 4

Research ethics committees are usually composed of?

Answer 4

At least five members, from diverse backgrounds, scientists and non-scientists.

Question 5

Some research ethics committees ask applicants to provide what?

Answer 5

A narrative research statement that addresses a list of possible ethical concerns

Question 6

A research protocol or narrative statements about a planned project should address each of these points required by the committees:

Answer 6

1) Participants
2) Risks & Benefits
3) Informed consent
4) Privacy and confidentiality
5) Safety monitoring
6) Conflicts of interest
7) Researcher training
8) Documentation

Question 7

Once all application materials have been submitted to a research ethics committee, there are three possible next steps:

Answer 7

1) Exemption from review: When the research involves the analysis of existing data, documents, or records or stored biological specimens that cannot be linked to individuals. (Public or anonymized)
2) Expedited review: When a minor change to a previously approved protocol is requested or the risk is no greater than in every day life.
3) Full review: When an intervention will be tested in individuals or a community, data will be collected through interaction with individuals, identifiable private information will be collected, or other criteria for expedited review are not met.

Question 8

Exemption from review is not allowed for which population?

Answer 8

Vulnerable populations

Question 9

Are routine daily practices/practice-based activities exempt, expedited, or fully reviewed?

Answer 9

Exempt

Question 10

True or false:
Expedited review may allow the chair of the ethics committee to approve the protocol without a full meeting of the committee

Answer 10

True

Question 11

True or false:

The full committee does not have to be there in order to give a full review.

Answer 11

False; Full review requires the full committee

Question 12

At least three issues must be resolved prior to submission of a research proposal to multiple committees:

Answer 12

1) The application documents that will be required
2) The wording of the informed consent statement
3) The order of review (reviewed by all committees at the same time OR “domino” where it is passed from one committee to the next)

Question 13

All ongoing research protocols must be re-reviewed how often?

Answer 13

Annually OR at the discretion of the ethics review committee until the completion of data collection or analysis.

Question 14

True or false:
Any desire changes to recruiting materials, informed consent statement, questionnaire, or other study documents must receive approval after it is implemented.

Answer 14

False; they must receive approval before it is implemented.

Question 15

If an adverse event happens when must it be reported to the IRB?

Answer 15

Immediately

Question 16

At the end of a study, most committees require a final report to be submitted that, at minimum, states:

Answer 16

1) The number of participants
2) Affirms that no adverse events occurred
3) Declares that the project is concluded

Question 17

When a financial or other relationship could bias the study, what must be disclosed?

Answer 17

The potential conflict of interest

Question 18

True or false:
The disclosure of a potential conflict of interest is a confession that bias has occurred or an admission that bias will occur.

Answer 18

False; it is not. It is an important assurance of transparency.

Question 19

Ethics review is required for:

Answer 19

Almost every single proposal that will involve living human subjects

Question 20

The decision to exempt project from review can be made only by:

Answer 20

The relevant ethics committee

Question 21

What are the incentives in place to encourage participation in the formal review process?

Answer 21

1) Provides a degree of legal protection to the researcher

2) Granting agencies release funds once the project has been approved by a research ethics committee.
3)  An increasing number of journals require the authors provide details about which research ethics committees reviewed the project.

Question 22

Researchers must take the time to undergo a formal review prior to collecting any data or analyzing any data files because:

Answer 22

Research protocols cannot be retroactively approved.