IRB Talk - Cisarik

Question 1

Published research using human subjects generally states

Answer 1

Adherence to established principles and procedures for protecting the subjects.

Question 2

Declaration of Helsinki

Answer 2

World medical association’s best known policy statement

Promotes the independence of physicians and high ethical standards in pt care and research

Question 3

The belmont report. What are the 3 principals

Answer 3

1. Respect for persons. Should be treated as autonomous individuals capable of making own decision. If cannot make own decision- should be protected.
2. Beneficence. The practice of doing good. Making all efforts to improve an individuals well being. Requires considering the benefit to risk ratio.
3. Justice. Each person is treated fairly. Equal distribution of benefits as well as burdens.

Question 4

The buzz word in human research protection is

Answer 4

Transparency (but not too much)

Question 5

Leadership is about ____. Which is about ____. Which comes through ___. Which is born in ___

Answer 5

Influence
Buy in
Trust
Transparency

Question 6

Transparency is a reflection of

Answer 6

Authenticity/credibility

Question 7

If subjects trust the researcher, it makes the research

Answer 7

More credible. Subjects are less likely to deviate from protocol and less likely to drop out.

Question 8

Does the funding source matter with respect to research transparency?

Answer 8

Yes. Could cause bias.

Question 9

Who/what regulates the protection of human subjects in research

Answer 9

DHHS. via office of human research protections. The common rule is a federal policy on human subjects protection that 17 agencies and offices have adopted.

Question 10

OHRP

Answer 10

Office for human research protections.

Question 11

In general, new or new uses of drugs/devices follows ___.

All others follow ____

Answer 11

FDA regulations

The common rule

Question 12

Which organization regulates the protection of human subjects in research?

Answer 12

OHRP

Question 13

Any institution engaged in human subjects research must have an

Answer 13

OHRP approved assurance of compliance with the HHS regulations for the protection of human rights

Question 14

IRB review is to assure that

Answer 14

Risk to subjects are minimized
Risks to subjects are reasonable in relation to benefits
The selection of subjects is equitable
The informed consent process and documentation are adequate

Question 15

IRB can require what?

Answer 15

They can monitor data collected to ensure safety
Adequate protections of privacy and subjects maintain confidentiality

Must tell patients if their data collected is confidential or not.

Question 16

IRB can require that additional safeguards are included to protect the rights and welfare of any subjects likely to be vulnerable. What populations are vulnerable?

Answer 16

Prisoners, mothers, nursing, students relying on grade

Question 17

Proper experimental design is critical to ensuring

Answer 17

Scientific validity, safety, and ethics of research involving human subjects.

Question 18

3 categories of an IRB review

Answer 18

Exempt
Expedited
Full

Question 19

Is an IRB review needed if the research doesn’t involve human subjects?

Answer 19

No

Question 20

If the research of human subjects has high risk, what kind of IRB review is needed

Answer 20

Full.

Question 21

If human research has minimal risk, what kind of IRB review happens if it does or doesn’t fall in the exempt category

Answer 21

Minimal risk and in exempt category: Exempt from IRB review.

Minimal risk and not in exempt category: Expedited IRB (full, but expedited)

Question 22

Why is assessment of risk contextual?

Answer 22

The definition of risk levels can differ for different people

Question 23

Areas of risk to consider

Answer 23

Physical, emotional/mental, financial, legal, social

The IRB may determine that a protocol is greater than minimal risk though the investigator thinks its not.

Question 24

Who determines the exempt status

Answer 24

The IRB. If the project does not qualify as exempt, it is sent back to the investigator, who then applies for a review.

Question 25

What is an expedited full review

Answer 25

All the rigor of a full IRB review with only 1-2 reviewers. Minimal risk AND involve only procedures in one or more of the categories listed in the OHRP guidance document.

Question 26

Are studies intended to evaluate the safety and effectiveness of the medical device eligible for expedited review?

Answer 26

No. Or FDA approved instrument in non-approved matter will require full review.

Question 27

Informed consent requires

Answer 27

A documentation unless waived. 8th grade reading level or lower.

Question 28

How does non compliance affect the investigator and others?

Answer 28

Suspends projects, serious penalties.

Also affects colleagues, institution of employment, profession of optometry.

Question 29

Why you shouldn’t use scientists kids for research

Answer 29

Once the parent becomes an investigator, it sets up an immediate potential conflict of interest. Distorts the parent/child relationship.

Question 30

Benefits of community research sites

Answer 30

Money incentives

More representative of national population

Question 31

Problems with community research sites

Answer 31

Fly under federal gov radar.