IRB Talk - Cisarik Flashcards
Published research using human subjects generally states
Adherence to established principles and procedures for protecting the subjects.
Declaration of Helsinki
World medical association’s best known policy statement
Promotes the independence of physicians and high ethical standards in pt care and research
The belmont report. What are the 3 principals
- Respect for persons. Should be treated as autonomous individuals capable of making own decision. If cannot make own decision- should be protected.
- Beneficence. The practice of doing good. Making all efforts to improve an individuals well being. Requires considering the benefit to risk ratio.
- Justice. Each person is treated fairly. Equal distribution of benefits as well as burdens.
The buzz word in human research protection is
Transparency (but not too much)
Leadership is about ____. Which is about ____. Which comes through ___. Which is born in ___
Influence
Buy in
Trust
Transparency
Transparency is a reflection of
Authenticity/credibility
If subjects trust the researcher, it makes the research
More credible. Subjects are less likely to deviate from protocol and less likely to drop out.
Does the funding source matter with respect to research transparency?
Yes. Could cause bias.
Who/what regulates the protection of human subjects in research
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.
OHRP
Office for human research protections.
In general, new or new uses of drugs/devices follows ___.
All others follow ____
FDA regulations
The common rule
Which organization regulates the protection of human subjects in research?
OHRP
Any institution engaged in human subjects research must have an
OHRP approved assurance of compliance with the HHS regulations for the protection of human rights
IRB review is to assure that
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
IRB can require what?
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.
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?
Prisoners, mothers, nursing, students relying on grade
Proper experimental design is critical to ensuring
Scientific validity, safety, and ethics of research involving human subjects.
3 categories of an IRB review
Exempt
Expedited
Full
Is an IRB review needed if the research doesn’t involve human subjects?
No
If the research of human subjects has high risk, what kind of IRB review is needed
Full.
If human research has minimal risk, what kind of IRB review happens if it does or doesn’t fall in the exempt category
Minimal risk and in exempt category: Exempt from IRB review.
Minimal risk and not in exempt category: Expedited IRB (full, but expedited)
Why is assessment of risk contextual?
The definition of risk levels can differ for different people
Areas of risk to consider
Physical, emotional/mental, financial, legal, social
The IRB may determine that a protocol is greater than minimal risk though the investigator thinks its not.
Who determines the exempt status
The IRB. If the project does not qualify as exempt, it is sent back to the investigator, who then applies for a review.
What is an expedited full review
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.
Are studies intended to evaluate the safety and effectiveness of the medical device eligible for expedited review?
No. Or FDA approved instrument in non-approved matter will require full review.
Informed consent requires
A documentation unless waived. 8th grade reading level or lower.
How does non compliance affect the investigator and others?
Suspends projects, serious penalties.
Also affects colleagues, institution of employment, profession of optometry.
Why you shouldn’t use scientists kids for research
Once the parent becomes an investigator, it sets up an immediate potential conflict of interest. Distorts the parent/child relationship.
Benefits of community research sites
Money incentives
More representative of national population
Problems with community research sites
Fly under federal gov radar.
