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Possible Questions for Investigators p1

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ghayda alghamdi

on 24 November 2013

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Transcript of Possible Questions for Investigators p1

Preparation for
Possible Questions for Investigators
Do you know what AAHRPP accreditation is and why KFSHD is seeking it?
• Through the accreditation process, KFSHD’s human research protection program (HRPP) will be examined and evaluated.
• KFSHD is seeking it in order to promote excellent, ethically sound research.
• AHHRPP through accredited research programs will ensure that all human research participants are respected and are protected from unnecessary harm.
Do you know what minimal risk is and how it is evaluated?
• “Minimal risk means Minor harm not exceeding potential risk encountered in daily life, and which cannot be avoided during ordinary clinical or psychological examination, including potential discomfort and inconvenience.” (NCBE)

• If the study is minimal risk, the IRB chair considers whether the research falls into an exempt category. If the research does not fall into one of the exempt categories, then the expedited review categories are considered.

What are the kinds and levels of risk?
• Risks can be categorized as
physical
psychological
sociological
Legal
economic
• Greater than Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

• Minimal risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

What is the difference between privacy and confidentiality?
• Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
• Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure, without permission.
What is the “process” of consent? How do you know how to do a consent form correctly?
The answer to this is person dependent, but should include a review for the inclusion of the essential elements of consent.
*review the educational material
What is meant by exempt and expedited and when are these categories used?

• Exempt Eligibility:
Research activities involving human subjects that are exempt from the requirement that they receive IRB full or expedited review if the research involves less than minimal risk. Only the IRB Chair may determine which activities qualify for an exempt review. Investigators do not have the authority to make an independent determination that research involving human subjects.
• Expedited Review Eligibility
The IRB may use an expedited procedure to conduct initial review of research provided all research activities present no more than minimal risk to human subjects, and involve no experimental procedures
Only the IRB Chair his deputy (or designee) normally deal with approving Expedited and Exempt research.
What is the difference between waivers of consent and waiver of documentation of consent? What justifies each?
Please read both the “CHECKLIST - Waiver of Written Documentation of the Consent Process” and “CHECKLIST - Waiver or Alteration of the Consent Process”
When was the first time you heard of the Belmont Report?
During the research training courses
What is the The Belmont Report? FDA? SFDA? NCBE?
The Belmont Report: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research wrote a report commonly called the “Belmont Report”
FDA: Food and Drug Administration
SFDA: Saudi Food and Drug Administration
NCBE: National Committee on BioMedical Ethics
What is ethical research? How does your research protect human subjects?
KFSHD is committed to conducting research involving human subjects under rigorous ethical principles. The IRB has been established to comply with existing regulations of the Saudi government in accordance with NCBE regulations.
The IRB reviewed my research and it was approved based on the ethical standards in the NCBE regulations.
What do you consider your primary responsibility in conducting a human research study?
The protection of human research subject rights and welfare during the research study
What kind of training did you receive in conducting human research?
CITI, GCP, NIH
Privacy Concerns People
Confidentiality Concerns Data
(AAHRPP) is Association for the Accreditation of Human Research Protection Programs.
The End of Part 1
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