IRB Law Questions with Certification

A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:

February 18, 2022 Emilia Clarke 0 Comments

Conflict of Interest Fraud Research Misconduct Malfeasance CLICK HERE TO DOWNLOAD FULL EXAM ANSWERS SHEET (PDF FORMAT) To see all

IRB Law Questions with Certification

The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:

February 18, 2022 Emilia Clarke 0 Comments

Any equity interest in a publicly held company that exceeds $5,000 Any equity interest in a publicly held company that

IRB Law Questions with Certification

When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.

February 18, 2022 Emilia Clarke 0 Comments

True False CLICK HERE TO DOWNLOAD FULL EXAM ANSWERS SHEET (PDF FORMAT) To see all the questions and correct answers

IRB Law Questions with Certification

Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker’s retention of a job, insurance or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly define:

February 18, 2022 Emilia Clarke 0 Comments

Who will have access to the data. If personal identifiers will be retained and used in the data analysis. How

IRB Law Questions with Certification

When workers are asked to participate in a research study, vulnerabilities related to the subject’s employment may include:

February 18, 2022 Emilia Clarke 0 Comments

Unions may encourage employees to participate with the expectation that “entitlements” may follow from study results. The research study’s finding

IRB Law Questions with Certification

Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations, except:

February 18, 2022 Emilia Clarke 0 Comments

Pregnant Women Prisoners Children Workers CLICK HERE TO DOWNLOAD FULL EXAM ANSWERS SHEET (PDF FORMAT) To see all the questions

IRB Law Questions with Certification

HIPAA includes in its definition of “research,” activities related to …

February 18, 2022 Emilia Clarke 0 Comments

anything a researcher does in a federally-supported laboratory. development of generalizable knowledge. quality assessment and improvement. population health. CLICK HERE

IRB Law Questions with Certification

When required, the information provided to the data subject in a HIPAA disclosure accounting …

February 18, 2022 Emilia Clarke 0 Comments

must be more detailed for disclosures that involve fewer than 50 subject records. is always the same, regardless of the

IRB Law Questions with Certification

HIPAA protects a category of information known as protected health information (PHI). PHI includes:

February 18, 2022 Emilia Clarke 0 Comments

identifiable health information that is created or held by covered entities, provided the data subject is a US citizen. identifiable

IRB Law Questions with Certification

Under HIPAA, a “disclosure accounting” is required:

February 18, 2022 Emilia Clarke 0 Comments

for all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets.

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