CITI Training

Question 1

(CITI Training)

What is the Belmont Report?

Answer 1

The Belmont Report (1979) provides the ethical framework for the federal regulations designed to protect human research subjects.

Question 2

(CITI Training)

What are the three basic ethical principles outlined in the Belmont Report?

Answer 2

Respect for persons (i.e. autonomy and confidentiality);

beneficience (and nonmaleficience);

justice

Question 3

(CITI Training)
How should research participants’ autonomy be respected in enrolling in a study?

Answer 3

Informed consent - the study participants must be in control of what does or does not happen to them

(Comprehension; voluntariness)

Question 4

(CITI Training)

What ethical principle may be violated in only enlisting prisoners or the mentally ill in a research study?

What same ethical principle may be violated in only your friends for a potentially beneficial study?

Answer 4

Justice (in sample selection)

Question 5

(CITI Training)

What is the difference between medical practice and medical research?

(Note: the line is blurry as there may be some frequent overlap in certain situations)

Answer 5

Practice - an intervention that is designed solely for enhanced well-being and has a likely / proven chance of success (e.g. an intervention, not placebo)

Research - an activity designed to test a provable hypothesis (note: experimental treatment does not necessarily mean research)

Question 6

(CITI Training)

How can the principle of beneficence be applied to a study employing human subjects?

Answer 6

Determining that the study has a maximization of benefits and a minimization of risks

Question 7

(CITI Training)

The Belmont Report’s principle of autonomy includes the following two points: That individuals should be treated as autonomous agents, and second, that…

Answer 7

persons with diminished autonomy are entitled to protection.

Question 8

(CITI Training)

Of the needs of which populations does the DHHS identify as groups that IRBs should be especially cognizant due to their higher risk of being coerced?

Answer 8

“Children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons”

Question 9

(CITI Training)
What types of questions should be asked by IRBs to prevent group harms due to study results?

Answer 9

What are the possible harms that could result from my research? Is it possible that there will be harms (psychological, social, economic, etc.) to the group(s) of which my research subjects are members?

Are there any possible unintended consequences of my research such as stigmatization or discrimination?

Do the potential benefits of my research outweigh the harms to the subjects and to the population?

Question 10

(CITI Training)
When must financial conflicts of interest be submitted to the IRB?

Answer 10

No later than the application for PHS funding (research proposal submission)

Question 11

(CITI Training)
What are the two primary types of conflict of interest?

Answer 11

Individual or institutional

(may also be financial or non-financial)

Question 12

(CITI Training)
What are some primary tenets of proper research according to the Nuremburg Code?

Answer 12

Voluntary consent;

benefits > risks;

must have some scientific merit

Question 13

(CITI Training)
What was the Beecher article (1966)?

Answer 13

A list of case studies showcasing unethical research in the post-WWII era

Question 14

(CITI Training)
When was the Tuskegee syphilis study?

Answer 14

1932 - 1972

Question 15

(CITI Training)
What happened in the WIllowbrook and Jewish Chronic Disease Hospital Studies?

Answer 15

Cognitively impaired individuals were infected with:

hepatitis - Willowbrook (1950 - 1970);

live cancer cells - JCDH (1963)

Question 16

(CITI Training)

What congressional Act established The National Commission to determine ethical boundaries in research, and what did this commission produce?

Answer 16

The 1974 Research Act;

the Belmont Report (1979)

Question 17

(CITI Training)
What are the two main points of respect for persons, according to the Belmont Report?

Answer 17

Informed consent;

privacy

Question 18

(CITI Training)
What governing bodies are responsible for verifying that ethical practices are incorporated and human subjects’ rights are protected in research settings?

Answer 18

IRBs

Question 19

(CITI Training)
What two types of information are protected via IRBs?

Answer 19

Identifiable (the person can be identified from the information) and private (the person could reasonably expect that no one was recording their private lives) information

Question 20

(CITI Training)
How are IRBs composed?

Answer 20

5 qualified individuals

(at least one of whom must not have ties to the organization being evaluated, at least one of whom must be a scientist, at least one of whom must be a non-scientist)

Question 21

(CITI Training)

What is assent?

Answer 21

A minor’s affirmative agreement

(as opposed to an adult’s consent)

Question 22

(CITI Training)

What type of information must be included in an IRB research application?

Answer 22

Risk-benefit analysis;

plans for informed consent and/or assent process, subject selection, research collection and storage procedures, and maintaining subject privacy;

researcher qualifications

Question 23

(CITI Training)
What are the three types of IRB?

Answer 23

Exempt (minimal risk; consistent with 8 specific Federal categories);

expedited (consistent with 9 specific Federal categories);

full (greater than minimal risk)

Question 24

(CITI Training)
“Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:”

Answer 24

The changes must be immediately implemented for the health and well-being of the subject.

Question 25

(CITI Training)

If you aren’t sure if your research requires IRB approval, who can you consult?

Answer 25

The IRB at your organization;

Tulane research faculty;

Tulane administrators

Question 26

(CITI Training)

What type of certificate can prohibit/protect disclosure of subjects’ private information in research data even if demanded in a civil or criminal legal proceeding?

Answer 26

Certificate of confidentiality (NIH or FDA)

Question 27

(CITI Training)
Can research involving just records be counted as ‘research involving human subjects?’

Answer 27

Yes;

if the information involves identifiers for living individuals

Question 28

(CITI Training)

In research using living human subjects’ private medical records, the research might need to be approved under what law in addition to the IRB approval?

Answer 28

HIPAA

Question 29

(CITI Training)

What is the Genetic Information Non-Discrimination Act (GINA)?

Answer 29

It protects against discrimination in health insurance and employment settings in relation to an individual’s genome

Question 30

(CITI Training)

If an individual originally consented for their biospecimen to be used for a certain type of study (e.g. a study on liver failure), but you want to use it for a different study (e.g. on how the cells react to a certain type of medication), what must be done?

Answer 30

De-identify all the samples

Question 31

(CITI Training)

What is a significant risk device?

Answer 31

A device presenting a potential for serious risk to the health, safety, or welfare of the subject and it:

(1) Is intended to be implanted into a human;

(2) Is used in supporting or sustaining human life;

(3) Is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise prevents impairment of human health;

(4) Otherwise presents serious risk to health, safety, and welfare of a subject.

Question 32

(CITI Training)

“An adult with attention deficit hyperactivity disorder (ADHD) presents to a physician. To date, no behavioral or drug interventions have proven useful. The physician has just read several reports about a drug that is approved and marketed for another indication, but has shown some benefit for ADHD. The physician wants to prescribe this drug, in the labeled marketed dose, for the individual patient. Which of the following would be the most appropriate course of action?”

Answer 32

“Treat the patient with the drug based on physician’s best medical judgment.”

Question 33

(CITI Training)

Does HIPAA protect all forms of identifiable personal information?

Answer 33

No;

a subset of this information called ‘Protected Health Information’ (PHI)

“the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual; or the past, present, or future payment for the provision of healthcare to an individual”

Question 34

(CITI Training)

Who is responsible under HIPAA?

Answer 34

Healthcare providers, healthcare provider organizations, health plans, and health information clearinghouses

Question 35

(CITI Training)

Are non-U.S. citizens protected by HIPAA?

Answer 35

Yes.

Question 36

(CITI Training)
What is the HIPAA definition of research?

Answer 36

“The systematic investigation, including research development, testing, and evaluation, designed to develop and contribute to generalizable knowledge”