Ethics in Research and IRB- Krysiak

If it says FYI, I added it for understanding the material, you don't have to memorize.

In 1979 because a lot of shady human experiments were going on a committee issued the “Ethical Principles and Guidelines for the protection of human subjects of research” AKA the __________________.

• FYI

Belmont Report

What are the 3 fundamental ethical principles that must be the basis of all research w/ human subject, that are stated in the Belmont Report?

1. respect for persons

2. beneficence

3. justice

How is the “respect for persons” principle of the Belmont Report demonstrated?

through the INFORMED-CONSENT process

The informed-consent process is a process by which…

• a potential study subject is presented w/info about the study and willingly volunteers to participate

  • YOU HAVE TO

    • have ongoing dialogue (convos) between study personnel and participants

    • info must be presented in an understandable manner

    • understanding of info must be verified

    • no coercion, influence is allows

    • if you have diminished autonomy (ex: mental disorder) you may require special safeguards so you aren’t exploited

The “beneficence” principle of the Belmont Report is demonstrated through what 2 general rules?

1. do not harm and

2. maximize possible benefits and minimize possible harms

(FYI: this principle is usually applied by a risk-benefit analysis, which is basically weighing the pros and cons)

How is the “justice” principle of the Belmont Report explained?

there must be a sense of fairness in distributing the burdens and benefits of research

What is the Institutional Review Boards (IRB)?

a committee that is formally designated to approve, monitor, and review biomedical and behavioral research

The mission of the IRB is to …

protect HUMAN SUBJECTS from physical or psychological harm caused by experimental research

Before study enrollment can occur, the IRB reviews and approves what?

all study protocols involving human subjects research

What is the definition of a “human subject”?

• a living individual about whom an investigator (professional or student) conducting research obtains:

  • data through interaction or intervention w/ the individual

  • identifiable private info or biospecimens from the individual

What 3 things are not classified as “human subjects”?

• cadaver studies

  • (a cadaver is a dead human body)

• studies where the subjects are institutions or geographic areas do not involve human subjects

• reviews or meta-analyses of existing published literature do not involve human subjects

Basically, anything that doesn’t involve anything LIVING

Every study has a research protocol that leads to standardization for implementation across investigators and sites. What is the definition of a research protocol?

• a standardized document that covers ALL aspects of a study- very specific details

For Investigational New Drugs (IND), ________ must approve ALL clinical protocols before administering the investigational agent to humans.

FDA

All protocols involving human subjects must be approved by an _______________________.

Institutional Review Board (IRB)

If I had no human subjects involved in my research study, would I need IRB approval?

nope- (no human subjects=no IRB)

What does an IRB exemption mean in terms of human subjects research?

• certain categories of human subjects research are “exempt” from all human subjects protection requirements:

  • no IRB needed

  • no subject informed consent needed

(FYI: An example of an exemption could be observation of public behavior)

NO MATTER WHAT, even if there are exemptions, ________ still applies to use of protected health info.

HIPAA

Regarding data confidentiality, Common Rule Law requires that every effort should be taken to maintain participant confidentiality.

What are some ways to maintain this confidentiality?

• interactions w/ subjects should be conducted in private

• data generated should be held confidentially

• secure servers and encryption software

HIPAA (Health Insurance Portability and Accountability Act) limits how health info can be used/disclosed.

How can a patients health information be shared/used for research?

• patient MUST CONSENT to its use through a research authorization

  • this authorization must describe PURPOSE OF THE RESARCH and HOW the data will be SECURED or SHARED

Review:

What is the role of the FDA and IRB in research protocol?

IRB- any protocols using HUMANS must be approved by IRB

FDA- must approve protocols before administering investigational agent to humans

Be familiar with the 4 phases of the drug approval process: