Chapter 7 - Informed Consent

What is an example of a circumstance in which the Investigator may terminate the subject’s participation without regard to informed consent?

Not following Protocol instructions.

What is the Health Insurance Portability and Accountability Act (HIPAA)?

National regulation that describes privacy requirements to obtain authorization to use and disclose an individual’s protected health information (PHI).

Which state requires the use of a “Bill of Rights” in the Informed Consent?

California.

Which requires withdrawal in writing: HIPAA, Informed Consent, or both?

HIPAA.

What is a “Covered Entity”?

The organization (e.g., academic research institution) that must comply with HIPAA

True or False: If an individual revokes authorization from HIPAA, a covered entity may not continue to use and disclose PHI that was obtained before the individual revoked authorization from HIPAA?

False.

In how many days within the close of enrollment of a clinical study does the revised Common Rule require that informed consent form templates be published online to a federal website?

Sixty (60).

What is Broad Consent?

Consent from research subjects to allow researchers to store, maintain and use identifiable private information and biospecimens for unspecified future studies.

At what reading grade level does the IRB typically advise Informed Consent forms be written in?

6th - 8th grade.

What is a Legally Authorized Representative (LAR)?

A person or entity who is legally permitted to consent on behalf of a research participant who is unable to provide their own informed consent due to decreased mental capacity (e.g., dementia).

Who must be present for the oral consent of participants who are illiterate or blind?

An impartial witness.

Why or why not does an illiterate or blind person require a LAR?

They do not require a LAR because they are not of diminished mental capacity.

Who signs the Short Form?

Subject (or his representative) and impartial witness.

Who signs the written summary?

Impartial witness and the person obtaining consent.

In what population is an assent form used?

Pediatric population.

May participants sign and date an informed consent form electronically?

Yes, this is known as eConsent.

What are the two main situations for FDA trials in which exceptions to consent may be made during a clinical trial.

1) Patients who do not have any other treatment possible (e.g., near death from a severe infection resistant to all suitable marketed antibiotics) and 2) Research where the subject population enrolled is very sick and without alternative approved treatment (e.g., head trauma, heart attack).

After how many days does the the Investigator and neutral physician need to submit documentation after the use of the test article for patients who do not have any other treatment possible?

Five days.