Broad Consent Requirements

Question 1

When someone gives Broad consent, what permission are they granting?

Answer 1

They’re giving permission now for how their data or samples might be used in the future — even in research not yet designed. It is about getting a one-time, forward-looking consent for the storage, maintenance, and future secondary use of a person’s identifiable private information or biospecimens — possibly across multiple future studies.

Question 2

Broad Consent is NOT what 4 things?

Answer 2

• Not a shortcut for mass recruitment
• Not applicable to all research studies
• Not the same as a waiver of consent
• Not required — it’s optional under the regulations

Question 3

Where are the requirements for Broad Consent Located?

Answer 3

45 CFR 46.116(d)(1)–(5)

Question 4

Broad Consent Requirement - 1 - bottom of magic cards

Answer 4

Description of materials

(What information or biospecimens will be stored or used)

Question 5

Broad Consent Requirement - 2 - Independence Day

Answer 5

Purposes of future use

(General types of research the materials may be used for)

Question 6

Broad Consent Requirement - 3 - Clock Border

Answer 6

Time frame

(How long the information/biospecimens may be stored and used)

Question 7

Broad Consent Requirement - 4 - Password Protected

Answer 7

Who may access/use

(Types of researchers or institutions who may use the materials)

Question 8

Broad Consent Requirement - 5 - Mr. Beast

Answer 8

Commercial profit

(Whether the subject’s materials might be used for commercial profit, and whether they will share in it)

Question 9

Broad Consent Requirement - 6 - These are In

Answer 9

Return of results

(Whether results (including individual research results) will be disclosed to the subject, and under what conditions)

Question 10

Broad Consent Requirement - 7 - The real villains of Frozen

Answer 10

Whole genome sequencing

(A statement if the future research will or might include whole genome sequencing)