Misc

Question 1

does an IRB need to register with the FDA before it approves studies?

Answer 1

yes

Question 2

what is an assurance?

Answer 2

document that confirms that the site will comply with 45 CRF part 46 (used when research is conducted or in some way supported by HHS)

Question 3

is an assurance required by the FDA?

Answer 3

no

Question 4

can irb members be paid for their services?

Answer 4

yes

Question 5

is the purpose of the irb review of the informed consent to protect the subject or institution?

Answer 5

rights, safety and welfare of subject

Question 6

does an IRB or institution have to compensate subjects if injury occurs as a result of study participation?

Answer 6

this is determined by institutional policy, not FDA regulation. If research involves more than minimal risk, a subject must be informed of any compensation or treatment available if injured.

Question 7

can an investigator be an IRB member?

Answer 7

yes, but they cannot participate in initial or CR of a study if they have a conflicted interest

Question 8

can one IRB member satisfy more than one membership category?

Answer 8

yes

Question 9

can an IRB member send someone from their department to vote for them if they can’t attend a meeting?

Answer 9

No. there are alternates listed in the membership roster.

Question 10

can the IRB use alternate members?

Answer 10

yes, if they are formally appointed and listed on the roster.

Question 11

does a non-affiliated member need to attend every meeting?

Answer 11

no

Question 12

which IRB members should be considered non-scientists?

Answer 12

members with little or no scientific or medical training or experience, i.e. lawyers, clergy, ethicists, etc. concerned with other areas of the study

Question 13

21 CFR 56.104(c) exempts emergency use of a test article from prospective IRB review but subsequent use IS subject to IRB review. What would subsequent use be?

Answer 13

second use with that subject or use with another subject. FDA allows for 1 emergency use of a test article in an institution without prospective IRB review, provided that emergency use is reported to the IRB within 5 days

Question 14

what is an expedited review?

Answer 14

research reviewed and approved without convening a meeting, or to review minor changes in previously approved research

Question 15

if a study is sent to a second IRB after not being approved at the first IRB, should the second IRB be told?

Answer 15

Yes. A written statement is provided.

Question 16

Can informed consent be obtained via phone from an LAR?

Answer 16

No

Question 17

Which regulation requires a signed consent form document but allows an ICF to be sent to a LAR with a subsequent phone discussion and mailed signed form?

Answer 17

21 CFR 56.109(c)

Question 18

which regulation requires a copy of the ICF be given to the subject?

Answer 18

21 CFR 50.27(a)

Question 19

does the subject’s ICF copy need to be signed?

Answer 19

No but this is encouraged