Information Sheets Flashcards
Does an IRB need to register with the FDA before it approves studies?
Yes.
What is an assurance? Is it required by FDA?
Assurance is a document that confirms that the performance-site institution will comply with 45 CFR part 46. Used when research is conducted by HHS or is in someway supported by HHS. An assurance is not required by FDA.
Can IRB members be paid for their services?
Yes.
Is the purpose of the IRB review of the informed consent to protect institution or the subject?
The rights, safety and welfare of the subject.
Does an IRB or institution have to compensate subjects if injury occurs as a result of participation in a research study?
Institutional policy, not FDA regulation, determines whether compensation and medical treatment(s) will be offered and the conditions that might be placed on subject eligibility for compensation or treatment(s). Any research involving more than minimal risk bust inform the subject of any compensation and medical treatment available if injury occurs.
May a clinical investigator be an IRB member?
Yes except they can not participate in initial or continuing review of a study in which they have a conflicted interest.
The IRB regulations require an IRB to have a diverse membership. May one member satisfy more than one membership category?
Yes.
When IRB members cannot attend a convened meeting, may they send someone from their department to vote for them?
No. Alternates are formally appointed and listed in the membership roster.
May the IRB use alternate members?
Yes, if they are formally appointed, listed on the IRB roster and proper IRB procedures are in place that describe their appointment and function.
Does a non-affiliated member need to attend every IRB meeting?
No.
Which IRB members should be considered to be non-scientists?
FDA believes the intent of the requirement for diversity of disciplines was to include members who had little or no scientific or medical training or experience. In the past, lawyers, clergy and ethicists have been cited as examples of persons whose primary concerns would be in non-scientific areas.
The FDA regulations [21 CFR 56.104(c)] exempt an emergency use of a test article from prospective IRB review, however, “… any subsequent use of the test article at the institution is subject to IRB review.” What does the phrase “subsequent use” mean?
“Subsequent use” would be a second use with that subject or the use with another subject. FDA regulations allow for one emergency use of a test article in an institution without prospective IRB review, provided that such emergency use is reported to the IRB within five working days after such use.
What is IRB expedited review?
Procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The IRB may also use the expedited review procedure to review minor changes in previously approved research.
If an IRB disapproves a study submitted to it, and it is subsequently sent to another IRB for review, should the second IRB be told of the disapproval?
Yes. When an IRB disapproves a study, it must provide a written statement of the reasons for its decision to the investigator and the institution and should be included in the subsequent submission to the second IRB.
May informed consent be obtained by telephone from a legally authorized representative?
No, A verbal approval does not satisfy the 21 CFR 56.109(c) requirement for a signed consent document. However, a consent form can be sent to the LAR and discussion can be conducted over the phone with the LAR signing the form and sending it back.
