SOCRA Review

YES. IRBs should strive, however, for a membership that has a diversity of representative capacities and disciplines

NO. Alternates who are formally appointed and listed in the membership roster may substitute, but ad hoc substitues are not permissible as members of an IRB. A member unable to be present at the convened meeting may participate by video-conference, conference telephone call, when the member has received a copy of documents that are to be reviewed at the meeting.

Procedural Requirements [21 CFR 56.108 (a)(3)]---requires ensureing "prompt reporting to the IRB of changes in a research activity: The completionof the study is a change in actibity and should be reported to the IRB. Although subjects will no longer be "at risk" under the study, a final report/notice to the IRB allows it to close its files as well as providing information that ma be used by the IRB in the evaluation and approval of related studies.

Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB Examples of Expedited Review: If the research involves no more than minimal risk. Expedited Review procedure to review minor changes in previously approved research during teh period covered by the orginial approval.

FDA regulations do not require public or sponsor access to IRB records, however, the FDA does not prohobit the sponsor from requesting IRB records

For studies conducted under an investigational new drug application, an investigators brochure is usually required by FDA [21 CFR 312.23 (a)(5) and 312.55]. This regulation requires the IRB to assure that the risks to subjects are reasonable in relation to the anticipated benefits. The risks cannot be adequately evaluated without the review of the results of previous animal and human studies, which are summarized in the investiagtors brochure.

Five members, with varied backgrounds. There must be at least one member who is not affiliated with the instituion (and who has no immediate family member affiliated with the institution ) other than his or her IRB membership. There must also be one member whose interests and background are non-scientific (i.e. layperson)

NO. The subjects signature provides documentation of agreement to participate in a study, but is only one part of the consent process. The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate oppurtunity for the subject to consider all options, responding to the subjects questions, ensuring that the subject has comprehended this information, obtaining the subjects voluntary agreement to participate and, continuing to provide information as the subject or situation requires.

A verbal approval does not satisfy the 21 CFR 56.109(c) requirement for a signed consent document, as outlned in 21 CFR 50.21(a). However, it is acceptable to send the informed consent document to the legally authorized representative (LAR) by facsimile and conduct the consent interview by telephone when the LAR can read the consent as it is discussed. If the LAR agrees, he/she can sign the consent and returm the signed document to the clinical investigator by facsimile.

No. The regulation does not require the copy of the form given to the subject to be a copy of the document with the subject's signature, although this is encouraged.

Yes, A fill-in-the-blank format provides only some standard wording and a framework for organizing the relevant study information. The IRB should review a completed sample form, individulallized for each study, to ensure that the consent document, in its entirety, contains all the infomartion required by 21 CFR 50.25 in language the subject can understand

FDA does not require a third person to witness the consent interview unless the subject or representative is not given the oppurtunity to read the consent document before it is signed. The person who conducts the consent interview should be knowledgeable about the study and able to answer questins. FDA does not specify who this individual should be. Some sponsors and IRBS require the clinical investiagtor to conduct the consent interview. However if someone other than the Inestuagtors conducts the interview and obtains consent, this responsibilty should be delegated by the clinical investiagtor.