Irb Focus Login (2024)

FAQs

Do I need IRB approval for a focus group? ›

IRB Review of Survey / Interview Research

Research that solely involves interpersonal interactions with participants such as surveys, interviews, and focus groups most often qualifies for review under exempt or expedited categories. Less commonly, some research of this type may require convened board review.

Some things that may delay approval of your IRB application include submitting an incomplete application by failing to: complete compliance training, cross-checking information on the consent form against information in the protocol, and proofreading the application and relevant documents.

The IRB Cover Page is returned to the Principal Investigator (or Correspondent) to verify receipt. From the date of receipt, the amount of time a review takes is as follows: Exempt reviews generally take one to two weeks. Expedited reviews generally take two to three weeks, depending on the time of year.

Federal regulations require that research projects involving human subjects be reviewed by an IRB. The IRB must approve or determine the project to be exempt prior to the start of any research activities.

An investigator's use of focus groups can qualify for exemption from IRB Review [CFR 46.104]. Focus groups are considered to be in the same category as surveys and interviews; data collected must come are from adults (at least 18 years old) and must not be both sensitive and identifiable.

The cost of an exemption review may be free or cost between roughly $500 and $1,000. A full review often costs between $1,000 and $5,000 for the initial review, with additional charges for changes and renewals. Which IRB should be contacted?

General Recruitment. Advertisem*nts and recruitment material are considered an extension of the informed consent and participant selection process. As such, recruitment of participants into a study may not begin prior to IRB approval.

Significant discrepancies exist between the protocol and consent form (e.g., sample size, duration of research procedures, description of risks). Recruitment and the informed consent process are not adequately explained in the protocol. Risks to the participants are not adequately justified or explained.

Information regarding registration of IORGs and IRBs, and the FWA status of an institution is available online. Click here to access the online database at http://ohrp.cit.nih.gov/search/. The status of recently submitted registrations and FWAs also can be tracked on that page.

How fast is IRB approval? ›

While the IRB aims to provide a first review of submissions within 10 days of receipt, some protocols will require several rounds of revisions and reviews, while others may require Full Board Review.

The 75th percentile data, which is how long the IRB takes to finalize the review of 75% of all submissions by type of review are also calculated for each quarter. For the second quarter of 2024 the results are: 27 days for full-board, 24 days for expedited, 130 days for ceded reviews, and 29 days for exempt reviews.

Human subject research activities may not begin until an exempt determination or IRB approval is issued by RCS and/or the IRB.

Federal regulations and institutional policy require a review by the IRB Full Board for applications where the research involves more than minimal risk to human subjects, does not meet the criteria for one of the categories of expedited review , or has been referred to the committee by an expedited reviewer or the ...

The IRB approval letter lists the consent document(s) and other study documents that were approved with the submission. Please note, it does not list the study application.

If your study involves one of the following, formal ethics review will be needed: Direct or indirect participation of human volunteers: For example, via online questionnaires, interviews or focus groups, experimental interventions, or observational studies.

Informing Potential Participants – Recruitment and Consent

The consent document must provide information regarding what a focus group is, the topic that will be discussed during the focus group session, who the other participants may be, where the group will meet, and how long the session will last.

Examples. Examples of projects that the IRB does not typically review: Teacher and student evaluations used solely by the institution. Class-related data collection projects (with adults and of no more than minimal risk) conducted solely for didactic purposes where the results are not disseminated outside the classroom.

The following activities typically do not need IRB review: Service or course evaluations (unless they can be generalized to other individuals) Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods (results of study will not leave the classroom)