sIRB - Use and Administration: When Serving as a sIRB of Record

Several authorization agreements with different provisions may exist for a single multi-site study, and the reviewing IRB must be able to comply with the provisions of the different agreements. IRBs should consider developing:

A template checklist that can be revised for each new agreement

Consent form review can be a labor-intensive process for reviewing IRBs. The IRB should consider the process it will use to review and approve informed consent documents. One approach is for the IRB to approve a consent form template during protocol review and provide the template to the participating sites. Relying sites can then:

Add organization-specific (boilerplate) language to the template and submit the document to the reviewing IRB for approval

Under the NIH policy, organizations submitting NIH grant applications for multi-site research must identify a sIRB for domestic participating sites. Grantee organizations can designate which of the following to serve as the sIRB of record?

An independent IRB, their own local organization's IRB, or the local IRB of another organization Under the NIH policy, organizations submitting NIH grant applications for multi-site research must identify a sIRB for domestic participating sites. Grantee organizations can designate an independent IRB, their own local organization's IRB, or the local IRB of another organization to serve as the sIRB of record.

By day 46, the HU IRB approved the last site's boilerplate language and Marla completed expedited review of the application. She uploaded the last set of approval documents in the HU's electronic system on day 47. Why could Marla not accept the relying site's internal initial review application?

Because the site's internal application would likely not include information about the PI, research staff, and resources.

Which of the following brought increased public attention to the problems with the IRB system?

Death of Research Subject (Jesse Gelsinger)

Marla sent out a second communication to the organizations and PIs. She thanked each for the progress made and included a copy of the updated flowchart. She reminded everyone that the review is pending completion of the submission process, so that all seven sites could begin the study at the same time. How could the relying sites reduce the time required to review and sign the proposed agreement?

Develop a process for review of authorization agreements that includes a description of the required and prohibited provisions in authorization agreements, and delegate signatory authority to an individual with appropriate knowledge about the purpose of and requirements for authorization agreements.

Under NIH guidance, costs associated with reviewing submissions from external organizations are:

Direct costs that can be included in the grant proposal

Which regulatory body sets standards describing how an organization administering a sIRB should operate?

Each sIRB can set its own practices for forms, submissions, record and document transmission, support hours, and other administrative aspects of managing an IRB While regulations and guidance dictate what types of information sIRBs must review, written policies they must have, and what records they must keep, there is no standard for how organizations that administer sIRBs must organize their forms, arrange submission procedures, or provide support to participating sites.

The National Research Act of 1974

Established the National Commission.

When a sIRB reviews a participating site, which of the following pieces of information is the sIRB required to consider?

Information concerning local community attitudes and other local context data concerning the participating site

When a sIRB reviews a participating site, which of the following pieces of information is the sIRB required to consider?

Information concerning local community attitudes and other local context data concerning the participating site Knowledge of local context is not only required under 45 CFR 46.107 and 21 CFR 56.107; it is also a "must" under FDA guidance.

Under the OHRP sample agreement, both parties will:

Maintain a copy of the agreement at their site and provide the agreement to OHRP upon request.

Organizations without an accredited human subject protection program:

May serve as the sIRB of record for multi-site research Organizations without an accredited human subject protection program may serve as the sIRB of record. Organizations with accredited human subject protection programs will likely have additional requirements when relying on a non-accredited sIRB. If the organization administering the sIRB is non-accredited, IRB administrators will likely need to complete additional requirements before accredited external participating sites can rely on the sIRB.

According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:

Obtains, uses, studies, analyzes, or generates identifiable private information.

Which of the following was the result of the Beecher article?

Realization that ethical abuses are not limited to the Nazi regime

Informed consent is considered an application of which Belmont principle?

Respect for Persons

What is the sIRB's primary responsibility in multi-site research?

Review research consistent with applicable human subject protection regulations Above all else, the sIRB reviewing research sites in the U.S. must review research in compliance with the applicable regulatory requirements, and should apply ethical principles during the review (such as, those outlined in the Belmont Report).

What important process could Marla complete to quickly move the submission process forward for the non-responding site?

She could individually contact the non-responding site earlier in the process to see if there is a reason for the delay in response.

A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members, and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB?

The IRB will not review this study because it is not research as defined by the federal regulations.

Which of the following is the top consideration when determining if a local institutional IRB will serve as a sIRB?

The local IRB's resources to service as sIRB All of these are important factors to consider when a local organization is determining if it will serve as a sIRB. However, resources is the top consideration. If the local institutional IRB has insufficient resources to carry out their regulatory required duties, then all the other choices have little or no practical value.

Why did Marla create a checklist for each of the agreements?

To see if there were any prohibited provisions in any of the agreements.

Which of the following is included in the Nuremberg Code:

Voluntary consent