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 Informed Consent
Single IRB Review for
Multi-site Studies
The "Common Rule Changes at USC" video presentation provides a summary changes: https://youtu.be/XqDf7rKvwKc
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Changes to Informed Consent
"Key Information" presented at the beginning of the consent must provide participant with enough information to decide whether they may, or may not want to not participate.
Consent forms of 4 pages or less may not require a "Key Information" section.
The following New Elements of Consent must be included as applicable:
 Required Element
- When research involves de-identified data or biospecimens the consent must state if the data will, or will not, be shared for future research.
Additional Elements
- The consent must indicate whether collected biospecimens will be used for commercial profit. And if so, state if the subject will, or will not,share in the profits.
- Subjects must be informed as to whether clinically relevant results will, or will not be returned to them.
- If the research will, or might include whole genome sequencing it must be stated in the consent.
Public Posting of Consent Forms for Clinical Trials  is required not later than 60 days after the last study visit. One consent used in the study must be posted to one of the two available sites: ClinicalTrials.gov or Regulations.gov (Docket Folder ID: HHS-OPHS-2018-0021). FDA guidance addresses penalties for failure to register and/or provide results of clinical trials. See "Registering a study in ClinicalTrials.gov" for more information on how to register your trial.
New Waiver of Consent for research with identifiable private information or identifiable biopspecimens is available. This waiver requires that the IRB determine the research can not practicably be carried out without accessing or using identifiers.
* Non-identifiable information should be used whenever possible.
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Multi-site Studies Must have Single IRB (sIRB) Review 
The New Rule requires that any USC participation in federally funded, cooperative/multi-site research, in the U.S., must rely upon approval by a single IRB effective January 2020. Single IRB (sIRB) review has been required for all NIH funded studies since September 2017. The single IRB of record may be proposed by the lead institution for the study, or will be identified by the funding department or agency. There are exceptions to the sIRB requirement. Single IRB review is not required when local law requires local IRB review (e.g.Tribal Law). Single IRB review is not required if it is determined not appropriate by the sponsor.
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