Updates to the Common Rule for human subjects were scheduled to take effect January 19, 2018 but have been postponed to take effect July 19, 2018. Researchers can expect minor changes to Cayuse IRB forms and informed consent templates when preparing protocol applications as well as updated review processes. A summary of the changes are described below. For more information, visit Training and Continuing Education. The 2018 Common Rule:
- Establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.
- Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.
- Establishes new exempt categories of research based on their risk profile. Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.
- Creates a requirement for U.S.-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. This requirement becomes effective 3 years after publication of the final rule.
- Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care. (Federal Register, Thursday, January 19, 2017, page 7150).
November 6, 2017
- Two Cayuse Rodeo: IRB Corral training sessions were held on Rinker Campus in Building 9401, Room 203 from:
November 1, 2017
- Two Cayuse Rodeo: IRB Corral training sessions were held on Main Campus in Beckman Hall, Room 306-C from:
October 10, 2017
- Two Cayuse Rodeo: IRB Corral training sessions were held on Rinker Campus in Bldg 9501, Classroom 181 from:
- 9-10:30 a.m. &
- 2-3:30 p.m.
October 1, 2017
- All IRB applications will now be submitted through the Cayuse IRB production system.
September 21, 2017
- Cayuse Rodeo: IRB Corral training session were held on Orange Campus in Beckman Hall, Room 201 from 9:30-11 a.m.
September 20, 2017
- Cayuse Rodeo: IRB Corral training session were held on Orange Campus in Beckman Hall, Room 201 from 2-3 p.m.
- The Cayuse IRB system underwent beta testing sessions with various IRB users, and integrated final comments. This included how best to include student users into the system. October 1, 2017 was announced as the date during which it became required for all IRB users to use the new system.
- Prior to October 1st, new IRB submissions using the old forms were accepted and submitted to firstname.lastname@example.org.
- As of October 1st, all IRB submissions will be submitted and reviewed using the Cayuse IRB system. See the Cayuse IRB webpage for instructions explaining how to submit.
- If you wish to test the new system, go to the Cayuse IRB webpage for instructions explaining how to log into the test site.
- Training (in person and online) was provided during September so all users were aware of the new Cayuse IRB system. Training materials and dates for in-person trainings were posted on the Cayuse IRB site.
August 1, 2017
- 60-Day Expiration Notices for protocols due after August 30th began to be emailed through Cayuse IRB system.
- Legacy Submissions began to be uploaded in Cayuse IRB for studies that were approved prior to August 2017.
July 27, 2017
- The Cayuse IRB test site opened for all Chapman Research users to practice and test. To log into the test site, login with your Chapman username (email address without the @chapman.edu) and with the password catcat. For more information please visit the Cayuse IRB tab.