The New Common Rule

1. The New Common Rule Overview of Changes to Human Subjects Research Regulations

2. Seth Hall, JD*, CIP Interim Director, Human Research Office * I am not an attorney for UMMC

3. The Common Rule • 45 CFR 46.101, et seq. • The Revised Common Rule was published on January 19, 2017 • Effective Date: January 21, 2019 • Applies to all research on human participants conducted here at UMMC • FDA has not harmonized all of their regulations

4. The Revised Common Rule • Stay tuned! • The most recent OHRP draft guidance document was released on January 10, 2019… • Aspects of the current law are not finalized • Human Research Office is your guide • HRO website • Research listserv • Presentations and training sessions • How will this affect YOU as a researcher? • No changes to the IRB process. All changes will be on the IRB review side.

5. Changes - Definitions • Research • Human Subject • Identifiable Private Information • Identifiable Biospecimen • Clinical Trial • Identical to the NIH 2018 definition

6. “Research” • “Research” is the same, with new exceptions: • A systemic investigation designed to develop or contribute to generalizable knowledge. • Public Health Surveillance: collection or testing of information or biospecimens ordered or required by a public health authority is NOT research • Only applies to public health authorities • Scholarly and Journalistic Activities is NOT research • Oral history, journalism, biography, literary criticism, etc.

7. “Human Subject” • The definition is unchanged, save for the inclusion of directly obtained or identifiable biospecimens • “A human subject means a living individual about whom an investigator… • Obtains information or biospecimens through intervention of interaction with the individual… or • Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.”

8. Identifiable Private Information and Identifiable Biospecimens • Definitions introduce the prospect that de-identified information can be re-identified • Identifiable private information: information for which the identity of the subject is or may be readily ascertained by the investigator or associated with the information • Identifiable biospecimen: where the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

9. Changes - Expedited/Exempt Review • Continuing Review for Expedited Research • Some Expedited Research qualifies as Exempt • New Exempt Categories

10. Types of IRB Review - UNCHANGED • Convened • Greater than minimal risk research, or does not fall into an expedited category, reviewed by full IRB • Expedited • Minimal risk research that fits a specified expedited category, reviewed by IRB Chair or designated member • Exempt • Minimal risk research that falls into a specified exemption category, initially reviewed like Expedited • “Exempt” from some regulations

11. Continuing Review • As of January 21, Continuing Review is no longer required for expedited research, but it may be an institutional requirement • Most institutions will still require some yearly update • At UMMC, expedited studies will need yearly Continuing Review for studies approved on or after January 21. • Merely an administrative review (not to IRB Chair) for yearly updates on study progress. • Any changes to an expedited study still need an amendment application.

12. Expedited to Exempt Review • With changes to Exempt categories, some formerly Expedited studies may now be initially reviewed as Exempt: • Medical Record Reviews involving identifiers (previously Expedited Cat. 5, now Exempt Cat. 4) • Surveys/Interview involving sensitive and identifiable content (previously Expedited Cat. 7, now Exempt Cat. 2) • Benign Behavioral Interventions (previously Expedited Cat. 3, now Exempt Cat. 3)

13. Exempt – “New” Categories • Exempt studies are of such limited risk that they don’t need detailed IRB review • “New” Categories: • 1 – Educational Research • 2 – Surveys/Interview/Educational Tests • 3 – Benign Behavioral Interventions • 4 – Secondary Research • 5 – Research and Demonstration Projects • 6 – Taste and Food Quality • 7 – Storage/Maintenance for Secondary Research (Broad Consent) • 8 – Secondary Research (Broad Consent)

14. Exempt – “New” Categories • Many Benign Behavioral Interventions (Cat. 3) were likely Exempt under the “Old” Common Rule. • Research takes less than a day, is harmless/painless, and no risk of harm, emotional discomfort, offense, or embarrassment • “Broad Consent” is optional and most institutions consider it currently unworkable • An alternative consent process for the storage and secondary use of identifiable private information or identifiable biospecimens for unspecified future research. • An institution must track those who have agreed or refused consent • Exempt Categories 7 and 8 will not be applied at UMMC at this time.

15. Exempt – “Limited Review” • For some Exempt studies, a “limited review” is required by the IRB. • Surveys/Interviews/Educational Tests (Cat. 2) can include sensitive and identifiable data, but not interventions, biospecimen collection, or links to additional identifiable data. • Secondary research (Cat. 4) can include prospective data collection and collection of identifiers if all study data is protected health information. • Limited review ensures that privacy/ confidentiality protections are in place.

16. Changes - Informed Consent • “Key Information” at beginning of document • New requirements of consent • Changes to waiver criteria • “Broad Consent” option • UMMC is not adopting Broad Consent at this time • Website Posting Requirement • UMMC is only applying to clinical trials under current requirements (clinicaltrials.gov). The New Common Rule has not established where other consent documents should be posted.

17. Informed Consent – Key Information • The consent document must begin with “a concise and focused presentation of the key information” to assist participants in deciding to participate • Eg, Procedures, Duration, Risks, and Benefits • UMMC’s Key Information description will be found on an updated consent document template – currently under development

18. Informed Consent – New Elements • New elements in consent document include: • Whether identifiers can be removed, • Whether de-identified information/biospecimens may or may not be used for future research • Whether biospecimens may be used for commercial profit, and whether the participant will share profit • Whether clinical results will be returned and how • Whether genetic research involves whole genome sequencing • The updated UMMC consent template will contain this new suggested language – to be applied only where necessary

19. Informed Consent – Waiver • For a waiver of informed consent for secondary use of identifiable private information or biospecimens • Researchers must show why the use of identifiers is necessary to carry out the research. • If research can be done on de-identified data, then that is what must be done.

20. New Common Rule - Take Home • Stay Tuned! • Additional guidance from OHRP and revisions to the regulations will be announced and clarified • Any relevant changes to institutional policy will likewise be announced and formerly presented • Don’t Worry! • For studies approved before January 21, the old Common Rule will apply • For studies approved on of after January 21, rely on the HRO to guide your research as required by regulations