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

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

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 “Common Rule” originally published in 1991. 19 Federal agencies follow these regulations when funding or conducting research involving human participants.

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 The most recent OHRP draft guidance document was released on January 10, 2019… Aspects of the current law are not finalized Human Research Office is your guide HRO website Research listserv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. We will update and educate you and IRB reviewers about future guidance or changes to the Common Rule or related regulations.

Changes - Definitions Research Human Subject Identifiable Private Information Identifiable Biospecimen Clinical Trial Identical to the NIH 2018 definition What is underlined will be discussed in the following slides.

“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.

“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.”

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. Identifiability for private information and biospecimens will be reassessed based on technology every four years.

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

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 Minimal risk: the probability and magnitude of harm or discomfort anticipated in the research is not greater than what the participant would normally encounter in daily life. All three still types of review will function the same under the New Common Rule.

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.

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)

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)

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.

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.

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.

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 Key Information must be organized in a way that facilitates comprehension. Appears at the beginning of the document and is presented first in the consent discussion

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

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.

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