1. Overview of Changes to Human Subjects Research Regulations
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
“Common Rule” originally published in Federal agencies follow these regulations when funding or conducting research involving human participants.

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The most recent OHRP draft guidance document was released on January 10, 2019…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.
We will update and educate you and IRB reviewers about future guidance or changes to the Common Rule or related regulations.

5. 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.

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

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
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.

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
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

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