1. 2018 New Human Subject Regulations Approval Periods & Review Categories
January 2018
Version 1

2. The new rules were scheduled to take effect on January 19, 2018
On January 17, 2018, HHS issued an interim final rule with a six-month delay
The new rules are now scheduled to take effect on July 19, 2018
The interim final rule raises the possibility of an additional notice of proposed rulemaking with a public comment period regarding a delay to January 21, 2019

3. Where does that leave us?
All new studies are still required to use the new consent template that was posted 12/20/2017
The new consent template will foster a better consent process for investigators and research participants
It also fits the new and old regulations

4. Where does that leave us?
Research that is FDA regulated or has any federal funding or support will continue to have a one-year approval period
Where possible, UMMS will move ahead with three-year approval periods for some minimal risk new studies

5. Where does that leave us?
We will not use the new exemption categories
All research will be evaluated against the existing pre-2018 exemption categories

6. What do researchers need to do?
Make sure that the Funding Sources for your research are appropriately captured in eIRB
If you are part of a multi-site study and the overall project has federal funding or support, it is important to list that federal funding or support in eIRB even if no money reaches UMMS

7. What do researchers need to do?
Download all forms and templates fresh from the IRB website whenever you need to prepare a submission

8. What do researchers need to do?
Continue to obtain prior IRB review and approval for all human subjects research — including research that fits one or more of the exemption categories
IRB staff automatically consider the lowest possible review category based on a single application

9. What do researchers need to do?
Note the expiration dates indicated in your approval letters
Create a reminder system to ensure timely submission of continuing reviews and study closures
Submit a closure to the IRB when your research is completed, even if it’s deemed exempt

10. The most noticeable changes under the New Rule include:
A new consent template – posted
For some minimal risk new studies
Three-year approval periods [UMMS: limited roll-out]
Additional exemption categories [UMMS: on hold]
Annual reminders from eIRB of investigator obligations

11. Even if the New Rule takes effect July 19, 2018 or January 21, 2019
It does not yet include FDA and Department of Justice (DOJ) as signatories
Research that is regulated by the FDA or is funded or supported by DOJ
Will use the new consent template, but will otherwise remain subject to the pre-2018 regulations
Is not eligible for extended approval periods or new exemption categories

12. The rest of this session focuses on the approval periods and review categories
Approval periods by review category (exempt, expedited, full Committee)
Annual reminders
New exemption categories
Other key changes in exemptions

13. Why any expiration at all?
Researchers benefit from longer approval periods for some new minimal risk studies
Exempt
No expiration, do submit Modification to close
Expedited
FDA regulated: 1 year
Department of Justice: 1 year
Any federal funding or support: 1 year
All others: 3 years
Full Committee
Max 1 year
Why any expiration at all?
At UMMS, there continues to be no expiration for exempt research. However, we will require investigators to submit a Modification to close the research once it’s complete.
With respect to Expedited review, research that is FDA-regulated or funded or supported by the Department of Justice will continue under the pre-2018 regulations. During this delay period, research that has any federal funding or support will also continue under the pre-2018 regulations. In these cases, the approval period will remain at one year. All other minimal risk expedited research will have a three-year approval period with annual reminders.
Research that undergoes Full Committee review is generally greater than minimal risk and will continue to be approved for no more than one year.
You may be wondering why expedited minimal risk research has a three-year approval period when the New Regulations actually do not require continuing review. The New Regulations continue to hold UMMS responsible for all research that the institution conducts. A three-year approval period reduces burden on investigators, while allowing UMMS to maintain oversight of non-exempt research and the capability to generate reporting metrics required by accrediting bodies and funding agencies. In the future, UMMS may consider extending the approval period or removing expiration dates entirely for minimal risk research.

14. The IRB automatically determines the appropriate level of review
Committee
Expedited
Exempt
Pre-2018 versus 2018
Human subjects research
With each new submission, the UMMS IRB automatically assesses whether the activity is human subjects research; if it is, whether it requires review under the pre-2018 or 2018 regulations; then, whether it fits within the exempt or expedited review categories, or requires review by the full Committee at a convened meeting. All activities must fit completely within the exempt categories or within the expedited categories to be deemed exempt or expedited, respectively. Research that doesn’t fit these categories or is greater than minimal risk requires review by the convened IRB.
While we do have a form through which to request a determination that an activity is NOT human subjects research, all other submissions use one application. Use of one application speeds the review process because it eliminates the need to ask investigators to convert to a different form when their activity turns out to be non-exempt.

15. eIRB will now send an annual reminder for all approved research
FOR EXEMPT:
This is an annual reminder that you are required to conduct the research in accordance with the Investigator's Manual. Your obligations include, but are not limited to:
ŸObtaining prior IRB review and approval for all Modifications that involve HIPAA or that potentially change the risks, exemption category, or scope of the research;
ŸMaintaining a current list of CITI-trained Active Study Staff in eIRB;
ŸAdhering to Prompt Reporting Requirements;
ŸUpdating conflict of interest declarations; and
Closing the study via Modification.
Research that was deemed exempt since eIRB went live on 10/1/2012 will now receive an annual notification until the research is closed.

16. eIRB will now send an annual reminder for all approved research
FOR NON-EXEMPT:
This is an annual reminder that you are required to conduct the research in accordance with the Investigator's Manual. Your obligations include, but are not limited to:
ŸObtaining prior IRB review and approval for all Modifications;
ŸMaintaining a current list of CITI-trained Active Study Staff in eIRB;
ŸAdhering to Prompt Reporting Requirements;
ŸUpdating conflict of interest declarations; and
Closing the study via Continuing Review.
If your research expires this year, you may receive additional reminder notifications related to the Continuing Review.
Continuing reviews are due in the IRB office 45 days before the study expires. eIRB sends two reminders automatically at 75 days before and 60 days before expiration. All studies – including exempt studies – will now receive an additional yearly reminder.

17. Set a reminder for yourself based on your approval letter
Exempt research has no expiration date
Set an annual reminder to submit a Modification to close the research once it’s complete
All non-exempt research lists a one-year or three-year approval period
Set a reminder to submit your continuing review
The eIRB reminders are provided as a courtesy, and investigators are ultimately responsible for closing research and submitting continuing reviews on time. We strongly encourage you to check each approval letter to check for an expiration date and to set appropriate reminders for yourself.

18. Researchers benefit from additional exemptions
ON HOLD
Researchers benefit from additional exemptions
The IRB is still responsible for prior review and approval
Compliant with “limited review” requirements
At UMMS, exempt research still has consent expectations and no expiration
Research that is FDA or DOJ regulated is not eligible for the new exemptions
At UMMS human subjects research that fits one or more exemption categories has always required – and will continue to require – prior IRB review and approval. This is already in compliance with the 2018 requirement that only an IRB issue exemptions that require “limited review.” Under the New Rule, when conducting a “limited review,” the IRB is checking to ensure there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data. This also is not new for UMMS. The exemption criteria already include such considerations.
As outlined in the Worksheet for Exemptions (HRP-423 WORKSHEET: Exemptions, exempt research may still require a process of informed consent. See the Worksheet for a small set of information that should be conveyed to research participants when you ask them to be in your exempt research. Exempt research at UMMS does not expire.

19. Researchers benefit from additional exemptions
ON HOLD
Researchers benefit from additional exemptions
Uses of secondary data and biospecimens that are already subject to HIPAA
Educational tests, surveys, interviews, or observations of public behavior even if identifiers are recorded and accidental disclosure poses minimal risk
Uses of secondary data and biospecimens that are already subject to HIPAA are now exempt. The HIPAA regulations are unchanged.
Educational tests, surveys, interviews, or observations of public behavior even if identifiers are recorded and accidental disclosure poses minimal risk are now exempt. Cases in which these data were recorded anonymously, or these data were recorded with identifiers but for which accidental disclosure did not put subjects at risk, are already exempt.

20. Researchers benefit from additional exemptions
ON HOLD
Researchers benefit from additional exemptions
Benign behavioral interventions with adults
Brief, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing
Excludes medical tests, procedures, devices (e.g., no EEG)
Tell participants if unaware/misled re: research
Benign behavioral interventions with adults is a completely new category. A benign behavioral intervention is brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Medical tests, procedures, and devices (e.g., EEG recording) are excluded. Research participants must be prospectively informed if they will be unaware of or misled regarding the nature or purposes of the research.
The preamble to the New Rule provides additional examples on p. 7191: “having the subjects play an online game, solve puzzles under various noise conditions, or decide how to allocate a nominal amount of received cash between themselves and someone else”

21. Other key changes include
ON HOLD
Other key changes include
Investigators will need to explain how curriculum research is not likely to adversely affect the students’ opportunity to learn or the assessment of the educators (category 1)
There is no longer an exemption for research with public officials (had been similar to category 2)

22. Other key changes include
ON HOLD
Other key changes include
Secondary research uses (category 4)
Explicitly mentions biospecimens
Prohibits contact or re-identification when recording anonymously
Has new sub-category for Government research for data protected by E-Government Act
New requirement for Federal department or agency to publicly post exemptions for research on public benefit or service programs (category 5)

23. Other key changes include
ON HOLD
Other key changes include
Two exemptions related to Broad Consent
Category 7: Broad consent for storage and maintenance of identifiable private information or identifiable biospecimens for potential secondary research use
Category 8: Secondary research requiring broad consent
Refer to material for which initial collection was not research-based, requires infrastructure to track consent, & limits subsequent use of waiver of informed consent
Category 7 not in use at UMMS at this time
Category 8 may apply if material procured from external site that implemented broad consent

24. Reminders
All exempt research still requires prior IRB review and approval
Make sure your funding source is appropriately identified in eIRB – you may need to submit a Modification
Always download forms and templates fresh from the IRB website
Check your approval letters for expiration dates and set reminders for yourself

25. Reminders
In eIRB – check that each submission moves out of Pre-Submission into Pre-Review

26. Transitioning (or not)
The UMMS IRB will determine on a case-by-case basis whether research approved before the effective date of the New Rule, stays under the pre-2018 regulations or transitions to the New Rule
The current goal will be to transition eligible research only when it does not require rewriting the approved informed consents or Modification to the study plans
In most cases, this will be research that obtained informed consent, is not FDA regulated or federally funded, and has only data analysis or long-term follow-up left to complete
In most cases, the research that transitions will be research that obtained informed consent, is not FDA regulated or federally funded, and has only data analysis or long-term follow-up left to complete. If your research is approved before the effective date of the New Rule, you should plan to remain under the pre-2018 regulations.

27. Short Summaries by Topic Available on the Website
Short Summaries by Topic Available on the Website
Bare Essentials
Key Definitions
Who, What, When, Where, Why, How
What is yet to come from the Fed Govt
Informed Consent
Transition Table
For Federally Funded
Annual Reminder Investigator Obligations
Exemptions and Waivers
Designated Review and Committee Review
Expedited Review
Broad Consent
Visit the IRB website for short one- to-two page summaries available by topic.

28. Questions?