Guidance on Continuing Review and Renewals for Research Investigators
C
O
N
T
I
N
U
I
N
G
R
E
V
I
E
W
/
R
E
N
E
W
A
L
S
MARCH 1, 2023
Objectives
To provide guidance for research investigators and
study teams on continuing review required for their
IRB protocols.
To provide guidance to investigators and study teams
on what information should be submitted as part of
the IRB renewal.
2
Continuing Review
Continuing Review = Process; Renewal = Application
•
Federal regulations require an IRB to conduct continuing review of
research at intervals appropriate to the degree of risk.
•
This review allows the IRB to monitor the progress of the study and
ensures that the study continues to meet the requirements for
approval.
•
Continuing Review is required until the Principal Investigator has
completed all research-related interactions and interventions with
participants or when the collection and analysis of identifiable private
information, as described in the IRB-approved research protocol, has
been completed.
3
Continuing Review Schedule
4
Although the revised Common Rule does not require continuing review of
Exempt and Expedited research, the LSUHSC IRB has elected to require regular
reporting on all research approved by our IRB.
Continuing Review Date vs Expiration Date
5
Kuali lists two dates related to continuing review of a study:
Continuing Review Reminders
6
Reminders for the study team to submit continuing review are sent
out in the following intervals:
Submitting a Renewal
7
How to Submit
Continuing reviews are submitted using the Renewal form in the Kuali
Research (KR) electronic submission platform.
When to Submit
To ensure adequate time for the IRB to review a Renewal application,
the Principal Investigator is required to submit the Renewal form:
•
No later than 30 days before the Continuing Review Date for
studies approved by the Full Board
•
No later than 15 days before the Continuing Review Date for
studies approved by the Expedited or Exempt procedure
If Approval Lapses…
8
If IRB approval lapses, all research activities must stop, except when
the investigator judges it to be in the best interest of current
participants to continue, in which case s/he must notify the IRB Office
promptly.
How to Resume the Study
The investigator may resume research activity once a Renewal
application has been reviewed AND approved by the IRB.
Study Expiration and Administrative Closure
A lapsed study that has not obtained Renewal approval by the
Expiration Date will be administratively and permanently closed. Once
permanently closed, the study cannot be re-activated. Continuation of
research that is administratively closed will require submission, review
and approval of a new protocol in KR.
F
r
e
q
u
e
n
t
l
y
M
i
s
u
n
d
e
r
s
t
o
o
d
Q
u
e
s
t
i
o
n
s
i
n
t
h
e
R
e
n
e
w
a
l
A
p
p
l
i
c
a
t
i
o
n
Study Type & Status:
Renewal Option
10
Which renewal option did you select when initiating this
submission?
Renew
Renew & Amend
TIPS:
•
Study Team response should match the submission type.
Data Protection
11
Does this study involve the collection and storage of protected
health information/HIPAA identifiers as defined here?
Yes
No
TIPS:
•
If the study team is collecting a HIPAA Authorization, then the
response to this question should be “Yes”.
Study Personnel & Modifications:
Approved Modifications
12
List and briefly summarize each IRB-approved modification to
the study (to funding, personnel, procedures, key documents,
etc.) during the most recent approval period.
TIPS:
•
Only amendments approved since the last renewal should be listed
•
If the study team is submitting a Renew/Amend application, do not
list the amendments being requested here.
Research Participants
13
Does this research involve the collection and analysis of data
from medical records (i.e., chart review study)?
If yes…
Total number of charts approved for review
Number of charts reviewed/searched since the last review
Number of charts used for data collection since the last review
Number of charts reviewed but not included in the data collection
since the last review
TIPS:
•
Only answer yes if a chart review is a primary component of your
research design (i.e., not used just for screening)
•
Total number of charts approved should match what is in the IRB
application
Research Participants
14
Does this research involve the collection and analysis of data
from medical records (i.e., chart review study)?
If yes…
Total number of participants approved for enrollment
Number of participants enrolled since the last review
Total number of participants enrolled since the start of the study
Total number of participants withdrawn since the start of the study
Number of participants withdrawn since the last review
TIPS:
•
Total number of charts approved should match what is in the IRB
application
•
Total numbers of enrolled and withdrawn should be based on last
year’s reported numbers plus any new subjects enrolled/withdrawn
during the past approval period
Reportable Events:
Promptly Reported Events
15
Have ALL EVENTS REQUIRING PROMPT REPORTING that have
occurred since the last review of the study been reported to the
IRB?
Yes
No
N/A; no such RNIs have occurred
TIPS:
•
If there are no events in the Reportable Events tab, then the study
team should respond “N/A”
Reportable Events:
Not Promptly Reported Events
16
Have there been any events since the last review of the study
that DID NOT REQUIRE PROMPT REPORTING to the IRB?
Yes
No
TIPS:
•
If “Yes,” be sure to attach the Event Tracking Log
•
If any issues are identified during the continuing review and the IRB
requests documentation of the RNI, then be sure the ETL is updated
and attached here
Renewal Supporting Documents
17
Attach ALL relevant supporting documents not previously
attached to the table below.
The most recent version of the approved protocol (
legacy only
)
The most recent version of the approved consent form or
information sheet (
legacy only
)
Two redacted copies each of the signed consent, HIPAA and Notice
of Privacy Practice forms (
if applicable
)
Current Investigator Brochure (
for FDA-regulated research
)
DSMB/DMC reports released since the last review (
if applicable
)
TIPS:
•
Make sure all pages of the consent, HIPAA, and NPP are scanned
•
Names, DOBs, and signatures of the subjects should be redacted;
please leave dates visible.
18
Save the Date!
19
This content provides guidance on continuing review and renewal processes required for IRB protocols, outlining the importance of ongoing oversight, key submission information, review schedules, and renewal submission procedures. It emphasizes the need for researchers to adhere to regulatory requirements and ensures the protection of participants in research studies.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
E N D
Presentation Transcript
CONTINUING REVIEW / RENEWALS CONTINUING REVIEW / RENEWALS MARCH 1, 2023
Objectives To provide guidance for research investigators and study teams on continuing review required for their IRB protocols. To provide guidance to investigators and study teams on what information should be submitted as part of the IRB renewal. 2
Continuing Review Continuing Review = Process; Renewal = Application Federal regulations require an IRB to conduct continuing review of research at intervals appropriate to the degree of risk. This review allows the IRB to monitor the progress of the study and ensures that the study continues to meet the requirements for approval. Continuing Review is required until the Principal Investigator has completed all research-related interactions and interventions with participants or when the collection and analysis of identifiable private information, as described in the IRB-approved research protocol, has been completed. 3
Continuing Review Schedule Although the revised Common Rule does not require continuing review of Exempt and Expedited research, the LSUHSC IRB has elected to require regular reporting on all research approved by our IRB. Expedited (Post-2018 Common Rule) & Transitioned Pre- 2018 Expedited Full Board & FDA- Regulated Expedited Expedited (Pre-2018 Common Rule) Exempt 1 year minus 1 day, unless transitioned 1 year minus 1 day 3 years minus 1 day 3 years minus 1 day 4
Continuing Review Date vs Expiration Date Kuali lists two dates related to continuing review of a study: X years minus 1 day from last approval If the renewal is not approved by this date, the IRB approval is considered lapsed, and all study activities must stop CR Date 60 days after the CR Date If a renewal is not approved by this date, the study will be closed permanently Expiration Date 5
Continuing Review Reminders Reminders for the study team to submit continuing review are sent out in the following intervals: Before CR Date After Lapse 60 days 1 day 45 days 7 days 30 days 15 days 15 days 30 days 7 days 45 days 1 day 59 days 6
Submitting a Renewal How to Submit Continuing reviews are submitted using the Renewal form in the Kuali Research (KR) electronic submission platform. When to Submit To ensure adequate time for the IRB to review a Renewal application, the Principal Investigator is required to submit the Renewal form: No later than 30 days before the Continuing Review Date for studies approved by the Full Board No later than 15 days before the Continuing Review Date for studies approved by the Expedited or Exempt procedure 7
If Approval Lapses If IRB approval lapses, all research activities must stop, except when the investigator judges it to be in the best interest of current participants to continue, in which case s/he must notify the IRB Office promptly. How to Resume the Study The investigator may resume research activity once a Renewal application has been reviewed AND approved by the IRB. Study Expiration and Administrative Closure A lapsed study that has not obtained Renewal approval by the Expiration Date will be administratively and permanently closed. Once permanently closed, the study cannot be re-activated. Continuation of research that is administratively closed will require submission, review and approval of a new protocol in KR. 8
Frequently Misunderstood Questions Frequently Misunderstood Questions in the Renewal Application in the Renewal Application
Study Type & Status: Renewal Option Which renewal option did you select when initiating this submission? Renew Renew & Amend TIPS: Study Team response should match the submission type. 10
Data Protection Does this study involve the collection and storage of protected health information/HIPAA identifiers as defined here? Yes No TIPS: If the study team is collecting a HIPAA Authorization, then the response to this question should be Yes . 11
Study Personnel & Modifications: Approved Modifications List and briefly summarize each IRB-approved modification to the study (to funding, personnel, procedures, key documents, etc.) during the most recent approval period. TIPS: Only amendments approved since the last renewal should be listed If the study team is submitting a Renew/Amend application, do not list the amendments being requested here. 12
Research Participants Does this research involve the collection and analysis of data from medical records (i.e., chart review study)? If yes Total number of charts approved for review Number of charts reviewed/searched since the last review Number of charts used for data collection since the last review Number of charts reviewed but not included in the data collection since the last review TIPS: Only answer yes if a chart review is a primary component of your research design (i.e., not used just for screening) Total number of charts approved should match what is in the IRB application 13
Research Participants Does this research involve the collection and analysis of data from medical records (i.e., chart review study)? If yes Total number of participants approved for enrollment Number of participants enrolled since the last review Total number of participants enrolled since the start of the study Total number of participants withdrawn since the start of the study Number of participants withdrawn since the last review TIPS: Total number of charts approved should match what is in the IRB application Total numbers of enrolled and withdrawn should be based on last year s reported numbers plus any new subjects enrolled/withdrawn during the past approval period 14
Reportable Events: Promptly Reported Events Have ALL EVENTS REQUIRING PROMPT REPORTING that have occurred since the last review of the study been reported to the IRB? Yes No N/A; no such RNIs have occurred TIPS: If there are no events in the Reportable Events tab, then the study team should respond N/A 15
Reportable Events: Not Promptly Reported Events Have there been any events since the last review of the study that DID NOT REQUIRE PROMPT REPORTING to the IRB? Yes No TIPS: If Yes, be sure to attach the Event Tracking Log If any issues are identified during the continuing review and the IRB requests documentation of the RNI, then be sure the ETL is updated and attached here 16
Renewal Supporting Documents Attach ALL relevant supporting documents not previously attached to the table below. The most recent version of the approved protocol (legacy only) The most recent version of the approved consent form or information sheet (legacy only) Two redacted copies each of the signed consent, HIPAA and Notice of Privacy Practice forms (if applicable) Current Investigator Brochure (for FDA-regulated research) DSMB/DMC reports released since the last review (if applicable) TIPS: Make sure all pages of the consent, HIPAA, and NPP are scanned Names, DOBs, and signatures of the subjects should be redacted; please leave dates visible. 17
Save the Date! Date Time Topic 04/05/2023 12:00PM Regulatory Binders 05/03/2023 12:00PM Expanded Access Use of a Test Article 06/07/2023 12:00PM Non-Human Subjects Research Determinations 18
