Irb

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

December 7, 2020

From

Kathy Masterson
IRB Administrator, NIOSH Institutional Review Board

Subject

IRB Approval of Continuation of NIOSH Protocol 17-DSR-05XP, “Assessment of
Occupational Injury among Fire Fighters Using a Follow-back Survey” (Expedited)

To

Suzanne Marsh, MPA
Project Officer, DSR, NIOSH
The NIOSH IRB has reviewed and approved your request to continue protocol 17-DSR-05XP
for the maximum allowable period of one year and it will expire on December 14, 2021. The
protocol was reviewed in accordance with the expedited review process outlined in 45 CFR
46.110(b)(1), Categories (4), (5), and (7).
The IRB determined the study poses no more than minimal risk to subjects.
A waiver of documentation of informed consent is granted per 45 CFR 46.117 (c) (2).
If other institutions involved in this protocol are being awarded NIOSH funds through the CDC
Procurement and Grants Office (PGO), you are required to send a copy of this IRB approval to
the CDC PGO award specialist handling the award. You are also required to verify with the
award specialist the awardee has provided PGO with the required documentation and has
approval to begin or continue research involving human subjects as described in this protocol.
As a reminder, the IRB must review and approve all human subjects research protocols at
intervals appropriate to the degree of risk, but not less than once per year. There is no grace
period beyond one year from the last IRB approval date. It is ultimately your responsibility to
submit your research protocol for continuation review and approval by the IRB along with
available IRB approvals from all collaborators. Please keep this approval in your protocol file
as proof of IRB approval and as a reminder of the expiration date. To avoid lapses in approval
of your research and the possible suspension of subject enrollment and/or termination of
the protocol, please submit your continuation request along with all completed supporting
documentation at least six weeks before the protocol's expiration date of December 14,
2021.
Any problems of a serious nature must be brought to the immediate attention of the
NIOSH IRB, and any proposed changes to the protocol should be submitted as an
amendment to the protocol for NIOSH IRB approval before they are implemented.
If you have any questions, please contact the CDC Human Research Protection Program
(513) 533-8591 or e-mail: cin-hsrb@cdc.gov.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service
Centers for Disease Control
and Prevention (CDC)

Memorandum
Date

December 7, 2020

From

Kathy Masterson
IRB Administrator, NIOSH Institutional Review Board

Subject

IRB Approval of Amendment to NIOSH Protocol 17-DSR-05XP, “Assessment of Occupational
Injury among Fire Fighters Using a Follow-back Survey” (Expedited)

To

Suzanne Marsh, MPA
Project Officer, DSR, NIOSH
The NIOSH IRB reviewed and approved your request to amend protocol 17-DSR-05XP,
“Assessment of Occupational Injury among Fire Fighters Using a Follow-back Survey”:
I.
II.
III.

Remove investigator Butler (title page and page 4);
Changes in investigator summaries (page 4);
Change in data analysis to a case series.

The action was reviewed in accordance with the expedited review process outlined in 45 CFR
46.110(b)(1), Categories (4), (5) and (7).
Reminder: IRB approval of protocol # 17-DSR-05XP will still expire on December 14,
2021.
Any problems of a serious nature must be brought to the immediate attention of the
NIOSH IRB, and any proposed changes to the protocol should be submitted as an
amendment to the protocol for NIOSH IRB approval before they are implemented.
If you have any questions, please contact NIOSH Human Research Protection Program
(513) 533-8591 or e-mail: cin-hsrb@cdc.gov.

0.1379

Centers for Disease Control and Prevention

Page for Human Research Review
Protocols and Related Documentation
Use this page when submitting HRPO forms to your center-level Human Subjects Contact.
When submitting materials with these forms, please consecutively number all pages, beginning
with the protocol title page and followed by consent form(s) and ancillary documents.

1

Protocol identifiers
Leave protocol ID blank if not yet assigned.
CDC protocol ID:
Protocol title:
Amendment number (if applicable):

2

Protocol version number

version date

Key CDC personnel
Name and degrees

User ID

(FirstName LastName, Degrees)

CITI Course
Expiration Date

CDC
CIO/Division

Primary contact
(required)

Principal investigator
(required)

CITI Course Expiration Date is the latest expiration date for Biomedical Research and RCR Combined or Social &
Behavioral Research and RCR Combined course required by CDC (expire every 3 years). In addition, all required
training must be verified for each Investigator by the lead CIO/Division. CDC CIO/Division is the national center or
equivalent and division or equivalent, or coordinating center or office if submitted at that level.

3

Forms submitted with this page
Check all that apply in the appropriate column.
IRB-reviewed protocols
0.1255: Initial Review by an Institutional Review Board

Exempted protocols
0.1255X: Request for Exemption or Review of Changes

0.1257: Request for Subsequent Action of IRB Approved Protocol

Additional protocol actions

4

0.1254: Incident Report

0.1254S: Supplemental Adverse Event Report

0.1371: CDC Rely on a Non-CDC IRB

0.1372: Outside Institution Rely on a CDC IRB

0.1370: CDC’s Research Partners

0.1260: End of Human Research Review

Additional comments

CDC Form 0.1379

Page 1 of 2

S

5

page for human research review

Signatures
As principal investigator, I hereby accept responsibility for conducting this CDC-sponsored research project in an ethical
manner, consistent with the policies and procedures contained in CDC's Procedures for Protection of Human Research
Participants, and to abide by the principles outlined in federal policies for the protection of human subjects at 45 CFR
part 46, 21 CFR part 50, and 21 CFR part 56.
Signature
Date
Remarks
Principal CDC Investigator:
Document conflicts of interest, if any, below:

As a supervisor of the principal investigator, I hereby accept responsibility for ensuring that this CDC-sponsored
research project is conducted in an ethical manner, consistent with the policies and procedures contained in CDC's
Procedures for Protection of Human Research Participants, and to abide by the principles outlined in federal policies for
the protection of human subjects at 45 CFR part 46, 21 CFR part 50, and 21 CFR part 56.
Signature
Date
Remarks
Team Lead:
Check if PI is Team Lead:
Branch Official (e.g., Chief or Senior Scientist):

Check if PI is Branch Official:

Division Official (e.g., Director or ADS):

Check if PI is Division Official:

I concur that this CDC-sponsored research project is consistent with the policies and procedures contained in CDC's
Procedures for Protection of Human Research Participants and with other applicable CDC and national center policies.
Signature
Date
Remarks
National Center Human Subjects Contact:
Other Clearance Official:
(e.g., Confidentiality Officer, Coordinating Center/Office Official)

6

Reminder regarding other regulatory clearance processes
The principal investigator is responsible for obtaining other regulatory reviews as needed, which may include OMB
clearance under the Paperwork Reduction Act (PRA) for federally sponsored information collections. Approval by or
exemption from the IRB is unrelated to OMB clearance requirements under the PRA. For more information on whether
your study requires clearance under PRA or other regulations, please consult the appropriate officials within your
CIO/Division.

CDC Form 0.1379
Version . 20 -0 -

Page 2 of 2

Use this form to submit a protocol for continuing review or amendment by a CDC IRB or a
non-CDC IRB. [See 45 CFR 46.109(e).] See
for
further details on how to complete this form.

CDC protocol ID:

Protocol version number

ersion date

Protocol title:
Continuing Review
Review of changes

No change in key CDC personnel. If no changes, please list only the primary contact and principal investigator.
Name and degrees
(First Name, Last Name, Degrees)

User ID

CITI
Expiration
Date

CDC

Primary contact
(required)

Principal investigator
(required)

Co-Investigator
Co-Investigator
Co-Investigator
Co-Investigator

Check yes or no for each of the following.
.
y
n CDC employees or agents will obtain data by intervening or interacting with
y
n CDC employees or agents will obtain or use identifiable (including coded) private data or bi
y
n CDC employees or agents will obtain or use anonymous or unlinked data or biospecimens.
y
n CDC employees will provide substantial technical assistance or oversight.
y
n CDC employees will participate as co-authors in presentation(s) or publication(s).
-site contractors, fellows, and others appointed or retained to work at a CDC facility conducting activities
under the auspices of CDC.

ivision

Have any

been enrolled in the last 12 months?

yes

no

umber of
Comments on

:

Study is not designed to involve research-related contact with
(e.g., research using existing
records); study activities involve only access to or analysis of data or biological specimens and writing
reports.
Study is designed to involve contact with
ts. Check one of the following:
Contact with
has not yet begun.
Contact with
has begun and continues; this may include follow-up for debriefing or
notification of results.
Contact with
is completed; study activities involve only data analysis or report writing.

The IRB previously waived all requirements to obtain consent in this study.
Although not waived, there is no further need to obtain or document consent (e.g., enrollment is
*
will be asked to provide consent (with or without documentation).

Summary of research activities to date. Briefly summarize study progress and interim findings.
Include the number of potential subjects who declined enrollment and the number who withdrew from the study. If
this study involves a registrable clinical trial, summarize registration status.

Summary of study changes reviewed and approved since the last continuation. Do not include
changes submitted with or before approval of this continuation but not yet approved.

Summary of any recent literature or other information relevant to the research study (not limited to
information with CDC co-authorship).

Summary of all adverse events to date. In particular, address adverse events that were serious,
unexpected (or more frequent or severe than expected), or at least possibly related to the research.

Summary of (a) incidents that are not adverse events and (b) other substantial concerns since last continuation.

List and include copies of progress or monitoring reports on safety or compliance (e.g., site
monitor, safety review, DSM report, multi-center trial report, but not reports to PGO).

Summary of remaining research activities, emphasizing future contact with subjects, use of
identifiable private data and biological specimens, and preparation of primary reports.

Change in vulnerable populations (added or dropped).
No Change

Change in consent process, forms, or approved waivers.
No Change

Change in other regulation and policy considerations.
Exception to PHS policy regarding notification of HIV test results
Human genetic testing
Inclusion of a registrable clinical trial or change in registration status
Plans for long-term storage of identifiable biological specimens
Involvement of drug, biologic, or device, including Investigational New Drug or Investigational Device
Exemption status (See
for guidance on
whether or not FDA regulations apply.)
No Change

Change in
No Change

.

Describe and justify proposed modifications to the protocol. Include page numbers in reference to clean copy and
marked copy. Continue summary in supplemental document if necessary.

Research partners include
direct and indirect recipients of CDC funding (e.g., grants, cooperative agreements,
contracts, subcontracts, purchase orders) other CDC support (e.g., identifiable private information, supplies,
products, drugs, or other tangible support and collaborators who do not receive such support. Include current
information on partners added or dropped since the last review using form 0.1370. Check one of the following
No research partners have been added since the last review.
Research partners have been added and are listed on form 0.1370, which accompanies this form.

Check all that apply. Describe additional material in the comments section. Required items are indicated. Optional
items may be requested by HRPO or the IRB.
Complete protocol (required if research poses more than minimal risk to subjects, is under IND/IDE, or has
changed in the past 12 months)
Consent, assent, and permission documents or scripts (required if consent will be sought in the future from
prospective subjects or their representatives Required clean/marked copy for amendment if applicable
Other information for recruits or participants (e.g., ads, brochures, flyers, scripts; required if consent will be
sought in the future from prospective subjects or their representatives) Required clean/marked copy for
amendment if applicable
Data collection instruments (e.g., questionnaires, interview scripts, record abstraction tools; required if protocol
has changes in the past 12 months) Required clean/marked copy for amendment if applicable
Certification of IRB approval or exemption for research partners (required only for partners being added or for
supported/nonexempt partners) Required for amendments relying on a non-CDC IRB
Progress and monitoring reports (recommended when available)

Signatures
Procedures for Protection of Human
Research Participants

Signature

Date

Remarks

CDC IRB
Non-CDC IRB through IRB authorization agreement [submit form 0.1371 if this is a new request]
RB registration number:
Federal wide assurance number:

Minimal

(
):
Convened-board review is suggested
Reason for convened review:
Expedited review is suggested, under the following categories (check all that apply):
1a Study of drugs not requiring Investigational New Drug exemption from FDA
1b Study of medical devices not requiring Investigational Device Exemption from FDA
2a Collection of blood from healthy, non-pregnant adults; below volume limit, minimally invasive
2b Collection of blood from other adults and children; below volume limit, minimally invasive
Prospective noninvasive collection of biological specimens for research purposes
3
Collection of data through routine, noninvasive procedures, involving no general anesthesia,
4
sedation, x-rays, or microwaves
5
Research that uses
materials
6
Collection of data from voice, video, digital, or image recordings made for research purposes
7
Research that uses interview, program evaluation, human factors, or quality assurance methods
Continuing review of research previously approved by the convened IRB where
8a the research is permanently closed to the enrollment of new subjects; all subjects have
completed all research-related interventions; and the research remains active only for long-term
follow-up of subjects
8b no subjects have been enrolled and no additional risks have been identified
8c the remaining research activities are limited to data analysis
9
Continuing review of research, not under IND/IDE, where categories 2 through 8 do not apply
but the IRB has determined and documented at a convened meeting that the research involves
no greater than minimal risk and no additional risks have been identified