Attachment 10 - IRB form 1250

Attachment 10 - HSRB Form 1250

Attachment 10: HSRB Form 1250

0.1250

Centers for Disease Control and Prevention

Date received

Request for Initial Review by
an Institutional Review Board
Use this form to submit a protocol for its first review by a CDC IRB or a non-CDC IRB. If
seeking review by a non-CDC IRB, also include form 0.1371. See HRPO Guide: IRB
Review Cycle for further details on how to complete this form.

1

Protocol identifiers
Leave protocol ID blank if not yet assigned.
CDC protocol ID:
Protocol version number
version date
Protocol title: Personal Flotation Devices and Commercial Fishermen: Preconceptions and Evaluations in Actual
Use
Suggested keywords (optional). Enter each term in a separate cell:
Commercial Fishing

Occupational Stafety

Alaska

Personal Flotation Device

2

Key CDC personnel
Name and degrees

User ID

SEV #

CDC NC/division

Jennifer Lincoln, PhD

jxw7

8443

NIOSH/OD/AFS

Jennifer Lincoln, PhD

jxw7

8443

NIOSH/OD/AFS

Investigator 2

Philip Somervell, PhD

gjx7

18423

NIOSH/OD/AFS

Investigator 3

Devin Lucas, MS

fok1

11190

NIOSH/OD/AFS

(FirstName LastName, Degrees)

Primary contact
(required)

Principal investigator
(required)

Investigator 4
Investigator 5
SEV # is CDC’s Scientific Ethics Verification Number. CDC NC/division is the national center (or equivalent) and
division (or equivalent), or coordinating center or office if submitted at that level.
List all other CDC investigators, if any (name and degrees, user ID, SEV #, CDC NC/division):

3

CDC’s role in project
Check yes or no for each of the following.
y
n CDC employees or agents will obtain data by intervening or interacting with participants.
y
n CDC employees or agents will obtain or use identifiable (including coded) private data or biological
specimens.
y
n CDC employees or agents will obtain or use anonymous or unlinked data or biological specimens.
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).
“Agents” includes on-site contractors, fellows, and others appointed or retained to work at a CDC facility
conducting activities under the auspices of CDC.

CDC Form 0.1250
Version 3.0 2006-04-13

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Request for initial review by an IRB

4

CDC’s research partners
Research partners include all direct and indirect recipients of CDC funding (e.g., grants, cooperative agreements,
contracts, subcontracts, purchase orders) and other CDC support (e.g., identifiable private information, supplies,
products, drugs, or other tangible support) for this research activity, as well as collaborators who do not receive such
support. See HRPO Guide: CDC’s Research Partners for further details. Check one of the following.
No research partners.
Research partners are listed on form 0.1370, which accompanies this form.

5

Study participants—planned demographic frequencies
Report estimated counts (rather than percentages). Include participants at domestic and foreign sites. See HRPO
Guide: IRB Review Cycle for definitions.
Number of participants
400
Location of participants
Participating at domestic sites
Participating at foreign sites

400
0

Sex/Gender of participants
Female
Male
Sex/gender not available

0
0
400

Ethnicity of participants
Hispanic or Latino
Not Hispanic or Latino
Ethnicity not available

0
0
400

Race of participants
American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or Other Pacific Islander
White
More than one race
Race not available
Comments on demographics

6

0
0
0
0
0
0
400

Regulation and policy

6.1 Mode of IRB review on CDC’s behalf
Location of IRB (check one):
CDC IRB
Non-CDC IRB through IRB authorization agreement [submit form 0.1371]
Institution or organization providing IRB review:
IRB registration number (if known):
Federalwide assurance number (if any):

CDC Form 0.1250
Version 3.0 2006-04-13

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Request for initial review by an IRB
Suggested level of risk to subjects (check one):
Minimal
Greater than minimal
Suggested level of IRB review (check one):
See HRPO Worksheet for Expedited Review for detailed assistance. If relying on a non-CDC IRB, please indicate
the level of review that you think is appropriate under human research regulations.
Convened-board review is suggested
Not eligible for expedited review. For example, poses greater than minimal risk; involves use of
drug, biologic, or device under IND or IDE; involves collection of large amount of blood; use of
x-rays or microwaves; anesthesia; or physically invasive procedures
Other specified reason:
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, nonpregnant adults; below volume limit, minimally invasive
2b Collection of blood from other adults and children; below volume limit, minimally invasive
3
Prospective noninvasive collection of biological specimens for research purposes
4
Collection of data through routine, noninvasive procedures, involving no general anesthesia,
sedation, x-rays, or microwaves
5
Research that uses previously collected 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

6.2 Vulnerable populations
Characterize the intention to include each of the following vulnerable populations. Choose one option in each row,
and indicate the page(s) where inclusion or exclusion is justified in the protocol.
Targeted

Allowed

Excluded

NA

Page(s)

Pregnant women or fetuses

12

Children (including viable neonates)

12

Prisoners

12

Describe other groups of potentially vulnerable subjects intended to be included or excluded, such as neonates of
uncertain viability or nonviable neonates, persons with mental disabilities, or persons with economic or educational
disadvantages.

6.3 Free and informed consent
Characterize requested changes to required features of the informed consent process. If a waiver is requested, enter
the page number of the protocol where the waiver is justified.
Which exceptions to the consent process are requested? Check all that apply:
Waiver or alteration of elements of informed consent for adults
Waiver of assent for children capable of providing assent
Waiver of parental permission

CDC Form 0.1250
Version 3.0 2006-04-13

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Request for initial review by an IRB
Which exceptions to documentation of informed consent are requested? Check all that apply:
Waiver of documentation of informed consent for adults
Waiver of documentation of assent for children capable of providing assent
Waiver of documentation of parental permission
Waiver or alteration of authorization under HIPAA Privacy Rule
How is it shown that the consent process is in understandable language? Check all that apply:
Reading level has been estimated
Comprehension tool is provided
Short form is provided
Translation planned or performed
Certified translation/translator
Translation and back-translation to/from target language(s)
Other method (specify:
)

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6.4 Other regulation and policy considerations
Check all that apply.
If requesting the exception to the PHS policy on informing those tested about HIV serostatus, enter the page number
of the protocol where the waiver is justified.
Exception is request to PHS informing those tested about HIV serostatus.
pg
Human genetic testing is planned now or in the future.
This study includes a registrable clinical trial.
This study involves long-term storage of identifiable biological specimens.
This study involves a drug, biologic, or device.
See HRPO Worksheet to Determine FDA Regulatory Coverage for guidance on whether or not FDA
regulations apply.
This study will be conducted under an Investigational New Drug (IND) exemption or Investigational Device
Exemption (IDE).
IND/IDE number(s):

6.5 Confidentiality protections
If at least one research site is within the US, then check either Granted, Pending, or No in each row. If no sites are
within the US, then check NA in each row.
Granted

Pending

No

NA

Certificate of Confidentiality (301(d))
Assurance of Confidentiality (308(d))
Describe any other formal confidentiality protections that are planned or are in place:

CDC Form 0.1250
Version 3.0 2006-04-13

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Request for initial review by an IRB

7

Material submitted with this form
Check all that apply. Describe additional material in the comments section.
Complete protocol
Peer reviewers’ comments or division waiver (NIOSH)
Consent, assent, and permission documents or scripts
Other information for recruits or participants (e.g., ads, brochures, flyers, scripts)
Data collection instruments (e.g., questionnaires, interview scripts, record abstraction tools)
Certification of IRB approval or exemption for research partners

8

Additional comments
The NIOSH standard consent form is being used, but has been modified to fit our project and to reduce the reading
level (standard consent form tested at the 12th grade level and was revised down to the 10th grade level.
Research Assistants who aide in data collection will complete ethics training prior to doing any field work. We will
submit a form 1370 when we have identified the people who will be working as research assistants.

CDC Form 0.1250
Version 3.0 2006-04-13

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