IRB Determination

REQUEST FOR DETERMINATION OF RESEARCH STATUS
To be completed by the staff member with lead responsibility for the project and approved by branch chief (if applicable) and Division
ADS. A separate PGO funding memo is required if project is research and involves human subjects regardless of the CDC staff role.
Instructions:

(1) Use this form to declare: (a) the research status of any project, (b) role or roles of CDC staff
(2) A short summary should be attached offering specific details about the project and the role of staff.
(3) Be sure to complete all applicable items, obtain appropriate signatures and submit this form for approval.

Tracking Number:

DP15-1513

(Use PGO number if cooperative agreement, grant, etc.)
Date submitted:

04/27/2016

Title of Project:

Puerto Rico Contraceptive Needs Assessment

Dates for project period:

Dates for funding (if applicable):

Beginning:

05/16/2016

Beginning:

05/16/2016

Ending:

09/30/2016

Ending:

09/30/2016

Project is (choose one):
NOTE: Revision, as used below, refers to any substantive change made to the project including scope of project, funding restrictions,
personnel, role of CDC staff member, determination of research status, etc.
[X]

New

[]

Revision

[]

Continuation, without revision(s)

[]

Continuation, with revision(s)

Lead staff member:

Contact information:

Name:

Howard Goldberg

Division:

User ID:

HIG1

Telephone: 770-488-5257

Scientific Ethics number:

1.

Please indicate your role(s) in this project:

15353 Mailstop:

DRH

F74

[X]

Project officer

[]

Technical monitor

[]

Principal
investigator

[]

Investigator

[]

Consultant

[]

Other (please explain)

Are any or all of the activities within this project DESIGNED to contribute to generalizable knowledge (i.e., research)?
[]

[X]

YES

NO

If YES, list those activities which are research:

2.

Is this CDC project research or public health practice (check all that apply)?
[]

3.

Research

[X]

Public health practice

Check one:

Check all that apply:

[]

Human subjects involved

[X]

Emergency Response

[X]

Surveillance

[]

Human subjects not involved

[]

Program evaluation

[]

Other (please explain)

If RESEARCH involving human subjects, has the project or research activities been reviewed by the CDC IRB for human
subjects protection?
a. [ ]

NO, New project, not yet reviewed

d. [ ]

b. [ ] NO, Existing project, not ready to submit

YES, Reviewed and approved by CDC
If YES, please list protocol number and

c. [ ] NO, Submitted for approval

expiration date
e. [ ]

NO, RESEARCH, no CDC investigators (CDC IRB not
required)

f. [ ]

N/A (Not Applicable)

If RESEARCH, list any other CDC staff involved in this project, please include the name, role, and scientific ethics number

Form 684R_NR (revised January 2003)
ID:

26242

1

Tracking NO. DP15-1513
Name

Role (project officer, investigator,
consultant, etc.)

Howard Goldberg

Scientific ethics
number Prin
15353

IF YOU THINK THE RESEARCH PROJECT MIGHT QUALIFY AS EXEMPT RESEARCH (as identified in 45CFR46.101),
PLEASE ANSWER questions 4-6, OTHERWISE SKIP TO question 7.
4.

5.

Does the proposed research involve prisoners?
[ ]

YES

[ ]

NO

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to question 7).

Does the proposed research involve fetuses, pregnant women, or human in vitro fertilization as targets (such that Subpart B
would apply)?
[ ]

YES

[ ]

NO

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to
question 7).

Educational Research
6.1

Is this research conducted in established or commonly accepted educational settings, AND does the research involve
normal educational practices (e.g., research on regular and special education strategies or research on the
effectiveness of, or comparison among instrucational techniques, curricula or classroom management methods)?
[ ]

YES

[ ]

NO

Research Involving Surveys, Interview Procedures (including Focus groups), Observation of Public Behavior, or Educational
Tests
6.2

Will this research use educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview
procedures or observation of public behavior?
[ ]

YES

[ ]

NO

If NO skip 6.3

Will children (<18 years of age) be research subjects?
[ ]

YES

[ ]

NO

6.2.1

Is the information obtained recorded in such a manner that human subjects can be identified directly or
indirectly through identifiers (such as a code) linked to the subjects;
[ ]

6.2.2

YES

[ ]

NO

Will any disclosure of the human subjects' responses outside of the research setting have the potential to
place the subjects at risk of criminal or civil liability, or be damaging to the subjects' financial standing,
employability or reputation? (Examples here may include: the collection of sensitive data regarding the
subjects' (or relatives' or associates') possible substance abuse, sexuality, criminal history or intent, medical
or psychological condition, financial status, or similarly compromising information).
[ ]

6.3

If YES, this research cannot be exempted and must be reviewed by an IRB (skip to item 7)

YES

[ ]

NO

Will this research use educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview
procedures, or observation of public behavior but the research is not exempt under paragraph 6.2 of this section:
[ ]

YES

6.3.1

Will this research involve human subjects that are elected or appointed public officials or candidates for
public office?
[ ]

6.3.2

[ ]

YES

NO

[ ]

If NO skip to 6.4

NO

Does federal statute(s) require(s) without exception that confidentiality of the personally identifiable
information will be maintained throughout the research and thereafter? (Note: CDC can use this exemption
criterion only in the case where a 308(d) Assurance of Confidentiality has been obtained to cover the
research).
[ ]

YES

[ ]

NO

Existing Data Which Is Publicly Available or Unidentifiable
6.4

Does this research involve only the collection or study of existing* data, documents, records, pathological or
diagnostic specimens? (* 'existing' means existing before the study begins)?
[ ]

YES

6.4.1

Is this material or information publicly available?
[ ]

[ ]
YES

Form 684R_NR (revised January 2003)
ID:

26242

NO
[ ]

If NO skip to 7
NO

2

Tracking NO. DP15-1513
6.4.2

Is this material or information recorded in such a manner by the investigator that the subjects cannot be
identified directly or indirectly through identifiers linked to the subjects?
(Note: If a link is created by an investigator even temporarily, for research purposes, this criterion is not met.
If a temporary link is created by clinical staff who already have access to the data, this criterion is met).

7.

[ ]

YES

(there are no identifying information and no unique identifiers or codes)YES

[ ]

NO

(there are identifiers (including codes))

Please prepare and attach a short summary paragraph (<1 page);
if this is new:
a.

Be sure to include the purpose of the project, specific details about the project and the role of the CDC staff member
(s) in the project. In explaining one's role as a consultant be particularly careful to identify involvement in things
like: study design decisions, oversight of protocol development, participation in review of data collection procedures,
and particpation in data analysis and/or manuscript preparation, as well as whether there will be access to
identifiable or personal data.

b.

Explain your project status selection (research--non-exempt, exempt, no CDC investigator or not involving human
subjects; public health practice). If you selected research not involving human subjects be sure to indicate if the data
includes any personal information (e.g., name, SSN), linkable study identification numbers or codes, or geographical
information.
Puerto Rico (PR) is in the midst of an outbreak of Zika virus, which carries a risk of severe birth defects for newborns.
Therefore, improving the ability of Puerto Rican women/couples to avoid unintended pregnancy has become extremely
important. There is a pressing need to provide comprehensive contraceptive services in PR. Unfortunately, no recent
surveillance data is available on contraceptive use in recent years. Contraceptive prevalence and method mix were most
recently measured in 2004 and the most recent comprehensive population-based Reproductive Health Survey took place in
1995-96.
This project consists of an assessment of various aspects of contraceptive use in PR. This assessment will provide current
information on the contraceptive prevalence rate; the mix of methods being used; the level of unmet need for family planning
methods; the rate of unintended pregnancy and the current proportion of pregnancies reported to be unintended; the reported
reasons that women who do not desire to become pregnant are not using contraception; the contraceptive methods
women/couples desire to use; and women's knowledge about Zika virus and how the threat of Zika has affected desires and
behaviors related to pregnancy and contraception.
This information will be used formulating the emergency response to the outbreak. The assessment will consist of a telephone
survey of a representative sample of women 18-44 years of age living in PR. Interviewing will be done using the PR Behavioral
Risk Factor Surveillance System (BRFSS) and will be conducted by female interviewers. The roles of the CDC staff involved
in the assessment consist of working closely with the implementing organization in determining the key parameters of the
assessment, survey design, questionnaire development, monitoring the progress of the assessment, data analysis, and report
writing and dissemination. The role of the implementing organization, the PR Department of Public Health, which houses the
PR BRFSS, will primarily be to carry out the assessment interviews and keep CDC updated about progress. Preparation of
data files for analysis will be carried out by the BRFSS staff at CDC/Atlanta and EOC staff will conduct all analyses and report
writing. No personally identifying information (such as names or addresses) will be collected. Telephone numbers will not be
included in the assessment's data files.
The data and findings from the assessment will be used purely to guide responses to the Zika outbreak, such as developing a
plan for distribution of contraceptives in PR in order to reduce the number of unintended pregnancies. The information is not
generalizable to other settings and will be used only for formulation of a public health response in PR

8.

Please list the primary project site and all collaborating site(s).
Explanation of project components:

9.

If project involves research that is funded extramurally, list amount of award that should be restricted pending IRB
approval and describe which project components will be affected, if known:

Approvals (signature and position title)
Howard Goldberg - Senior Scientist

Date
04/28/2016

Research Determination / Remarks
[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB

Form 684R_NR (revised January 2003)
ID:

26242

3

staff member completing this form

Comments:
approved
04/28/2016

Howard Goldberg - Senior Scientist

[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
Team Lead

Comments:
approved & sent to division
04/29/2016

Shanna Cox - Associate Director for
Science

[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
Division ADS

Comments:
05/02/2016

Joan Redmond Leonard - PUBLIC
HEALTH ANALYST

[X]
[ ]
[ ]
[ ]
[ ]

Public health practice
Research not involving human subjects
Research involving human subjects, no CDC investigators
Research involving human subjects, CDC investigators, exempt
Research involving human subjects, CDC investigators, not exempt

(check if applicable)
[ ]
Local IRB
[ ]
CDC Exemption
[ ]
CDC IRB
CUC ADS, Deputy ADS, or Human
Subjects Contact

Comments:

List of Grantees
Grantee #

Grantee Name

6057

Puerto Rico Department of Health

Form 684R_NR (revised January 2003)
ID:

26242

4