If yes, what is the evidence that research procedures are sensitive to local research context?

Please complete the following sections in enough detail for the IRB to
understand the nature, intent, and procedure of your project. Enter the
following information within this document.

1. Title:

2. Project Summary:

Summarize your project in
enough detail to give the IRB an overview of the project

3. Research Question:

State your research questions
and hypotheses if applicable

4. Foreseeable Benefits:

What are the potential benefits
associated with this project?

a. What if any is the
immediate benefit of this research to the participant?

b. How does this research
benefit the population of persons similar to participants?

c. How does this research
contribute to closing a gap in the professional literature?

5. Target Sample Demographics:

a. How many total subjects?
What is the age range?

b. Inclusion and exclusion

c. How will participants be
assessed for inclusion and exclusion?

d. Who will assess for
inclusion and exclusion?

6. Procedures to identify and mitigate risk
to human subjects:

a. Recruitment procedures
designed to protect privacy. (Privacy is defined as having control over extent,
timing and circumstances of sharing oneself with others.)

(1) What is your source of
information for recruiting potential participants? Please be attentive to
threats to participants’ privacy. An acceptable practice is to distribute
invitations to a broad population and ask for persons to self-identify as
meeting more narrow criteria.

(2) Who will make initial
contact with the participants? What is the setting for initial contact?

(3) What is the content of
your invitation to participate?

  • Attach the final
    text of verbal scripts
  • Attach final text
    of recruitment materials to be posted or distributed via the internet, poster,
    flyer, or other vehicle

(4) What is your professional
relationship with potential participants?

b. Consenting Process to
protect privacy

Privacy is defined as having
control over extent, timing and circumstance of sharing oneself with others.
Threats to privacy are mitigated by the participant’s informed consent for
participation in the research.

(1) What are the specific
research related issues that the participant needs to understand in order to
give informed consent? How do you plan to educate potential participants about
possible risks in the research? How will the participant affirm they

(2) Include a copy of the
Informed Consent document, prepared according to the template for face-to-face
consent or the template for electronic consent. If children are participants,
address the Informed Consent to parents and address an Assent Document to
children. If the research involves a focus group, the Informed Consent must
state that the Primary Investigator cannot guarantee that participants will
honor privacy pledges.

(3) Who will discuss Informed
Consent documents with potential participants or their guardians?



Does that person speak the
same language as the potential participants?

How will you train that
person to properly follow the procedures of Informed Consent and to be aware of
confidentiality and privacy issues?

Are all members of the
research team NIH certified?

(4) What is the procedure for
persons who administer Informed Consent to document that the potential
participant understands the terms of the consent. See last paragraph of the
Informed Consent template.

(5) Where will the Informed
Consent documents be stored and how will you protect the security of the

(6) Do you plan to use
electronic surveys? Yes/No:

If yes, do you agree to
decline the privilege of access to personally identifiable data?

c. Steps to protect
confidentiality of data

Confidentiality pertains to
treatment of information that an individual discloses in a relationship of
trust with the expectation that it will not be divulged to others without
permission. Confidentiality is often protected by anonymous responses or by
de-identifying data by replacing names with codes.

What are your procedures to
protect confidentiality of participants?

d. Data retention and storage

How will you protect stored
data and who will have access to the data? Data is typically stored in a locked
cabinet with limited access.

e. Risks for physical discomfort
and emotional distress associated with research procedures

What components of the
research procedures might cause physical discomfort or emotional distress for

What is the anticipated
evidence of physical discomfort or emotional distress?

f. How will the researcher
respond to evidence of physical discomfort or emotional distress?

What resources are available
to the participant?

g. Host for data collection

(1) If potential participants
will be recruited from a school, hospital, religious group, professional
association, or any other organization, an official of the host organization
for data collection must provide written approval of data collection procedures
on their site.

  • Have you included
    the approval with your application? Yes/No:

(2) Do potential participants
reside outside the US? Yes/No:

  • If yes, what is
    the evidence that research procedures are sensitive to local research context?
    (Possible sources of evidence are approval from an Institutional Review Board
    in the host country, or written approval from a governmental health or education
    agency in the host country.)
  • Have you attached
    this approval to your application? Yes/No:

7. Research Methods

For quantitative studies:

a. Treatment and control
conditions, including evidence of safety for participants

b. Randomization procedures

c. Data collection instruments

(1) Attach all data
collection instruments that will be used

(2) State here the evidence
of instrument suitability for participants, psychometric properties, and
required copyright permission

d. Data analysis procedures,
including power analysis

For qualitative studies:

e. Theory/conceptual framework
guiding data collection, including references to established researchers who
have conducted studies with similar procedures

f. Data analysis procedures,
including coding and software

8. Research Plan

List approximate dates for
major activities in your research plan.



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