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

Institutional Review Board (IRB) – Full Review Form

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 criteria

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 understand?

(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 documents?

(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 participants?

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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