This form effective August 28, 2017

If you are collaborating with investigators at another institution, contact an IRB staff member before completing this form.

Instructions

IRB review must be secured for preliminary field work. The approved protocol may be amended when you are ready to do your formal fieldwork.
The IRB review process:

You will:

  1. Complete and submit this form, and any attachments, as a single Word file or the IRB staff person you who has been helping you.
  • If you are a student or fellow, we encourage you to work with your advisor to prepare your application and appendices.
  1. Submit a signed copy of Section 1 (Project Identification and Signatures) as soon as possible. Faxed and scanned signatures are acceptable, as are electronic signatures. Typed names are not acceptable.
  • Do not wait until your protocol is reviewed to prepare the signed form.

The IRB staff will:

  1. Pre-review your application and send you feedback.
  1. Arrange for review by one or more members of the IRB.
  1. Notify you if your protocol requires review by the full IRB.
  1. Send you feedback from the IRB reviewer(s).
  1. Send you an official email notice when your protocol is approved.

Do not begin your research without receiving an official approval notice!

This form effective August 28, 2017

1. Project Identification and Signatures

1.1Project Title

1.2On what date do you plan to begin your research?

1.3Investigator

Name (Last name, First name): / Select One:
Faculty
Postdoc or Fellow
Graduate Student
Other:
E-mail Address & NetID: / Phone Number:
Source of Funding:
(If research is externally funded, submit a copy of the application or the award.)
If Federally Funded, Proposal/Grant Number:
As the Investigator of this study, I certify to the following:
  1. The research will not be initiated until officialapproval is secured from the IRB. (Note: Approval will not be provided unless certification to conduct research with human subjects is current for the investigator(s) and for the faculty advisor, if applicable.)
  2. I will conduct this study as described in the approved protocol. If any changes are anticipated, I will submit a Request to Amend the Protocol, and I will not implement the changes until I receive approval from the IRB. I will contact the IRB staff immediately if any of the following events occur: unanticipated risks, protocol deviations, and findings during the study that would affect the risks of participation.

Signature of Investigator / Date

1.4Faculty Advisor(s) – for postdocs, fellows, graduate students, and undergraduate students

Your faculty advisor must be Duke University faculty member who assumes responsibility for the content of this application and the conduct of the research.

Name (Last name, First name): / University Department or School:
E-mail Address & NetID: / Phone Number:
As Faculty Advisor of this study, I affirm that I have read and approved the protocol, andI assume responsibility (1) for ensuring that student researchers are aware of their responsibilities as investigators, and (2) that the IRB will be immediately informed in the event of research-related unanticipated risks, protocol deviations, or findings during the study that would affect the risks of participation.
Signature of Faculty Advisor / Date

1.5 Financial Conflict of Interest

If any of the investigators or personnel listed on this research protocol have a financial conflict of interest that must be reported, check this box:

HUMAN SUBJECTS ADMINISTRATION

This section is to be completed by IRB staff or IRB members only.

APPROVED as Exempt Expedited or Full
IRB Staff Expedited Reviewer or Full Board / Date

2. Research Overview

2.1 Describe your research project. Describe the community or culture you wish to study and your proposed participant population. What issue do you intend to explore? Provide background information that would help the reviewer understand your research. Avoid discipline-specific jargon.

2.2 What prior experience, if any, do you have in this community or with this culture? If you have no or limited experience in the community, how will you become conversant in its cultural norms and the differences from your own culture, for example, language training, literature immersion, or consultation?

2.3 How will you communicate with the IRB while in the field?

3. Subject Selection

3.1 How do you plan to recruit potential participants?

3.2 Will your research subjectsbe minors, as defined at your research site(s)?

No

Yes

4. Research Methods

4.1 What methods will you use throughout the course of your research? (Check all that apply.)

Participant-observation

Informal interviews

Formal interviews

Focus groups

Other:

4.2 Do you plan to audio-record participants either individually or in groups?

No–SKIP to Question 4.4

Yes:

4.3 What will you record and what will you do with the recordings?Clarify whether you will destroy the recordings after you have made transcripts. If you intend to save the recordings for further research and education, explain where the recordings will be stored and how they might be used. Audio-recordings of groups is allowed only if all participants in the group have given their explicit permission to be recorded.

4.4 Will you photograph or video-record your participants as part of your research?

No–SKIP to Section 5, Risks of Harm

Yes:

4.5 Describe which of your participants you will record, in what setting, and how you will secure releases for the use of images. Generally, releases need to be documented with a signed form or recorded statement.

4.6 Explain why the images (photos or videos) are necessary for your study.The IRB will consider approving the collection of photographs or videos if they are necessary to helping you answer your research question.

Our website has sample image and audio releasesyou can review.

5. Risks of Harm

There are two ways to identify people, directly or indirectly. Direct identifiers include names. Indirect identifiers are bits of information about subjects that, when combined, could allow someone to deduce the identity of subjects. For example, family size and occupation might identify a subject in a rural village. In a small fishing community, the make and age of a fishing boat might identify the captain.

5.1 Will you collect identifiable information (direct or indirect) about your subjects?

No–SKIP to Question 5.4

Yes:

5.2 List the types of identifiable information you will collect and how you will store them.

5.3 Explain how you will use the identifiable information in your research. If you plan on using participants’ names in your research, explain how you will secure permission to do so, and if you will request permission to use some participants’ names, but not others’ (for example, you want to cite authorities or experts by name, but not the average community member).

Harms include being labeled or stigmatized. They include embarrassment within one’s business or social group, loss of employment, or criminal prosecution. In some cases, the research activities or the research topic may cause risk of emotional or physical harms, such as causing subjects to feel uncomfortable, anxious, or distress.

5.4 Could your participants be placed at risk of harm if they participate in your research?

No–SKIP to Section 6, Informed Consent

Yes:

5.5 Discuss your assessment of the potential risk of harm. Your assessment of the potential risk of harm should take into account the setting, the population, the questions that will be asked, as well as the interaction among these and many other contextual factors.

5.6 Describe how you will protect the data.

6. Informed Consent

The informed consent process involves two parts:

  1. The process of sharing information about your research study, and
  2. Documentation (a signed consent form or an audio- or video-recorded statement by the research participant) that the process took place

Unless you plan to do covert observation, you will always need to create a process for sharing information about your research study with prospective participants; however, it is not always necessary to have a signed consent form or an audio-recorded statement of consent.

The Informed Consent guide provides an outline, including sample language. Our website has sample oral and written consentprocesses you can review.

Participant Observation

6.1Describe the setting and events that you hope to observe.

6.2Please explain how you will ensure that subjects know you are a researcher. This information can be provided on a one-to-one basis or in a group setting, for example at a religious service, meeting, or event. If you intend to covert observation, please explain why it is necessary.

6.3 If you know what questions you will ask while engaging in participant observation, list them here.

Formal Interviews:

An interview is considered formal if an appointment is made to sit down and speak with someone, often a key informant. The form or script will include the basic elements of informed consent, address the issue of attributing quotations or identifying subjects by name, methods and permissions for recording the interview, and any image-making you propose.

If any of the following apply to your research, you can use an oral consent script. Check all boxes that apply.

The data you gather will not be identifiable, either directly or indirectly.

Your participants do not read and write. (If there is a risk of harm, you will need a third-party witness.)

The research will take place in settings where written consent is considered disrespectful or in settings in which asking people to sign a document would cause distress.

The primary risk to participants is a breach of confidentiality and a signed consent form or audio- or video-recorded statement would be the only documented link between individuals and their participation in the study. (Example: A study about illegal or stigmatized behavior.)

6.3 Provide the questions you will ask during the interview. If you plan to conduct unstructured, or open-ended, interviews, provide a description of the type and range of questions, but not a specific interview schedule.

6.4 If you plant to use focus groups, please describe the purpose and structure of the group.

Note: Consent processes for focus groups include the basic elements of informed consent, including what you are studying, what topics you are interested in exploring, and what you will do with the information subjects provide.

Because it is not possible for a researcher to prevent other participants from repeating comments outside the group, focus group participants must be informed that confidentiality cannot be offered. Our website has sample focus group consent forms you can review.

Parental Permission and Child Assent:

Please review ourpolicyonResearch with Children for guidance on parental permission and child assent. Our website also has sample parental permission forms and child assent scripts you can review.

6.7Discuss the culturally appropriate ways to secure parental permission and child assent.

7. Appendices

Please list the items in your appendices.

Following the discussion in Section 6, Informed Consent, provide the processes that you will use when consenting your subjects. Depending on your research, these processes might include consent forms or scripts for formal interviews and focus groups, as well asparental permission and child assent forms or scripts.

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