APPLICATION FOR PROTOCOL APPROVAL - …€¦ · Web viewCombine this form and any appendices into a...

This form effective August 29, 2017This form is to be used for undergraduate student research.

Instructions

Please review the Undergraduates as Researchers page before completing this form.

How does the IRB review process work?

You will:

1. Work with your advisor to prepare your application.

2. Fill out this application and email it to [email protected] or the IRB staff person you are working with. Combine this form and any appendices into a single Word file.

Identify the lead student researcher. The lead student researcher will be responsible for communicating with the IRB. If you are the only student on the project, you are the lead researcher.

Be sure to include the e-mail addresses of all other student researchers on the project and contact information for your faculty advisor on the project.

3. 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. We cannot accept a typed name.

Do not wait until your protocol is reviewed to submit the signed form because securing signatures make take longer than expected. Also, your advisor may leave town, or even leave the country, as soon as classes are over.

Your protocol will not be approved without a signed copy of Section 1.

The IRB staff will:

1. Pre-review your application and send you feedback.

2. Arrange for review by one or more members of the IRB.

3. Notify you if your protocol requires review by the full IRB.

4. Send you feedback from the IRB reviewer(s).

5. Send you an official email notice when your protocol is approved.

We will be happy to chat with you about your protocol over the phone and we will meet with you, too, if that would be helpful.

Do not begin your research without receiving an official approval notice! of 21

mailto:[email protected]

https://campusirb.duke.edu/node/100


Contents of Application Form

The form includes:

Questions for you to answer Notes to help you answer the questions Discussion about two key issues: assessing risk and informed consent Links to guides to help you prepare informed consent documents and releases Link to a guide about research with children

Sections:

1. Project Identification and Signatures2. Research Abroad, in Non-English-Speaking, or Native/Tribal Communities3. Research Question4. Participant Population5. Description of Activities6. Recruitment7. Compensation8. Benefits9. Risks10. Data Protection Plan11. Photographs, Videos, and Audio-recordings12. Informed Consent Process13. Putting Together Your Appendices File

Look for this symbol in the form. It will alert you that you may need to prepare appendices.

If your research includes deception, complete the Request to Use Deception in Undergraduate Research, from the Forms page of our website.

Please note that IRB policy prohibits undergraduate student researchers from collecting or accessing individually identifiable sensitive data about other undergraduate students. Sensitive data include but are not limited to information about illegal activities, sexual behavior, and mental health. To protect the privacy of the student participants, research involving sensitive identifiable data will need a third party to collect and de-identify data before they are made available to undergraduate student researchers.

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This form effective August 29, 2017

1. Project Identification and Signatures

1.1 Project Title

1.2 Project Type? (check all that apply)

Fellowships and Scholarships (for example, Howard Hughes or Deans Summer Research) Bass Connections Independent Study Project Senior Honors Thesis Center, Program, or Institute Award (for example, Human Rights Center, Asian/Pacific Studies

Institute) Vertical Integration Program Other

1.3 Will you be using a subject pool, for example the Psychology and Neuroscience Pool?

No Yes. If yes, which pool?

1.4 Research Site, if research is taking place abroad:

1.5 Will the research take place in public elementary or secondary schools? Yes NoIf yes, identify the school district(s):

1.6 Potentially Vulnerable Subject Populations: Please check all that apply.

Children, as defined at research site (under 18 years old in NC) Cognitively impaired persons, for example, people with dementia Prisoners Refugees Stigmatized populations Undocumented immigrants Victims of abuse Other:

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

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2. Researcher Information and Assurances

Researchers: (Undergraduate or Graduate Student, or Postdoctoral Fellow)

All signatories certify to the following:

1. I will not begin the research until written approval is secured from the IRB. Note: Approval will not be provided unless certification to conduct research with human subjects is current.

2. I will conduct this study as described in the approved protocol.

3. If any changes are anticipated, I will submit a Request to Amend an Approved Protocol, and I will not implement the changes until I receive approval from the IRB.

4. I will contact the IRB staff promptly if any of the following events occur: unanticipated risks of harm to participants, protocol deviations, and findings during the study that would affect the risks of participation.

Lead Undergraduate Researcher:Name: Trinity Pratt SanfordE-mail Address: Phone Number: Expected Graduation Date:

Signature: Date:

Other Undergraduate Researchers:Name: Trinity Pratt SanfordE-mail Address: Phone Number: Expected Graduation Date:

Signature: Date:

Name: Trinity Pratt SanfordE-mail Address: Phone Number: Expected Graduation Date:

Signature: Date:

If there are more undergraduate research team members, copy and paste the researcher information and signature block.

Other Research Team Members:Name: Department or School: E-mail Address: Phone Number:

Graduate student Postdoc Other:

Signature: Date:

If there are more non-undergraduate research team members, copy and paste the researcher information and signature block.

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Faculty Advisor(s) for Students and Postdoctoral Fellows

All signatories certify to the following:

1. I have read and approved the protocol.

2. I assume responsibility for ensuring that my advisees are aware of the responsibilities as researchers.

3. I ensure that the IRB will be immediately notified in the event of unanticipated risks to participants, protocol deviations, or findings during the study that would affect the risks of participation.

Name (Last name, First name):

University Department or School:

E-mail Address:

Phone Number:

Signature of Faculty Advisor Date

Name (Last name, First name):

University Department or School:

E-mail Address:

Phone Number:

Signature of Faculty Advisor Date

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

APPROVED as Exempt Expedited or Full

IRB Designee or IRB Member Date

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2. Research Abroad, in Non-English-Speaking, or Native/Tribal Communities

You need to fill out this section if:1. Your research will take place abroad, or2. Your research will take place in the United States with a non-English-speaking community.

Otherwise, skip to Section 3.

2.1 Site and Contact Information

Research Site:

Contact person in country where research will be conducted:

Agency or institutional affiliation of the contact person:

E-mail, phone, and/or other means to reach contact person:

Describe how you will be able to maintain contact with the IRB and your advisor while abroad:

2.2 Language

Is English the primary language of your participants?

Yes: Skip to 2.3 No: What is their primary language?

How well do you speak/write the language?

Native speaker Very fluent Moderately fluent Not well or at all Will you require the services of an interpreter?

No Yes

If yes, how will you obtain the services of an interpreter?

2.3 Cultural Competence

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?

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Were you invited into the community, and if so, by whom?

Will someone review your research study materials, such as interview questions and consent forms, to make sure they are culturally appropriate? Please tell us who and briefly explain his/her or their qualifications to know what is culturally appropriate.

Please provide contact information for a Duke faculty member or other expert who is familiar with the culture in which you will be conducting your research in case the IRB needs to consult with him or her. This person might be your advisor.

2.4 Community-level Ethics Review

Does your research need community-level (including native/tribal communities), institutional-level or national-level review in the country where it will take place? If yes, please elaborate.

3. Research Question

3.1 What is your research question?

3.2 Provide background information about the research that will help the reviewer understand your research. Avoid discipline-specific jargon.

4. Participant Population

List and describe your proposed participant population(s). Be specific and include the expected number of participants in each population. For example, “15 adult members of female monastic centers in Japan.” Indicate if any will be children. The age at which someone is considered an adult is defined at the research site. In the US it is usually, but not always, 18 years of age.

Guide: Read the policy on Research with Children if the research will involve children, as defined at the research site. Include a parental permission and child assent forms in the appendices.

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5. Description of Activities

To ensure the protection of participants in research, the IRB needs to understand the experience of your research participants. When you complete this section be sure that the experiences of your participants, from recruitment through completion of the study, are clearly described.

5.1 Describe the study activities and how long each activity will take. If the study involves observation, describe the setting and events that you will observe.

5.2 List here all surveys, questionnaires, structured and unstructured interview questions, focus group guides, and any other instruments you will use to gather data. If you plan to conduct open-ended or unstructured interviews, you will need to provide a description of the type and range of questions. Compile these documents as Appendix A.

If your research includes deception, complete and submit the Request to Use Deception in Undergraduate Research with your form.

6. Recruitment

Resource: Guide on Recruitment.

6.1 How do you plan to recruit potential participants?

6.2 Check all the recruitment methods that apply and provide text and or scripts for each method.

Compile recruitment materials as Appendix B.

Introductory letter or e-mail messages Flyers/posters Newspaper ads Text for social networking sites or other on-line recruitment Script(s) for personal contact Other. Please describe:

7. Compensation

Guide: The guide to Compensating Research Participants provides more information on different methods of compensation, including drawings and lotteries, and compensation restrictions.

7.1 Will you give participants gifts, payments, or tokens of appreciation?

No Yes

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If yes, please describe:

7.2 If you plan to pay participants, under what conditions will they receive partial or no payment?

8. Benefits Notes: The opportunity to participate in research is not a benefit. Compensation is not a benefit.

Describe any anticipated direct benefits of you research for individual participants. If your research provides no direct benefits to your participants, state “None.”

9. Risks

There are three parts to this section:

Part 1: Risks associated with the research topicPart 2. Physical risksPart 3: Risks associated with information that identifies participants

Risks of Harm, Part 1: The Research Topic

Researchers sometimes ask people to share deeply personal information about their lives or ask them about past trauma. For example, researchers may ask about sexual practices or ask people to talk about experiences in which they were victims of a natural disaster or of violence.

It is not always the case that these and similar topics will be distressing to individuals and the sensitivity of topics varies between cultures; however, potential participants must be informed about the types of questions the researcher will ask and be given the option to decide whether they want to take part in the research.

9.1 If your research questions might upset or distress participants, please discuss.

9.2 Describe the strategies you will use to mitigate the risks.

Risks of Harm, Part 2: Physical Harm or Discomfort of 21

It is unlikely your research will present any risks of physical harm or discomfort to participants. However, your study may ask participants to complete visual or physical tasks that could pose risks if your participants have a health condition, such as back problems, a seizure disorder, or a heart condition. Even something as simple as asking participants to complete tasks on a computer may cause eye strain or fatigue if the task requires participants to stare at the computer screen for an extensive period of time. Ways to mitigate such risks of physical harm or discomfort include incorporating breaks into your study and communicating exclusion criteria in the recruitment and informed consent processes.

9.3 If there are any risks of physical harm or discomfort, please describe.

9.4 What steps will you take to mitigate the potential risks?

9.5 Are there people who should be excluded from your study because of the potential risks?

Risks of Harm Part 3: Risks Associated with Information that Identifies Participants

There are two ways to identify people.1. The first is by direct identifiers, such as names or email addresses. Images of participants’ face

are considered direct identifiers; currently audio-recordings are not.2. The second is by indirect identifiers. Indirect identifiers are bits of information that, if combined,

could identify someone. For example, the ethnicity, gender, and major of a Duke student might identify the student. In small fishing community, the make and age of a fishing boat might identify the captain.

When you conduct research, it is important to think carefully about how you will collect, store, and report identifiable information about your participants. Contact information collected for recruitment or follow-up purposes is identifiable information. Depending on the research topic (for example, behavior that challenges social norms), contact information may need to be protected.

In some situations, research participants will be identified in research reports because they are community leaders or experts and have been agreed to be identified and perhaps quoted. Sometimes people have a story to tell and they wish to be identified. However, in most research it is advisable to not collect or retain individually identifiable information.

There are four sections to this part: Recruitment, Data Collection and Storage, Data Protection Plan, and Reporting.

1. Recruitment

9.6 If you need individually identifiable private information to contact and recruit participants, for example, email addresses, describe the identifiers, and explain how you will collect them and what you will do with the identifiers when the recruitment process is complete. If you are not sure whether the data you collect will include individually identifiable private information, contact the IRB.

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2. Data Collection and Storage

9.7 Do you plan to collect individually identifiable private information (direct or indirect) that will be associated with participants’ responses? Note: If you create a key linking direct identifiers with unique identification numbers, the data are considered identifiable.

No Yes

If yes, describe the direct identifiers you will associate with participants’ responses. If relevant, describe data you will collect that could be used by someone with knowledge about the study population to deduce someone’s identity. Explain why it is necessary to collect identifiers.

9.8 Would the inadvertent disclosure of identifiable data place participants at risk of harm?

No Yes

If no, skip Section 3. Data Protection Plan, and go to Section 4. Reporting.

If yes, describe the specific harms that could occur if individually identifiable data were disclosed in the box below. Also, complete Section 3. Data Protection Plan.

3. Data Protection Plan

If your participants could be harmed by an inadvertent release of identifiable data, the data are classified as sensitive.

Responses to the questions in this section will assist IRB reviewers, and are needed by the Duke University Information Security Technology Office (ITSO) to assess your data protection plan. ITSO will review the data protection plan to ensure appropriate measures are in place to protect data. The IRB will send the entire protocol to ITSO.

Please review the Developing Data Protection Plans for a list of best practices and ITSO recommendations.

9.9 Who is your departmental or unit IT contact?

9.10 Who is responsible for data security, including upgrades?

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https://security.duke.edu/

9.11 Where will you store data? If data will not be stored on an ITSO-approved storage medium, where will they be stored?

9.12 How will transfers of data from the data collection site to the data storage medium described above be handled?

9.13 Do you plan to create a key linking unique identifiers participants’ responses? If yes, describe the key, where it will be stored, how it will be protected, and who will have access to it (list by name).

9.14 Who will have access to the identifiable data? (List by name.)

9.15 How will access to the identifiable data be controlled?

9.16 Where will data be analyzed? Who will perform the analysis?

9.17 If the data need to be de-identified, what are the plans for de-identifying data? Describe when in the process the data will be de-identified and identify who will do the de-identification. In some cases, a third-party broker may be required to de-identify the data.

9.18 Will you apply for a Certificate of Confidentiality to protect the data from subpoena, if for example, you have identifiable data about illegal drug use or unlawful behavior?

9.19 Is a non-Duke entity giving you Protected Health Information? If yes, please provide the data disclosure agreement as an attachment to this form.

No Yes

9.20 If you have entered into a data use agreement that specifies a data destruction date, what is the data destruction date?

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4. Reporting

9.21 Will you use participants’ names in your research reports?

Yes No

If yes, please explain how you will secure permission to do so.

9.22 If no, based on your research topic, setting, and reported characteristics of your participants, could their identities be readily deduced?

Yes No

If yes, discuss the rationale for using the data in your reports and any possible risks of harm to participants.

Important: Undergraduate students may not take individually identifiable data with them when they graduate from Duke. If they wish to retain individually identifiable data for future research purposes, the data must be kept at Duke, in accordance with Duke’s data protection standards, by the student’s faculty advisor. The data could be accessed in the future with IRB approval from the students’ post-graduate institution. It is okay to take de-identified data.

10. Photographs, Videos, and Audio-recordings

The IRB will consider approving the collection of identifiable photographs or videos only if they are necessary to answer the research question.

Guide: For guidance about when photographic releases are needed and to see sample release language, go to the Guide for Releases for Images and Recordings.

10.1 Will you make identifiable photographs or videos of your participants, for example portraits?

No: Skip to 10.2 Yes: Complete the following questions:

Explain why the identifiable images (photos or videos) are necessary to answer your research question.

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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. The informed consent process you design can include the photograph or video-recording release.

Where do you plan to display, present, or distribute the images outside of your research team? Your advisor is a member of your team.

10.2 Do you plan to audio-record participants either individually or in groups? Audio-recordings of groups is allowed only if all participants in the group have given their explicit permission to be recorded.

No Yes: What will you do with the recordings?

Destroy the recordings after I have made transcripts. Save the recordings for further research and education activities.

11. Informed Consent Process

The informed consent process involves two parts:

1) The process of sharing information about your research study and2) The documentation (a signed consent form or an audio- or video-recorded statement by the

research participant) that the process took place

You will always need to create a process for sharing information about your research study with prospective participants. Your consent processes must be included in Appendix C.

In some circumstances it may be appropriate to request that the IRB waive the requirement to document consent. That is, the IRB can waive the requirement to collect a participant’s signature or recorded statement. Even if a waiver is appropriate, your consent process must be included in Appendix C.

You may be able to use an oral consent process without documentation if one or more of the following is true. Please check any that apply to your research.

Participants do not read and write. (If there is a risk of harm, a third-party witness will be present.)Data will be collected on-line. Participants will have the option to “click” to the survey if they would like to talk part in the study. The study data will be collected through a telephone interview. If appropriate, I will provide a copy of the consent process for their reference.Participants will complete a mailed survey. Prepare a cover letter that includes all the elements of informed consent. People who wish to take part will return the survey; thereby, demonstrating their consent. They do not need to sign a consent form.

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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-recorded statement would be the only documented link between individuals and their participation in the study. (Example: a study about people with HIV/AIDS.)

Note: In most cases, other than telephone interviews, where the consent process is oral, researchers should give participants contact information in case the participants have any questions later. It may be appropriate to give them a copy of your oral script for reference.

Guides:1. The Informed Consent Guide provides guidance on informed consent, instructions for

preparing informed consent processes, and sample language.

2. The Guide to Confidentiality provides examples of how to talk about confidentiality procedures.

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12. Putting Together Your Appendices The next few pages are designated to the different items to help you compile your appendices. Use the checklist provided below to identify the possible items that might be included.

Appendix A: Research Instruments:

Surveys, questionnaires, in-person interview questions, focus group guides, and/or instruments you will ask your participants to complete

Description of the type and range of questions for life history or other open-ended/unstructured Interviews

Appendix B: Recruitment Materials:

Introductory letter or e-mail Telephone contact script Personal contact script Flyers/posters Newspaper ads

Appendix C: Informed Consent Materials:

Oral consent script Written consent form Parental permission process Child assent process Combined adult consent (to participate) and parental permission (for child to participate) Contact information cards to give participants (if appropriate)

Appendix D: Releases:

Photograph release Video-recording release Audio-recording release Release requesting permission to add a recording or photograph to a public archive

Appendix E: Permissions to Conduct Research, if Needed:

Letter requesting permission to conduct research from community leaders or school principals

Please use the following pages provided to include your appendices.

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Undergraduate Student Request for Protocol ApprovalAppendix A

RESEARCH INSTRUMENTS

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Undergraduate Student Request for Protocol ApprovalAppendix B

RECRUITMENT MATERIALS

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Undergraduate Student Request for Protocol ApprovalAppendix C

CONSENT MATERIALS

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Undergraduate Student Request for Protocol ApprovalAppendix D

RELEASES

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Undergraduate Student Request for Protocol ApprovalAppendix E

PERMISSIONS TO CONDUCT RESEARCH(IF NECESSARY)

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