STUDY TITLE:Include the full study title

PRINCIPAL INVESTIGATOR:Name:Department:

NOTE: Per Northwestern University policy, undergraduate and graduate students are not allowed to be the Principal Investigator on a research study. Visiting faculty, visiting scholars, postdoctoral fellows, and medical residents are not eligible to serve as Principal Investigator on a research study unless special permission is granted. For further information on who is eligible to serve as a Principal Investigator, see https://irb.northwestern.edu/process/new-study/requirements#PI%20Eligibility .

CO-INVESTIGATORS:Name:Department:

NOTE: students should not be listed as co-investigators

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This protocol template may be used for any new Social Behavioral studies submitted beginning on May 6, 2019. This template MUST be used for new Social Behavioral studies submitted in eIRB+ on or after July 1, 2019.

NOTE: The protocol should describe your research procedures and participant population in detail. Your consent documents, data collection instruments (surveys, questionnaires, interview guides, etc.), and recruitment materials need to be uploaded in eIRB+ in the consent, recruitment, and supporting documents sections of the application and should NOT be attached or incorporated into this protocol document.

TIPS ON COMPLETING THE PROTOCOL FORM:

If any sections are not applicable to your research, mark that section as N/A (for not applicable)

Keep an electronic copy of your protocol. If you submit modifications to your study at a later time, you will need to include tracked changes to all affected study documents, including the protocol.

As you write this protocol, remove the text boxes and all instructional text contained inside the text boxes in each section. There should be no text boxes or instructional text (including these instructions) in the final version of your protocol.

STUDENT INVESTIGATOR (complete this section only if the project is student-initiated):

Name:Department:

Are you an:☐ Undergraduate Student☐ Graduate Student or Medical Student

VERSION DATE:Include the version date of this protocol (today’s date)

Check any applicable boxes in the table below – you will be asked for further detail on these topics later in the protocol form:

Indicate Vulnerable Population(s) to be Enrolled

☐ Children ☐ Cognitively Impaired Adults ☐ Pregnant Women (IF the research activities will affect the pregnancy or the fetus)☐ Prisoners (or other detained/paroled individuals)

International Research (check this box if you will collect data from individuals located outside the United States)

☐

Research involving external collaborators (some research activities will be carried out by individuals not employed by Northwestern or NU affiliates)

☐

Research has U.S. Federal government funding (e.g., NIH, NSF, other federal agencies/departments)

☐

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1.0 Purpose of the study:

(Describe the purpose, specific aims, or objectives. State the research questions that will guide the study.)

2.0 Background / Literature Review / Rationale for the study:

Briefly (500 words or fewer) describe:

Provide the scientific or scholarly background for, rationale for, and significance of the proposed research based on the existing literature and how it will add to existing knowledge.

3.0 Inclusion and Exclusion Criteria:

Briefly describe the criteria (age range, gender, language, etc.) that define who will be included or excluded in your study sample.

Indicate specifically whether you will include any vulnerable populations. You may not include members of these populations as participants in your research unless you indicate this in your inclusion criteria.

Adults unable to consent/Cognitively Impaired Individuals who are not yet adults ( specify exact age range of

children to be enrolled) Pregnant women (where the activities of the research may affect

the pregnancy or the fetus) Prisoners or other detained individuals

⁎ Undergraduate Student Researchers Only: It is unlikely that the IRB office would approve undergraduate researchers doing an independent project that plans to enroll prisoners, pregnant women (if the research activities may affect the pregnancy or the fetus), children, or cognitively impaired individuals as target populations.

4.0 Sample Size:

Briefly describe the anticipated total number of participants. If there will be multiple study sub-groups, describe how many participants you plan to enroll in each sub-group.

Provide a justification for the sample size.

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5.0 Recruitment and Screening Methods:

Recruitment process: Describe how potential participants will be identified. When, where, and how will potential participants be invited to participate in the study?

Describe the types of strategies and materials that will be used to recruit participants (e.g., fliers, online recruitment advertisements, phone calls/word of mouth, registry or subject pool, Amazon MTurk, etc.). If you plan to use online websites/platforms (e.g., Facebook or Craigslist) for recruitment, specify which online venues you will use to post recruitment information. If you will use a registry or subject pool, specify which one.

Note: For additional guidance on the recruitment process and documents see: http://irb.northwestern.edu/process/new-study/requirements/recruitment-materials-guidelines.

Screening process: If you will use a screening process to determine whether potential participants are eligible to participate, explain how the screening will be performed (telephone interview, online questionnaire, etc). Be sure to attach a copy of the screening questions/criteria to your eIRB+ application (not in this protocol document).

Although you do not need to obtain full informed consent to conduct eligibility screening, your screening process should include an explanation of the purpose of the research study, why you are doing a screening process, what happens to the screening data for individuals who are not eligible to participate in the study, and whether there is any compensation for participating in the screening process (apart from compensation for participating in the study itself).

If you will be asking for sensitive information during the screening process (e.g., whether the participant is using illegal substances, has a history of psychiatric disorders, etc.), you must have thorough data security practices for collection of that data, and for destruction of the screening data for anyone who does not qualify to be in the study. Sensitive research data, including screening data, should not be collected via email.

6.0 Research Locations:

A research location is defined as a location or place where the research procedures will be conducted by the NU researchers. Examples: lab space at Northwestern, schools, community centers, public venues, online, etc.

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Indicate that all required permissions and/or approvals are already obtained or will be obtained at each research location prior to project implementation. Please keep in mind that if you will be doing research in K-12 schools, some school systems require an additional research review process (including Chicago Public Schools, Evanston/Skokie District 65, and Evanston Township High School.)

If your study will collect data through or from online/internet sources, please describe specifically which survey platforms or websites you plan to use for data collection (e.g., Qualtrics survey panels, Amazon Mechanical Turk, internet chat rooms and support groups etc).

7.0 Multi-site Research (research that involves external collaborating institutions and individuals):

The NU IRB has agreements in place to serve as the IRB of record for Shirley Ryan AbilityLab, NMHC, and Lake Forest Hospital – for research that involves collaboration with these institutions, you do not need to fill out this section of the protocol.

Where there are external institutions or individual external investigators involved in carrying out the research, a plan needs to be in place as to which institutions/individuals need IRB review of their activities, and which IRB will be responsible for reviewing those activities. To make those determinations, the IRB needs to know where activities will take place and who will be doing which activities on the study.

For each institution involved, briefly describe which activities that institution will be carrying out for this study (including recruitment, consent, data collection, data analysis (specify whether data to be analyzed will be identifiable or de-identified)).

If you will be collaborating with an individual who is not affiliated with another institution (e.g., an independent contractor or consultant), describe which study activities will be carried out by that individual.

If the study has grant funding, explain who is the primary grant awardee.

Describe the processes you have in place to ensure successful coordination of activities among collaborating institutions. How will modifications to study procedures be communicated to collaborating institutions and approved prior to implementation? How will participating institutions be kept abreast of any problems, interim results, or the eventual closure of the study?

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RELIANCE AGREEMENTS:

Reliance agreements are formal arrangements between institutions allowing the IRB of one institution to rely on the IRB of another institution for review of human research. Investigators working with multiple institutions, each having an IRB, may request to have one IRB become the IRB of record with oversight over some or all participating institutions. However, the IRB at each engaged institution makes the final decision on whether it will rely on another IRB or serve as the IRB of record.

Describe the proposed plan for IRB review of this study – will each institution’s IRB review that institution’s activities or are you proposing that one IRB serve as the IRB of record for all institutions engaged in the study? The IRB at each engaged institution must decide whether they agree to rely on another IRB’s review or to serve as the IRB of record – the NU IRB will not serve as IRB of record for other institutions unless the IRBs at those other institutions have agreed to this arrangement. Information on the reliance agreement process is available at: https://irb.northwestern.edu/reliance-agreements

As of January 25, 2018, many studies that have NIH funding must identify one IRB to serve as the IRB of record for the study (see https://grants.nih.gov/policy/humansubjects/single-irb-policy-multi-site-research.htm)

8.0 International Research (where data collection will occur outside the United States and U.S. territories)

For guidance on IRB review of research that will take place outside the United States, see https://irb.northwestern.edu/sbs/review-international

The HHS Office of Human Research Protections annually updates a compilation of international laws and regulations governing human research, available at: https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html

If your research will take place outside the United States, please explain:

Will you obtain review by an IRB/research ethics committee located in the country where you will be doing research? Some countries do not have IRBs/research ethics committees, and in

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some countries the IRBs only review biomedical research – we understand that IRB review in another country is not always possible, but expect that review by an IRB/research ethics committee be obtained whenever possible in the country where research will take place – it is your responsibility to determine whether there is an IRB/research ethics committee that can review your research in the countries where you plan to collect data.

What sociocultural factors could affect the consent process in the countries/regions where you will do research? For example, are there low rates of literacy, are there cultural customs that require consent from a community or family leader, etc?

Are there any mandatory reporting laws that apply to your research (e.g., mandatory reporting of child abuse and neglect?)

NOTE: If you plan to collect data from individuals located in the European Economic Area, you must take into consideration the General Data Protection Regulations (GDPR) (see GDPR guidance).

NOTE: If you will be collecting data that are sensitive, you must use good data security practices to collect, store, and transport your data. Keep in mind that officials in other countries, as well as U.S. Customs and Border Protection, could potentially try to access data stored on a phone, laptop, or other device. For more information on good data security practices when traveling, see https://www.it.northwestern.edu/security/travel.html

9.0 Procedures Involved:

Describe the study design. If your study has multiple aims/phases and you are requesting IRB review at this time of only certain aims or phases, please specify.

Provide a description of all research procedures and the timeline of data collection – explain step-by-step what participants will be asked to do in this study, and whether you will access any secondary data sources (e.g., student educational records, electronic health records, or other datasets) to carry out this study. We need to know the what, when, where, and how of your project and how your procedures connect to your research

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purpose/questions. Specify what data collection instruments and/or datasets you plan to use.

If you will be using any attention check measures or performance bonuses/incentives, you must describe them and explain what happens if a participant fails the attention checks or does not qualify for a bonus/incentive. If you plan to access data from medical records maintained by Northwestern Memorial HealthCare, Shirley Ryan AbilityLab, other NU-affiliated institutions, or other physician/clinic/hospital medical records from sources not affiliated with Northwestern University, explain which variables you will access from the medical record.

If you plan to use mobile apps for data collection, please see guidance on the IRB website: Mobile Apps and Mobile Medical Apps Guidance

If the study involves multiple conditions where each condition involves different procedures, please provide a table or diagram that breaks down the procedures by condition and in chronological order.

Describe the duration of an individual’s participation in the study for each study activity and the estimated total time for each participant to complete all study activities.

⁎ Student Researchers Only: For student research, if your study may involve risks to participants, explain how you will check in with your PI and receive appropriate supervision while carrying out the study.

10.0 Research with Vulnerable Populations

If the research will involve individuals who are vulnerable or susceptible to coercion or undue influence, describe any applicable additional safeguards included to protect their rights and welfare. Vulnerable populations include children, prisoners, cognitively impaired adults, and pregnant women where the research activities are expected to affect the pregnancy (other populations may be vulnerable as well – that is not an exclusive listing of participants who may be considered vulnerable).

If members of the research team have roles that can give rise to concerns about undue influence with participants (such as physician-patient, teacher-student), please explain the steps you will take to minimize the possibility of undue influence/coercion.

The IRB has checklists for vulnerable populations at

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https://irb.northwestern.edu/templates-forms/templates-forms-sops to help you ensure you have provided sufficient information (NOTE—these checklists are completed by the IRB office, refer to them only as a source of guidance).

11.0 Incomplete Disclosure or Deception:

If you will be using incomplete disclosure (withholding information about some aspect of the research during the consent process, whether it is related to the procedures or the purpose of the research) or deception (purposely misleading participants by providing them with overt misdirection or false information about some aspect of the research during the consent process), see the Deception and Incomplete Disclosure Guidance on the IRB website.

If the study will use incomplete disclosure or deception, describe the incomplete disclosure or deception and provide a rationale explaining why it is necessary to the research.

Because deception and incomplete disclosure alter the information presented during the consent process, the debriefing process serves as the remedy by completing the consent process. If debriefing is appropriate, explain how you will conduct the debriefing process. (Sample debriefing text is included in the Deception and Incomplete Disclosure Guidance on the IRB website.)

NOTE: If you plan to alter the consent process because you are using deception/incomplete disclosure as a research technique, you must complete Protocol Section 15 to request an alteration of the consent process.

12.0 Consent Process:

Describe the process you will use to obtain informed consent (written, verbal, online, etc.) from participants, including where and when the consent process will occur. If consent will be obtained in different ways for different participant groups or study phases, describe the consent process that will be used for each participant group and/or study phase.

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Consent is not merely a document – it is a process, in which the participant gains an understanding of the research procedures and the potential study benefits and risks in order to make an informed, voluntary decision on whether to participate in a research study.

The standard is that consent should be documented by having the participant sign a consent form after having the study explained to them, the opportunity to have any questions answered, and time to think about whether to agree to participate.

There are many exceptions where obtaining a participant’s signature on the consent document is not feasible (e.g., research collecting data online or via telephone), or where obtaining consent is not feasible (primarily for studies that are only analyzing secondary data).

If you do not plan to obtain the participant’s signature on the consent document, you must complete Protocol Section 14. If you are requesting a complete waiver of the consent process, or plan to alter the consent process because you are using deception/incomplete disclosure as a research technique, you must complete Protocol Section 15.For more information, see the Process of Obtaining Consent guidance on the IRB website

TEMPLATE CONSENT FORMS AND SCRIPTS:

If you will document consent in writing (that is, the participant will sign the consent form), you must use SOCIAL BEHAVIORAL CONSENT DOCUMENT TEMPLATE (HRP-582) to create the consent document.

If you will be obtaining consent online, use the ONLINE CONSENT TEMPLATE (HRP-1709).

If you will be obtaining verbal consent (without the participant’s signature), use the VERBAL CONSENT TEMPLATE (HRP-1710).

All templates for consent forms and scripts can be found on the IRB website at:https://irb.northwestern.edu/templates-forms/templates-forms-sops

SPECIAL CONSIDERATIONS FOR THE CONSENT PROCESS:

CHILDREN: See Section 13 below for a discussion of parental permission and child assent.

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Protected Health Information (HIPAA): If you plan to access protected health information as part of your study, you must use the Social and Behavioral consent Template Document (HRP-582) and be sure to include the HIPAA authorization language. HIPAA Authorization requires the participant’s signature. Under Illinois law, if you plan to access mental health information or “all medical records,” you must have both the participant and a witness sign the consent form.

Student Educational Records (FERPA): If your study seeks access to student educational records that are protected by the FERPA law, FERPA requires that the consent to access FERPA-protected information be signed and dated by the student (or the student’s parent, depending on what level of school the student is enrolled in). For more information on FERPA, see https://studentprivacy.ed.gov/?src=fpcoFor information on how FERPA applies to records at Northwestern University, see https://www.registrar.northwestern.edu/records/student-information-privacy/privacy-policy-ferpa.html

NON-ENGLISH SPEAKING PARTICIPANTS:Explain which language(s) will be used by the individuals obtaining consent and which language(s) it is anticipated are understood by the potential participants.

Describe the process to ensure that oral and written information provided to participants who are not fluent in English (whether in the United States or in other countries) will be in the language with which they are most comfortable.

If you will be using a translator, explain how you will identify an appropriate translator.

If your recruitment, consent, and data collection materials will be translated into other languages, we recommend first obtaining IRB approval of the English-language versions of those materials, and then submitting the translated materials as a modification to your study.

INDIVIDUALS WHO LACK CAPACITY TO CONSENT:Describe how you will assess capacity to consent if your study will include individuals who may lack capacity to consent.

If you will have more than one interaction with the participants, you must re-check capacity to consent at each interaction with the participant – some participants may lack capacity to consent at one time point and have capacity to consent at other time points.

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When research involves adults unable to consent, permission to participate in research must be obtained from a Legally Authorized Representative (unless the IRB has granted a waiver of consent). For assistance in determining who can serve as a Legally Authorized Representative, review SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013) .

13.0 Research with Children – Parental Permission, Child Assent, and Other Considerations:

Parental permission must be obtained for children’s participation in research unless the IRB grants a waiver of parental permission. The IRB expects an assent process to be used and documented with children ages 7 years to 17 years old, unless special circumstances justify a waiver of assent.  Describe how parental permission will be obtained and the assent process for child participants. What age range of children will you seek to enroll, and how will you tailor the assent process to the developmental stages and capacity of the children you will seek to enroll?

IF YOU WILL NOT BE OBTAINING PARENTAL PERMISSION, you must request a waiver of parental permission in Protocol Section 15.

For parental permission and assent form templates, please see the IRB website at: https://irb.northwestern.edu/templates-forms/templates-forms-sops

NOTE: Children generally cannot provide “consent” to participate in research – rather, children provide assent. Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Who is a “child” for research purposes is determined by state and local law (or international law, customs, and societal norms, for studies outside the United States). For research conducted outside of Illinois, it is your responsibility to

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determine the age at which participants are no longer considered children for research purposes. In a large majority of states in the United States, 18 years of age is the legal age of adulthood, but this is not true in every state, locality, or territory. 

The assent process must be tailored to the reading and comprehension levels of the children to be enrolled in your study.   Children younger than 7 years old may not be able to participate in a written assent process, or if very young or otherwise incapable, in any meaningful assent process – in such cases, only a parental permission form is needed (the research team should still provide a simple explanation to the child of what will happen to him/her during the study whenever possible).  

For children ages 7 years to 17 years old: If the parent will be present with the child during the assent process, you can use either: 1) a combined parental permission and child assent form, or 2) separate forms, one for parental permission and one for child assent.  If the parent will not be present during the assent process with the child, a separate assent form must be used documenting what information the child was provided with about the study – the child should sign the form if possible, and if not, the assent form or study records must document that verbal assent was obtained.

If the parent and child will both be participants in the study, a combined adult consent, parental permission, and child assent form can be used, but must explain very clearly which study procedures will be completed by parents and which will be completed by children.

Wards of the state: If your research will involve children who are wards of the state, you must let the IRB know – there are special considerations and protections for research that involves children who are wards of the state.

Longitudinal studies: If you will be collecting data from children and you plan to continue collecting data from those individuals when they turn 18 years old, you must obtain consent from participants as they turn 18 years old or request a waiver of consent from the IRB and explain your rationale for a waiver.

14.0 Waiver of Participant Signature on Consent Form:

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There are a variety of reasons why a research study might not find it feasible to obtain the participant’s signature on the consent form. For example, if consent and data collection will take place via telephone, Skype, or through an online survey, obtaining the participant’s signature on the consent is cumbersome and can render obtaining consent infeasible. In other studies (e.g., studies of illegal or socially stigmatized activities), the participant’s signature on the consent could create additional risks for the participant. If doing research in other countries, it may not be the norm for members of a distinct cultural group or community to sign a consent form.

If you will not obtain the participant’s signature on the consent, explain why.

15.0 Waivers and Alterations of Consent Information:

For some studies, not obtaining consent or parental permission is appropriate (for example, studies that only involve analysis of secondary data, or studies where requiring parental permission could result in harm to child participants). For some studies, omitting certain information in the consent process may be necessary to render the research feasible and to produce valid data (research that is using deception as a technique).

If you want to request a complete waiver of consent/parental permission OR an alteration of consent, please explain why:

i) the study is no more than minimal risk to the participants; ii) the research could not practicably be carried out without the

requested waiver or alterationiii) if the research involves using identifiable private information or

identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;

iv) the waiver or alteration will not adversely affect the rights and welfare of the participants; and

v) whether participants will be provided with additional pertinent information after participation (i.e, whether debriefing will occur)

Debriefing primarily applies to studies that use deception/incomplete disclosure – if participants will not be debriefed, just say “debriefing is not applicable to this study.”

NOTE: If you are requesting a waiver of parental permission on the basis that parental permission is not a reasonable requirement to protect the participants (e.g., research with neglected or abused children), explain your rationale and what additional protections will be put in place for child research participants.

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16.0 Financial Compensation:

There is no requirement to compensate research participants.

If you will compensate participants, describe any financial or other compensation that will be provided to participants. Describe the payment method, including how much money or other compensation will be provided for which activities, as well as when (the timing) compensation will be provided. If you will use a lottery/raffle process to provide compensation, please describe that process and how many participants will receive compensation.

Describe whether compensation will be prorated if there are multiple research activities or if a participant withdraws from the study before finishing. If your study will involve multiple visits/interactions, it is recommended that compensation be provided at regular intervals and not be contingent upon completing the entire study.

Describe any costs that participants may be responsible for because of participation in the research, such as parking, cellphone-related costs, etc.

If the research involves more than Minimal Risk to participants, describe the available compensation in the event of research related injury.

Northwestern University’s policy on paying human research participants is available at: https://www.northwestern.edu/financial-operations/policies-procedures/policies/HumanSubjectPayments.pdf

17.0 Audio/Video Recording/Photography

Describe the type of recording being utilized, why the type of recording is necessary to the research, and whether recording is mandatory or optional to participate in the research.

Describe how the recordings will be utilized in the research (e.g., data analysis only or data analysis and presentations). If the intent is to use recordings or images for public presentation or publication, you must obtain the participants’ consent to those uses of the data and there must be compelling rationale provided for why you are asking the IRB to waive the fundamental right to privacy regarding participation in research.

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Describe how and where the recordings will be stored, who will have access to them, and if/when they will be destroyed.

If recording is mandatory for participation, a rationale must be provided here and the consent form must include this detail.

18.0 Potential Benefits of this Research:

Explain the potential benefits that could result from your research -- indicate if there is no direct benefit to participants. Include discussion of potential benefits to society or others.

Note: participation in the research itself and payment for participating in the research are not benefits and cannot be described as research benefits in the consent process.

19.0 Risks to Participants:Describe the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the participants’ participation in the research. Describe the probability, magnitude, duration, and reversibility of the risks.

Consider physical, psychological, social, legal, and economic risks as well as community or group harms. Note: a breach of confidentiality is a common risk in social and behavioral research.

20.0 Provisions to Protect Participant Privacy and Data Confidentiality:

Participant Privacy:Describe the steps that will be taken to protect participants’ privacy interests. “Privacy” refers to a person’s desire to place limits on with whom they interact or to whom they provide personal information. For example, will you conduct interviews that ask sensitive questions in areas where the interview cannot be overheard by others?

Confidentiality of data/biospecimens:

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Describe how you will maintain confidentiality for data/specimens throughout the life-cycle of your study, including initial collection, data management (including data transfers), and storage. We need to know the procedures you will implement to maintain good data security (e.g., authorization of access, password protection, encryption, physical controls, and separation of identifiers and data) during collection, transmission, and storage.

Discuss the following elements, as applicable to your study:

• Will participant identifiers (e.g., name, residential address, phone number, email address, etc.) be included and stored with the data/specimens? Will identifiers be stripped at some point? Keep in mind that some participants may be identifiable from video or audio-recordings.

• If no direct participant identifiers will be collected, will you use a coding system with a key? Where will the key to the coding system be stored and who will have access to the key?

• Do you plan to transcribe audio-recordings, and if so, will you delete the audio-recordings when transcription is completed?

• How will data be transported from point of collection to point of storage?

• Where and how will data/specimens be stored? How long will the data or specimens be stored? What will happen to the data/specimens at the end of your study? (Note: Under NU policy, research data must be kept a minimum of 3 years after the completion of the study. However, there are circumstance when other time periods may apply. Consent forms that contain HIPAA authorizations must be retained for at least 6 years after completion of the study.)

For detailed guidance on good research data security practices, please see NU IT’s website at https://www.it.northwestern.edu/security/research.html.

If you will be collecting research data while outside the United States, please see NU IT’s tips on data security when traveling: https://www.it.northwestern.edu/security/travel.html

21.0 Data Monitoring Plan to Ensure the Safety of Participants:This section must be filled out if your study is a clinical trial and/or if you will be collecting data that could indicate potential harm to participants (e.g., participants expressing intent to harm self or others, data indicating child, spousal, elder or other forms of abuse or neglect).

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Describe the plan to monitor and evaluate the information collected regarding risks or harms to determine whether participants and others remain safe – the frequency of monitoring should be appropriate to the sensitivity of the data and level of risk. For example, if participant responses could suggest likelihood of intent to harm self or others, what is your plan for monitoring severity and how will you respond if a participant indicates intent to harm? If directly assessing this data, someone on the research team must be appropriately qualified.

22.0 Long-term Data and Specimen Storage and Sharing: If data/specimens will be stored and shared long-term for future research studies, explain the plan for storing and sharing the data. If you plan to place your data in a data repository, explain which repository/database and why.

Explain whether identifiers will be included with the data/specimens when they are shared.

23.0 Qualifications of Research Team to Conduct the Research:

Describe the qualifications of the research team to conduct this research. The IRB is looking for information such as area(s) of expertise, past research experience, relevant certifications, etc.

For international research or research with vulnerable populations, describe your qualifications (e.g., training, experience, oversight) to conduct the research and your knowledge of the local study sites, culture, and society.

Note: If you specify a person by name, a change to that person will require prior approval by the IRB. If you specify people by role (e.g., coordinator, research assistant, co-investigator, or pharmacist), a change to that person will not require prior approval by the IRB, provided that person meets the qualifications described above to fulfill their roles.

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