Initial Protocol Application Sample Questions
The Initial Protocol Application, like all of the HRPP webforms, is an interactive form with built-in logic. That means that the answers to some questions will reveal other questions. Only the questions that need to be answered for your specific research protocol will be visible to you. Please provide complete and detailed answers to every question that you see.
Below is a preview of the questions on the Initial Protocol Application, organized by section of the form, which you may want to use to prepare your response (e.g., in Word) before using the form. Many of the conditional questions can be seen in this sample, even if you may not see them when you are working on your submission.
Protocol Preliminary Questions
- Does your research fall under one or more exempt category?
- Which exempt category?
- Does your research involve analysis of secondary data or biospecimens only?
- Is this an initial or de novo submission?
- Are you, the person submitting this form, a student or faculty member?
Project Detail
- Project Title
- PI Name
- PI Department
- PI Phone
- PI Email
- Supervised Researcher Name
- Supervised Researcher Status
- Supervised Researcher Phone
- Supervised Researcher Email
- Estimated Level of Risk
- Anticipated Start Date
- Anticipated End Analysis Date
- NIH Clinical Trial
- Funding Status
- Sponsor
- Sponsor ID
- Grant PI
- Grant Title
Purpose of Research
- Briefly describe the overarching goal of what you seek to discover from the research, as well as its expected benefits.
Personnel
- List all personnel who will be taking part in the research, their institutional affiliation, role in the research, and CITI training in Human Subjects Research, as well as a concise explanation of qualificatons/relevant experience with regard to the research. Please do not include an entire CV.
- Name
- Institutional Affiliation
- Role in Research
- CITI Training
- Will this investigator have access to identifiable data?
Collaborations and Subcontracts
- Describe any additional collaboration or subcontract with an outside institution or vendor (e.g. Boston Children's Hospital, ABC transcription services).
Conflicts of Interest
- List any actual, potential, or apparent conflicts of interest - financial or otherwise - any research personnel or collaborator may have regarding this research. (This includes any actual, potential, or apparent financial conflicts of interest that do not rise to the level of significant financial interest.)
Results of Previous Research
- Discuss past research undertaken by others and/or by yourselft that places the proposed research in context and explain how it fits within the literature of your field. (Please keep this brief, 1-2 pages max.)
Study Location
- Will this research take place outside of the United States?
- Will this research be conducted in one or more non-English language?
- Outline where the proposed research will be conducted.
Data Source
- Are the data, records, or specimens publicly available?
- Is authorization to access the data required?
- Were the original data, records, or speciments collected for non-research purposes?
- Attach authorization documents.
Secondary Data and Protected Information
- Does the proposed research involve the use of secondary data, documents, records, or pathological or diagnostic specimens?
- Are the data, records, or specimens publicly available?
- Is authorization to access the data (if not publicly available) required?
- Were the original data, records, or specimens collected for non-research purposes?
- Does the proposed research involve the use of de-identified HIPAA-Protected Health Information (PHI)?
- Does the proposed research involve the use of non-de-identified HIPAA-Protected Health Information (PHI)?
- PHI will be in the form of a limited data set.
- PHI will be preparatory to research only (data will be reviewed only to establish that sufficient or appropriate data will be available for the proposed work).
- PHI will only include information on decedents whose date of death was over 50 years prior to this application.
- A written HIPAA authorization will be obtained from individual subjects.
- A waiver or alteration of authorization from the covered entity has been secured.
- The covered entity does not have a privacy board and a waiver or alteration of authorization is being requested.
- Select identifiers to be collected.
- Names (individual, employer, relatives, etc.)
- Addresses (street, city, county, precinct, zip code - initial 3 digits if geographic unit contains >20,000 people, or any other geographical codes)
- Telephone Numbers
- Fax Numbers
- Social Security Numbers
- Medical Record Numbers
- Dates (except for years) connected to subjects, including date(s) of birth, admission, discharge, death, ages>89, and all elements of dates indicative of such age (except that such age and elements may be aggregated as “Age ≥90”)
- E-mail Addresses
- Health Plan Beneficiary Numbers
- Account Numbers
- Certificate/License Numbers
- Vehicle Identifiers and Serial Numbers (e.g., VINs, License Plate #, etc.)
- Device Identifiers and Serial Numbers
- Universal Resource Locators (URLs)
- Internet Protocol (IP) Address Numbers
- Biometric Identifiers (e.g. finger or voice prints)
- Full Face Photographic Images (and any comparable images)
- Any other unique identifying number, characteristic, or code
- Type of covered entity supplying the PHI data
- Name of covered entity
- Address of covered entity
- Contact Person
- Phone
- Does the proposed research involve the use of FERPA-protected educational records?
- Will you be obtaining consent from each student for access to their data?
- Will the data be de-identified prior to use in the research?
Study Design
- What data recording methods will you employ?
- What Data Collection Tools/Study Instruments will you use?
- How will you interact with your subjects/conduct your research?
- Describe the scientific design of your research. Be sure to include a discussion of the appropriateness of your chosen research methods.
Subject Details
- Subject Details - Please check only the populations you are targeting.
- Approximately how many subjects do you plan to enroll?
- Estimate the number of subjects whose secondary data you will be using/analyzing.
- Describe your subjects – explain any inclusion and exclusion criteria you plan to employ (e.g., over 18 years of age).
- Justify the use of any special/vulnerable populations for this research.
Recruitment Methods
- Describe the recruitment methods you plan to employ.
Data to be Collected
- Will you be collecting data that will not be linked to research data?
- What identifiers will you collect that will not be linked to research data (e.g., name, phone number, email for compensation purposes)?
- Check identifiers you will be collecting as data for research purposes only (do not include those you listed above if you will be collecting them for other reasons only - e.g., name, phone number, email for compensation purposes).
- Describe the specific type of data you will be collecting (e.g., survey data about or medical record data...) and what you plan to do with it (e.g., determine the link between...).
Deception/Incomplete Disclosure
- Does this research include deception or incomplete disclosure?
- Justify the need for its use in this research and describe how/when you will debrief your subjects.
Risk and Benefits
- What risks - other than loss of privacy or confidentiality (always a risk when private data is involved) - do you foresee for subjects in this research?
- Describe in more detail the risks you foresee for subjects and your provisions for managing these risks.
- Describe the anticipated benefits to subjects, society, and/or other specific groups from this research. Note that compensation is not a benefit.
Costs and Compensation/Incentives/Reimbursements
- Describe any costs to subjects for their involvement in this research (e.g., time – specify the amount , transportation, economic – loss of work, need for child care).
- Will subject receive compensation, incentives, or reimbursements?
- Describe any form of compensation/incentive subjects will receive (e.g., cash, gift card, course credit, medical care) and the terms and conditions of receiving the compensation/incentive (e.g., partial or full compensation for partial participation), as well as any reimbursements for which the subjects may be eligible (e.g., cost of travel or child care).
Informed Consent
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Request for Waiver of Documented Informed Consent
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Note that one of the three following conditions must be met:
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The consent document would provide the only link to the adult subject and the principal risk of the research would be a breach of confidentiality. Note that the adult subject must be asked whether they want documentation linking the adult subject with the research - the subject's wishes will govern.
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The risk to the adult subjects is minimal and consent would not be required outside the research context.
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The adult subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to adult subjects, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.
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- Explain your reasons for and the conditions that necessitate the request.
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Request for Alteration of Informed Consent
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Note that all five of the following conditions must be met:
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The research could not practicably be carried out without the alteration.
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The research involves no more than minimal risk to the adult subjects.
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The waiver will not adversely affect the rights and welfare of the adult subjects.
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All data will be de-identified, OR research could not practicably be carried out without using identifiable private information or biospecimens.
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The adult subjects will be provided with additional pertinent information/debriefed after participation (e.g., if deception or incomplete disclosure is being used), OR debriefing is not appropriate.
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- Explain your reasons for and the conditions that necessitate the request.
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Request for Waiver of Informed Consent
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Note that all five of the following conditions must be met:
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The research could not practicably be carried out without the waiver.
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The research involves no more than minimal risk to the adult subjects.
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The waiver will not adversely affect the rights and welfare of the adult subjects.
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All data will be de-identified, OR research could not practicably be carried out without using identifiable private information or biospecimens.
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The adult subjects will be provided with additional pertinent information/debriefed after participation (e.g., if deception or incomplete disclosure is being used), OR debriefing is not appropriate.
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- Explain your reasons for and the conditions that necessitate the request.
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- Describe the circumstances surrounding your procedures for the informed consent of adult subjects - remember that obtaining informed consent is a continuous process.
- Describe the setting in which you will be obtaining informed consent.
- Describe any special considerations you will make for vulnerable or non-English speaking adult subjects (e.g. witnesses translators), if applicable.
LAR Permission
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LAR (Parent/Guardian) Permission
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Standard procedures for obtaining documented LAR permission will be followed (LARs will sign a permission form).
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Approval for a waiver of documented LAR permission is being requested (LARs will undergo permission procedures, but will not sign a LAR permission form).
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Approval for an alteration of LAR permission is being requested (elements of LAR permission will be altered or left out of the LAR permission procedures and/or form).
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Approval for a waiver of LAR permission is being requested (LARs will not undergo permission procedures of any kind).
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LAR permission is not a reasonable requirement (e.g., the children are neglected or abused); therefore approval for a waiver of LAR permission is being requested (LARs will not undergo permission procedures of any kind).
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Request for Waiver of Documented LAR Permission
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Note that one of the three following conditions must be met:
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The LAR permission document would provide the only link to the subject and the principal risk of the research would be a breach of confidentiality.
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The risk to the subjects is minimal and LAR permission would not be required outside the research context.
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The LARs are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that LAR permission was obtained.
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- Explain your reasons for and the conditions that necessitate the request.
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Request for Alteration of LAR Permission
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Note that all five of the following conditions must be met:
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The research could not practicably be carried out without the alteration.
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The research involves no more than minimal risk to the subjects.
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The waiver will not adversely affect the rights and welfare of the subjects.
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All data will be de-identified, OR research could not practicably be carried out without using identifiable private information or biospecimens.
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The LARs will be provided with additional pertinent information/debriefed after participation (e.g., if deception or incomplete disclosure is being used), OR debriefing is not appropriate.
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- Explain your reasons for and the conditions that necessitate the request.
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Request for Waiver of LAR Permission
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Note that all five of the following conditions must be met:
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The research could not practicably be carried out without the waiver.
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The research involves no more than minimal risk to the subjects.
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The waiver will not adversely affect the rights and welfare of the subjects.
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All data will be de-identified, OR research could not practicably be carried out without using identifiable private information or biospecimens.
-
The subjects will be provided with additional pertinent information/debriefed after participation (e.g., if deception or incomplete disclosure is being used), OR debriefing is not appropriate.
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- Explain the reasons for and the conditions that necessitate the request.
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LAR consent is not a reasonable requirement
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Explain your reasons for and the conditions that necessitate the request and what other mechanism will be in place for the protection of the LARs.
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Describe the circumstances surrounding your procedures for LAR permission - remember that obtaining LAR permission is a continuous process.
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Describe the setting in which you will be obtaining LAR permission.
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Describe any special considerations you will make for vulnerable or non-English speaking LARs (e.g. witnesses translators), if applicable.
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Informed Assent
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Informed Assent for Child Subjects – Procedure Options
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Standard procedures for obtaining documented informed assent will be followed (subjects will sign an informed assent form).
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Approval for a waiver of documented informed assent is being requested (subjects will undergo informed assent procedures, but will not sign an informed assent form).
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Approval for an alteration of informed assent is being requested (elements of informed consent will be altered or left out of the informed assent procedures and/or form).
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Approval for a waiver of informed assent is being requested (subjects will not undergo informed assent procedures of any kind).
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Request for Waiver of Documented Informed Assent
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Note that one of the four following conditions must be met:
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The assent document would provide the only link to the subject and the principal risk of the research would be a breach of confidentiality.
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The risk to the subjects is minimal and assent would not be required outside the research context.
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The subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that informed assent was obtained.
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Other (e.g., the age of the children).
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- Explain your reasons for and the conditions that necessitate the request.
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Request for Alteration of Informed Assent
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Note that one of the two following conditions must be met:
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The capability of some or all of the subjects is such that they can not reasonably understand all elements of informed consent
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All five requirements for an alteration of informed consent are met:
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The research could not practicably be carried out without the alteration.
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The research involves no more than minimal risk to the subjects.
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The waiver will not adversely affect the rights and welfare of the subjects.
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All data will be de-identified, OR research could not practicably be carried out without using identifiable private information or biospecimens.
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The subjects will be provided with additional pertinent information/debriefed after participation (e.g., if deception or incomplete disclosure is being used), OR debriefing is not appropriate.
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- Explain your reasons for and the conditions that necessitate the request.
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Request for Waiver of Informed Assent
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Note that one of the three following conditions must be met:
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The capability of some or all of the subjects is so limited that they cannot reasonably be consulted.
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The research offers the subject the possibility of a direct benefit that is important to the health or well being of the subject and is available only in the context of the research.
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All five requirements for a waiver of informed consent are met:
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The research could not practicably be carried out without the waiver.
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The research involves no more than minimal risk to the subjects.
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The waiver will not adversely affect the rights and welfare of the subjects.
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All data will be de-identified, OR research could not practicably be carried out without using identifiable private information or biospecimens.
-
The subjects will be provided with additional pertinent information/debriefed after participation (e.g., if deception or incomplete disclosure is being used), OR debriefing is not appropriate.
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- Explain the reasons for and the conditions that necessitate the request.
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Describe the circumstances surrounding your procedures for the informed consent/assent of subjects/LARs - remember that obtaining informed consent is a continuous process.
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Describe the setting in which you will be obtaining informed consent.
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Describe any special considerations you will make for vulnerable or non-English speaking subjects (e.g. witnesses translators), if applicable.
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Study Description
- Describe your research plan, including the procedures, steps, and actions you will be performing, in chronological order. Include in more detail any procedures/steps/actions not previously discussed. Note that if helpful, you may use bullet points.
Procedures
- Provide an outline of all procedures, steps, and actions you will be performing in chronological order. Include in more detail any procedures/steps/actions not previously discussed. Note that if helpful, you may use bullet points.
Data Security
- Will you be coding the data (i.e., linking a code/pseudonyms to the subjects' names/personal information)?
- Will you have a master list to keep track of the linked codes/pseudonyms and names/personal information? Note that any master lists must be kept separate from the research data collected.
- Describe how you will keep the data secure during initial collection (e.g., use of an online survey, audiotaping directly to Box.com instead of a recording device, use of a private room or lab).
- Describe how you will keep the research data secure during transportation (i.e., while moving them from location to location) (e.g., in a locked briefcase, on an encrypted computer, on researcher's person at all times).
- Describe how you will keep the research data secure during storage (e.g., in a locked file cabinet, on Box.com).
- Describe how you will keep the research data secure during data analysis (e.g., on Box.com).
- Describe how and at what point the research data will be de-identified (e.g., when the master list is destroyed).
- If research data will not be de-identified, explain why.
- Note that data are not de-identified if linked in any way to the subjects - coded data are not de-identified data.
- Describe how you will protect confidentiality when the research data are presented/published (e.g., use of pseudonyms, use of data aggregation).
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Describe when and how the research data will be destroyed (e.g., scrubbing computer files).
- If the research data will be stored indefinitely, describe how you will continue to keep them secure (e.g., data repository).
- Note that data must be retained for a minimum of three years.
- Describe who will have access to the research data throughout their life (must always include PI).
- Discuss any additional data security plans you may have.
Additional Committee Approvals
- This research involves human blood, fluids, tissues, or cell lines; infectious agents; select agents; or rDNA.
- IBC protocol number
- IBC approval date
- This research involves animals.
- IACUC protocol number
- IACUC approval date
Bibliography/Citations
- List the works you cited in this application (particularly in your discussion of previous related research).
Additional Comments
- Additional comments
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