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Study Application Questions and Guidance

Below is a listing of all the questions asked in the new study/grant application. The questions are sorted by screen and many will not be required for your specific study. The guidance links, presented to the right of the questions, will open the guidance window displaying IRB guidance and help on answering the specific question.

1. Project Identification Information
1.1. Type of Submission Guidance
1.2. Full Title of Research Protocol Guidance
1.3. Short Title Guidance
1.3.1. If there is a sponsor protocol number associated with this file, specify it here Guidance
1.4. Please indicate which IRBs you are requesting review from (check all that apply) Guidance
1.4.1. If there are any individual collaborators from other institutions, check here Guidance
2. Study Personnel
2.1. Principal Investigator (PI) Guidance
2.2. Study Coordinator or Contact Person Guidance
2.3. Co-Investigators Guidance
2.4. Other Study Personnel and their roles:  (who will be able to edit this online application and study materials for this Campus) Guidance
2.5. Is the Principal Investigator a student, resident, or visiting scholar? Guidance
2.6. If yes, please designate a Faculty Advisor Guidance
2.7. (HSC Only) Does this study require Cancer Center Committee (CIC) approval? Guidance
2.8. (HSC Only) Specify the group/organization who has reviewed this study for scientific merit Guidance
2d. Collaborators from other institutions
2d. Collaborators from other institutions Guidance
3. Required Organizational Approvals
3.1. Required department/division approvals needed for this study. This list is automatically generated from the home departments/divisions of the listed investigators. Guidance
3.2. Please select any additional department or division approvals that may be needed for this study. Do not specify organizations already listed above. Guidance
3.3. Are there other campus committees that will need to review and approve this protocol? Guidance
4. Study Location(s)
4.1. Indicate the locations where this study will be conducted by the USC/CHLA investigator(s) Guidance
4.2. Is this a multi-site study? Guidance
5a. HSC Location(s)
5a.1. HSC Locations Guidance
5a.2. If Other Location, please specify Guidance
5a.3. If you are conducting this research at a location marked with an asterisk "*", please attach a letter of approval from the medical director Guidance
5a.4. Will the research be conducted through the GCRC? Guidance
5b. UPC Location(s)
5b.1. UPC Locations Guidance
5b.2. If campus location, please specify Guidance
5b.3. If off-campus location, please specify Guidance
5c. Other Sites/Institutions
5c.1. Other Sites/Institutions (In the United States): List all of the non-USC/CHLA sites at which the Principal Investigator will conduct the study Guidance
5c.2. Other Sites/Institutions (Outside the United States): List the institution(s) and country(ies) at which the Principal Investigator will conduct the study Guidance
6. Information For Multi-Site Study
6.1. Is the coordinating center at HSC, UPC, or CHLA? Guidance
6.2. If no, what is the location of the coordinating site? Guidance
7. Funding Information
7.1. Are you or the institution receiving any financial support for the conduct of this study? Guidance
7a. Funding Information - Details
7.2. Please specify any funding source that will not be independently submitted to the IRB. If you have previously submitted or are planning to submit the funding source to the IRB, use question 7.3 instead. Guidance
7.3. Please select sources of funding that have already been independently submitted to the IRB. Guidance
7.3.1. If the grants selected in question 7.3 fund multiple studies, please attach the specific pages of the grant that are relevant to THIS study. Guidance
8. Type of Study Review
8.1. Please indicate the type of review that you are requesting for this study Guidance
8.2. Attach the Protocol(s) or Proposal(s) below if applicablem Guidance
8a. Type of Study Review - Expedited Review
8a. If you checked expedited review, please choose the applicable category from the list and attach your data collection forms below Guidance
8a.1. If you checked expedited review, please attach a copy of the forms you will be using to collect data, if applicable Guidance
8b. Type of Study Review - Application for Exempt Status
8b. If you checked that your study meets the qualifications for exempt status, please choose the applicable category from the list and attach your data collection forms below Guidance
8b.1. If you checked that your study meets the qualifications for exempt status, please attach a copy of the forms you will be using to collect data, if applicable. In addition, include any applicable data use agreements Guidance
8c. Type of Study Review - Application for Nonhuman Subjects Status
8c.1. Check here if the private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals Guidance
8c.2. Check here if the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain Guidance
8c.2.1. Indicate the reason the investigators cannot readily ascertain the identity of the individuals Guidance
8c.2.2. If you selected other, please specify Guidance
8c.3. This research will NOT be submitted to the FDA Guidance
9. Methods and Procedures - Selected Descriptors
9.1. Social-Behavioral Procedures Guidance
9.2. Medical Procedures/Considerations Guidance
9.3. Data Collection Types Guidance
9.4. Does this study involve the use of existing/retrospective data/specimens? Guidance
10. Characteristics of the Study Subject Population
10.1. What is the maximum number of subjects you plan to recruit for this site? Guidance
10.1.1. If this is a multi-site study, indicate the projected total subject accrual? Guidance
10.2. Indicate the inclusion criteria for enrollment Guidance
10.3. Indicate the exclusion criteria for enrollment Guidance
10.3.1. If there are any age, ethnic, language, or gender-based exclusion criteria, please provide justification Guidance
11. Study Summary
11.1. Abstract: Provide a brief (1 to 2 paragraph) description of the study in lay language. This should not be a scientific abstract Guidance
11.2.1. Describe the specific objectives or aims of the study and hypotheses or research questions Guidance
11.2.2. Provide a summary of the background of the study, and explain how this research will contribute to existing knowledge. Describe previous work that provides a basis to show that the proposed research can be carried out without undue risk to human subjects. Include relevant citations Guidance
12. Methods and Procedures - Prospective Studies
12.1. Describe in detail the design and methodology of the study. If applicable, include information on stratification or randomization plans. Identify and distinguish between those procedures that are standard of care and those that are experimental. Include the frequency and duration of each activity and the total length of subject participation Guidance
12.2. Provide a detailed description of the planned data collection, specific outcomes, and criteria for evaluation and endpoint definition Guidance
12.3. Describe the statistical considerations for the study, how the sample size was determined, and how the results will be analyzed, if applicable Guidance
13. Biohazardous Containment
13.1. Describe the measures that will be taken for safe disposal of biohazardous waste Guidance
14. Methods and Procedures - Retrospective Studies/Existing Data
14.1. Specify the dates of and number of records/specimens that will be used. Describe the method of collection for the records/specimens Guidance
14.2. Does the retrospective/existing data involve records/specimens from deceased individuals? Guidance
14.3. (UPC Only) Attach the approval/permission letter to access existing data, if applicable. Do not include data use agreements here Guidance
15. Methods and Procedures - Banking of Specimens/Data
15.1. Specify the organization/site at which the data/specimens will be banked Guidance
15.1.1. Attach a copy of the IRB approval for the bank below, if applicable Guidance
15.2. If the specimens/data will be banked at USC or CHLA, please provide the IRB# for the banking/repository protocol in the space below Guidance
15.2.1. If IRB approval has not yet been sought, please attach the Standard Operating Procedures and forms that will be used for the bank Guidance
16. Methods and Procedures - Deception
16.1. Describe the information that will be withheld from, or misinformation that will be provided to subjects, and the justification Guidance
16.2. Describe the plans for de-briefing subjects after their participation Guidance
16.3. Attach the debriefing statement that will be given or read to subjects Guidance
17. Methods and Procedures - Drug Information
17.1. Fill in an entry for all drugs that will be administered in this study. Guidance
17.2. Indicate where the drugs will be stored Guidance
17.3. Attach a copy of the Investigators Drug Brochure for each IND and other study medications as applicable Guidance
18. Methods and Procedures - Device Information
18.1. Fill in an entry for all devices that will be used in this study Guidance
18.2. Attach a copy of any Investigators Device Brochures for the devices listed above Guidance
19. Methods and Procedures - Interview/Focus Groups
19.1. Attach copies of any scripts and/or questions that will be used to guide the interviews/groups Guidance
19.2. Indicate the member(s) of the study team who will conduct the interviews/focus groups and any necessary qualifications such as special training Guidance
20. Methods and Procedures - Psychophysiological Testing
20.1. List all of the measures/instruments that will be used for this study and attach copies below Guidance
20.1.1. Attach copies of all measures/instruments that will be used for this study here Guidance
20.2. Indicate the member(s) of the study team who will use these measures/instruments and any necessary qualifications such as special training or licenses Guidance
21. Methods and Procedures - Surveys/Questionnaires/Psychometric Testing
21.1. List all of the measures/instruments that will be used for this study and attach copies below Guidance
21.1.1. Attach copies of all measures/instruments that will be used for this study here Guidance
21.2. Indicate the member(s) of the study team who will use these measures/instruments and any necessary qualifications such as special training or licenses Guidance
22. Special Subject Populations
22.1. Special Subject Populations (Check all that apply) Guidance
22a. Special Subject Populations - Normal Volunteers
22a. If this research involves a medical procedure(s), provide a justification for involving normal volunteers in research Guidance
22b. Special Subject Populations - Employees/Students
22b. If you selected Employees or Students, please indicate how you will minimize the potential for them to feel coerced to participate. Discuss how the potential confusion in roles will be addressed Guidance
22c. Special Subject Populations - Adults Not Competent To Consent
22c. Provide a justification for including adults not competent to consent in research Guidance
22d. Special Subject Populations - Minors
22d.1. Provide a justification for involving minors in this research Guidance
22d.2. Choose the proposed category of permissible research with children Guidance
22e. Special Subject Populations - Pregnant Women, Human Fetuses, or Neonates
22e.1. If applicable, indicate how the measures that will be taken to ensure that the fetus is placed at risk only to the extent necessary to meet the woman's, neonates, and/or fetuses health care needs. Or, indicate that the risk is minimal and how the knowledge to be obtained through research cannot be obtained through other means Guidance
22e.2. Will the researchers have any part in a decision about termination of the pregnancy and the viability of the fetus/neonate? Guidance
22e.3. If the research involves termination of a pregnancy, please discuss if and how the research team would be involved Guidance
22f. Special Subject Populations - Prisoners/Detainees
22f. If you selected Prisoners/Detainees, choose the applicable category of permissible research with prisoners Guidance
22g. Special Subject Populations - Wards
22g. Describe how you will make accommodations for wards as per regulations Guidance
23. Subject Identification
23.1. Describe the method(s) by which subjects will be identified, eligibility will be determined, and by whom Guidance
23R. Study Purpose/Subject Identification (For retrospective chart reviews)
23R.1. Briefely describe the purpose of the retrospective study Guidance
23R.2. Describe the method(s) by which subject records will be identified Guidance
24. Subject Recruitment
24.1. Recruitment Tools (Check all that apply) Guidance
24.1.1. If Other Recruitment Tool, please specify Guidance
24.2. Attach copies of all recruitment tools indicated above Guidance
24.3. Describe in detail all recruitment strategies for each subject group involved in this study. Explain who will approach the subjects, how and when the subjects will be approached, and what will be said Guidance
24.4. What measures will be taken during the recruitment process to safeguard against potential coercion or the appearance of coercion? Guidance
24.5. (HSC Only) Describe any competing protocols of which you are aware and how issues of subject selection and recruitment will be addressed Guidance
25. Financial Obligation and Compensation
25.1. Financial Obligation: Describe any financial obligations that the subject may incur as a result of participating in the study. Indicate which costs will be covered by the study Guidance
25.2. Payment for Participation: Describe how much, if any, financial or other form of compensation will be provided to the subject/family. Describe the requisite conditions that must be fulfilled to receive full or partial compensation. If children are involved, please specify how the compensation will be distributed Guidance
25.3. Emergency Care and Compensation for Injury: If applicable, describe how the financial liability for research related injuries would be handled Guidance
26. Data Privacy and Confidentiality
26.1. How will the data for this study be collected and recorded? Guidance
26.2. How will the data be recorded to protect personal privacy? Guidance
26.2.1. If Other is selected, please specify Guidance
26.3. Where will the research data be stored? Please specify the physical location and how it will be secured to protect confidentiality Guidance
26.4. Who, other than the specified study team, will have access to the study records or data? Specify their name, role and affiliation. Guidance
26.5. If coded or identified data will be released, specify the persons, agencies to whom the information will be released. Please also indicate the provisions that will be taken to assure that the transmission of the data will maintain confidentiality Guidance
26.6. Describe what will happen to the data or data set, when the study is completed. Please indicate your plans for destruction of identifiers at the earliest opportunity consistent with the conduct of the research and/or clinical needs, if applicable Guidance
26.7. Will a Certificate of Confidentiality be obtained for this study? Guidance
26.7.1. If yes, please attach the Certificate of Confidentiality Guidance
26.8. If audio/video recordings or photographs will be used, specify your plans for deidentifying or anonymizing the material and when it will be destroyed Guidance
27. Risk/Benefit Assessment - Risks
27.1. Risk classification for this study (select one). Guidance
27.2. Risks, Discomforts and Potential Harms: Describe the risks associated with each intervention.  Include consideration of physical, psychological, social, and other factors.  If data is available, estimate the probability that a given harm may occur and the potential reversibility. Guidance
27.3. Describe the safety precautions that will be taken to minimize risks/harms. Guidance
27.4. Data Safety Monitoring Plan: Describe how the studies are monitored for the safety of the participants and for the validity and integrity of the data.  (If a DSMB is involved with this study, please describe the composition, plans for monitoring and distributing information to the local IRBs.) Guidance
27.4.1. (CHLA Only) Attach the CHLA DSMP form, if applicable. Guidance
28. Risk/Benefit Analysis - Potential Benefits and Alternatives
28.1. Describe any potential for direct benefits to participants in the study. Guidance
28.2. Describe any potential benefits to society. Guidance
28.3. Alternatives to Participation: If applicable, describe alternatives (research or non-research) that are available to subjects if they choose not to participate in this study.  This could include not participating in the study. Guidance
28.4. Risk/Benefit Analysis: Describe the risk to benefit relationship of participation in the research (relative to non-participation and/or alternatives). Guidance
29. Informed Consent and Waivers
29.1. Indicate the types of consent that will be involved in this study (check all that apply) Guidance
29.1.1. Attach copies of all of the informed consent/assent, information sheet, and verbal script documents that will be used for this study Guidance
29.2. Waivers: If you are applying for any waivers of consent (check all that apply) Guidance
30. Description of Informed Consent Process
30.1. Personnel Obtaining Consent: indicate the names and qualifications of study personnel who will be involved in the informed consent process Guidance
30.2. Describe the consent process. Discuss when and where the consent process will take place relative to the initiation of the study procedures, as well as, how opportunities will be made for possible subjects/families to discuss their participation with others before signing the consent form Guidance
30.3. Describe the steps that will be taken to assure that subjects (including children) fully understand the nature of their involvement in research Guidance
30.4. Will you be recruiting non-English speaking subjects? Guidance
30.5. Describe how capacity for consent will be determined if some or all of the subjects have cognitive and/or language/hearing impairments Guidance
30.5.1. If applicable, attach any instruments that will be used to determine the subject's capacity to consent Guidance
30.6. Describe the procedures for identifying a legally authorized representative/guardian for those unable to consent (adults) or for minors not accompanied by their parents, as applicable Guidance
31. Waiver of Consent
31.1. Explain why the research involves no more than minimal risk to the subjects Guidance
31.2. Explain why the waiver or alteration will not adversely affect the rights and welfare of the subjects Guidance
31.3. Explain why the research could not practicably be carried out without the waiver or alteration Guidance
31.4. Explain how whenever appropriate, the subjects will be provided with additional pertinent information after participation. (e.g., an information sheet) Guidance
32. Waiver of Assent
32.1. 45 CFR 46.408 Guidance
32.1.1. Describe why the capability of some or all of the children is so limited that they cannot reasonably be consulted Guidance
32.1.1. Describe why the procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of research Guidance
32.2. 45 CFR 46.116 (d) Guidance
32.2.1. Explain why the research involves no more than minimal risk to the subjects Guidance
32.2.2. Explain why the waiver or alteration will not adversely affect the rights and welfare of the subjects Guidance
32.2.3. Explain why the research could not practicably be carried out without the waiver or alteration Guidance
32.2.4. Explain how whenever appropriate, the subjects will be provided with additional pertinent information after participation. (e.g., an information sheet) Guidance
33. Waiver of Parental Permission
33.1. 45 CFR 46.408 (c) Guidance
33.1.1. Explain why parental or guardian permission is not a reasonable requirement to protect the subjects in this study (for example, neglected or abused children) Guidance
33.1.2. Provide a description of appropriate mechanisms that will be taken to protect the children who will participate as subjects in the research Guidance
33.2. 45 CFR 46.116 (d) Guidance
33.2.1. Explain why the research involves no more than minimal risk to the subjects Guidance
33.2.2. Explain why the waiver or alteration will not adversely affect the rights and welfare of the subjects Guidance
33.2.3. Explain why the research could not practicably be carried out without the waiver or alteration Guidance
33.2.4. Explain how whenever appropriate, the subjects will be provided with additional pertinent information after participation. (e.g., an information sheet) Guidance
34. Waiver of Written or Signed Consent
34.1. 45 CFR 46.117 (c) Guidance
34.1.1. Explain how the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the reseach, and the subject's wishes will govern. NOTE: THIS STILL REQUIRES SUBMISSION OF CONSENT FORMS AND DOCUMENTATION OF THE SUBJECTS WISHES Guidance
34.1.2. Describe how the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context Guidance
34.2. 45 CFR 46.116 (c) Guidance
34.2.1. Describe how the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs Guidance
34.2.2. Explain why the research could not practicably be carried out without the waiver or alteration Guidance
34.3. 45 CFR 46.116 (d) Guidance
34.3.1. Explain why the research involves no more than minimal risk to the subjects Guidance
34.3.2. Explain why the waiver or alteration will not adversely affect the rights and welfare of the subjects Guidance
34.3.3. Explain why the research could not practicably be carried out without the waiver or alteration Guidance
34.3.4. Explain how whenever appropriate, the subjects will be provided with additional pertinent information after participation. (e.g., an information sheet) Guidance
35. Is HIPAA Applicable?
35.1. Do you intend to use/disclose protected health information (PHI) in your research? Guidance
35.2. If Yes, will you use data with any of the 18 HIPAA identifiers, listed below, in your research? Guidance
36. HIPAA Analysis
36.1. The following identifiers are considered to be personal information. Please check off whether any of the following will be obtained or recorded (check all that apply) Guidance
36.1.1. If "Any other unique identifying number, characteristic or code" is selected above, please specify Guidance
36.1.2. If "A link to an identifier will be used (code)" is selected above, please describe the coding mechanism that will be used Guidance
36.2. If you only checked items in question 36.1. marked with an asterisk ( * ) and you will not be obtaining authorization from the subject, your research may be considered to use a "limited data set". As such, you are not required to apply for a waiver of HIPAA authorization and may, instead, sign a Data Use Agreement. Either attach a copy of the signed Data Use Agreement below or complete the section for a Full Waiver of HIPAA Authorization Guidance
36.3. Indicate the sources of the specimens/data (Check all that apply) Guidance
36.3.1. If you selected "Data/Specimen Repository", "Data", "Specimens", or "Other types of recors", please identify and/or describe the sourcem Guidance
36.4. Indicate the categories of data that will be obtained for this study (Check all that apply) Guidance
36.4.1. If Other data category, please specify Guidance
36.5. If it is necessary to access clinical records (PHI) for the purposes of screening, recruiting, or idenitifying subjects, please indicate whether these activities fall under the rules for Activities Prepartatory to Research or you will be applying for a Partial Waiver of HIPAA Authorization for the purposes of screening and recruiting Guidance
36.6. For study research, please indicate whether you will be obtaining authorization from the subject or requesting a Full Waiver of HIPAA Authorization Guidance
36.6.1. If you are obtaining authorization from the subject, attach the HIPAA authorization forms here (USC Only) Guidance
38. Waiver of HIPAA Authorization
38.1. Explain how the use of and disclosure of the information presents no more than minimal risk to the privacy of the individual Guidance
38.2. Describe the plan to protect PHI identifiers from improper use and disclosure Guidance
38.3. Describe the plan to destroy identifiers at the earliest opportunity consistent with conduct of the research. If there is a health or research justification for retaining the identifiers, or if such retention is required by law, please provide this as well Guidance
38.4. By checking the "I Agree" box you are providing assurance that the PHI will not be reused or disclosed to any other person or entity except (a) as required by law, (b) for authorized oversight of the research study, or (c) for other research for which the use or disclosure of the PHI is permitted by the Privacy Rule Guidance
38.5. Explain why the research could not be practicably conducted without the requested waiver or alteration. Note, this is the same as question 3 on screen 31 (Waiver of Consent) and your answer will be copied from there Guidance
38.6. Explain why the research could not be practicably conducted without access to and use of the PHI Guidance
39. Conflict of Interest Information
39.1. Do any of the participating study investigators or other research personnel (or their immediate family/significant other) have a financial and/or intellectual property interest in the sponsor or products used with this project Guidance
39.2. If yes, attach a completed Financial and Intellectual Interest Disclosure Form for each person who has a potential conflict to be managed Guidance
40. Additional Supporting Documents
40. Attach any other documents that have not been specifically specified in previous questions, but are needed for IRB Review Guidance
41. Non-English Speaking Subjects
41.1. Describe the process of how you will explain the study and assure that the non-English speaking subjects understand the study and their participation in research. For example, the use of translators, translated informed consent documents, short forms, and any other methods that would be taken Guidance
41.2. If the study will likely include subjects and families for whom Spanish is the primary language, the consent documents must be translated into Spanish. Please indicate the method of translation Guidance
41.3. If the research will primarily include subjects who speak a language other than English or Spanish, the informed consent documents should be translated into that language. Please indicate the languages and method of translation Guidance
41.4. (CHLA Only) If the consent translation fee is in the contract for this study, please record the cost center to be charged. If there is no cost center, indicate "Not Applicable" Guidance
99. Instructions for Study Submission
G1. Grant Funding Information
G1.1. Name of Sponsor Guidance
G1.2. Institution awarded the grant-award Guidance
G1.3. Grant-award number provided by the Sponsor Guidance
G1.4. Type of Funding Guidance
G1.4.1. If Other type of funding is selected, please specify Guidance
G1.5. Attach a copy of the grant/proposal/contract here Guidance
G1.6. Please select the research protocol(s) associeated with this grant Guidance
G2. Grant Personnel
G2.1. Principal Investigator (PI) Guidance
G2.2. Study Coordinator or Contact Person Guidance
G2.3. Guests: Other registered users who will have read-only access to this grant submission. Please include all investigators, other than the principal investigrator listed above, who will use this grant as a funding source Guidance
G3. Instructions for Grant Submission
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