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.
Required department/division approvals needed for this study. This list is automatically generated from the home departments/divisions of the listed investigators.
Other Sites/Institutions (Outside the United States): List the institution(s) and country(ies) at which the Principal Investigator will conduct the study
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.
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
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
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
Check here if the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain
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
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
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
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
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
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
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
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
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
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.
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.)
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.
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
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
Explain how whenever appropriate, the subjects will be provided with additional pertinent information after participation. (e.g., an information sheet)
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
Explain how whenever appropriate, the subjects will be provided with additional pertinent information after participation. (e.g., an information sheet)
Explain why parental or guardian permission is not a reasonable requirement to protect the subjects in this study (for example, neglected or abused children)
Explain how whenever appropriate, the subjects will be provided with additional pertinent information after participation. (e.g., an information sheet)
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
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
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
Explain how whenever appropriate, the subjects will be provided with additional pertinent information after participation. (e.g., an information sheet)
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)
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
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
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
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
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
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
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
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
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
(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"
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
