1.0 Research Project Title
1.0 Research Project Title
Study Title:2.0 Principal Investigator
Name & Degree: / Position/Title:Responsibility for Study Conduct:
Principal Investigator Assurance: As Principal Investigator, I affirm that:· I will supervise and accept responsibility for the conduct of this research.
· I accept responsibility for the safety of the human subjects taking part in this research.
· I certify that all information submitted as part of this application is accurate, complete and true to the best of my knowledge.
· I confirm that I will report any serious or unanticipated problems, adverse effects or protocol deviations.
· I will ensure every subject meets eligibility criteria.
· I acknowledge that no changes will be put into effect without prior approval from the IRB except when necessary to eliminate apparent immediate hazards to research participants.
· I will renew this application with the IRB as directed but no less than annually.
· I will conduct the research project in compliance with the IRB conditions of approval.
· I will provide all of the information about the research project necessary for complete review by the IRB.
· No research participants may be involved, recruited or enrolled or their private records reviewed until the research receives final approval from the IRB.
· All investigators and research team members as outlined in the IRB application and protocol have completed approved training in Human Subjects Protection.
Principal Investigator Attestation: In lieu of my signature, by virtue of submission of this application from my e-mail account, I attest to my intention to apply for IRB approval as well as to the accuracy and completeness of the statements contained herein. I further attest to the fact that I understand and accept the responsibilities conveyed to me as a Principal Investigator.
In addition, by virtue of submission of this application, I attest to the fact that I have informed and obtained approval from the appropriate institutional officials (i.e., Division Director, Department Chairperson, Children’s Executive Administrator, Faculty Sponsor for Students and Trainees) for this research.
PI Signature: ______Date______
(Optional signature if submitted from PI’s e-mail account.)
IRB Approval
IRB Chairperson Signature:
______Date______
Approve Disapprove
Subject to the Following Conditions: ______
______
______
Period of Approval: From: ______Through ______
VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED
Pediatric CRCN Scientific Review Committee Approval
Pediatric CRCN Scientific Review Committee Chairperson or Pediatric CRC Medical Director Signature:
______Date______
Approve Disapprove
IRB SUBMISSION CHECKLIST
Please be sure to fill out and keep as part of your submitted application.
Did you include (if applicable)?
Yes N/A Research protocol.
Yes N/A Copy of funding proposals listed in section 7.
Yes N/A Appendix (section 8.4) – complete citation list of all work cited.
Yes N/A Copies of recruitment materials (advertisements, approach letters).
Yes N/A Letters of cooperation from participating sites that includes FWA numbers for sites.
Yes N/A Copies of consent and assent forms.
Yes N/A HIPAA Authorization Form (if applicable).
Yes N/A Oath of Confidentiality (if applicable).
Yes N/A Oath of Confidentiality-Recruitment (if applicable).
Yes N/A Flow chart of study procedures, section 12.1.
Yes N/A Copies of the research data collection forms.
Yes N/A Copies of surveys, questionnaires.
Yes N/A Investigator’s brochure (for investigational drugs) or package inserts.*
*If you submit package inserts for review they must be in legible font size.
Yes N/A Manufacturer’s notebook (for investigational devices).
Yes N/A Are you utilizing the ITHS Pediatric CRC resources?
If yes, then please complete section 19.
Submit completed application and relevant documents/attachments to: .
3.0 Research Team Members/Investigators
List below all personnel sharing responsibility for the design, conduct, or reporting of the research by name as well as their title and role in the research. Each person so identified must then, first, indicate whether or not s/he has a “significant financial interest” in the project as defined by policy, and second, sign to certify: a) that s/he has read the Children’s policy on Significant Financial Interest (RIA-03); b) that the declaration made herein is correct; and c) that if s/he has declared a significant financial interest, the appropriate SFI disclosure form has been submitted to the Office of Research Compliance (Mailstop: C9S-10).
*Please note that if an investigator is external to Children’s and his/her work will be covered by subcontract, then that investigator does not need to sign below.
*Note: The first person listed below as a Research Team Member should be the Principal Investigator.
Yes No
Role in Research; Position/Title / School/Department/Division (e.g. School of Medicine/Pediatrics/Nephrology)
Principal Investigator;
Human Subjects Protection Training* / Phone & Pager / Email / Mailstop/Address
I HAVE a significant financial interest in this research, its products, or its sponsor. / I DO NOT have a significant financial interest in this research, its products, or its sponsor. / Signature (Required)
Name & Degree (Last, First, Degree) / eRA Commons Username / ITHS Member?
Yes No
Role in Research; Position/Title / School/Department/Division (e.g. School of Medicine/Pediatrics/Nephrology)
Human Subjects Protection Training* / Phone & Pager / Email / Mailstop/Address
I HAVE a significant financial interest in this research, its products, or its sponsor. / I DO NOT have a significant financial interest in this research, its products, or its sponsor. / Signature (Required)
*Human Subjects Protection Training: Provide the date, location, and type of training (e.g. web based training or in person workshop). Research team members/investigators should not be listed here unless they have already completed human subjects protection training. They should instead be added to the study after they have completed such training.
4.0 Contact Person
Name & Degree / Role in Research (e.g. Research Coordinator) / Department/Division / Phone / Mail Stop/
Address / Email
5.0 Human Subjects Protection Training
Human subjects protection training is required for all research team members/investigators. This training is distinct from HIPAA or Good Clinical Practice training. If any of the individuals listed in Sections 2 or 3 have not completed human subjects protections training, they should not be included on this application. Instead, they should be added to the study after they have completed such training.
6.0 Commercial Products/Patents
6.1 Is it possible that a commercial product or patent could derive from the research or use of research participants’ data or tissue?
No Yes
If Yes, explain the possible commercial applications of the research and any plans to compensate
research participants if the research results lead to commercial products.
7.0 Funding Sources For The Research Project
Provide information for all funding proposals (grants, contracts, etc.; awarded or pending) that support the research activities described in this IRB application. If there is more than one funding proposal, you may either copy the table and make a separate table for each funding proposal, or use one table and label the information for each grant listed by number (i.e., 1., 2., 3).
*Note: A copy of the entire final version of any grants or subcontracts listed below must be attached.
Name of Principal Investigator on Funding Proposal:Title of Funding Proposal:
Type of Funding Proposal:
[Grant, Contract, Cooperative Agreement, Subcontract, Fellowship, Training Grant, Other (describe)]
Status of Funding Proposal:
[New, Resubmission, Competing Continuation, Non-competing continuation (renewal)]
Status of Funding Award (funded, pending):
Name of Funding Agency (Sponsor):
Type of Funding Agency (Sponsor):
[Public; Private, non-profit; Corporate]
ID Number Assigned by Sponsor to Funding Proposal
Funding Period of Funding Proposal
Funds (monies) to be Administered by:
[Children’s; Univ. of WA; FHCRC; Other (describe)]
Are research activities described in the IRB application described in the funding proposal? If Yes, explain if entire grant applies or which specific sections or objectives of the funding proposal apply to this IRB application. If No, explain why the funding proposal is listed.
8.0 OUTLINE OF RESEARCH ACTIVITY
THIS ENTIRE SECTION (8.0) MAY NOT EXCEED 3 PAGES. ITEM 8.1 MAY NOT EXCEED ½ PAGE.
8.1 Provide a brief summary in lay language of the research project that includes the following information:
§ Purpose of the research
§ Hypothesis to be tested
§ General type of study design to be used
§ Type and number of participants to be enrolled
§ How long the research lasts for the participant.
8.2 Describe any scientific review of this research proposal (local or national) that has occurred to date.
8.3 What specific question(s) (aims) does this research project attempt to answer? List all of the study’s aims (also referred to as objectives or study questions). This can be taken directly from a study protocol if available. Each study aim should be distinct and clearly attainable from data that will be collected as part of the study. Formal research hypotheses associated with study aims may be included here, but it is not necessary to do so.
8.4 Describe the background and the significance of this research project. Cite key published findings and critically evaluate the existing knowledge base and identify the gaps that the current project is intended to fill.
8.5 Cite previous work (preliminary studies) in the area by you and your co-investigators. The purpose of this section is to establish the qualifications of the study Investigators.
PROVIDE COMPLETE CITATION LIST FOR ALL WORK CITED IN SECTIONS 8.4 AND 8.5. ATTACH AS AN APPENDIX TO APPLICATION.
9.0 RESEARCH DESIGN AND METHODS
THIS ENTIRE SECTION (9.0) MAY NOT EXCEED 4 PAGES. ITEM 9.1 MAY NOT EXCEED ½ PAGE.
9.1 State the primary hypothesis or objective. Specifically define the primary outcome variable. Identify which aim (section 8.3) is the main reason behind doing the study. If you have any formal research hypotheses associated with the primary aim, please state here. For most types of studies it is preferable to define one primary study aim or objective and one corresponding primary outcome variable.
9.2 List the secondary outcome variables and covariates that relate to the specific research questions described in 8.3 above. Include relevant demographic or clinical descriptors that will be collected. List the data items or variables that will be used to accomplish analyses relating to the secondary aims. Do not restate the aims in their entirety.
9.3 The following relate to study design. Please check all of the boxes that describe this study.
Single center Randomized Interventional
Multi center Controlled Observational
Phase I Pilot Study Therapeutic
Phase II Cohort Study Other (Please explain)
Phase III Longitudinal Study
Phase IV Coordinating Center
9.4 Provide a brief description of the study design, to include such items as (if applicable):
§ Treatment regimens
§ Frequency of study visits
§ Total duration of follow-up
§ Source of controls
§ Appropriateness of controls
§ Randomization ratio and process
§ Whether randomization strata or criteria (such as age, severity of disease, site) are to be used, and if so, the definitions for the levels within each stratum
9.5 Explain briefly how study results will be evaluated to answer the study questions. Describe the statistical methods you are using to assess each hypothesis.
9.6 Provide the rationale for the proposed sample sizes. Provide power/sample size calculations for your primary hypothesis, if appropriate.
10.0 RESEARCH PARTICIPANTS
10.1 Approximate number and ages:
Subject Group / How Many / Age RangeCurrent Year / Entire Study / Current
Year / Entire
Study
Children’s / All Other Sites / Children’s / All Other Sites
Healthy Participants
Patients
Other
(Specify, e.g., parents, other family members, school teachers)
10.2 Will you be enrolling participants from any of the following categories? If your research involves one of the first four categories, see federal regulations for research with these categories of research participants. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
Prisoners. (Juveniles in detention would be considered prisoners.)? Yes No
Wards of the State or Foster Children* (Living in state facility, foster care, or with other family members)? Yes No
Pregnant women and fetuses? Yes No
Neonates? Yes No
Children (under the age of 18)? Yes No
Persons with diminished decision making capacity who may not be competent to provide informed consent or assent (e.g., cognitively impaired, critically ill, mental disorders)? Yes No
*If you will be enrolling wards of the state or foster children please document what steps you will take to obtain proper consent. See federal regulations for research with these categories of research participants. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
10.3 Describe the inclusion criteria for EACH group of research participants.
10.4 Describe the exclusion criteria for EACH group of research participants.
10.5 Targeted/Planned Enrollment. Provide information on the composition of the proposed study population in terms of sex/gender and racial/ethnic group and provide a rationale for selection of such subjects in terms of the scientific objectives and proposed study design. The description may include (but is not limited to) information on the population characteristics of the disease or condition under study, national and local demography, knowledge of the racial/ethnic/cultural characteristics of the population, or prior experience and collaborations in recruitment and retention of the populations and subpopulations to be studied.
TARGETED/PLANNED ENROLLMENT: Number of SubjectsEthnic Categories / Sex/Gender
Females / Males / Total
Hispanic or Latino
Not Hispanic or Latino
Ethnic Category Total of All Subjects*
Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
Racial Categories: Total of All Subjects*
*The “Ethnic Categories Total of All Subjects” must be equal to the “Racial Categories Total of All Subjects.”
A. Does the population of research participants include equitable age, gender and minority representation?
Yes No If No, explain the rationale. Please speak to the IRB’s concern that research data include equitable gender and minority representation of individuals affected by the disorder or condition being
studied.
B. Do you anticipate you will be enrolling families with limited English proficiency (LEP)?
Yes No
If No, explain the rationale:
If Yes, explain the following: