Interventional Research
Date: / This box is for IRO only
Protocol #: / Version date (if applicable) / IR File # / Date Received:
Principal
Investigator: / Mailstop: / Phone:
Contact
Person: / Mailstop: / Phone:
Study
Title:
PI Primary Appointment: / Fred Hutch (select division)
University of Washington
Seattle Children’s
Other: / Basic HB VIDD CRD PHS Admin
INSTITUTIONAL APPROVAL(Required per Office of the Director’s Policy on Human Research Protection Program)
Fred Hutch PIs get approval from Division Director or designee; UW PIs get approval from Department Chair or designee.
Check one box to indicate which method of institutional approval this application has received.
Note: In addition to departmental approval, UW PIs must submit the signed Review Authorization Form.
Approval signature from Division Director, Department Chair, or designee is below.
Other approval documentation (e.g., email from Division Director or designee) is attached separately.
This research project has scientific merit. The Principal Investigator is qualified to oversee this project.
Printed Name / Signature / Date
Is this an NCTN Cooperative Group Study? No Yes
Would you likethisresearch to beconsidered as a minimal risk activity qualifying for Expedited Review?
No
Yes please submit an Expedited Review Checklist for Minimal Risk Activity(053) along with this application.
1.0RESEARCH DESIGN AND RESOURCES: The IRB requests the following information to confirm that risks to participants are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk.
1.1Is there a separate research protocol, synopsis, or other document detailing the study’s research procedures?
Yes please submit protocol
No please describe research plan in detail:
1.2What are the background, rationale and experimental aspects of this study? If this information is clearly described in the protocol, reference the specific page(s) where applicable:
1.3What are the objectives that will be met?If this information is clearly described in the protocol, reference the specific page(s) where applicable:
1.4What are the study’sInclusion Criteria?If this information is clearly described in the protocol, reference the specific page(s) where applicable:
1.5What are the study’s Exclusion Criteria?If this information is clearly described in the protocol, reference the specific page(s) where applicable:
1.6Who will determine eligibility?If this information is clearly described in the protocol, reference the specific page(s) where applicable:
1.7What are the appropriate alternatives to the study procedures or course of treatment?
Please check all that apply,and add all alternatives to the Informed Consent document.
Same treatment offered off-study
Standard care
Supportive care
No therapy
Not to participate in this research study
Other, please describe: 1.8How long will individual participants be in the study, and how long do you expect the entire study will take to complete?
1.9What are the estimated number and ages of the following?
- For a multi-center study, both local and total enrollment numbers must be provided.
- If this study does not involve multiple sites, complete only the local enrollment rows.
NUMBER OF PARTICIPANTS / AGE RANGE OF PARTICIPANTS
as specified per study
First Year / Entire Study / First Year / Entire Study
Locally
Study-wide
1.10What Fred Hutch or Cancer Consortium locations will be involved in the research? Note, non-Cancer Consortium sites, including SCCA Network sites, must complete separate Participating Site Applications. Please check all that apply:
Fred Hutchmain campus
Hutchinson Center Research Institutein Uganda (HCRI-Ug)
Hutchinson Center Research Institute in South Africa (HCRISA)
Seattle Cancer Care Alliance (SCCA) South Lake Union
SCCAat Evergreen Hospital
SCCA at Northwest Hospital
Seattle Children’s Hospital
University of Washington (UW)Medical Center
University of Washington Clinics
Harborview Medical Center
OtherFred Hutch or Cancer Consortium location, please list:
NAno research at Fred Hutch or Cancer Consortium locations
1.10.a.Will Fred Hutch IRB be the IRB of Record for all of the locations listed above?
Yes
No, please explain 1.10.b.Will you, or members of your research team personally be conducting research activities at locations other than those listed above and Fred Hutch will not be the IRB of Record (e.g., Swedish)?
No
Yes, please identify the locations 1.11Will there be sites outside the Fred Hutch and Cancer Consortium that will be engaged in this research?
No Continue to 1.12.
Yes Please complete 1.11.a and 1.11.b.
1.11.a.Will Fred Hutch IRB be the IRB of Record for any locations outside the Fred Hutch and Cancer Consortium?
No
Yes Note, each site outside the Fred Hutch and Cancer Consortium relying on Fred Hutch IRB will need to submit separate Participating Site Applications after the study is approved.
1.11.b.Will you be serving as the overall coordinating center for this research?
No
Yes Please complete and include the Multi-CenterSupplement(0323) with this application.
1.12Is it possible that this study may involve non-English speaking participants?
No
Yesplease describe how the study team will communicate with the participant during the course of the research (e.g., interpretation service, study staff who speak the native language, etc.).
1.13What steps willthe Principal Investigator of this study take to ensure that each staff member involved is adequately informed about the protocol and their research-related duties and functions (e.g., new staff orientation, weekly staff meetings)?
1.14Have all members of the research team receivedtraining on Human Subject Protections and/or Good Clinical Practice (GCP) as required per IRB Policy 2.20 Training(038)?
Yes
No, please explain Note: If any new members join the research team, the Principal Investigator is responsible for ensuring everyone receives and maintains required training.
1.15Will this study include the establishment of a local repository, registry, or data bank for the purpose of sharing research specimens or data collected for this study with other studies in the future?
No
Yes please complete the Repository, Registry or Data Bank Supplement(063) and submitwith this application.
1.16Will this study be funded or supported by grants, contracts, or other external support?
No please explain how the study will be conducted with no support:Yes please complete aFunding Source Supplement(049) and submit it along with a copy of the grant, contract, or other funding documentation with this application.
1.17Will this research activity be funded by Department of Defense (DoD) or one of its component agencies (e.g., Dept.of Army, DARPA, etc.)?
No
Yes please complete theDoD Supplement(0299) and submit with this application.
1.18Does this research activity use a “community based participatory research” approach?
No
Yes please describe how community members and organizational representatives will be involved in the research process:1.19Does this research activity use any sources of specimens or data beyond what is provided by the enrolled human research participant?
No Continue to Section 2.0.
Yes Provide the following information:
What are the study’s sources of specimens and/or data? Provide name, address, institution/company, and a brief description of what specimens and/or data will be provided from each source.
Name / Address / Institution/Company / DescriptionFor non-public/non-medical record sources, please submit a letter of support (e.g., a gatekeeper letter, material or data transfer agreement, contract, etc.) from the provider of the specimens or data acknowledging your use of the specimens or data for purposes of this project.
1.19.a.Are there any restrictions on the research uses for these specimens or data (e.g. they may not be transferred from Fred Hutch to another researcher, or no genetic testing is allowed on the samples)?
No
Yes please explain:
1.19.b.Will the study’s specimens include human fetal tissue?
No
Yes Provide information about where the tissue is obtained and attach an attestation from the provider or third party supplier, that informed consent was obtained at the time of tissue collection.
2.0RISK/BENEFIT ASSESSMENT: The IRB is responsible for determining that risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.
2.1What arethe anticipated risks associated with this study?
2.2What are the expected benefits of the research for the individual participants, society, or both?
Please explain how the benefits outweigh the risks.
2.3What procedures in this research are already being performed for diagnostic or treatment purposes?
2.4Is it possible that this studywill discover a previously unknown condition such as a disease, suicidal intentions, or genetic predisposition in a participant as a result of the procedures?
No
Yes please explain how you will manage this situation.
2.5Will this study involve the collection or analysis of biological specimens from participants for research purposes?
No go to Question 2.6
Yes please respond to 2.5.a. – 2.5.d.
2.5.a.Will the results be useful for predicting the occurrence or prognosis of a disease in the participant?
No
Yes please explain:
2.5.b.Will the results potentially be used for predicting disease risk/susceptibility in family members?
No
Yesplease explain:
2.5.c.Will the results reveal information about paternity?
No
Yes please explain:
2.5.d.Which research test results will be provided to research participants?
All respond to 2.5.d.i and 2.5.d.ii.
None please explain why this study will not provide test results to the research participants:
Someplease describe which results and explain why only some of the results will be provided to the research participants. Then respond to 2.5.d.i and 2.5.d.ii.
2.5.d.i.Willthe research tests returned to the participant be performed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab?
Yes
No please explain why not:2.5.d.ii.Also explain how research results will be provided to theparticipant or his or her healthcare provider. Describe any counseling that will be offered, if applicable.
2.6Will this study collect information about research participants’ family history that includes personal identifiers (i.e.,involvement of secondary subjects)?
No go to Question 2.7
Yes please respond to 2.6.a. – 2.6.d.
2.6.a.Please list all the personal identifiers that will be collected on family members.
2.6.b.How will this family history information be used?
2.6.c.Will family history information, such as disease status of family members, be shared among other family members?
No
Yes please respond to 2.6.c.i.
2.6.c.i.Does the consent form describe how family history information will be shared among other family members?
Yes
No please explain:
2.6.d.Will the study seek consent from the family members?
Yes please submit the consent form you will use for this purpose.
No please complete a Waiver of Consent Supplement(0202) and indicate you are seeking a waiver of consent for the secondary subjects only.
2.7What measures will the study take to assure that an individual or group cannot self-identify in publications/presentations?
3.0SELECTION AND RECRUITMENT OF PARTICIPANTS IS EQUITABLE: The IRB is responsible for determining that the research does not exploit vulnerable populations or exclude participants on the unjustifiable basis of race, gender, ethnicity or socioeconomic status.
3.1What is the group or population that this study will recruit from in order to reach your targeted accrual goals?
3.1.a.Will the study identify potential participants through public sources (e.g., telephone directories, public access databases, commercial name lists, etc.)?
No
Yes Please list the sources:
3.1.b.Will the study identify potential participants through nonpublic sources (e.g., Cancer Surveillance System, other research projects, patients’ medical records, surgery logs, etc.)?
No
Yes Please list the nonpublic sources:
Name and address of each nonpublic source If you answer Yes to 3.1.b. you must state in Question 4.1 that Yes, you are requesting a waiver for a portion of the research.
3.2How willthis study recruit participants?Check all that apply, andsubmitany written documents or scriptswiththis IRB application:
personal contact
contact or approach letters
telephone calls
home visits
brochures
radio or TV (include written text of the advertisement and brief layout of images)
print advertisements
flyers
Internet, including social media
Other, please describe 3.3Who will approach or recruit potential participants?
Principal Investigator
Study staff
Other, please describe 3.4When will participants be recruited? (e.g., after a doctor’s visit)
3.5Where will participants be recruited? (e.g., doctor’s office)
3.5.a.Will the PI on this application oversee any research activities (e.g., recruitment, consenting, etc.) to be conducted in countries other than the United States?
No
Yes Complete the International Research Performance Site Assessment Supplement(054) for each country.
3.6What steps will be taken to avoid coercion or undue influence in the recruitment of research participants?
3.7Will the research potentially involve any of the following vulnerable participants? This includes research procedures, enrollment, and accessing identifiable data (e.g., name, social security number, age) about any of these populations. Please check all that apply.
3.7.a.Pregnant women. Specify how pregnant women will be involved. Select all that apply.
3.7.a.i Pregnant women will be enrolled in the research study.
3.7.a.ii Pregnant women, either participants or pregnant partners, will be involved for the purposes of following the outcome of a pregnancy. (You must also answer yes to Question 4.14.)
3.7.b.Fetuses in utero
3.7.c.Nonviable neonates or neonates of uncertain viability
3.7.d.Females of childbearing potential
3.7.e.Prisoners (including juvenile detainees) → complete the PrisonerCertification Checklist for Investigator(060)
3.7.f.Children → complete aChildren Supplement(0320)
3.7.g.Decisionally impaired adults requiring a legally authorized representative (LAR) — complete Question 4.6 regarding LAR consent.
3.7.h.Limited or non-readers (e.g., illiterate, sight impaired, etc.)
3.7.i.Others (e.g., educationally or economically disadvantaged, etc.)
If you checked any of the boxes above, please describe the additional safeguards taken to protect the rights and welfare of the vulnerable population. If applicable, reference the page number(s) in the protocol that describe the additional safeguards.
3.8Will anyone on the study team be a research participant in this study?
No
Yes please provide details of the involvement:
3.9Ethnicity, Race and Gender of Anticipated Local Enrollment Table.
Table 3.9.a
ANTICIPATED/PLANNED LOCAL ENROLLMENT:Number of Participants (must provide exact numbers, not a range)
Ethnic Categories / Sex/Gender
Females / Males / Total
Hispanic or Latino
Not Hispanic or Latino
Ethnic Categories: Total of All Participants*
Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More Than One Race
Racial Categories: Total of All Participants *
*“Ethnic Categories: Total of All Participants” must be equal to the “Racial Categories:
Total of All Participants.”
3.9.b.Please provide the basis for the above ethnic and racial local enrollment targets.
3.9.c.If the anticipated Ethnic/Racial/Gender data is not available, pleaseexplain:
4.0CONSENTING AND COMPENSATING RESEARCH PARTICIPANTS: The IRB is responsible for determining that informed consent will be sought from each prospective subject or the subject’s legally authorized representative in accordance with, and to the extent required by regulations.
4.1Is this study requesting a waiver of consent for any part of the research (e.g., complete waiver of consent, waiver of consent to access medical records to screen for eligibility) or any group of participants (e.g., waiver of consent for the retrospective chart review comparator arm)?
No
Yes Waiver for a portion of the research, screening process, or for some participants: Submit a Waiverof Consent Supplement(0202) describing the aspect of consent to be waived and go to Question 4.2
Note: If you are accessing medical records prior to obtaining consent (e.g., screening for eligibility) you must also submit a corresponding HIPAA Supplement and Authorization form (and answer yes to question 8.2.d).
Yes Waiver for all aspects of the research: Submit a Waiver of Consent Supplement(0202) and go to Section 6.0
4.2Describe the consenting process in detail including when participants will be consented (e.g., during intake visit, consultation visit, etc.), in what setting will the consenting process be conducted (e.g., private waiting room, participant’s home, by telephone, etc.), and any waiting period between discussing the research with the prospective participant and obtaining consent. If conducting consent remotely, describe in detail how informed consent will be documented. Refer to IRB Policy 2.11 Informed Consent(017) for more information.
4.3Who will obtain consent from participants?
PI
Attending/Physicians
AdvancedPractice Providers (e.g., Physician assistant, Nurse practitioner)
Licensed Registered Nurse (RN)
Other, please list: 4.4If this is a clinical intervention trial, will someone other than a physician or other qualified, and licensed, health care provider obtain consent from the participants?Note: IRB Policy 2.11 Informed Consent(017) states that if medical judgment is needed in order to adequately explain the risks and benefits of the study, consent must be obtained by a physician or other qualified, and licensed, health care provider as appropriate.
N/A
No
Yes please explain:
4.5What methods will this study use to confirm participants understanding of the study? Check all that may apply:
Brochure or post consent questionnaire:please submit a copy with this application
Conference with participant
Conference with participant and family member(s)
Conference with an interpreter
Follow-up discussion
Q & A Session
Other, please describe: 4.6Will the study enroll individuals who are decisionally impaired? (Persons whose decision-making capacity is restricted, wholly or in part, due to illness, mental disability or other circumstances.) Note: If you answered “Yes” to decisionally impaired individuals in Question3.7.g. you must answer “Yes” to Question 4.6.
No
Yes please describe the process you will use and then respond to Question 4.6.a:
4.6.a.Will you obtain assent from the adult research participant who is decisionally impaired?
Yes
No please explain:
4.7Is any deception (withholding of complete information) required for the validity of this study?