IRB Form Application for Review Observational Research



|[pic] |[pic] |Application for Review |

| | |Observational Research |

|Date: |      |IR File # |      |This box is for IRO only |

| | |(if known): | | |

|RG # |      |Sponsor’s |      |Date Received: |

|(required): | |Protocol #: | | |

| | |(if applicable) | | |

|Principal |      |Email: |      |Phone: |      |

|Investigator: | | | | | |

|Contact |      |Email: |      |Phone: |      |

|Person: | | | | | |

|Study Title: |      |

|PI Primary | Fred Hutch (select division) ( Basic HB VIDD CRD PHS Admin |

|Appointment: |University of Washington* |

|(Institution that |Seattle Children’s |

|pays the PI’s |Other:       |

|salary) | |

|Have you consulted with anyone in the IRO about this research? Who and when?       |

Use this application for non-interventional research (e.g., no intent to change the participant) that involves any interactions with participants.

Would you like this research to be considered for either of the following?

Minimal risk activity qualifying for Expedited Review ( Please submit an Expedited Review Checklist for Minimal Risk Activity (053) along with this application. [pic]

Research Exempt from requirements for IRB review under the special conditions of Exemption category 1, 2, 3, 5, or 6 ( Please submit an Exempt Checklist (048) along with this application. Only Complete Sections 1, 7, 8, and 9 of this application. [pic]

Note: For research under Exempt category 4, stop and use the Application for Review Human Specimens or Data Research (0326) application instead.

*Note: UW investigators should submit all minimal risk or Exempt research to UW’s Human Subjects Division, unless single IRB requirements apply or as otherwise agreed to with the Fred Hutch IRO.

RESEARCH 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.

1.1 Attach your research protocol document to the submission. (A copy of a grant does not suffice.) [pic]

Note: The protocol should address the following elements: Study summary, background/significance, objectives, endpoints, study procedures, study timelines, subject population and inclusion/exclusion criteria, statistics and rationale for number of subjects, risks and benefits, recruitment methods, the proposed consent process, data management and confidentiality, use of data and specimens, and provisions to monitor data and protect privacy.

Clinical Research Support has protocol templates for transplant and solid tumor research available on the Clinical Research Resources Website (CRRW).

1.2 What are the background and rationale of this study? If this information is clearly described in the protocol, reference the specific page(s) where applicable:

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1.3 What are the objectives that will be met? If this information is clearly described in the protocol, reference the specific page(s) where applicable:

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1.4 What are the study’s Inclusion Criteria? If this information is clearly described in the protocol, reference the specific page(s) where applicable:

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1.5 What are the study’s Exclusion Criteria? If this information is clearly described in the protocol, reference the specific page(s) where applicable:

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1.6 Who will determine eligibility? If this information is clearly described in the protocol, reference the specific page(s) where applicable:

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1.7 How long will individual participants be in the study, and how long do you expect the entire study will take to complete?

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1.8 What 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, leave the “Study-Wide” row blank.

| |NUMBER OF PARTICIPANTS |AGE RANGE OF PARTICIPANTS |

| | |as specified per study |

| |First Year |Entire Study |First Year |Entire Study |

|Locally |      |      |      |      |

|Study-wide |      |      |      |      |

1.9 What Fred Hutch or Cancer Consortium locations will be engaged in the research? Please check all that apply.

Note: Non-Cancer Consortium sites, including FHCC Network Members, must complete separate Participating Site Applications.

Fred Hutchinson Cancer Center - FWA00001920

FHCC South Lake Union - Clinic

FHCC South Lake Union - Other

FHCC Covid Clinical Research Center

FHCC at EvergreenHealth Medical Center

FHCC Issaquah

FHCC at Northwest Hospital

FHCC Overlake

FHCC Peninsula

FHCC Proton Therapy Center

FHCC Seattle Vaccine Trials Unit (VTU)

Fred Hutch Center for Community Health Promotion (Sunnyside, WA)

Hutchinson Centre Research Institute Uganda (HCRI-Ug)

Hutchinson Centre Research Institute South Africa (HCRISA)

Seattle Children’s Hospital - FWA00002443

University of Washington (UW) - FWA00006878

UW Medical Center – Montlake

UW Medical Center – Northwest (formerly Northwest Hospital)

UW Clinics

UW Medicine: Harborview Medical Center

Other Fred Hutch or Cancer Consortium location, please list: (      

N/A ( No research at Fred Hutch or Cancer Consortium locations

1.9.a. Will Fred Hutch IRB be the IRB of Record for all the locations listed above?

Yes

No, please explain:

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1.9.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)?

Yes, please identify the locations:

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No

1.10 Will there be sites outside Fred Hutch and the Cancer Consortium that will be engaged in this research?

Yes ( Please complete 1.10.a. – 1.10.c.

No ( Go to 1.11.

1.10.a. Will Fred Hutch IRB be the IRB of Record for any locations outside the Fred Hutch and Cancer Consortium?

Yes ( Please complete and include the Multi-Center Supplement (0323) with this application. [pic]

Note: Each site outside Fred Hutch and the Cancer Consortium relying on Fred Hutch IRB will need to submit a separate Participating Site Application (0395) after this main application is approved.

No

1.10.b Will you be serving as the overall coordinating center for this research?

Yes ( Please complete and include the Multi-Center Supplement (0323) with this application. [pic]

No

1.10.c. Will the PI on this application oversee any research activities to be conducted in countries other than the United States?

Yes ( Complete the International Research Performance Site Assessment Supplement (054) for each country. [pic]

No

1.11 Is it possible that this study may involve non-English speaking participants?

Yes ( Please 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.).

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No

1.12 What steps will the 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?

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1.13 Have all members of the research team received training on Human Subject Protections and/or Good Clinical Practice (GCP) as required per IRB Policy 2.20 Training (038)?

Note: If any new members join the research team, the Principal Investigator is responsible for ensuring everyone receives and maintains required training.

Yes

No, please explain:

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1.14 Establishment of a local repository, registry or data bank: Will information and/or biospecimens collected for this study be used, stored, or shared for Secondary Research purposes?

Yes ( Please complete the Repository, Registry or Data Bank Supplement (063) and submit with this application. [pic]

No

1.15 Will this study be funded or supported by grants, contracts, or other support, including internal funding?

Yes ( Please complete a Funding Source Supplement (049) and submit it. For external funding, include a copy of the grant, contract (draft or fully executed), or other funding documentation with this application. [pic]

No ( Please explain how the study will be conducted with no support:

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1.16 Will this research activity be funded by Department of Defense (DoD) or one of its component agencies (e.g., Dept of Army, DARPA, etc.)?

Yes ( Complete the Department of Defense (DoD) Supplement (0299) and submit with this application. [pic]

No

1.17 Does this research activity use any sources of information and/or biospecimens beyond what is provided to you directly by the enrolled human research participant?

Yes ( Provide the following information and complete 1.17.a – 1.17.b.

What are the study’s other sources of information and/or biospecimens? Provide name, address, institution/company, and a brief description of what information and/or biospecimens will be provided from each source.

|Name |Address |Institution/Company |Description |

|      |      |      |      |

|      |      |      |      |

|      |      |      |      |

For each source listed above (except public or medical record sources), you must submit a letter of support (e.g., a gatekeeper letter, material or data transfer agreement, contract, etc.) from the provider of the information and/or biospecimens. The documentation should acknowledge your use of the information and/or biospecimens for this specific project and should confirm consent was appropriately obtained or waived for future use. [pic]

Note: Receiving biospecimens or information from outside your home institution may require a material transfer or data use agreement (MTA/DUA). Fred Hutch researchers, review or contact Business Development at MTA@ for more information. UW researchers, contact the Agreements Group at mta-group@uw.edu.

No ( Continue to Question 1.18.

1.17.a. Are there any restrictions on the research uses for the information and/or biospecimens (e.g. they may not be transferred from Fred Hutch to another researcher, or no genetic testing is allowed on the samples)?

Yes ( Please explain:

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No

1.17.b. Will the study’s biospecimens include human fetal tissue?

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. [pic]

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No

1.18 Does this research activity use a “community-based participatory research” approach?

Yes ( Please respond to the following questions:

Please describe how community members and organizational representatives will be involved in the research process:

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Please describe any process to communicate the progress, interim results, or final results back to the community during the research:

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No

1.19 If you would like this research to be considered for an “Exempt” determination, complete an Exempt Checklist (048) and submit it for review with this application.

(Only complete Sections 7, 8, and 9 of this application. You do not need to complete Sections 2 - 6.

RISK/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.

2.1 What are the anticipated risks associated with this study?

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2.2 What are the expected benefits of the research for the individual participants, society, or both?

Please explain how the benefits outweigh the risks.

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2.3 Is it possible that this study will discover a previously unknown condition such as a disease, suicidal intentions, or genetic predisposition in a participant as a result of the procedures?

Yes ( Please explain how you will manage this situation.

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No

2.4 Will this study involve the collection or analysis of biospecimens from participants for research purposes?

Yes ( Please respond to 2.4.a. – 2.4.e.

No ( Go to Question 2.5.

2.4.a. Will the results be useful for predicting the occurrence or prognosis of a disease in the participant?

Yes ( Please explain:

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No

2.4.b. Will the results potentially be used for predicting disease risk/susceptibility in family members?

Yes ( Please explain:

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No

2.4.c. Will the results reveal information about paternity?

Yes ( Please explain:

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No

2.4.d. Which research test results will be provided to research participants?

All ( Respond to 2.4.d.i and 2.4.d.ii.

Some ( Please describe which results and explain why only some of the results will be provided to the research participants. Then respond to 2.4.d.i and 2.4.d.ii.

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None ( Please explain why this study will not provide test results to the research participants. Then go to 2.4.e.

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2.4.d.i. Will the research tests returned to the participant be performed in a Clinical Laboratory Improvement Amendments (CLIA) certified lab?

Yes

No ( Please explain why not:

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2.4.d.ii. Also explain how research results will be provided to the participant or his or her health care provider. Describe any counseling that will be offered, if applicable.

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2.4.e. Do you plan to collect research blood draws after consent but before confirmation that the participant meets the eligibility criteria?

Yes( Please respond to 2.4.e.i.

No

2.4.e.i. Blood drawn before eligibility confirmation should be limited to the lesser of 50 mL or 3 mL per kg of body weight. Will you exceed this limit?

Yes( Please provide justification:

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No

2.5 Will this study collect information about research participants’ family history that includes personal identifiers (i.e., involvement of secondary participants)?

Yes ( Please respond to 2.5.a. – 2.5.d.

No ( Go to Section 3.0

2.5.a. Please list all the personal identifiers that will be collected on family members.

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2.5.b. How will this family history information be used?

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2.5.c. Will family history information, such as disease status of family members, be shared among other family members?

Yes ( Please respond to 2.5.c.i.

No

2.5.c.i. Does the consent form describe how family history information will be shared among other family members?

Yes

No ( Please explain:

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2.5.d. Will the study seek consent from the family members?

Yes ( Please submit the consent form you will use for this purpose. [pic]

No ( Please complete a Waiver of Consent Supplement (0202) and indicate you are seeking a partial waiver of consent for one cohort only, the family members. [pic]

SELECTION 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.

3.1 What is the group or population that this study will recruit from in order to reach your targeted accrual goals?

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3.1.a. Will the study identify potential participants through public sources (e.g., telephone directories, public access databases, commercial name lists, etc.)?

Yes ( Please list the sources:

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No ( Go to Question 3.1.b.

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.)?

Yes ( Please list the nonpublic sources (name and address of each of the nonpublic sources):

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No

3.2 How will this study recruit participants? Check all that apply, and submit any written documents or scripts with this IRB application: [pic]

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:

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3.3 Who will approach or recruit potential participants?

Principal Investigator

Study staff

Other, please describe:

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3.4 When will participants be recruited? (e.g., after a doctor’s visit)

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3.5 Where will participants be recruited? (e.g., doctor’s office)

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3.6 What steps will be taken to avoid coercion or undue influence in the recruitment of research participants?

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3.7 Will the research potentially involve participants from any of the following special populations? This includes research procedures, enrollment, and accessing identifiable information or identifiable biospecimens (e.g., name, social security number, age) about any of these populations. Please check all that apply.

3.7.a. Pregnant women

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. (If following pregnant partners, you must also answer yes to Question 4.12.)

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 Prisoner Certification Checklist for Investigator (060) [pic]

3.7.f. Children → Complete a Children Supplement (0320) [pic]

3.7.g. Adults with impaired decision-making capacity requiring a legally authorized representative (LAR) — complete Question 4.5 regarding LAR consent.

3.7.h. Limited or non-readers (e.g., illiterate, sight impaired, etc.) . Note a witness must be present for the consent discussion and a witness line included in the consent form.

3.7.i. Others (e.g., educationally or economically disadvantaged, etc.)

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If you checked any of the boxes above, please describe the additional safeguards taken to protect the rights and welfare of the special population. If applicable, reference the page number(s) in the protocol that describe the additional safeguards.

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3.8 Will anyone on the study team be a research participant in this study?

Yes ( Please provide details of the involvement.

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No

3.9 Ethnicity, Race and Gender of Anticipated Local Enrollment Table

Note: All NIH-funded studies that meet the NIH definition for clinical research must address plans for the inclusion of women and minorities. See . All other studies should also collect this information to the extent possible based on the study design.

For assistance in planning for diverse recruitment, please contact the Cancer Consortium Office of Community Outreach and Engagement (OCOE) via their request form:

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.”

Comments:

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3.9.b. Please provide the basis for the above ethnic and racial local enrollment targets.

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3.9.c. What is your plan for collecting demographic data, including, race and ethnicity, from enrolled participants?

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3.9.d. If the disease being studied disproportionately affects certain populations, or if examining health disparities is relevant to this research, please describe your plan for recruiting racial and ethnic minorities.

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3.9.e. If the anticipated Ethnic/Racial/Gender data is not available, please explain:

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CONSENTING AND COMPENSATING RESEARCH PARTICIPANTS: The IRB is responsible for determining that informed consent will be sought from each prospective participant or the participant’s legally authorized representative in accordance with, and to the extent required by regulations.

4.1 Is this study requesting a waiver of consent for any part of the research?

Yes ( Partial waiver (for only certain aspects of the research or for specific cohorts: Submit a Waiver of Consent Supplement (0202) describing the aspect of consent to be waived and go to Question 4.2 [pic]

Note about screening waivers: For studies first approved on or after 01/21/2019, a consent waiver is not required for screening, recruitment and determining eligibility when those activities only involve gathering information (please check “No” above). See the Waiver of Consent Supplement, section D, for more information. However, please note that a HIPAA waiver is still required for screening activities; submit a HIPAA Supplement and Waiver of Authorization (0208) and answer yes to question 8.2.d in this application.

Yes ( Full waiver (for all aspects of the research): Submit a Waiver of Consent Supplement (0202) to request a full waiver, and go to Section 6.0 [pic]

Note: If you are accessing medical records without obtaining consent, you must also submit a corresponding HIPAA Supplement and Waiver of Authorization (0208) and answer yes to question 8.2.c in this application.

No

4.2 Describe 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.

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4.3 Who will obtain consent from participants?

PI

Attending/Physicians

Advanced Practice Providers (e.g., Physician assistant, Nurse practitioner)

Licensed Registered Nurse (RN)

Other, please list:

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4.4 What 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 [pic]

Conference with participant

Conference with participant and family member(s)

Conference with an interpreter

Follow-up discussion

Q & A Session

Other, please describe:

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4.5 Will the study enroll adults with impaired decision-making capacity? (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 this question, you must also check “individuals with impaired decision-making capacity” in Question 3.7.g.

Yes ( Please describe the process you will use to assess and document the individual’s lack of capacity to provide informed consent (e.g., post-consent interview, standardized cognitive tests, court guardianship documentation, etc.):

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No ( Go to 4.6

4.5.a. How will you obtain and document verbal assent, or obtain written assent, from the adult research participant with impaired decision-making capacity? Please explain:

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4.6 Is any deception (withholding of complete information) required for the validity of this study?

Yes ( Please complete a Waiver of Consent Supplement (0202) to request an alteration of consent. Please explain below why the deception is necessary and submit a copy of the debriefing procedure to be used at the conclusion of the study to inform the participant of the deception. [pic]

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No

4.7 What components of the study are provided free of charge to the participant (e.g., procedures, etc.), and what components will be the participants responsibility?

Please explain and include details in the Informed Consent document:

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4.8 Will medical or psychological resources be made available to research participants as a consequence of this research study?

Yes ( Please describe the resources and include details in the Informed Consent document:

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No

4.9 Will participants be paid or otherwise be compensated or reimbursed? For example, reimbursement of travel expenses or time required to participate in the study.

Yes ( Please respond to 4.9.a– 4.9.c. and include details in the Informed Consent document.

No ( Go to Question 4.10

4.9.a. What is the amount and type of compensation (e.g., cash, services, etc.)?

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4.9.b. Will this amount be prorated?

Yes ( Please describe the payment schedule and include this information in the Informed Consent document:

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No

4.9.c. What is the reason for compensation?

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4.10 Who will be financially responsible for research related injuries? Please check all that apply and include this information in the Informed Consent document.

Study Sponsor (or other entity outside Fred Hutch)

Research participant or participant’s insurance / third party payer

Other, please describe:

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4.11 Is it possible that a commercial product or patent could result from this study?

Yes ( Please include this information in the Informed Consent document and describe the remuneration/compensation, if any, to the research participant(s).

|      |

No

4.12 If the partner of a research participant becomes pregnant during the study, do you plan to follow the pregnant partner for pregnancy outcome?

Yes ( Please answer 4.12.a.

No ( Proceed to Section 5.0.

4.12.a Is there a consent form available to allow for the pregnancy outcome to be followed?

Yes ( Attach the consent form. [pic]

No ( If necessary, we will submit a Modification form to add the consent form.

DOCUMENTING CONSENT/ASSENT: The IRB is responsible for determining that informed consent will be appropriately documented in accordance with, and to the extent required by regulations.

5.1 How will consent be documented? (Check all that apply.)

5.1.a. Written consent document with ink signature of participant (or LAR) and all other necessary individuals (person conducting consent discussion, witness if applicable, etc.). Please submit the consent form(s) with this application. [pic]

5.1.a.i. If phone or video consent is planned, review IRB Policy 2.11 Informed Consent (017) to understand the expectations around remote consenting, and include a specific plan or phone script with this application.

Note: Remote consenting must be documented in the research chart (and if a medical trial, in the patient medical record per policies of the institution where consent is taking place).

5.1.b. Minimal risk studies only:

5.1.b.i. Oral consent or written information sheet with no signature. Please complete a Waiver of Consent Supplement (0202) to request a waiver of documentation of consent (waiver of the signature requirement), and submit it along with the consent script or written materials used to consent the participant. [pic]

5.1.b.ii Electronic consenting (e-consent) (e.g., REDCap form). Review IRB Policy 2.11 Informed Consent (017) to understand the requirements for e-consent. Please complete a Waiver of Consent Supplement (0202) to request a waiver of documentation of consent (waiver of the signature requirement) and include a specific plan with this application. Also attach a report from the Information Security Officer. [pic]

5.2 How will participants who do not speak/read English provide consent? Please refer to IRB Policy 2.13 Use of Interpreter Services and Translated Documents (039) for more information about the requirements. If enrolling non-English speakers, you must also check yes to Question 1.11.

5.2.a. Short form translated generic consent in participant’s native language with qualified interpreter providing interpretation of the English consent document(s). NOTE: To use the short form process, a witness must be present for the consent discussion. An in-person interpreter is permitted to serve as the witness.

5.2.b. Translated consent document(s): Translated document(s) in the non-English language and a certification of translation showing credentials of the translator will be required. Are you submitting these now?

Yes ( Note: If the IRB requires changes to the English consent(s), the translated forms will also need to be updated and resubmitted for IRB review [pic]

No, the translated documents and certification of translation will be submitted with a Modification after the IRB approves the English versions of the site-specific consent(s).

5.2.c. This research will not allow non-English speaking / reading participants to enroll. Please provide rationale for the exclusion of non-English speaking / reading participants. Refer to IRB Policy 2.13 Use of Interpreter Services and Translated Documents (039) for the types of justifications the IRB may allow.

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DATA AND SAFETY MONITORING: The IRB is responsible for determining, when appropriate, that the research plan makes adequate provisions for monitoring the data collected to ensure the safety of research participants.

6.1 Is there a data and safety monitoring plan for this study?

Yes ( Please reference the page(s) of the protocol where the data safety monitoring plan is described. Or, briefly describe the plan for monitoring, reporting, and analyzing unanticipated problems, serious adverse events (SAEs), and other adverse events (AEs). The plan must include a description of the events or problems that will be tracked and analysis plan for monitoring interim results.

|      |

No ( Please explain:

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6.1.a. Does the data safety monitoring plan call for an independent Data Safety Monitoring Board (DSMB), or similar committee for this study?

Yes ( Please submit the DSMB charter, or if unavailable, please explain: [pic]

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Please reference the page(s) of the protocol where the committee/board is described:

|      |

No ( Go to Question 6.2

6.2 Will there be any external monitoring conducted for this study?

Yes ( Please describe who will conduct the monitoring (e.g., sponsor, Fred Hutch CRS, etc.) and how frequently:

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No ( Explain:

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PRIVACY AND CONFIDENTIALITY: The IRB is responsible for determining that there are provisions for protecting the privacy of research participants and maintaining the confidentiality of information and biospecimens.

Privacy:

7.1 What methods will the study use to protect the privacy interests of research participants?

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7.2 What safeguards will be used to protect participants, or small groups of participants, against being identified, directly or indirectly, in study reports, publications, etc.?

|      |

Confidentiality:

7.3 What method will be used to store and protect the confidentiality of participant information? Please check as appropriate.

Hardcopy (paper documentation)

Study’s Database System

Electronic storage device (USB drive, CD ROM)

Audio Tapes

Other, please describe:

|      |

7.4 How will participant information and/or biospecimens be kept confidential and secured? Please check as appropriate.

File cabinets with combination or key lock

Locked room with cardkey access

Freezer with a padlock or secure locking mechanism

Off-site backup vendor

Electronic records with user identification and unique password

Biometric authentication (e.g., fingerprints, voice, retinal/iris scan)

Smart card (e.g., memory or microprocessor cards)

Other, please describe:

|      |

7.5 Who will have access to participant identifiers? Please check as appropriate and include this information in the Informed Consent document:

National Cooperative Groups (e.g., NCTN, NRG, BMT CTN)

Office of Human Research Protections (OHRP)

US Food and Drug Administration (FDA)

Department of Defense (DoD)

IRB

NIH/NCI

Study Sponsor

Fred Hutch staff

UW staff

Seattle Children’s staff

Other agencies or groups, please describe:

|      |

7.6 What procedures will be in place for ensuring that only authorized study personnel have access to participants’ information and/or biospecimens? Please respond to the following:

7.6.a. Identify anyone other than the Principal Investigator who is authorized to give access to the information and/or biospecimens.

|      |

7.6.b. How does the PI ensure that access is revoked when a study staff member leaves the study?

|      |

7.6.c. Are access privileges periodically reviewed?

Yes ( State by whom and how often they are reviewed.

|      |

No

7.6.d. Please describe the confidentiality training given to study staff regarding access to participant information and/or biospecimens.

|      |

7.6.e. Please describe the timing and methods to remove or destroy identifying information about participants.

|      |

7.6.f. Will you retain identifiable information and/or biospecimens for purposes of another research project (e.g., keeping participants’ contact information to recruit them for future research projects)?

Yes ( Please describe what information will be retained. This must be described in the Informed Consent document

|      |

No

7.7 Will this study involve the collection of potentially sensitive and private information directly from study participants through the use of a website, email, or similar internet-based collection tool (e.g., REDCap)?

Yes ( Please respond to 7.7.a. – 7.7.c.

No ( Go to Question 7.8.

7.7.a. Please submit a copy of the web pages or internet-based collection tool. [pic]

7.7.b. Contact the Information Security Officer at iso@ to obtain a security risk assessment for the web pages or internet-based collection tool for information security issues.

7.7.c. Status of Security Review from the Information Security Officer (check one):

Completed review is submitted with this application [pic]

Pending

7.8 Will this study collect information that, if disclosed, could have significant negative consequences to the participants such as damage to their financial standing, employability, insurability or reputation (e.g., HIV, AIDS, other STDs beyond just a screening test; use of alcohol, drugs, or other addictive products; illegal behaviors, etc.)?

Yes ( Please describe the sensitive information that will be collected:

|      |

No

Certificates of Confidentiality:

7.9 Will this study receive NIH, FDA* or CDC funding?

*Note: FDA here refers only to funding by FDA, not research regulated by FDA.

Yes ( Certificates of confidentiality are automatically issued to research funded by NIH, FDA, or CDC. Refer to for information about what it means to have a Certificate.

No ( Continue to 7.9.a.

7.9.a. Have you applied, or do you plan to apply, for a Certificate of Confidentiality from the NIH or other funding agency?

Yes ( Please submit either a copy of the issued Certificate of Confidentiality or the application you have sent or will send to NIH or other funding agency. [pic]

No ( If you answered “yes” to question 7.8 (sensitive information) please provide an explanation why you will not obtain a Certificate of Confidentiality (for example, describe the privacy protections in place for this research):

|      |

Note: Certificates of Confidentiality generally require researchers to refuse to disclose, in response to legal demands, the name of a participant or any information, document, or biospecimen that contains identifiable, sensitive information about the participant and that was compiled for the purposes of the research. Certificates are issued by NIH and other HHS agencies to researchers to help protect the privacy of human research participants enrolled in research studies. When consent is obtained, the consent should inform subjects that a Certificate is in place and describe the protections and limitations.

For more information visit:

OTHER REGULATORY AND/OR ADMINISTRATIVE REVIEW REQUIREMENTS

8.1 Other IRB Reviews.

8.1.a. Is this study being transferred from another IRB?

Yes ( Submit the Transfer of IRB Oversight Supplement (0366). [pic]

No

8.1.b. Has this study received disapproval from another IRB for this research prior to submission to the Fred Hutch IRB?

Yes ( Please explain:

|      |

No

8.2 Health Insurance Portability and Accountability Act (HIPAA):

8.2.a. Will this study involve access to, or use of, any participant’s protected health information that is not stripped of all 18 identifiers defined under HIPAA (45 CFR 164.514(A)(2)) from a covered entity or business associate of a covered entity?

Yes

No ( HIPAA does not apply. Go to Question 8.3

8.2.b. Will this study be accessing only a limited data set of PHI (where 16 of the 18 individual identifiers have been removed)?

Yes ( A data use agreement may be required. Please contact the Office of the General Counsel at 206.667.1224. Skip to Question 8.3.

No, we will be accessing more than a limited data set.

8.2.c Are you requesting a full waiver of HIPAA authorization (for all aspects of the research)?

Yes ( Please submit a HIPAA Supplement and Waiver of Authorization (0208) to request a full waiver of HIPAA. Go to Question 8.3[pic]

No

8.2.d. Will you access or use PHI for the purpose of determining eligibility prior to obtaining written authorization, or will you be waiving HIPAA for some other part of the study?

Yes ( Please complete and submit a HIPAA Supplement and Waiver of Authorization (0208) to request a partial waiver of HIPAA. [pic]

No

8.2.e. How will you obtain written authorization to access PHI?

Separate HIPAA Authorization Form(s) as indicated below: Please submit a copy of the form(s) checked. [pic]

Fred Hutch Protocol-Specific HIPAA Authorization for the Use of Patient Information in Research.

Fred Hutch Clinical Research Division Transplant Program General HIPAA Research Authorization Form.

UW HIPAA form – required for UW Consortium investigators.

Seattle Children’s HIPAA form.

Other HIPAA authorization form.

HIPAA authorization language included in the research consent form.

8.2.f. If you may enroll non-English speakers (see questions 1.12 and 5.2 above), how will participants who do not speak English provide HIPAA authorization? Check all that apply.

8.2.f.i. Translated HIPAA authorization form(s) (  Are you submitting these now?

Yes( Attach along with certificate of translation. [pic]

No, the translated documents and certification of translation will be submitted with a Modification later, but prior to use in the study.

NOTE: The IRO does not arrange for, nor pay for, written translation of HIPAAs. This is the responsibility of the study team, or may be provided by the institution (e.g., UW).

8.2.f.ii. HIPAA authorization will be obtained using the English HIPAA form with a qualified interpreter providing interpretation(  Please submit a HIPAA Supplement and Waiver of Authorization (0208) to request an Alteration of HIPAA (to waive of the signature) for this specific population. [pic]

NOTE: For a verbally obtained HIPAA authorization, the non-English speaking participant does not sign the English HIPAA form. Instead, the researcher documents the verbal HIPAA authorization in the research chart (and if a medical trial, in the patient medical record per policies of the institution where consent is taking place)

8.2.f.iii. HIPAA authorization language is included in the research consent form, which will be translated (see also Question 5.2.b).

8.3 Does the study involve the transfer of materials (e.g., biospecimens or information) from Fred Hutch to an outside entity other than the sponsor?

Yes ( Please respond to 8.3.a. – 8.3.b.

No ( Go to Question 8.4

8.3.a Please describe the materials/data to be transferred:

|      |

8.3.b List the outside entity and what activities they will perform:

|      |

Note: Transfer of biospecimens or information outside your home institution generally requires a Material or Data Transfer Agreement (MTA/DUA). Fred Hutch researchers, review or contact Business Development at MTA@ for more information. UW researchers, contact the Agreements Group at mta-group@uw.edu.

8.4 Genomic Data Sharing:

8.4.a Does the study involve the Fred Hutch depositing genotype or phenotype data generated during this study directly to a genetic information database whose purpose is to share data with the wider research community (e.g., dbGaP, Genome Atlas Project)?

Yes ( Please complete and submit the Genomic Data Sharing Supplement (0205) [pic]

No

Note: Please see the NIH Genomic Data Sharing Policy for consent requirements, etc. (specifically section IV; Part C).

8.5 Embryonic Stem Cell Research:

8.5.a. Does this study involve the use or destruction of embryonic stem cells?

Yes ( Provide information about where the stem cells are obtained (e.g., NIH approved line). For UW investigators, also provide the location and approval date of the Embryonic Stem Cell Research Oversight (ESCRO) Committee review and submit a copy of the ESCRO approval letter. [pic]

|      |

No

8.6 Radiation Safety Committee Review:

8.6.a. Will radioactive materials (e.g., nuclear medicine, radio-immune therapy) or an ionizing radiation producing machine (e.g., CT, X-ray, Accelerator, DEXA scanner) be used as part of the study and result in a study participant or a healthy volunteer receiving a radiation dose they would not otherwise receive as part of their standard clinical care?

Yes ( Indicate which Radiation Safety Committees (RSC) will approve the radiation use and submit a copy of the RSC approval letter(s). [pic]

If approval is pending, enter “pending” in the approval date field.

|Radiation Safety Committee |Approval Date: |

| |Joint HSRAC for UW or FHCC Clinic |      |

| |Seattle Children’s RSC |      |

| |Fred Hutch Radiation Safety |      |

| |Other:       |      |

No ( Go to Question 8.6.b.

8.6.b. Will the study be reviewed by the UW Radioactive Drug Research Committee (RDRC)?

Yes ( Please submit a copy of the RDRC approval confirming that the study will be conducted in accordance with 21 CFR 361.1 and does not require an IND. [pic]

No

8.7. Total Body Irradiation: Does this study use Total Body Irradiation procedures (even if considered standard of care)?

Yes ( Submit documentation of protocol approval by the University of Washington Radiation Oncology department. Contact 206.598.4100 or ROinfo@uw.edu with questions. [pic]

No

8.8 FDA-regulated research:

8.8.a. Are you, or the sponsor, intending to use results from the study to support FDA approval of a new indication for a drug, biologic or food supplement or to support any other significant change in the labeling?

Yes, Please explain:

|      |

No

8.8.b. Are you, or the sponsor, intending to use study results to support a significant change in the advertising for a drug, biologic or food supplement?

Yes, Please explain:

|      |

No

8.8.c. Will this study involve the evaluation of a device, unapproved in vitro diagnostic test, device software function (including mobile medical applications), use of a Humanitarian Use Device (HUD)?

Yes ( Please submit a Device Supplement (0322) [pic]

No

8.8.d. Will this study involve the use of an unapproved in vitro diagnostic test for decision-making (e.g., eligibility determination or treatment assignment) or data analysis (e.g., response assessment)?

Yes ( Please submit a Device Supplement (0322) [pic]

No

8.9 International Conference on Harmonization (ICH) Good Clinical Practice (GCP):

8.9.a. Does the sponsor of this study require compliance with ICH-GCP E6 guidelines?

Yes ( The PI and research team have completed or will complete training as required by the sponsor.

No

8.10 Conflict of Interest:

8.10.a. Will this study receive monetary or other support (study drug, equipment, personnel time, etc.) from a for-profit company?

Yes ( Please provide the name(s) of the for-profit company, and briefly describe the type of support being provided. Note: If a sponsor is providing study drug, equipment, etc., this represents support that should be listed on the Funding Source Supplement and be covered by a contractual agreement (see Question 1.16).

|      |

No

8.10.b. Do any investigators or study team members have an individual conflict of interest that is subject to a conflict management plan?

Yes ( Attach the conflict management plan. [pic]

No

8.10.c. Are you aware of any institutional conflicts of interest related to this study?

Yes ( Describe:      

No

CHECKLIST: Order of attachments. (Check all that apply.)

Research Design and Resources

|9.1 |Expedited Review Checklist for Minimal Risk Activity (053) |Per Page 1 | Yes |

|9.2 |Exempt Checklist (048) |Per Page 1 | Yes |

|9.3 |Protocol Synopsis |Per Question 1.1 | Yes |

|9.4 |Protocol/Activity Plan (for a minimal risk study, the entire grant application may be |Per Question 1.1 | Yes |

| |submitted if there is no protocol document) | | |

| |If a DHHS-approved protocol (complete) exists, include below. | | |

| |If N/A, please provide an explanation:       | | |

|9.5 |Questionnaires required by the protocol, participant completed data collection forms, |Per Question 1.1 | Yes |

| |logs, etc. | | |

| |If yes, please list each item below in sequential order: | | |

| |Document Title |

| |Version |

| | |

| |      |

| |      |

| | |

| |      |

| |      |

| | |

| |      |

| |      |

| | |

|9.6 |Multi-Center Supplement (0323) |Per Question 1.10.a, b | Yes |

|9.7 |International Research Performance Site Assessment Supplement (054) |Per Question 1.10.c | Yes |

|9.8 |Repository, Registry or Databank Supplement (063) |Per Question 1.14 | Yes |

|9.9 |Funding Source Supplement (049) and funding documents (e.g. grant) |Per Question 1.15 | Yes |

|9.10 |Department of Defense (DoD) Supplement (0299) |Per Question 1.16 | Yes |

|9.11 |Letter of Support from Gatekeeper of Repository, Registry or Databank |Per Question 1.17 | Yes |

|9.12 |Attestation from the provider or third-party supplier |Per Question 1.17.b | Yes |

|9.13 |Exempt Checklist (048) |Per Question 1.18 | Yes |

Selection and Recruitment of Participants is Equitable

|9.14 |Letters of approach/recruitment, flyers/advertisements, recruitment phone scripts, text of |Per Question 3.2 | Yes |

| |radio ads, etc. | | |

| |If yes, please list each item below in sequential order: | | |

| |Document Title |

| |Version |

| | |

| |      |

| |      |

| | |

| |      |

| |      |

| | |

|9.15 |Prisoner Certification Checklist for Investigator (060) |Per Question 3.7.e | Yes |

|9.16 |Children Supplement (0320) |Per Question 3.7.f | Yes |

Consenting and Compensating Research Participants

|9.17 |Waiver of Consent Supplement (0202) |Per Questions 2.5.d, 4.1, 4.6, | Yes |

| | |5.1.b | |

|9.18 |Post Consent Questionnaire |Per Question 4.4 | Yes |

|9.19 |Debriefing procedure for studies involving deception |Per Question 4.6 | Yes |

|9.20 |Pregnant Partner Consent Form |Per Question 4.12 | Yes |

Documenting Consent

|9.21 |Consent and Assent Form(s): |Per Questions 2.5.d, 4.5.a, | Yes |

| | |4.12a, 5.1.a | |

| |If yes, please list below. If clinical or other IRB approved consent forms of another IR file will be used as a basis for | |

| |this study, please list below and provide most recent date of IRB review. If the consent form(s) is new with this | |

| |application, leave IR File number and date of review blank. All copies of the consent documents listed below MUST be | |

| |attached. If a DHHS-approved sample consent document or an industry-sponsor consent template exists, please include. | |

| |Consent / Assent Form# | |

| |Title | |

| |Date of IRB Review | |

| |IR number | |

| | | |

| |      | |

| |      | |

| |      | |

| |      | |

| | | |

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| |      | |

| |      | |

| |      | |

| |      | |

| | | |

|9.22 |Script used for oral consent, information sheet, or other consent materials |Per Question 5.1.b | Yes |

|9.23 |Plan for e-consent and a report from the Information Security Officer |Per question 5.1.b.ii | Yes |

|9.24 |Translated documents in the non-English language and certification of translation |Per Question 5.2.b | Yes |

Data and Safety Monitoring

|9.25 |DSMB Charter |Per Question 6.1.a | Yes |

Privacy and Confidentiality

|9.26 |Webpages or internet-based collection tool and Security Review from the Information Security |Per Questions 7.7.a, 7.7.c | Yes |

| |Officer | | |

|9.27 |Certificate of Confidentiality Application |Per Question 7.9 | Yes |

Other Regulatory and/or Administrative Review Requirements

|9.28 |Transfer of IRB Oversight Supplement (0366) |Per Question 8.1 | Yes |

|9.29 |HIPAA Supplement and Waiver of Authorization (0208) |Per Question 8.2 | Yes |

|9.30 |HIPAA Authorization Forms (0206) |Per Question 8.2.e | Yes |

|9.31 |Certificate of translation for translated HIPAA authorization form |Per Question 8.2.f.i | Yes |

|9.31 |Genomic Data Sharing Supplement (0205) |Per Question 8.4.a | Yes |

|9.32 |ESCRO approval letter |Per Question 8.5.a | Yes |

|9.33 |Radiation Safety Committee approval documentation |Per Question 8.6.a | Yes |

|9.34 |RDRC approval letter |Per Question 8.6.b | Yes |

|9.35 |Documentation of protocol approval by UW Radiation Oncology department |Per Question 8.7 | Yes |

|9.36 |Device Supplement |Per Question 8.8.c and 8.8.d | Yes |

|9.37 |Conflict of Interest Management Plan |Per Question 8.10 | Yes |

|9.38 |Other pertinent information. | Yes |

| |If yes, please list below in sequential order: | |

| |      | |

INVESTIGATOR STATEMENT AND SIGNATURE

As PRINCIPAL INVESTIGATOR, I acknowledge that all of the information provided in this application is true to the best of my knowledge; that I am responsible for reporting any emergent problems, unanticipated problems involving risks to participants or others, serious or continuing noncompliance, or proposed procedural modifications and that no modifications will be put into effect without prior Institutional Review Board (IRB) approval except where necessary to eliminate apparent immediate hazards; that unless otherwise directed by the IRB Chairperson, I will renew this application with the IRB at the frequency specified in the IRB approval; that the research project is being conducted in compliance with the IRB's understanding and recommendations; that the IRB is provided all the information on the research project necessary for its complete review; that each individual listed in the Conflict of Interest section has complied with the Fred Hutch requirement to submit an “Annual Summary of Outside Activities and Interests”; and that this research project will not be put into effect until final IRB approval is received.

|      | | | |      |

|Investigator Name | |Investigator Signature | |Date |

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