Institution Approval

Application for Review Interventional Research Institutional Review Board

Date: This box is for IRO only Date Version date Protocol #: IR File # Received: (if applicable)

Principal Mailstop: Phone: Investigator: Contact Mailstop: Phone: Person:

Study Title:

Fred Hutch (select division)  Basic HB VIDD CRD PHS Admin

PI Primary University of Washington Appointment: Seattle Children’s Other:

This research project has scientific merit. The Principal Investigator is qualified to oversee this project. INSTITUTION APPR OVAL

(Required)  Division Director or Designee Signature Date

Is this an NCTN Cooperative Group Study? No Yes

Would you like this research to be considered as a minimal risk activity qualifying for Expedited Review? No Yes  please submit an Expedited Review Checklist for Minimal Risk Activity along with this application.

This box is for IRO only Reviewing Committee (Reg ID):  A (0021)  B (0022)  C (5619)  D (9831) Assurance #: FWA00001920

 Full Review  Expedited Agenda Date:

Approval Signature, Chair or Designee Date Printed Name

Dates of IRB Approval: to:

**VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED** DISTRIBUTION: ORIGINAL – IR File COPIES to: Investigator, Contact Person

0324IRBform_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 1 of 28 1.0 RESEARCH DESIGN AND RESOURCES

1.1 Is 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:

1.2 What 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:

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

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: N/A – This is an expanded access, individual patient protocol. See treatment plan/protocol.

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: N/A – This is an expanded access, individual patient protocol. See treatment plan/protocol.

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

1.7 What 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: 

1.8 How long will individual participants be in the study, and how long do you expect the entire study will take to complete? Duration of treatment will be determined by patient’s clinical status/response. See treatment

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 2 of 28 plan/protocol for details.

1.9 What are the approximate number and ages of the following?  For a multi-center study, both local and total accrual numbers must be provided.  If this study does not involve multiple sites, complete only the local accrual rows.

AGE RANGE OF PARTICIPANTS NUMBER OF PARTICIPANTS as specified per study

First Year Entire Study First Year Entire Study Locally

Study-wide

1.10 What FHCRC or Cancer Consortium locations will be involved in the research? Please check all that apply: FHCRC main campus Other FHCRC sites (e.g. HCRI-Uganda, HCRI-South Africa) please list:  Seattle Cancer Care Alliance (SCCA) South Lake Union SCCA at Evergreen Hospital SCCA at Northwest Hospital Seattle Children’s Hospital University of Washington (UW) Other UW research sites (e.g., Haborview, UW Clinics) please list:  NA  no research at FHCRC or Cancer Consortium locations

1.10.a. Will FHCRC 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 FHCRC will not be the IRB of Record (e.g., Swedish)? No Yes, please identify the locations 

1.11 Will FHCRC IRB be the IRB of Record for any locations outside the FHCRC or Cancer Consortium; or, are you serving as the overall coordinating center for this research? No Yes  Please complete the Multi-Center Supplement and submit it along with this application.

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 3 of 28 1.12 What types of staff will be involved in this research? Please check all that apply: Research Nurse Attendings/Physicians Mid Level Providers (e.g., Physician Assistant) Study Interviewers Study/Data Coordinators Laboratory Technicians Programmers Systems Support Personnel Other, please list:  Members of the Patient’s Clinical Team

1.13 Is it possible that this study may involve non-English speaking participants? No 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).

1.14 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)? Members of clinical team will be fully informed and oriented about this treatment prior to beginning work on this protocol. Communications with clinical team will be conducted as needed to keep staff current on treatment-related issues.

1.15 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? 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.

1.16 Will 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 and submit with this application.

1.17 Will this study be funded? No, please explain how the study will be conducted with no

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 4 of 28 funding: Yes  please complete a Funding Source Supplement and submit it along with a copy of the grant, contract, or other funding documentation with this application.

1.18 Will 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 the DoD Supplement and submit with this application.

2.0 RISK/BENEFIT ASSESSMENT

2.1 What are the anticipated risks associated with this study? This is an expanded access, individual patient protocol. The consent form explains the risks of [Drug Name] and the treating physician will reinforce the risks of the drug to the patient at the time of consent.

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. Expected benefit is that the patient may successfully respond to treatment with [Drug Name]

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? No Yes  please explain how you will manage this situation.

2.4 Will this study involve the collection or analysis of biological specimens from participants for research purposes? No  go to Question 2.5 Yes  please respond to 2.4.a. – 2.4.d.

2.4.a. Will the results be useful for predicting the occurrence or prognosis of a disease in the participant? No Yes  please explain:

2.4.b. Will the results potentially be used for predicting disease risk/susceptibility in family members? No Yes  please explain:

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

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 5 of 28 No Yes  please explain:

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.

None  please explain why this study will not provide test results to the research partici pants:

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.

2.4.d.i. Will the research tests returned to the participant be performed in a Clinical Labor atory Improvement Amendments (CLIA) certified lab? Yes No  please explain why not:

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.

2.5 Will this study collect information about research participants’ family history that includes personal identifiers (e.g., secondary subjects)? No  go to Question 2.6 Yes  please respond to 2.5.a. – 2.5.d.

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

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

2.5.c. Will family history information, such as disease status of family members, be shared among other family members? No Yes  please respond to 2.5.c.i.

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

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 6 of 28 No  please explain:

2.5.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 and indicate you are seeking a waiver of consent for the secondary subjects only.

2.6 What measures will the study take to assure that an individual or group cannot self-identify in publications/presentations? If a case report were to be published or information about this case presented, it would not include patient name or any other identifying information.

3.0 SELECTION AND RECRUITMENT OF PARTICIPANTS IS EQUITABLE

3.1 What is the group or population that this study will recruit from in order to reach your targeted accrual goals? N/A - This an expanded access, individual patient protocol.

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 

3.2 How will this study recruit participants? Check all that apply, and submit any written documents with this 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)

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 7 of 28 print advertisements flyers Internet, including social media Other, please describe  N/A - This is an expanded access, individual patient protocol.

3.3 Who will approach or recruit potential participants? Principal Investigator Study staff Other, please describe  Treating Physician

3.4 When will participants be recruited? (e.g., after a doctor’s visit) The proposed treatment plan will be explained to the patient during a routine clinical visit. [or Patient has already been identified and referred by an attending physician.]

3.5 Where will participants be recruited? (e.g., doctor’s office) The clinical visit will take place in the outpatient clinic or inpatient unit.

3.5.a. Will participants be recruited and enrolled from countries other than the United States? No Yes  Complete the International Research Performance Site Assessment Supplement for each country.

3.6 What steps will be taken to avoid coercion or undue influence in the recruitment of research participants? The patient and/ parents/ family members will be informed of the risks, benefits and alternatives and will have a formal data review/consent conference after IRB approval. They will have ample time to ask questions before making a final decision about whether to participate.

3.7 Will 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 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

3.7.f. Children → complete a Children Supplement 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., Non-English speakers, sight impaired)

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 8 of 28 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.

3.8 Will anyone on the study team be a research participant in this study? No Yes  please provide details of the involvement:

3.9 Ethnic, Racial and Gender Anticipated Local Accrual Table 3.9.a. Is this a prospective study? - N/A – Patient demographic information included in the Protocol document No  go to Section 4.0 Yes  complete Table 3.9.b. and then respond Questions 3.9.c. and 3.9.d

Table 3.9.b ANTICIPATED/PLANNED LOCAL ENROLLMENT: Number of Participants (must provide exact numbers. i.e., no 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: 

3.9.c. Please provide the basis for the above ethnic and racial local enrollment targets. N/A - This is an expanded access, individual patient protocol.

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 9 of 28 3.9.d. If the anticipated Ethnic/Racial/Gender data is not available, please explain: N/A - This is an expanded access, individual patient protocol.

4.0 CONSENTING AND COMPENSATING RESEARCH PARTICIPANTS

4.1 Is 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  Partial waiver for a portion of the research, screening process, or for some participants: complete a Waiver of Consent Supplement describing the aspect of consent to be waived and go to Question 4.2

Yes  Complete waiver for all aspects of the research: complete a Waiver of Consent Supplement and go to Section 6.0 Note: If you are accessing medical records prior to obtaining consent (e.g., screening for eligibility) you must also submit a Partial Waiver of HIPAA authorization (question 8.2).

4.2 When will participants be consented (e.g., during intake visit)? Patient will be consented during routine clinical visit prior to treatment.

4.3 Who will discuss and obtain consent from participants? PI Research Nurse Attendings/Physicians Study Staff Other, please list:  Patient’s Treating Physician or PI

4.4 If 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?

N/A No Yes  please explain:

4.5 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

Conference with participant Conference with participant and family member(s) Conference with an interpreter

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 10 of 28 Follow-up discussion Q & A Session Other, please describe: 

4.6 Will 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.) If you answered “Yes” to decisionally impaired individuals in Question 3.7.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:

4.7 Is any deception (withholding of complete information) required for the validity of this study? No Yes  Please complete a Waiver of Consent Supplement and indicate for which elements of consent you are requesting a waiver. Please explain 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.

4.8 What components of the study are provided free of charge to the participant (e.g., drugs, procedures, etc), and what components will be the participants responsibility? Please explain and include details in the Informed Consent document:

4.9 Will medical or psychological resources be made available to research participants as a consequence of this research study? N/A* No Yes  please describe the resources and include details in the Informed Consent document: * N/A - This is an expanded access, individual patient protocol.

4.10 Will participants be paid or otherwise compensated? For example, reimbursement of travel expenses or time required to participate in the study. No  go to Question 4.11 Yes  please respond to 4.10.a– 4.10.c. and include details in the Informed Consent document.

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 11 of 28 4.10.a. What is the amount and type of compensation (e.g., cash, services, etc.)?

4.10.b. Will this amount be prorated? No Yes  please describe the payment schedule and include this information in the Informed Consent document:

4.10.c. What is the reason for compensation?

4.11 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 the Center) Research participant or participant’s insurance / third party payer UW’s compensation plan Seattle Children’s compensation plan Other, please describe: 

4.12 Is it possible that a commercial product or patent could result from this study? No Yes  please include this information in the Informed Consent document and describe the remuneration/compensation, if any, to the research participant(s).

4.13 If a research participant withdraws from the study, does the PI plan to ask the participant to remain in any non-interventional long term follow-up portion of this study? N/A* No Yes  please describe the plan for obtaining consent from the participant to continue long term follow-up. If separate consent will be used, please submit a copy with this application.

*N/A - This is an expanded access , individual patient protocol.

5.0 DOCUMENTING CONSENT/ASSENT

5.1 How will consent be documented (check all that apply)? 5.1.a. Written consent document with signature of participant. Please submit the consent form(s) with this application.

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 12 of 28 5.1.b. Oral consent or written information sheet with no signature. Please submit the consent script or materials used to consent the participant.

Confirm that a waiver of documentation of consent is appropriate by checking the appropriate option below:

5.1.b.i. The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern; and, the research is not FDA-regulated.

5.1.b.ii. The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

5.2 How will participants who do not speak/read English provide consent?

5.2.a. Short form translated generic consent in participant’s native language with qualified interpreter providing interpretation of the English consent document(s). 5.2.b. Translated consent document(s): Please submit the following with this application: translated document(s) in the non-English language; and, certification of translation showing credentials of the translator.

5.2.c. This research will not allow non-English speaking subjects to enroll. Please provide rationale for the exclusion of non-English speaking subjects.

6.0 DATA AND SAFETY MONITORING

6.1 Is there a data and safety monitoring plan for this study? No  Please explain:

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. Study will comply with the Cancer Consortium DSMC. [Refer to protocol section] Patient will also be monitored for adverse events per the treatment plan.

6.2 Is there an independent safety monitoring committee or Data Safety Monitoring Board (DSMB) for this study?

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 13 of 28 No  go to Question 6.3 Yes  please respond to 6.2.a

6.2.a. Please reference the page(s) of the protocol where the committee/board is described and if there is a DSMB submit the board’s charter:

Page Number(s) 

6.3 Is this a double blind randomized study in which neither the research participant nor you know the assignment to study drug or placebo? No Yes  please describe the unblinding plan:

7.0 PRIVACY AND CONFIDENTIALITY

Privacy:

7.1 What methods will the study use to protect the privacy interests of research participants? Records will be maintained securely in accordance with Institutional procedures. No personal information will be used in any reports.

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.? If a case report were to be published or information about this case presented, it would not include patient name or any other identifying information.

Confidentiality:

7.3 What format will be used to store and protect the confidentiality of participant information? Please check as appropriate. Hardcopy (paper documentation) Study’s Database System Disk (CD ROM, floppy disk) Audio Tapes Other, please describe: 

7.4 How will participant information 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

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 14 of 28 Off-site backup vendor Electronic records with user identification and secret password Biometric authentication (e.g., fingerprints, voice, retinal/iris scan) Smart card (e.g., memory or microprocessor cards) Other, please describe: 

7.5 Who else besides FHCRC study staff will have access to participant identifiers? Please check as appropriate and include this information in the Informed Consent document: National Cooperative Groups (e.g., GOG, ECOG) Office of Human Research Protections (OHRP) US Food and Drug Administration (FDA) Department of Defense (DoD) IRB NIH/NCI Seattle Cancer Care Alliance (SCCA) staff Study Sponsor 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? Please respond to the following: 7.6.a. Identify anyone other than the Principal Investigator who is authorized to give access to the information.

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? No

Yes  please state by whom and how often they are reviewed:

7.6.d. Please describe the confidentiality training given to study staff regarding access to participant information. HIPAA and/or confidentiality training per standard institutional requirements

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 15 of 28 7.6.e. Please describe the timing and methods to remove or destroy identifying information about subjects. Information will be archived following institutional policy and regulation requirements.

7.6.f. Will you retain identifying information for purposes of another research project (e.g., keeping participants’ contact information to recruit them for future research projects)? No

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

7.7 Will this study involve the collection of potentially sensitive and private information directly from study participants through the use of a web-site or similar internet based collection tool? No  go to Question 7.8

Yes  please respond to 7.7.a. – 7.7.c.

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

7.7.b. Contact the Information Security Officer at [email protected] to obtain a security review 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):

Submitted with this application

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; use of alcohol, drugs, or other addictive products, illegal behaviors, etc.)? No  go to Question 8.1

Yes  please describe the sensitive information that will be collected:

7.9 Will the study obtain a Certificate of Confidentiality issued by the NIH? Yes  Please submit a copy of the Certificate of Confidentiality or the application you plan to send to NIH.

No  If you answered “yes” to question 7.8 please provide an explanation why you will not obtain a Certificate of Confidentiality:

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 16 of 28 8.0 OTHER REGULATORY AND/OR ADMINISTRATIVE REVIEW REQUIREMENTS

8.1 Has the Principal Investigator of this study received disapproval from another IRB for this research prior to submission to the FHCRC IRB? No

Yes  please explain:

8.2 Health Insurance Portability and Accountability Act (HIPAA): 8.2.a. Will this study involve access to, or use of, any participants’ 18 identifiable pieces of protect ed health information (PHI) defined under HIPAA (45 CFR 164.514(A)(2)) from a covered en tity? No  HIPAA does not apply; go to Question 8.3 Yes  please respond to 8.2.b. and 8.2.c. 8.2.b. Will this study be accessing only a limited data set of PHI?

Yes  please submit the HIPAA Supplemen t and Waiver of Authorization. Answer “No” to the first question on the supplement and follow the remaining instruction s. Go to Question 8.3

No, we will be accessing more than a limited data set  continue to Question 8.2.c.

8.2.c. How will you get authorization to access PHI? Check all that apply: Separate HIPAA Authorization Form(s) as indicated below: FHCRC Protocol Specific HIPAA Authorization to Use, Create and Share Health Inform ation for Research FHCRC Clinical Research Division Transplant Program General HIPAA Research Autho rization Form UW HIPAA form – required for UW Consortium investigators Seattle Children’s HIPAA form Other HIPAA authorization form Please submit a copy of the form(s) to be used.

HIPAA authorization language included in the research consent form. Requesting a complete waiver of HIPAA authorization. Please complete and submit a HIPAA Supplemen t and Waiver of Authorization. Requesting a partial waiver of HIPAA authorization for recruitment purposes. Please complete and submit a HIPAA Supplemen t and Waiver of Authorization.

Note: If you will be accessing University of Washington medical records prior to consent and/or authorization you must also obtain a confidentiality agreement from University of Washington Human Subjects Division prior to accessing medical records. For more information visit http://www.washington.edu/research/hsd/docs/393

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 17 of 28 8.3 Does the study involve the transfer of materials (e.g., specimens or data) from FHCRC to an outside entity other than the sponsor? No  go to Question 8.4 Yes  please respond to 8.3.a. – 8.3.b. 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 specimens or data may require a Material or Data Transfer Agreement, contact the FHCRC Technology Transfer Department at 667-4304 for more information.

8.4 Does the study involve the FHCRC 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)? No

Yes  please complete the GWAS Submission Supplement and submit with this application.

8.5 Institutional Biosafety Review:

8.5.a. Will this study involve the deliberate transfer/administration of recombinant DNA, DNA/RNA derived from recombinant DNA, or synthetic DNA into one or more study participants? No

Yes  Institutional Biosafety Committee (IBC) review and approval is required prior to enrolling any study participants. Please check one of the check boxes below:

IBC and NIH RAC have approved the study: Please submit the IBC approval documents outlining the Appendix M items, and submit approval documents from NIH RAC review.

IBC and/or NIH RAC review is pending

Status of IBC and NIH RAC review: 

Note: For multicenter studies where FHCRC is the IRB of record for an external clinical trial site please include a copy of the clinical trial site’s IBC review and approval with this application.

8.6 Embryonic Stem Cell Research:

8.6.a. Does this study involve the use or destruction of embryonic stem cells? No

Yes  Provide information about where the stem cells are obtained (e.g., NIH approved line). Provide the location and approval date of the ESCRO committee review and submit a copy of the ESCRO approval letter.

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 18 of 28 8.7 Radiation Safety Committee Review:

8.7.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? No

Yes  Indicate which Radiation Safety Committees (RSC) will approve the radiation use and submit a copy of the RSC approval letter(s). If approval is pending, enter “pending” in the approval date field.

Radiation Safety Committee Approval Date: Joint HSRAC for UW or SCCA

Seattle Children’s RSC

FHCRC Radiation Safety Other Performance Site(s) Radiation Safety (If Required by the Performance Site) Name of performance site:

8.7.b. Will the study be reviewed by the UW Radioactive Drug Research Committee (RDRC)? No 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.

8.8 Scientific Review Committee and Clinical Research Support management:

8.8.a. Is this an intervention or prevention study being conducted at the FHCRC/UW cancer consortium involving participants who have cancer or are at risk for cancer? No

Yes  please submit Scientific Review Committee (SRC) approval.

8.9 Investigational New Drug (IND) research:

8.9.a. Is this study being done under an IND number assigned by the FDA? No  go to Question 8.10

Yes → provide the following IND information and if available, submit an Investigator Brochure (IB) with this application and then respond to Question 8.9.b.:

Name of Drug/Biologics

Phase of Study (select one) Phase I Phase II Phase III

Dosage Name of IND Holder (e.g., Dr. Jones; Drug Company Name;

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 19 of 28 Institution Name, etc.)

Location of IND Holder (i.e., FHCRC, other university, non- profit, or drug company)

Name of Manufacturer

8.9.b. How is the FDA IND number assigned for this study documented? Select the appropriate check box below and submit with this application. Written communication from the FDA documenting the IND number and a letter from you confirming that the 30 day clearance has passed: please submit.

Written communication from the research sponsor (not the PI): please submit.

IND number is part of the sponsor’s protocol.

IND is Pending FDA review and has not been issued.

Other, explain: 

8.10 Other FDA regulated research:

8.10.a. Is this study designed to evaluate any commercially available drugs, biologics, or food supplements that are not under an IND? No  go to Question 8.11

Yes  this research is regulated by the FDA for purposes of IRB review – please respond to 8.10.b:

8.10.b. Will a commercially available drug, biologic, or food supplement be used in a way that is different from product labeling (e.g., different dosage level or schedule, new combination of drugs, new formulation or route of administration, or for a new indication or population)? No  The drug, biologic, or food supplement is being used in accordance with its labeling. Go to Question 8.11

Yes  please submit documentation from FDA confirming exemption from IND requirements under 21 CFR 312

Yes  I would like the IRB to confirm my determination that this research is exempt from the FDA requirement for an IND. Respond to 8.10.b.i. – 8.10.b.iv

8.10.b.i. Are you or your sponsor/funding source intending to use results from the study to support FDA approval of a new indication for use of the study drug or to support any other significant change in the labeling for the study drug? No

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 20 of 28 Yes 8.10.b.ii. Are you or your sponsor/funding source intending to use study results to support a significant change in the advertising for the study drug? No Yes

8.10.b.iii. Does the study involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the study drug? No  please submit a memorandum explaining your analysis why there is not a significant increase in risk. Yes 8.10.b.iv. Will the results from this study be used to promote use of the commercially available drug, biologic, or food supplement for unapproved indications? No Yes

Note: If you responded “yes” to any of the questions (8.10.b.i – 8.10.b.iv) above, please contact the Regulatory Affairs at 667-1394 to discuss if an IND is required for this study.

Note: Failure to address the issue of IND requirements in a timely and thorough manner may delay the approval of your study.

8.11 Device Research:

8.11.a. Will this study involve the testing of a device or mobile medical application, use of a Humanitarian Use Device (HUD), or use of an unapproved in vitro diagnostic test? No Yes  please submit a Device Supplement

8.12 Conflict of Interest:

Which institution’s budget is being charged to conduct this study (e.g. where are PI salary and study expenses being charged)? Check all that apply (at least one must be checked) and follow the instructions. Fred Hutchinson Cancer Research Center: Please refer to the instructions - http://centernet.fhcrc.org/CN/depts/iro/irb/forms/prot- p2-instructions.pdf for definitions of ‘Capitalized’ terms as they related to FHCRC Conflict of Interest questions and respond to questions 8.12.a and 8.12.b below.

University of Washington: Please go to http://www.washington.edu/research/hsd/docs/741 to fulfill the UWs Conflict of Interest requirements. Submit the completed UW/CC Coversheet with this application along with any conflict management plans developed by the UW. Go to Section 9.

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 21 of 28 Other Institution Relying on FHCRC for IRB Review: (e.g. Seattle Children’s) identify 

If the other institution has a conflict management plan please attach. Go to Section 9.

8.12.a. FHCRC Conflict of Interest:

8.12.a.i. To your knowledge is there an Institutional Conflict of Interest relating to this study? No

Yes  Please describe the conflict:

8.12.a.ii. To your knowledge, do you or any other Key Personnel who will Participate in Human Subjects Research as part of this study have a Conflict of Interest related to the study (see COI instructions for definitions)? No  Go to Question 8.12.b.

Yes  Please provide the name(s) of the Key Personnel with a Conflict of Interest and their role in the study:

8.12.a.iii. Has the Conflict(s) of Interest been reviewed in accordance with the Center’s Policy and Guidelines for Involvement of Outside Interests? Yes

No  Please explain why the review has not been completed:

8.12.a.iv. Did the Conflict of Interest review(s) result in a finding that any Key Personnel have a Significant or Prohibited Financial Interest that limits his/her ability to participate in the human subjects research described in this study? No  Go to Question 8.12.b.

Yes  please submit a copy of the approved FHCRC conflict management plan.

8.12.a.v. Does the FHCRC conflict management plan require disclosure of the conflict in the consent(s) for this study? No

Yes  Please describe the disclosure requirements:

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 22 of 28 8.12.b. Study Involving a Commercial Sponsor or the Testing of a Commercial Product and/or Service: 8.12.b.i. Will this study receive monetary or other support (e.g. study drug, equipment, personnel time, etc.) from a for-profit Business Entity? No Yes  Please provide the name(s) of the for-profit Business Entity and briefly describe the type of support being provided:

8.12.b.ii. Is this study designed to specifically test the efficacy, or safety, of a product (e.g. drug, device, diagnostic test, etc.) or service of a for-profit Business Entity? No Yes  Please provide the name(s) of the for-profit Business Entity and briefly describe the product or service being tested:

8.12.b.iii. Are you aware of any license, or other agreement, between the Center and the for-profit Business Entity(s) listed in Question 8.12.b.i or 8.12.b.ii relating to the commercialization of any product or service of that Business Entity? NA  No for-profit Business Entity involved  Go to Section 9.0. No Yes  Please briefly describe the license or agreement:

8.12.b.iv. If you answered “Yes” to either 8.12.b.i or 8.12.b.ii, please list in the table below the PI and all other individuals who will participate in Human Subjects Research as part of this study (see COI section instructions for definition, and an example of who must be listed). INCLUDE ONLY INDIVIDUALS who are FHCRC employees or Affiliates.

Role / Name Role / Name PI -

NOTE: All individuals listed above must have submitted an FHCRC “Annual Summary of Outside Activities and Interests” in accordance with FHCRC policy. If there have been changes since the last submission, or an Annual Summary of Outside Activities and Interests has not been submitted within the last twelve months, a new submission must be made before the individual may participate in this study.

For more information visit: https://centernet.fhcrc.org/CN/depts/general_counsel/index.html.

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 23 of 28 By initialing and dating here, the principal investigator confirms that each individual listed above has complied with the FHCRC requirement to submit an “Annual Summary of Outside Activities and Interests”. PI initials and date:

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 24 of 28 9.0 CHECKLIST: Order of attachments. (Check all that apply.)

Research Design and Resources

9.1 Expedited Review Checklist for Minimal Risk Activity Per Page 1 Yes 9.2 Protocol Synopsis Per Question 1.1 Yes 9.3 Protocol/Activity Plan (for non-clinical or minimal risk study, the Per Question 1.1 entire grant application may be submitted if there is no protocol document) Yes If a DHHS-approved protocol (complete) exists, include below. If NA, please provide an explanation: 9.4 Questionnaires used as part of the protocol, subject Per Question 1.1 completed data collection forms, logs, etc. Yes If yes, please list each item below in sequential order: Document Title Version

9.5 Multi-Center Supplement Per Question 1.11 Yes 9.6 Repository, Registry or Databank Supplement Per Question 1.16 Yes 9.7 Funding Source Supplement and funding documents (e.g. grant) Per Question 1.17 Yes 9.8 Department of Defense (DoD) Supplement Per Question 1.18 Yes

Selection and Recruitment of Participants is Equitable

9.9 Letters of approach/recruitment, flyers/advertisements, Per Question 3.2 recruitment phone scripts, text of radio ads, etc. Yes If yes, please list each item below in sequential order: Document Title Version

9.10 Prisoner Certification Checklist for Investigator Per Question 3.7.e Yes 9.11 International Research Performance Site Assessment Per Question 3.5.a Yes Supplement 9.12 Children Supplement Per Question 3.7.f Yes

Consenting and Compensating Research Subjects

9.13 Waiver of Consent Supplement Per Questions Yes 2.5.d, 4.1, 4.7 9.14 Post Consent Questionnaire Per Question 4.5 Yes 9.15 Debriefing procedure for studies involving deception Per Question 4.7 Yes

Documenting Consent

9.16 Consent and Assent Form(s): Per Questions Yes 2.5.d, 4.13, 5.1.a

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 25 of 28 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 exists, please include.

Consent / Date of IR Assent Title IRB Review number Form#

9.17 Script used for oral consent Per Question 5.1.b Yes 9.18 Translated documents in the non-English language and Per Question 5.2.b Yes certification of translation

Data and Safety Monitoring

9.19 Independent Safety Monitoring Committee or DSMB Charter Per Question 6.2.a Yes

Privacy and Confidentiality

9.20 Webpages or internet-based collection tool and Security Review Per Questions Yes from the Information Security Officer 7.7.a, 7.7.c 9.21 Certificate of Confidentiality Application Per Question 7.9 Yes Other Regulatory and/or Administrative Review Requirements

9.22 HIPAA Supplement Per Question 8.2 Yes 9.23 HIPAA Authorization Forms Per Question 8.2.c Yes 9.24 GWAS Submission Supplement Per Question 8.4 Yes 9.25 Institutional Biosafety Committee (IBC) Approval Documents Per Question 8.5.a Yes 9.26 ESCRO approval letter Per Question 8.6.a Yes 9.27 Radiation Safety Committee approval documentation Per Question 8.7.a Yes 9.28 RDRC approval letter Per Question 8.7.b Yes 9.29 Scientific Review Committee (SRC) Minutes Per Question 8.8 Yes Investigator's Brochure, drug booklet or information sheet 9.30 Per Question 8.9.a Yes supplied by the drug company (sponsor) FDA letter with the IND/IDE assignment # or PI confirmation 9.31 Per Question 8.9.b Yes letter or documentation of FDA approval from the sponsor Per Question 9.32 FDA Exemption Determination Yes 8.10.b Per Question 9.33 Analysis of IND Exempt requirements Yes 8.10.b.iii Per Question 9.34 Device Supplement Yes 8.11.a 9.35 UW/CC IRB Coversheet Per Question 8.12 Yes 9.36 UW Conflict of Interest Management Plan Per Question 8.12 Yes 9.37 Other Institution Conflict of Interest Management Plan Per Question 8.12 Yes Per Question 9.38 Office of the General Counsel plan Yes 8.12.a.iv 9.39 Other pertinent information. If yes, please list below in sequential order: Yes

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 26 of 28 10. INVESTIGATOR STATEMENT AND SIGNATURE

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 27 of 28 Study Title:

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 subjects 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; and that this research project will not be put into effect until final IRB approval is received.

Signature of Investigator Date

0324IRBForm_NewAppIntervention.doc / Version 1.04 / 08-01-14 / Page 28 of 28