Completing the Initial Review Application

• The first section of the Initial Review Application is prepopulated by CIRB staff and is not open to edits. Review the information in these fields and click Next. If you notice an error, please contact the CIRB Operations Office using the emails listed above.

• Header section: Contains OMB boilerplate language regarding the purpose of the application and estimated time to complete the application.
• Study ID: Prepopulated.
• Study Title: Prepopulated.
• Protocol Version Date: Enter the protocol version date (PVD) of the protocol.
• Provide the protocol and consent form that matches this date: Upload the protocol and consent form(s) for the study, if applicable. Ensure the PVDs match.
• Event: Prepopulated.
• Study Chair: Prepopulated based on the protocol received from PIO.
• Change of Study Chair: If the Study Chair has changed, enter the new Chair’s email address.
• Additional Contacts: List up to four names and email addresses of individuals who should receive CIRB letters in addition to the Study Chair. Each name and email address should be entered as separate lines.
• Contact Person: Enter the email address of the person responsible for communicating with the CIRB. This is typically the protocol coordinator. Note: Press the Tab key after entering the email to populate the field.

• Question 1.1: Indicate the regulatory phase of the study (FDA phase). Select the FDA phase that applies to this protocol (e.g., Phase I, II, III, IV). If not applicable, state so.
• Question 1.2: Summarize the purpose or objective of the study. Describe in plain language the study objectives or hypothesis being tested in the study.
• Question 1.3: Explain the rationale and background for this study. Summarize the research or medical background that led to the development of this study. Reference prior findings that support the study’s objectives or hypothesis if applicable.
• Question 1.4: Describe how the study is designed to test the research question. Explain the structure of the study (e.g., randomized, controlled trial) and how it will provide answers to the study questions or hypothesis.
• Question 1.5: Describe what is being tested or administered in the study. Identify the drug, device, or other intervention being used in the study.
• Question 1.5.1: Summarize the usual or standard treatment for this condition. Briefly outline how patients with this condition are typically treated outside of a study.
• Question 1.5.2: Highlight how the study’s intervention differs from usual care. Describe the ways the study intervention differs from standard care (e.g., different timing, combination, method).
• Question 1.6: List any study procedures that are not part of routine care for the cancer. List procedures done only for research purposes that are not part of routine care.
• Question 1.7: Provide eligibility criteria in simple terms. Include a summary of who is allowed or excluded from participating. Reference the protocol or consent for specifics if the information is provided in plain language. Otherwise summarize in plain language below.
• Question 1.8: Changes to Current Medications or standard of care. (Select: Yes/No). Indicate if participants will need to stop or change any of their current treatments due to study participation.
• If Yes, briefly explain what will be modified or withheld and why. Reference the protocol section or consent for specifics if the information is provided in plain language. Otherwise summarize in plain language.
• Question 1.9: Outline how participant safety will be monitored. Explain how safety checks will be done, who is responsible, and how often monitoring will occur. Reference the protocol or consent for specifics if the information is provided in plain language. Otherwise summarize in plain language.
  Question 1.10: Describe the potential future impact of the study. Explain the possible value of the study for treating this disease or advancing scientific knowledge.
• Question 1.11: Explain how study results will be shared with participants. Describe the process for informing participants about the study outcomes, either individually or in summary.
   

• Question 2.1: Number of participants. Enter the number of participants expected to take part in the study.
• Question 2.2: Will participants under 18 be included? Select Yes/No.
• Question 2.3: Enrollment breakdown by ethnicity and race. Provide the protocol section and page number where tables for race/ethnicity enrollment can be found.
• Question 2.3.1:  Are there zeroes in any of the categories in either chart? Explain any zeroes in the referenced chart.
• Question 2.4: Indicate if there are any zeroes in the enrollment categories. Select Yes/No. If Yes, provide an explanation.
• 2.4.2 Is a waiver of documentation or alteration of the informed consent process being requested? Select Yes/No
• Type of Waiver being requested. Select Waiver/alteration of elements of informed consent or Waiver of documentation of informed consent.

A study must meet specific criteria in order to qualify for a waiver/alteration of elements of informed consent. The questions below are designed to assist the CIRB in making either or both of these determinations.

INSTRUCTIONS: Answer the following questions. You may cite the protocol section and page number that includes this information:

Waiver or Alteration of Elements of Informed Consent

Only complete this section if you are requesting a full waiver of consent or a waiver or alteration of the required elements of consent.

This form has been designed to meet the regulatory requirements for review, so answer each question as completely as possible.

All answers must be in lay language.

• If an answer to any question cannot be provided, provide an explanation for the missing answer.
• If you have any questions regarding the completion of this application, contact the CIRB Helpdesk at support@ncicirbcontact.zendesk.com or 888-657-3711 or refer to the Waiver of Consent (WoC) QuickGuide.

• Question 1: Type of waiver or alteration requested.
• Basic Elements (Unless a waiver is granted, basic elements of consent are required) [CFR 45 46.116(b)].
• Additional Elements as Appropriate (A waiver for these elements is only needed if the elements are applicable to your study.  More information can be found here [CFR 45 46.116(c)].
• Question 2: The study involves only research activities that are no more than minimal risk to the subjects [46.116(d)(1) / 46.116(f)(3)(i)].
  Provide the details of the research activities and rationale for response.
• Question 3: The research activities could not be practicably carried out without the requested waiver or alteration [46.116(d)(3) / 46.116(f)(3)(ii)]. Select Yes/No.
  Provide rationale for this response.
• Question 4: If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format [46.116(d)(3) / 46.116(f)(3)(iii)]. Select Yes/No.
  Provide a rationale for this response.
• Question 5: The waiver or alteration will not adversely affect the rights and welfare of the subjects [46.116(d)(2) / 46.116(f)(3)(iv)]. Select Yes/No.
  Provide procedures for how subjects rights and welfare will be protected.
• Question 6: Whenever appropriate, subjects or legally authorized representatives will be provided with additional pertinent information after participation [46.116(d)(4) / 46.116(f)(3)(v)]. Select Yes/No/N/A.
  Provide a rationale for this response, including a description of how participants or legally authorized representatives will be informed.

A study must meet specific criteria in order to qualify for a waiver/alteration of elements of informed consent or a waiver of documentation of informed consent. The questions below are designed to assist the CIRB in making either or both of these determinations.  If you are requesting a waiver of documentation of informed consent, please complete this section, providing your assessment below along with the requested rationales.  

INSTRUCTIONS: Answer the following questions. You may cite the protocol section and page number that includes this information.

Waiver of Documentation of Informed Consent

Only complete this section if you are requesting a waiver of documentation of informed consent (waiver of the signature requirement).

This form has been designed to meet the regulatory requirements for review, so answer each question as completely as possible.

All answers must be in lay language.

• If an answer to any question cannot be provided, provide an explanation for the missing answer.
• If you have any questions regarding the completion of this application, contact the CIRB Helpdesk at support@ncicirbcontact.zendesk.com or 888-657-3711 or refer to the Waiver of Consent (WoC) QuickGuide.
   

• Question 1: The only record linking the subject and the research would be the informed consent form and the principal risk would be the potential harm resulting from a breach of confidentiality.  Select Yes/No. [NOTE:If ‘Yes”, each subject (or legally authorized representative) should be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern] [46.117(c)(1)(i)].
  Provide the details of the activity and rationale for response.
• Question 2: The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context [46.117(c)(1)(ii)]. Select Yes/No. 
  Provide the details of the activity and rationale for response.
• Question 3:. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects and there is an appropriate alternative mechanism for documenting that informed consent was obtained [46.117(c)(1)(iii)]. Select Yes/No/N/A.
  Provide rationale for response.
• Question 4: Subjects or legally authorized representatives will be provided with a written statement regarding the research. [NOTE:A “Yes” response is not required but the IRB has the authority to require that a written statement be provided to subjects or legally authorized representatives.] [46.117(c)(2)]. Select Yes/No. 
  Provide rationale for response: 

• Question 2.4: Cite the protocol reference for the consent process. Enter the section and page number in the protocol where the consent process is described. This must show how informed consent will be obtained, in line with federal regulation 45 CFR 46.116.
• Question 2.4.1: Indicate if full written consent will be obtained from participants. Select Yes/No.

• Question 2.5.1: For each population, select Eligible/Ineligible. If eligible, check all appropriate safeguards that apply. If additional safeguards will be used, describe them in the text field provided.
  a. Children
  b. Prisoners  Note: The CIRB does not review research involving prisoners. If any non-CIRB site will enroll prisoners, indicate this. Otherwise, select Ineligible.
  c. Pregnant Women
  d. Persons with Impaired Decision-Making Capacity
  e. Economically Disadvantaged
  f. Educationally Disadvantaged
  g. Physically Disabled
• Question 2.5.2: Rationale for Ineligibility. If any of the categories above are marked Ineligible, provide a justification in accordance with 45 CFR 46.111(a)(3) and 21 CFR 56.111(a)(3). Explain the scientific, ethical, or regulatory basis for excluding that population.

Recruitment materials must be CIRB-approved before use.
   For CTEP studies: Submit directly to CIRB.
   For DCP studies: Submit to DCP Protocol Information Office (PIO) for approval before CIRB review.
 

• Question 2.6.1: Are recruitment materials already available? Select Yes/No.
  If Yes, upload materials and describe how they will be distributed.
  Question 2.6.2: Will recruitment materials be prepared in the future? Select Yes/No/Unknown.
• Question 2.6.2.1: Describe planned recruitment materials and how they’ll be used. If Yes to the above, explain what types are planned and how they will be distributed.
  Attach draft versions if available
• Question 2.6.3: Indicate if any medical care or study-related services will be provided free of charge.
  If Yes, specify what items (e.g., drugs, tests) will be provided. Select Yes/No.
• Question 2.6.4: Indicate if participants will receive any incentives. Select Yes/No.
  If Yes, describe what incentives will be offered (e.g., travel reimbursements, stipends).
   

• Question 2.7.1: Indicate if participants are responsible for any study-related costs. Select Yes/No.
  If Yes, explain what costs participants may be responsible for.
• Question 2.7.2: Will there be help covering costs for those who can't afford it? Select Yes/No.
  If Yes, explain the reimbursement plan for financially challenged participants.

Provide the following for each agent/drug/biologic. Use the "Repeat" option on the form to create new entries for each agent/drug/biologic.

• Indicate whether any agents, drugs, or biologics are used in the study. Select Yes/No.
• List each agent, drug, or biologic (generic and trade name).
• Document manufacturer.
• Select who is providing the agent—NCI, the manufacturer, or another source.
  If "Other" is selected, enter the name of the provider.
• Indicate if the agent is used under an IND. 
  If Yes, enter the IND number and the IND holder's name.
• Indicate if an Investigator’s Brochure is available.
  If Yes, attach a copy.
• Indicate whether the use of the Agent/Drug/Biologic is off-label. Select Yes/No

Provide detailed information for each investigational medical device used in the study. Use the "Repeat" option on the form to create new entries for each device.
 

• Question 4.1: FDA Definition of Device. Indicate whether any device used in this study meets the FDA’s definition of an investigational medical device? (See instructions for more details) Select Yes/No.
• Question 4.2: Device Information. For each device being used, complete the following fields:
  Enter the generic or proprietary name.
  Enter the name of the manufacturer.
  Indicate the current FDA status of the device. Refer to FDA Registration and Listing, Databases for Approvals and Clearances, and 510(k) Exemptions for more information on these statuses.
  Briefly describe any interactions held with FDA regarding the use and regulatory status of the device.
• Question 4.3: Supporting Documents. Upload device manuals, safety documents, and other relevant materials.
• Question 4.4: Effectiveness/Safety. Indicate whether the study will evaluate the device’s effectiveness, safety, both, or neither.
  Device Classification
  Using FDA guidance or instructions indicate if the device qualifies under any listed category (General Wellness Device – Low Risk, Non-Medical Exercise Equipment, FDA Exempt Device). If so, briefly explain how it meets the criteria (see FDA guidance for more information).
• Question 4.5: Risk Determination. If the device does not meet criteria for General Wellness, Non-Medical Exercise Equipment, or FDA exemption, submit it for CIRB risk determination.
  Indicate whether the device is Non-Significant Risk (NSR) or Significant Risk (SR).
  Summarize any known safety concerns or risks related to the device and rationale for classification. Refer to the FDA’s guidance on Significant Risk and Nonsignificant Risk Medical Device Studies to make a determination.
• Question 4.6: Device Management & Monitoring.
• Question 4.6.1: Device Accountability. Describe how and where the device will be obtained
• Question 4.6.2: Secure Storage. Describe how the device will be stored securely.
• Question 4.6.3: Dispensing. Describe how the device will be distributed to study participants.
• Question 4.6.4: Use Tracking. Describe how you will monitor use and maintain inventory records.
• Question 4.6.5: End-of-Study Disposal. Describe how the device will be disposed of after the study ends.
• Question 4.6.6: Protocol & Safety Monitoring.
  Attach written SOPs if available for device handling and tracking.
• Question 4.6.7: Monitoring Protocol Compliance (Refer to the monitoring plan for more information). Describe how you will ensure the protocol is followed.
• Question 4.6.8: Subject Safety and Data Monitoring. Describe your plan for ongoing data and participant safety monitoring.
  Action: Attach relevant SOPs if available.

• Question 5.1: Indicate if the study involve radiation? Select Yes/No. 

  If Yes, specify the type of radiation used.
  Indicate whether it’s diagnostic, therapeutic, or both.

• Question 5.2: Indicate if any radiation dose or modality is experimental? Select Yes/No. 

  If Yes, and the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.

• Question 6.1: Indicate if the study involves experimental surgery. Select Yes/No. 
  If Yes, and the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.

Genetic research is carried out on a continuum comprising of four stages: (1) to discover the pattern of inheritance of a disease and to catalog the range of symptoms involved (pedigree studies); (2) to localize and identify specific genes (positional cloning studies); (3) to develop techniques for determining the presence of specific DNA mutations (DNA diagnostic studies); and (4) to develop treatments for genetic disease at the DNA level (gene therapy research).
 

• Question 7.1: Indicate whether the study will identify genetic characteristics. Select Yes/No. If Yes, complete all related questions in this section.
• Question 7.1.1: Indicate if the identified genetic traits will be shared with the study doctors? Select Yes/No.
  If Yes, can participants opt out of sharing results with physicians? Select Yes/No
• Question 7.1.2: Will the identified genetic traits results be shared with study participants? Select Yes/No.
• Question 7.1.2.1: If Yes, can study participants decline to receive the identified genetic traits results? Select Yes/No.
• Question 7.1.2.2: Explain how the identified genetic traits results will be communicated to study participants.
  State if the results will be verbal, written, or electronic.
• Question 7.2: Explain confidentiality protections
  Outline how personal genetic data will be kept secure.
• Question 7.3: Explain the psychological or social risks
  List possible emotional, family, or societal risks.
• Question 7.3.1: What steps will be taken to reduce those risks?
  If the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.
• Question 7.4: Explain how samples will be stored.
  Explain storage procedures and access restrictions.
• Question 7.5: Explain what will happen to collected samples if a participant withdraws from the study
  State whether samples are destroyed, returned, or anonymized.

• Question 8.1 Risks of the study interventions. Explain the side effects or health risks from study drugs, biologics or agents including any reproductive risks for both men and women, if applicable.
  If the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.
• Question 8.2 Risks of radiation. Explain the side effects or health risks from radiation methods, including any reproductive risks for both men and women, if applicable. If the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.
• Question 8.3 Risks of surgery. Outline the side effects or health risks associated with the surgery listed in section 5.0, including any reproductive risks for both men and women, if applicable. If the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.
• Question 8.4 Risks of associated study procedure. Explain the side effects or health risks associated with the study procedures listed in question 1.6, including any reproductive risks for both men and women, if applicable.
  If the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.
• Question 8.5 How risks will be reduced. Outline steps to reduce risks or discomforts described in 8.1–8.4.
  If the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.
• Question 8.6 What are the conditions for participant withdrawal. Explain clinical reasons a participant may be removed from the study. If the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.

• Question 9.1: Outline how identifiable information will be kept confidential. Briefly explain the steps in place to protect participant privacy and secure any identifiable data (e.g., coding, limited access, secure storage. If the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.
• Question 9.2: Identify any non-medical risks related to participation. Indicate if the study involves risks outside of health (e.g., social, legal, emotional and economic). If the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.

• Question 10.1: Summarize potential benefits for participants. Briefly state how participants may benefit from being in the study, if any. If there are no direct benefits, indicate that as well. If the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary below.
• Question 10.2: Indicate if benefits outweigh risks. Select Yes/No.
  If Yes, provide justification for why benefits are greater than risks.

• Question 11.1: State alternatives to participation. List other treatments available other than standard care or joining this study. If the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.

• Question 12.1: Indicate if specimens will be stored for future research. Select Yes/No. Complete all parts if Yes.
• Question 12.1.1 Explain the types, collection methods, and quantity of specimens to be obtained
  Include the kind of samples to be collected, how they will be obtained, and the amount taken. Justify why these are necessary for the study.
• Question 12.1.2 Indicate if study samples will be identifiable. Select Yes/No.
  If Yes, explain if specimens are coded, anonymous, or linked.
• Question 12.1.3 Explain how specimens will be accessed and who will have access.
  Describe the process for accessing the samples and list the individuals or groups who will be allowed to access them.
• Question 12.1.4 State what happens to samples if a participant withdraws consent.
  Explain what will happen to samples if a participant leaves the study. Say if they will be destroyed, anonymized or retained, and under what circumstances or conditions.

• Question 13.1: Indicate if participants will be asked to join any additional research. Select Yes/No. 
  If Yes, and the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.
• Question 13.2: Indicate if joining another study is a requirement for taking part in this one. Select Yes/No. 
  If Yes, and the information is described in lay language, reference the protocol section and page number. Otherwise, provide a summary.

Ensure all recruitment materials are CIRB-approved before they are shared with participants.
   For CTEP studies, send directly to the CIRB.
   For DCP studies, submit to the DCP Protocol Information Office (PIO) for approval before CIRB review.

• Question 14.1: Quality Of Life or Patient Reported Outcome Questionnaires. Indicate if participants will complete Quality of Life (QOL) or Patient-Reported Outcome (PRO) questionnaires. Select Yes/No.
  If Yes, confirm whether copies will be submitted with this initial application. Select Yes/No.
  Briefly describe the materials you plan to use and how you plan to share them with participants.
  Upload the forms participants will be asked to complete.
• Question 14.2: Educational Materials. Indicate if participants will receive any study-related educational materials at enrollment. Select Yes/No.
  If Yes, confirm whether the materials will be submitted with this initial application. Select Yes/No
  Upload the materials and your plan for distribution to study participants.

• Question 15.1: Indicate if the Study Chair or any listed team member has a financial conflict of interest related to the study. Select Yes/No.
• Question 15.2: If Yes, confirm whether a management plan is in place to address the conflict. Select Yes/No.
  If Yes, upload the conflict management plan.

• Check all applicable items from the list and confirm they are uploaded with your submission.
  If draft versions are included for CIRB reference only, select all that apply and upload them. These will not be reviewed until final submission.
• Ensure the full application is submitted within 10 days of the CTEP Approval-On-Hold notification. Meeting and submission deadlines can be found here.