Form 5a NCI Adult/Pediatric CIRB Application for Treatment Studi

NCI ADULT/PEDIATRIC CIRB APPLICATION

FOR

TREATMENT STUDIES

OMB#: 0925 – 0625

Expiry Date: 01/31/2014

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of your participation in the NCI CIRB is protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the NCI CIRB at any time. Refusal to participate will not affect your benefits in any way. The information collected will be kept private to the extent provided by law. Names and other identifiers will not appear in any report of the NCI CIRB. Information provided will be combined for all participants and reported as summaries. You are being requested to complete this instrument so that we can conduct activities involved with the operations of NCI CIRB Initiative.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN

Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0625). Do not return the completed form to this address.

This application, when completed, contains information required by CIRB members to conduct a meaningful review of the study so answer each question as completely as possible. If an answer to any question cannot be provided, please provide an explanation for the missing answer. If you have any questions regarding the completion of this application, please contact the CIRB Helpdesk at 888-657-3711 or [email protected].

APPLICATION COMPLETION DATE:      

GROUP STUDY ID NUMBER:      

STUDY TITLE:      

PROTOCOL VERSION DATE:      

Please provide the protocol and informed consent document with this Protocol Version Date.

CTSU Menu? Yes No

     

STUDY CHAIR
Name
Title
Institution/Address
Phone Number
E-mail
FAX Number
Administrative Assistant Name
Administrative Assistant E-mail
Administrative Assistant Phone Number

STUDY CO-CHAIR (If applicable)
Name
Title
Institution/Address
Phone Number
E-mail
FAX Number
Administrative Assistant Name
Administrative Assistant E-mail
Administrative Assistant Phone Number

CONTACT PERSON (Person to contact with questions about this application)
Name
Title
Institution/Address
Phone Number
E-mail
FAX Number

PLEASE NOTE: CIRB membership includes individuals who are not part of the scientific community. Therefore, you must use lay language (non-medical, non-legal terms) and define all terms unique to science when completing this application.

1.0 Summary of Study

Please answer each of the following questions in 250 words or less per question.

1.1 Indicate the FDA Phase of the study.      

1.2 Describe the purpose of this study (i.e. hypothesis or study objectives).

     

     

1.3 Provide the rationale for the study, including a summary of the background research that has led to your hypothesis/objectives.      

1.4 Explain the study design and how it is appropriate to obtain an answer to the hypothesis.  FORMTEXT          

1.5 Describe the study intervention. (Include schema.)

     

1.5.1 Describe the standard of care treatment for this cancer.      

1.5.2 How does the proposed intervention differ from the standard of care?           

1.6 Describe any exams, tests, and/or procedures that are required for the research and are part of routine cancer care.      

1.7 Describe any exams, tests, and/or procedures that are required for the research and are NOT part of routine cancer care.      

1.8 List inclusion/exclusion criteria for this study.      

     

1.9 Will study participants be required to discontinue or modify current medication or be denied standard of care for any non-cancer condition?      

1.10 Describe the safety monitoring plan for this study.      

1.11 How will the information gained from this study impact the treatment for this disease or condition?      

1.12 How will the research findings be disclosed to study participants?      

2.0 Participants

2.1 Number of participants to be enrolled in the study:      

2.2 Specify the age range of eligible participants:      

If participants under the age of 18 years old are eligible, an assent form must be submitted.

2.3 Projected Enrollment Information at Study Institutions

For your convenience, we have retained the NIH formatting so that you can easily include the information in this application.

2.3.1 Describe the target population in terms of ethnicity:

TARGETED/PLANNED ENROLLMENT: Number of Subjects
Ethnic category	Sex/Gender
	Females	Males	Total
Hispanic or Latino
Not Hispanic or Latino
Ethnic Category Total

2.3.2 Describe the target population in terms of race:

TARGETED/PLANNED ENROLLMENT: Number of Subjects
	Sex/Gender
Racial Categories	Females	Males	Total
American Indian/Alaska Native
Asian
Black or African American
Native Hawaiian or Other Pacific Islander
White
Racial Categories: Total of all Subjects

2.3.3 If there are zeroes in any of the categories in either chart, provide a justification for the exclusion.      

2.4 Vulnerable Populations

2.4.1 Which of the following vulnerable populations are eligible to participate in the study?

a. Children Eligible Ineligible

b. Prisoners Eligible Ineligible

c. Pregnant women Eligible Ineligible

d. Persons with Impaired Decision-Making Capacity

Eligible Ineligible

5. Economically Disadvantaged Eligible Ineligible

6. Educationally Disadvantaged Eligible Ineligible

g. Physically Disabled Eligible Ineligible

2.4.2 Rationale for Ineligibility: Federal regulations [45 CFR 46.111(a)(3) and 21 CFR 56.111(a)(3)] require equitable selection of participants. If you checked “Ineligible” for any of the categories above, provide a scientific reason for the ineligibility.      

2.4.3 If vulnerable populations are eligible to participate in the study, indicate safeguards included in the protocol to protect their rights and welfare per 45 CFR 46.111(b) and 21 CFR 56.111(b).

List of possible safeguards by vulnerable population:

a. Children

Youth Information Sheets to facilitate assent

Risk-appropriate clinical monitoring

Researchers participating in the study are credentialed in pediatrics

Additional Safeguards:      

b. Pregnant Women

Inclusion is scientifically appropriate based on preclinical studies

Information is provided in the protocol pertaining to how study intervention could impact the woman and the fetus

Information is provided in the informed consent document pertaining to how study intervention could impact the woman and the fetus

Risk-appropriate clinical monitoring

Additional Safeguards:      

c. Persons with Impaired Decision-Making Capacity

Protocol permits Legally Authorized Representative

Protocol permits assent

Additional Safeguards:      

d. Economically Disadvantaged

Cost burden is fully explained in the informed consent document.

No financial incentives are provided to study participants.

Additional Safeguards:      

e. Educationally Disadvantaged

Investigators are encouraged to provide verbal explanation of the research in lay language

Investigators are encouraged to provide extra time to answer questions

Investigators are encouraged to include family members/significant others in the informed consent process at the participant’s request.

Additional Safeguards:     

f. Physically Disabled

Investigators are encouraged to consider the unique needs of the disabled when considering them as study participants.

Risk-appropriate clinical monitoring

Additional Safeguards:      

2.5 Recruitment

2.5.1 Have any recruitment materials targeted to potential study participants (videos, brochures, letters, etc.) been prepared for this study?

Yes No

If yes, please include a copy of the recruitment materials.

NOTE: As a reminder, any recruitment material targeted to potential study participants must be CIRB-approved prior to distribution. We encourage you to submit drafts for review prior to final production.

2.5.2 Will the participants receive agents/drugs/biologics, tests, procedures, or medical care without charge? Yes No

2.5.2.1 If yes, please describe.      

2.5.3 Are there any incentives for participating in this study?

      Yes No

2.5.3.1 If yes, please describe.      

2.6 Costs

2.6.1 Will the study participants be responsible for any research-related costs?Yes No

If yes, please describe.      

2.6.2 Does the Cooperative Group have any plans to subsidize these extra costs for study participants who cannot afford them?

Yes No

If yes, please describe.      

3.0 Agents/Drugs/Biologics

3.1 Please provide the following information for all agents/drugs/biologics to be used in this study. Sections for three agents/drugs/biologics have been provided. Copy and paste additional sections if needed.

Information for Agent/Drug/Biologic

a. Agent/drug/biologic name (generic and trade):      

b. Manufacturer:      

c. Provided by: NCI Manufacturer Other,      

d. For this study, is the agent/drug/biologic being used under an IND?

Yes No

If yes, please provide:

IND#:      

Holder of IND:      

e. Is there an Investigator’s Brochure? Yes No

If yes, please provide a copy of the Investigator’s Brochure.

f. Is the agent/drug/biologic being used off-label? Yes No

Information for Agent/Drug/Biologic

a. Agent/drug/biologic name (generic and trade):      

b. Manufacturer:      

c. Provided by: NCI Manufacturer Other,      

d. For this study, is the agent/drug/biologic being used under an IND?

Yes No

If yes, please provide:

IND#:      

Holder of IND:      

e. Is there an Investigator’s Brochure? Yes No

If yes, please provide a copy of the Investigator’s Brochure.

f. Is the agent/drug/biologic being used off-label? Yes No

Information for Agent/Drug/Biologic

a. Agent/drug/biologic name (generic and trade):      

b. Manufacturer:      

c. Provided by: NCI Manufacturer Other,      

d. For this study, is the agent/drug/biologic being used under an IND?

Yes No

If yes, please provide:

IND#:      

Holder of IND:      

e. Is there an Investigator’s Brochure? Yes No

If yes, please provide a copy of the Investigator’s Brochure.

f. Is the agent/drug/biologic being used off-label? Yes No

4.0 Radiation

4.1 Does this study involve radiation? Yes No

(If no, skip to Section 5.0.)

If yes, specify the type of radiation that the participant will receive:

Diagnostic Therapeutic Both

4.2 Is any radiation modality or dose experimental?

Yes No

If yes, describe.      

5.0 Surgery

5.1 Does the study question involve experimental surgery? Yes No

(If no, skip to Section 6.0.)

If yes, describe.      

6.0 Genetic Research

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).

6.1 Will the research identify genetic characteristics? Yes No

If yes, complete this section. If no, go to Section 11.0.

   6.1.1 Will the identified genetic characteristics be disclosed to the study physician?

Yes No

If yes, will study participants be given the option to not have the identified genetic characteristics disclosed to the study physician? Yes No

6.1.2 Is it the plan to disclose the identified genetic characteristics to the study participant?

Yes No

6.1.2.1 If yes, will study participants be given the option to not receive the results?

Yes No

6.1.2.2 Describe how the identified genetic characteristics will be communicated to the study participant.      

6.2 Describe the confidentiality measures taken to protect the data from disclosure to third parties.      

     

6.3 Describe the storage and security measures taken to protect the tissue samples.      

     

6.4 What will happen to the tissue samples in the event that a participant withdraws from the study?      

7.0 Medical Risks

7.1 Describe the known or foreseeable risks or discomforts, including reproductive risks for both women and men, by agent/drug/biologic or regimen for all agents/drugs /biologics to be used in this study as listed in section 3.0.

     

7.2 Describe the known or foreseeable risks or discomforts, including reproductive risks for both women and men, associated with the radiation modality to be used in this study as listed in section 4.0.      

7.3 Describe the known or foreseeable risks or discomforts, including reproductive risks for both women and men, associated with the surgery to be performed in this study as listed in section 5.0.

     

7.4 Describe the known or foreseeable risks or discomforts, including reproductive risks for both women and men, associated with procedures pertaining to the research question.

     

7.5 List measures planned to minimize known or foreseeable risks or discomforts identified in Questions 7.1, 7.2, 7.3, and 7.4.

     

7.6 What are the medical criteria for withdrawing a participant from the study?      

8.0 Non-Medical Risks

8.1 Describe measures taken by the Cooperative Group to maintain the confidentiality of identifiable information.      

8.2 Describe the possible psychological and social risk associated with the genetic research, if applicable.      

8.2.1 Describe measures taken to minimize these risks.      

8.3 Are there any other non-medical risks associated with participation in this research (for example, psychological, social, economic, or legal risks)?

Yes No

If yes, describe.      

9.0 Benefits

9.1 Describe the potential benefits of participating in the study.      

   9.2 Do the potential benefits outweigh the risks inherent in participating in the study?

Yes No

If yes, explain.      

10.0 Alternatives

10.1 Other than standard of care, are there any alternative procedures or other courses of therapy for this cancer that could be used outside of the research?

Yes No

If yes, explain.      

11.0 Storage of Specimens for Future Research Studies

11.1 Does this study involve collection of specimens for future research studies?

Yes No

If no, skip to Section 12.0. If yes, complete this section.

11.1.1 Describe and justify the types of specimens to be collected, the procedure for collecting the specimen, and the amount of the specimen to be collected.      

11.1.2 Will the specimens be linked to the study participants?

Yes No      

If yes, explain.      

11.1.3 For what types of research are study participants consenting to have the tissues used?      

     

11.1.4 How will access to the specimens be governed?      

     

11.1.5 What procedure will be used if the study participant withdraws consent after the specimen has been collected and stored?

     

     

12.0 Ancillary Studies

12.1 Will study participants be asked to register in any ancillary/companion studies?

Yes No

If yes, describe the study(ies) and indicate if the study(ies) is mandatory or option.      

NOTE ABOUT ANCILLARY STUDIES:

The CIRB reviews new ancillary/companion studies that have not been included in the main research study. Complete the Cooperative Group Ancillary Protocol Review Application - Treatment Studies.

13.0 Conflicts of Interest

13.1 Does the Study Chair or any principal involved in the development or coordination of this study have any significant financial conflicts of interest as defined in the Conflict of Interest Policy for Cooperative Group Phase 3 Clinical Trials?

Yes No If yes, please answer question 13.2.

     

13.2 Does the Cooperative Group have a management plan in place to address the conflicts disclosed in question 13.1?

Yes No

If yes, provide a copy of the management plan.

Summary of CIRB-Requested Supporting Documents

Protocol upon which this application is based (REQUIRED)

Informed consent document with the same Protocol Version Date as the protocol (REQUIRED)

Recruitment material (Question 2.5.1, if applicable)

Investigator’s Brochure (Question 3.1.e, if applicable)

Management plan to address new or revised conflicts (Question 13.2, if applicable)

Materials for reconsenting participants (as outlined below, if applicable)

** Special Section: Amendment-Specific Information**

This section should be completed only when this application is being updated as the result of an amendment to the study.

1.0 Briefly describe what prompted this amendment:      

2.0 Are any of the changes in this amendment significant enough to impact a study participant’s willingness to continue participation in the research?

Yes No

2.1 If yes, describe how these findings will be presented to study participants.

     

2.2 If yes, should the study participants be reconsented?

Yes No

If yes, indicate how study participants will be reconsented (letter, addendum, reconsent).      

Provide drafts of reconsent documents.

If you have any questions regarding the completion of this application, please contact the CIRB Helpdesk at 888-657-3711 or [email protected].

Thank you for completing the NCI Adult/Pediatric Application for Treatment Studies. Please submit the completed application and the required supporting documents via email to [email protected] or [email protected].

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