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Background:
iStar questions that are marked with a red asterisk (*) require a response from you. If you do not respond to a required question, you will receive an error message when you click “Continue.” You must provide a response to all required questions before you can proceed to the next iStar screen.

 1.1 *Type of Submission:
Select the type of submission:

§         Research Protocol or Study. Choose this for any research involving human subjects (both funded and unfunded research). For more information on student research, please refer to the Student Researchers Page and the brochure, Making Sense of Human Subjects Research: A Student Guide.

§         Grant/Contract Only. Choose this only if you have been awarded a grant or contract and you are submitting the grant application or contract for administrative review. Administrative review by the IRB is required for certain types of grants, cooperative agreements, and contracts that will either: (1) involve human subjects research at a later date, but definite plans are not described at the time the grant or contract is awarded (45 CFR 46.118) or (2) involve research undertaken without the intention of involving human subjects (45 CFR 46.119) or (3) support more than one human subjects research protocol.

§         If your grant or contract will not fund any human subjects research, you do not need to submit the award to the IRB for administrative review.

Examples:

·         Research Program Project Grants, Cooperative Agreements, or other multidisciplinary, long-term awards that will fund multiple human subjects research protocols

·         Center Grants or Core Grants that support a number of investigators and will fund multiple human subjects research protocols

·         Research Training Grants in which the activities involving human subjects remain to be selected

·         Research Projects in which the involvement of human subjects is dependent upon completion of animal studies, development of instruments or methods, or other preliminary activities

·         Private or Foundation Grants that fund multiple human subjects research protocols

·         HSC only: Grant renewals or progress reports for grants that received administrative approval prior to the implementation of iStar

Administrative approval of the award does NOT constitute approval of any research involving human subjects; it simply acknowledges the intent of the award application. No human subjects may be involved in any project supported by these awards until that project has been reviewed and approved by the IRB.  

If you were awarded a grant that funds only one project involving human subjects, you do not need to submit the grant separately for administrative review. You may submit the grant and research protocol together in one iStar application. If two or more grants fund one project involving human subjects research, you need to submit each grant separately for administrative review.

NOTE: Grant applications sent to the National Institutes of Health (NIH) should not be submitted to the IRB until you receive a fundable score from NIH.

§         Facilitated Review (NCI CIRB). Choose this only for studies previously approved by the CIRB (Central Institutional Review Board of the National Cancer Institute). This option should be chosen only for phase III multi-center cancer trials. If you are unsure whether your study qualifies for facilitated review, please consult your IRB/CCI before continuing with this application.

1.2. *Full Title of Research Protocol
Type the full title of the research project. If there is a clinical protocol or grant application, use the same title that appears on the protocol or application.
 

1.3. *Short Title
Type a short title, using main key words from the full title. This short title cannot exceed 256 characters.

1.3.1. (HSC/CHLA only) If there is a sponsor protocol number associated with this file, specify it here:
(HSC/CHLA only) If your research is funded by a sponsor and the sponsor provided a protocol or proposal, please add the protocol number here.
 
1.4. *Please indicate which IRB you are requesting review from:
You may submit this research protocol to one of three IRBs, depending on the location of your research. The IRB site you choose will determine which items must be completed in the remainder of this application.

Background:
All key personnel listed on the iStar application must complete the CITI human subjects training before the study can be approved by the IRB. “Key personnel” are those responsible for development of the protocol and conduct and reporting of the research. This includes, but is not limited to, the Principal Investigator, Co-Investigators, Study Coordinator or Contact Person, Faculty Advisor, recruitment staff, and anyone else performing study procedures or interventions. Individuals who are NOT considered “key personnel” include technical staff such as data entry personnel, statisticians, IT support, and administrative staff who provide secretarial support or logistics coordination.

The status and expiration date for the human subjects certification (“HS Certification”) appears in iStar when the individual completes CITI and is added to the iStar application in section #2. For more information on obtaining certification, visit the CITI Human Subjects Education Program web page.

The following grid shows some common activities that can be performed by the study team in iStar:

Activity	Principal Investigator	Co-Investigator	Study Team (Normal Access)	Study Team (Read Only Access)	Study Team (Edit Only Access)
submit a new study	✓
withdraw a study	✓	✓	✓
submit a new amendment	✓	✓	✓
submit a reportable event	✓	✓
submit a continuing review	✓	✓	✓
view a study, amendment, continuing review or reportable event	✓	✓	✓	✓	✓
edit a study, amendment, continuing review or reportable event	✓	✓	✓		✓
close a study	✓	✓	✓

2.1. Principal Investigator (PI)
Using the “Select” button, choose the single individual who will be responsible for the conduct of the research study at this site. Only one Principal Investigator may be assigned per study.. If the name of the Principal Investigator does not appear in the list, it means he or she does not yet have an iStar account. To obtain an iStar account for yourself or on behalf of another, send an email request including the name, email address, and department / school to istar@usc.edu.

If you are a student, please consult with your academic unit or faculty advisor to determine if you should be listed as the Principal Investigator (with a Faculty Advisor) or as a Co-Investigator.

For Aditional Information:
If your study uses an investigational drug, additional information on the roles and responsibilities of the Principal Investigator is available from the Food and Drug Administration’s E6: Good Clinical Practice.

Study Coordinator or Contact Person
Using the "Select" button, choose the individual who will serve as the main contact for the IRB.  This person will send and receive IRB correspondence, study-related documents, and revisions. The IRB will contact this person, if needed, to answer application-related questions.. If the name of the Study Coordinator or Contact Person does not appear in the list, it means he or she does not yet have an iStar account. To obtain an iStar account, send an email request including the name, email address, and department / school to istar@usc.edu.

Examples:

The following study personnel are commonly listed as the study coordinator or contact person on an IRB application:

·         Principal Investigator or Co-Investigator

·         Clinical Nurse Coordinator or Research Nurse

·         Department Administrator

·         Research Assistant

·         Research Coordinator

·         Student Researcher

·         Teaching Assistant

Co-Investigators
Using the "Add" button, choose all co-investigators who will be involved with the conduct of this study (you may select more than one at a time). If the name of a Co-Investigator does not appear in the list, it means he or she does not yet have an iStar account. To obtain an iStar account, send an email request including the name, email address, and department / school to istar@usc.edu.

Please note that this application will be routed automatically to all listed Co-Investigators and to their Department Chairs and Division Chiefs for electronic signatures. The iStar system will not forward the application to the IRB until all of these individuals have signed off electronically. You can monitor whether or not signatures have been provided by looking at the study status in iStar.

Other Study Personnel and their roles
Using the "Add" button, choose any other individuals whom the PI wishes to authorize to make changes to this application (you may select more than one at a time). If the name of the individual does not appear in the list, it means he or she does not yet have an iStar account. To obtain an iStar account, send an email request including the name, email address, and department / school to istar@usc.edu.

Do NOT add any individual who is already identified as a Co-Investigator or contact person above. Please include any study personnel who will be involved in the informed consent process both here and in section #30.1.

Add a brief description of the individual's role in this research, such as data collection, data management, nursing, regulatory, pharmacy, or clinical coordination. 

Examples: The following are commonly listed as “Other Study Personnel” on an IRB application:

·         Colleague at another institution

·         Research Assistant

·         Teaching Assistant

·         Department Administrator

·         Data Manager

2.2. Is the Principal Investigator a student, resident, or visiting scholar? (HSC)

Is the Principal Investigator an undergraduate student, graduate student, postdoctoral fellow, or visiting scholar? (UPC)

Is the Principal Investigator a student, resident, trainee, or visiting scholar? (CHLA)
If the Principal Investigator is an intern, resident, fellow, or visiting scholar at UPC, HSC, or CHLA, answer “Yes” to this question. If the Principal Investigator is a student at USC (HSC or UPC), please contact the student’s academic unit to determine if the student should be listed as the Principal Investigator (answer "Yes" to this question) or as a Co-Investigator (answer “No” to this question). If the Principal Investigator is a student at CHLA, answer "Yes" to this question.

If yes, please designate a Faculty Advisor:
If you answered “Yes” to #2.5 above, you must select a Faculty Advisor. The Faculty Advisor assumes responsibility for the Principal Investigator's conduct of this research protocol. Please note that this application will be routed automatically to the Faculty Advisor for approval. The iStar system will not forward your application to the IRB until the Faculty Advisor has signed off electronically.

If the name of your faculty advisor does not appear in the list, it means he or she does not yet have an iStar account or they do not have the faculty advisor user role. To obtain an iStar account or to request the faculty advisor user role, send an email request including the name, email address, and department / school to istar@usc.edu.

Examples:The Faculty Advisor should be a faculty member associated with USC and/or CHLA, such as:

·         Chair of Dissertation Committee, who may also be a Professor and the Faculty Advisor/Sponsor

·         Faculty Member

·         Lead Physician

·         Senior CHLA Staff Member (CHLA only)

·         Other researchers (investigators) involved in the conduct of the research

(HSC Only) Does this study require Cancer Center Clinical Investigations Committee (CIC) approval?
Choose "yes" if the proposed research study involves cancer patients. If so, you must submit your study to the Clinical Investigations Support Office (CISO) for approval prior to IRB review. You may contact CISO at (323) 865-0451 for more information.

2.4. (HSC Only) Specify the group/organization who has reviewed this study for scientific merit
Examples include scientific merit review by the Cancer Center Clinical Investigations Committee (CIC); by NIH, FDA, or other federal agency; or by a dissertation committee. If your study is investigator-initiated and has not undergone scientific review, add “None.”

If you checked the box for “If there are individual collaborators from other institutions, check here” in section #1.4.1, you will be prompted to complete #2d. Please click “Add” and enter the collaborator’s name, institution, and brief description of the role of the collaborator in the study.

3(a/b/c).1. Required department/division approvals needed for this study. This list is automatically generated from the home departments/divisions of the listed investigators.
(HSC/CHLA only)Your iStar application will be routed first to the appropriate Division Chiefs and then to the appropriate Department Chairs/Designated Reviewers, as applicable, for electronic signature. The research application will not be forwarded to the IRB by iStar until these individuals have signed off electronically. You can monitor whether or not signatures have been provided by looking at the study status in iStar.

3(a/b).2. Please select any additional department or division approvals that may be needed for this study. When the conduct of research involves services not under the control of the investigator (such as radiology, pathology, or nursing) those departments should be added here.  Do not specify organizations already listed above. If the service or organization does not presently have electronic review, attach a written approval or agreement to 3(a/b).3.
(HSC/CHLA only) If the Principal Investigator or Co-Investigators have appointments in more than one division or department, select the divisions/departments that do not already appear in section #2. The application will be routed to the specified divisions/departments in addition to those listed above. If your research will use the resources of another organization (or division or department) and the organization must agree to your utilization of resources, add the organization (or division or department) here. Please note that if you add a division/department, service, or organization that is not required to approve your application, you may significantly delay the routing and review process.

Please note that if you add a division/department, service, or organization, the application will be routed to them automatically for electronic signature / approval. The application will not be routed to the IRB until all departments/divisions, etc. have signed off electronically.

3a.3. Are there any other campus committees, services, or organizations that need to review and approve this protocol? If so, list the name(s) of the committee(s) and attach approval memos as applicable.
If any other campus committee (or service or organization) not listed above must review and approve your project, click the “Add” button, type in the name of the committee and the name of the committee chair, and attach the approval letter.

Examples:

·         (HSC) Institutional Biosafety Committee (IBC), if the research procedures involve the handling/storage/shipment of human tissue or fluid samples

·         (HSC) Radiation Safety Committee (RSC), if the research procedures involve radiation exposure from x-rays, PET scans, or CT scans.

The approval letter must be attached to the iStar application before the IRB can approve your study. If the committee, service, or organization has not reviewed your study when you submit your iStar application to the IRB, you will be asked to provide the approval letter when it is available.

Please note that iStar does NOT automatically forward your application to any of these committees for review. You must submit your protocol to each committee separately. Please contact each committee to find out how to submit your research for review.

3a.4. (HSC) Will the research be conducted through the GCRC?

3c.4 (CHLA) Are you planning to submit this study to the GCRC for review?
If this study will be conducted on the General Clinical Research Center (GCRC), approval from the GCRC is required prior to initiating this study on the GCRC.

For more information on the GCRC at HSC, please visit the GCRC website at http://www.usc.edu/hsc/gcrc/.

4.1. Please indicate the type of review that you are requesting for this study:

§         Full Committee Review: If the research activities involve greater than minimal risk to human subjects, your study must be reviewed at a convened meeting of the IRB.

Examples:

·         Clinical trials of investigational drugs or devices

·         Clinical trials of experimental surgical or rehabilitation techniques

·         Research procedures involving exposure to radiation

·         Interviews or surveys involving sensitive issues such as physical abuse, substance abuse, or criminal activity

 §         Expedited Review: Your study may qualify for expedited review if the research activities involve no more than minimal risk to human subjects and fall under one or more of the categories authorized by federal regulations (45 CFR 46.110 and 21 CFR 56.110). The expedited review categories are described in section #4a and can be viewed at this link: Expedited Review Research Categories. Studies that qualify for expedited review are reviewed by the IRB Chair, Vice Chair, or designated IRB member rather than the full committee.  

Examples:

·         Collecting biological specimens by noninvasive methods (such as hair or nail clippings, saliva, or buccal cells) or collecting blood samples

·         Collecting data by noninvasive methods (such as body weight, body temperature, electroencephalogram (EEG), magnetic resonance imaging (MRI), or moderate exercise and muscle strength testing)

·         Collecting research data from voice, video, or photographic recordings

·         Administering surveys, interviews, focus groups, oral histories, or other research on individual group characteristics

 §         Exempt Review: Your study may be exempt from further IRB review if all the research activities fall under one or more categories identified in the federal regulations (45 CFR 46.101(b)). These activities represent the lowest risk to human subjects. The exemption categories are described in section #4b and can be viewed at the following link: Exempt Review Research Categories.

 Examples:

·         Research on educational methods or comparison of instructional techniques or curricula in typical educational settings

·         Research involving educational tests, surveys, or interviews in other settings or observation of public behavior, as long as the subjects cannot be identified

·         Research on existing data, documents, or specimens that are publicly available or if the subjects cannot be identified (i.e. census data, , medical chart reviews where no identifiers are being recorded).

§         Coded Specimens/Data (Not Human Subjects Research): Your study may not be considered human subjects research if you are analyzing only coded private information or biological specimens that cannot be linked to specific individuals, either directly or indirectly through coding systems. This type of research is not considered to be human subjects research if both of the following conditions are met: (1) the coded specimens or data were not collected specifically for the current proposed research through an interaction or intervention with living individuals, and (2) the investigators cannot readily ascertain the identity of the individuals to whom the coded data or specimens pertain. For additional information, refer to the Guidance on Research Involving Coded Private Information or Biological Specimens. The IRB will make the final decision of the appropriate review type. .

Examples:

·         Analysis of coded data originally collected by a student’s faculty advisor, where the student does not have access to any identifiers or a “key” to decipher the code.

·         Analysis of biological specimens obtained from a repository, as long as no information that could be used to identify any subject is provided to the study team by the repository  

·         Analysis of coded clinical information (such as diagnosis and treatment outcomes) provided by a treating physician, as long as the investigator and the treating physician have a written agreement prohibiting the release of the key to decipher the code 

For Additional Information:

For additional information and examples of the review categories, please refer to Chapter 7 of the USC Human Subjects Protection Program Policies and Procedures or Chapter 3 of the  CHLA Committee on Clinical Investigations Policies & Procedures Manual.

4.2. Attach the protocol, sponsor’s template informed consent document. For small investigator initiated simple studies an investigator developed protocol may not be necessary; however for larger, randomized, complex studies, multi-site studies a fully developed protocol may be needed.  If you have questions contact the IRB office to discuss.

(HSC/CHLA only): If there is a research proposal or a clinical protocol, attach it here. If the study has a sponsor, attach the sponsor's documents (template informed consent(s), protocol, protocol amendments, and summary of changes).  

(HSC Only): If you need assistance developing a clinical protocol for biomedical research, please refer to the Template of a Protocol for Investigator-Initiated Study.

4a. If you checked expedited review, please choose the applicable category from the list and attach your data collection forms below (click on the abbreviated category to receive the full description): The expedited review categories and additional information regarding expedited review can be viewed at this link: Expedited Review Research Categories.

 

Also refer to Chapter 7, Section 7.2 of the HSPP Policies and Procedures manual.

4a.1. If you checked expedited review, please attach a copy of the forms you will be using to collect data, if applicable.
Please attach any forms or spreadsheets that will be used to collect data in the study. If the data you are collecting will be obtained from surveys, questionnaires, or interview instruments, you will be asked to attach these documents later in sections #19, #20, or #21. Do NOT attach these instruments or documents here.

Data collection forms are used to record and organize data that you gather from one or more sources, such as medical records or databases, or to capture data from new research interventions. Data collection forms are typically developed by the study staff, but they may be provided by a study sponsor; . The IRB reviews data collection forms to ensure that the information collected is consistent with the iStar application and the informed consent document.

4b. If you checked that your study meets the qualifications for exempt status, please choose the applicable category from the list and attach your data collection forms below. (Note: these exemptions do not apply to research involving prisoners. For children, all exemption categories apply except for (2) unless it is simply observation of public behavior and the investigator does not interact with the children.) Click on the abbreviated category to receive the full description:
The categories for expedited review of new research projects are:

The complete list of exempt review categories can be viewed at this link: Exempt Review Research Categories.

Also refer to Chapter 7, Section 7.1 of the HSPP Policies and Procedures manual.

Please attach any forms or spreadsheets that will be used to collect data in the study. If the data you are collecting will be obtained from surveys, questionnaires, or interview instruments, you will be asked to attach these documents later in sections #19, #20, or #21. Do NOT attach these instruments or documents here.

Data collection forms are used to record and organize data that you gather from one or more sources, such as medical records or databases, or to capture data from new research interventions. Data collection forms are typically developed by the study staff, but they may be provided by a study sponsor. The IRB reviews data collection forms to ensure that the information collected is consistent with the iStar application and the information sheet.

 
4b.1. If you checked that your study meets the qualification for exempt status, please attach a copy of the forms you will be using to collect data, if applicable. In addition, include any applicable data use agreements.
Please attach any forms or spreadsheets that will be used to collect data in the study. If the data you are collecting will be obtained from surveys, questionnaires, or interview instruments, you will be asked to attach these documents later in sections #19, #20, or #21. Do NOT attach these instruments or documents here.

Data collection forms are used to record and organize data that you gather from one or more sources, such as medical records or databases, or to capture data from new research interventions. Data collection forms are typically developed by the study staff, but they may be provided by a study sponsor. The IRB reviews data collection forms to ensure that the information collected is consistent with the iStar application and the information sheet.

A data use agreement is a written agreement between two parties under which one party may disclose protected health information to another party for research purposes. The data use agreement identifies and limits the permitted uses of the information, restricts who can use the data, and requires the recipient of the data to agree not to re-identify the data or contact the individual. Data use agreement forms can be downloaded from:

 

·         USC University Policies Web Site at: http://policies.usc.edu/hipaa/datause041403.doc

·         CHLA - CCI Web Site at: http://www.childrenshospitalla.org/body.cfm?id=455.

For more information about developing or signing data use agreements, contact the respective IRB.

4b.2 Are study activities limited to observation of public behavior where the investigators do not participate in the activities being observed? 
Answer “yes” if the only activity in your study is the observation of public behavior and no member of the study team participates in the activities being observed. Answer “No” if any member of the study team will participate in the activities being observed or interacts with the subjects performing these activities, or if your study involves activities in addition to observation of public behavior.

4b.3. Is the source of data/biological specimens publicly available (ie, available to the general public)?
Answer “Yes” if your research involves existing data or specimens that are publicly available. Publicly available refers to specimens that can be purchased from laboratories or banks and data that are readily available to the general public, such as census data and government health, labor, or education statistics. Investigators should not assume that information qualifies as publicly available merely because it has been posted on a web site and can be accessed without authorization.   


4b.4. For the data/biological specimens collected, will identifiers or links to identifiers be recorded?
Answer “Yes” if the study team will record (either on paper or electronically) any information that can be used to identify subjects, or any code/numbers that link the data or specimens to the subjects’ identities. Answer “No” if the study team will not record any identifying information or any code numbers linking the data or specimens to the subjects’ identities.

Examples:

·         Retrospective review of medical charts – the investigator reviews a subject’s medical chart to obtain data. The investigator will view data that identifies the subject, such as name, address, date of birth, social security number, or medical record number, in the medical chart. If the investigator does not write down or save any identifying information and does not use a code number to link the subject to the recorded data, the study qualifies for exempt review. If the investigator does record identifying information, or if the investigator uses a code number to link the subject to the recorded data, the study does not qualify for exempt review.

·         The investigator accesses existing data that contains identifying information, but does not record any identifiers during data collection (e.g names, phone numbers, social security number, student ID number, etc.)   

If you are planning to record identifying information, the research in most cases will not qualify for exempt status. In this case, the research may qualify for expedited review.


4b.5. Does all the data exist at the time this application is submitted?
If you are planning to analyze data or specimens, they must exist at the time the application is submitted to the IRB. If the research involves any analysis of data or specimens that will be collected in the future,  it is considered prospective research and the study does not qualify for exempt status. It may qualify for expedited review.

Background:
If your research involves only the analysis of coded private information or specimens that cannot be linked to specific individuals, either directly or indirectly through a coding mechanism, your research may not be considered human subjects research. Your research may fall under the category of “Coded Specimens/Data (Not Involving Human Subjects)” if BOTH of the following conditions are met: (1) the coded specimens or data were not collected specifically for the current proposed research through an interaction or intervention with living individuals, AND (2) the investigators cannot readily determine the identity of the individuals to whom the coded data or specimens pertain. For additional information, refer to the Guidance on Research Involving Coded Private Information or Biological Specimens.

This category applies to existing private information and specimens, as well as to private information and specimens to be collected in the future for purposes other than the currently proposed research. Examples of private information or specimens that will be collected in the future for purposes other than the currently proposed research are (1) medical records and (2) ongoing collection of specimens for a tissue repository.

Examples:

·         Analysis of biological specimens obtained from a repository, as long as no information that could be used to identify any subject is provided to the study team by the repository 

·         Analysis of coded clinical information (such as diagnosis and treatment outcomes) provided by a treating physician, as long as the investigator and the treating physician have a written agreement prohibiting the release of the key to decipher the code

·         Analysis of coded data originally collected by a student’s faculty advisor, where the student does not have access to any identifiers or a “key” to decipher the code.

The IRB will make the final decision regarding the appropriate review type for your study. If your study qualifies for this type of review, you will receive an acknowledgment letter from the IRB. This letter may be required by funding agencies, publishers, and faculty advisors.

4c.1. Check here if the private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals: 
Check this box if you are obtaining data or specimens that were not collected for the purposes of this research project. Usually, the data or specimens will be obtained from another entity, researcher, repository, or data set. If the private information or specimens were collected through interactions or interventions with living individuals specifically for this study, it is human subjects research and you should not check this box You must request another type of IRB review.

-AND-

4c.2. Check here if the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain (indicate the reason below):

4c.2.1. Indicate the reason the investigators cannot readily ascertain the identity of the individuals:
The IRB must ensure that the study team cannot identify the subjects from the data / specimens or the code linked to the data/specimens. Choose the method that describes how you will be prohibited from learning the identity of subjects:

§         (a) The data or specimens were linked to subject identifiers through a code at one time, but the key to decipher the code is destroyed before the research begins.

§         (b) The data or specimens are linked to subject identifiers through a code, but the investigator and the individual or entity that holds the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased. Please note that the HSIRB and UPIRB do not need to review this agreement.

§         (c) The data or specimens are obtained from a repository or data management center and there are IRB-approved written policies and operating procedures for the repository or data management center that prohibit the release of the key to the investigator under any circumstances, until the individual(s) are deceased.

§         (d) The data or specimens are linked to subject identifiers through a code, but there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.

§         Other method(s) are used. Please describe the method(s) in #4c.2.2 below.

4c.2.2. If you selected other, please specify:
If you are using a method other than the choices above, please describe how you will be unable to learn the identity of the subjects in this study.


4c.2.3. If option (b) is selected in the above question 4c.2.1, attach the agreement prohibiting the release of the key when required by the IRB.

4c.3. This research will NOT be submitted to the FDA:
The FDA regulatory definition of “human subjects” differs from the Common Rule definition. If data from your research will be submitted to the FDA, the study may be subject to FDA regulations and may require a different type of IRB review. If you believe your study qualifies under exempt review, it involves a drug, device, or biological, and the data will be submitted to the FDA, contact your IRB office for guidance.

5.1 Indicate the locations where this study will be conducted by the USC/CHLA investigator(s) (check all that apply)

5.2 (HSC or CHLA only) Is this a multi-site study?
Multi-site studies are those conducted at several institutions, each with its own local Principal Investigator. If your study will be conducted at one or more other institutions other than USC HSC, USC UPC, and CHLA, it is a multi-site study and you should answer “Yes.”

Examples of multi-site studies:

·         The AIDS Clinical Trials Group is studying the effects of antiretroviral therapy on lipid metabolism in people with HIV infection. USC HSC is one of 100 participating sites.

·         A pharmaceutical company is conducting a clinical trial of an investigational drug at USC HSC and 50 other locations around the United States.

If your study will be conducted at more than one location but all the locations are affiliated with USC HSC, USC UPC, and CHLA, it is not considered a multi-site study and you should answer “No.”  These examples are NOT multi-site studies:

·         A USC HSC investigator is administering quality of life questionnaires to people with kidney disease and recruiting subjects from USC University Hospital, LAC+USC Medical Center, and El Monte Comprehensive Health Center. This is NOT considered a multi-site study because there is only one Principal Investigator, all three locations are affiliated with USC, and the HSIRB is the IRB of record for each location.  

A UPC investigator is enrolling subjects at 4 different schools in the LAUSD. This is not a multi-site study because there is only one Principal Investigator.

6a.1. HSC Locations (check all that apply):
Identify all sites where this research will be conducted.

6a.2. If Other Location, please specify:
If you checked the box for “Other Location” under section #6a.1 above, list all the other locations here. Examples include subjects’ homes, community centers, retirement homes, and schools.

6a.3. If you are conducting this research in an LAC location, please specify the room numbers:
List the room numbers and the clinic or department name for locations at LA County facilities.

6a.4. If you are conducting this research at a location marked with an asterisk “*”, please attach a letter of approval from the medical director
If you will be recruiting from and/or conducting research at Roybal Comprehensive Health Center, H. Claude Hudson Comprehensive Health Center, or El Monte Comprehensive Health Center, you must obtain written approval from the health center’s Medical Director. The IRB requires an approval letter to ensure that the health center’s Medical Director is aware of and approves the research to be conducted at the health center. Attach the approval letter(s) to this application.

6b.1. UPC Locations (check all that apply and provide room numbers or location where indicated):
Select all location(s) where the research will take place at UPC.

6b.2. If campus location, please specify:

Examples:

·         Research in Psychology Department, SGM Room 8xx

·         McCarthy Quad, outside in the park area

·         Leavey Library

·         Lab in PI’s office

6b.3. If off-campus location, please specify:

Examples:

·         Clinics

·         Community centers

·         Retirement homes

·         Schools and school district sites

·         Private homes

Background:
The IRB needs to know if other institutions are involved in the research, and if they are, understand the nature of their involvement. The IRB needs to determine if your research requires review and approval by an IRB or permission from a representative of the institution.

6c.1. Other Sites/Institutions (in the United States): List all of the non-USC/CHLA sites at which the Principal Investigator will conduct the study.

6c.1.1. Site Name

6c.1.1.1. Please provide a short purpose, justification, or rationale for selecting this site:

6c.1.2. Address: 

6c.1.3. Will any of the personnel at this non-USC/CHLA institution carry out research activities such as obtaining consent or conducting study procedures?
If another institution is part of your research, the IRB needs to understand how the institution, its employees, and its facilities will be involved in the research activities. This concept is known as “engagement in research.” The other site or institution is considered to be “engaged” in human subjects research when employees or agents of the other institution either intervene or interact with living people or obtain identifiable private information for the purposes of your research. The concept of “engagement” is not the same as institutions participating in a multi-site study. If you are conducting a multi-site study, the other institutions/sites will have their own local Principal Investigators who will obtain IRB approval from their respective institutions.

Choose “Yes” to this question if any personnel at the other institution will intervene or interact with living subjects for research purposes (such as performing research procedures; making audio, video, or photographic recordings; conducting interviews; and obtaining informed consent) or obtain, receive, or possess information that can individually identify subjects or release that information to investigators without the subject’s consent. Choose “No” if no personnel at the other institution will perform any of these activities. It may be helpful to review all the categories in section #6c.1.4 below before answering “Yes” or “No” to this question. Simpler versions of these categories are listed below.

6c.1.4. If yes, indicate under which category(ies) the institution is engaged, and attach a copy of the IRB approval from that site below.
After reviewing the information in #6c.1.3 above, choose all the categories that apply to your research activities at the other institution.

For additional information and examples, refer to the OHRP Guidance, Engagement of Institutions in Research.

6c.1.5. Does the institution have an IRB?

If you are unsure, contact that institution for more information.

6c1.6 If the site has a local IRB, attach the IRB approval here.
If a non-USC/CHLA site in the United States is “engaged” in the research, the IRB at that institution must review and approve the study. The approval letter from the other institution’s IRB must be attached here when it is available. No research activities can take place at the other institution until their IRB approval letter is submitted through iStar and the USC/CHLA IRB has given final approval for your study.

6c.1.7 If the site does not have an IRB, please attach a letter of agreement for the conduct of the study from that site.  The IRB will contact that individual to verify authority, and to obtain an IRB authorization agreement from that site.  The IRB authorization agreement will define reporting between the study site, the investigators and the IRB.

UPC Users: If you are conducting non-exempt research at Non-USC sites, attach a permission letter from that site authorizing you to conduct your research there. The letter should be signed by a person of authority from the institution who is not affiliated with the research and who can represent the institution where the research is taking place (e.g. letter from a school Principal).

If the institution is engaged in the research but does not have its own IRB, the institution will have to enter into a formal agreement with the USC/CHLA IRB authorizing the USC/CHLA IRB to act as the institution’s IRB for this study. This agreement is called an IRB Authorization Agreement, and it requires several forms to be completed by the engaged institution, the IRB, and the institutional official for the USC/CHLA IRB. Please contact your IRB office to initiate the IRB Authorization Agreement.

If the non-USC/CHLA site is not engaged in the research, you must provide a letter of agreement from the institution permitting you to use their facility. Please attach the letter as soon as it is available.

6c.1.8. If the site has an IRB but they have elected to have USC/CHLA be the IRB of record, please explain why and attach an IRB authorization agreement at 6c.1.6.
Please explain why the non-USC site is requesting USC/CHLA to be the IRB of record. 

6c.2. Other Sites/Institutions (Outside the United States): List the institution(s) and country(ies) in which the Principal Investigator will conduct the study.
The IRB needs to know if institutions outside of the United States are involved in the research, and if they are, understand the nature of their involvement. The IRB needs to determine if your research requires review and approval by an IRB, Ethics Committee, or other similar committee at those international sites. The local customs, procedures, and regulatory requirements may be very different from those in the United States. If you will be conducting research at an institution outside the United States, you should request information and assistance from your IRB as early as possible when planning your project.

6c.2.1. Site Name:

6c.2.1.1. Please provide a short purpose, justification, or rationale for selecting this site:

6c.2.2. Address:

6c.2.3. Country:

6c.2.4. Will any of the personnel at this institution carry out research activities such as obtaining consent or conducting study procedures?
If another institution is part of your research, the IRB needs to understand how the institution, its employees, and its facilities will be involved in the research activities. This concept is known as “engagement in research.” The other site or institution is considered to be “engaged” in human subjects research when employees or agents of the other institution either intervene or interact with living people or obtain identifiable private information for the purposes of your research. The concept of “engagement” is not the same as institutions participating in a multi-site study. If you are conducting a multi-site study, the other institutions/sites will have their own local Principal Investigators who will obtain IRB approval from their respective institutions.

Choose “Yes” to this question if any personnel at the other institution will intervene or interact with living subjects for research purposes (such as performing research procedures; making audio, video, or photographic recordings; conducting interviews; and obtaining informed consent) or obtain, receive, or possess information that can individually identify subjects or release that information to investigators without the subject’s consent. Choose “No” if no personnel at the other institution will perform any of these activities. It may be helpful to review all the categories in section #6c.1.4 below before answering “Yes” or “No” to this question. Simpler versions of these categories are listed below.

For additional information and examples, refer to the OHRP Guidance, Engagement of Institutions in Research.

6c.2.5. If yes, indicate under which category(ies) the institution is engaged and attach a copy of the IRB approval from that site below.

After reviewing the information in #6c.2.4 above, choose all the categories that apply to your research activities at the other institution.

For additional information and examples, refer to the OHRP Guidance, Engagement of Institutions in Research.

6c.2.6. Attach a copy of the IRB approval/permission letter from that site here.

6c.2.7. If “No” please attach a letter of agreement from that site.
If the other institution is NOT engaged in the research, you must provide a letter of agreement from the institution permitting you to use the facility. The letter should be signed by a person of authority from the institution who is not affiliated with the research and who can represent the community or institution where the research is taking place. The IRB will accept e-mail correspondence as the letter of agreement. No research activities can take place at the other institution until the letter of agreement/permission letter is submitted through iStar and the USC/CHLA IRB has given the study final approval.

6c.2.8. Does the institution have an IRB or Ethics Committee?
Choose “Yes” if the international institution has an IRB, an Ethics Committee, or an equivalent committee. Choose “No” for international institutions without an IRB or equivalent committee.

You can search for international IRBs that are registered with the federal Office for Human Research Protections (OHRP) at the Institutional Review Board Registry. You can also view OHRP’s list of approved assurances.

6c.2.8.1. If yes, attach a copy of the IRB or Ethics Committee approval letter for this study.

If a non-USC/CHLA site outside the United States is engaged in the research, the IRB (or Ethics Committee or equivalent committee) at that institution must review and approve the non-exempt study.

The IRB approval must be attached here when it is available.

No research activities can take place at the other institution until the letter is submitted through iStar.

6c.2.9. Does the institution have a FederalwWide Assurance?
A Federalwide Assurance (FWA) is a written agreement between an institution and the Office for Human Research Protections (OHRP) in the Department of Health and Human Services. In this agreement, the institution assures OHRP that is will comply with the federal regulations regarding human subjects research.

Choose “Yes” if the international institution has an FWA; choose “No” for international institutions without an FWA. You can search for FWA numbers for international institutions at: OHRP Approved Assurances. (add link)

6c.2.9.1. If yes, please indicate the FWA number:
If the international institution has an FWA number, add it here.

You can search for international IRBs that are registered with the federal Office for Human Research Protections (OHRP) at the Institutional Review Board Registry. You can also view OHRP’s list of approved assurances.

7.1. Is the coordinating center at HSC, UPC, or CHLA?

7.1.1. If yes, describe how the information relevant to protecting participants, such as reporting of unexpected problems, protocol modifications, and interim results are managed.
A coordinating center receives, manages, analyzes, and disseminates data, including safety data, for a multi-site trial. Therefore, if USC/CHLA is the coordinating center, the Principal Investigator has additional responsibilities in the protection of human subjects. Please describe how the coordinating center will monitor the data, conduct interim analyses, report unexpected problems, and disseminate modified protocols and other documents to the participating sites. Based on your response, the IRB must determine and document that the coordinating center has sufficient mechanisms in place to ensure that (1) data management, data analysis, and safety monitoring are adequate, given the nature of the research involved; (2) sample protocols and informed consent documents are developed and distributed to each collaborating institution; (3) each collaborating institution holds an applicable OHRP-approved assurance; (4) each protocol is reviewed and approved by the IRB at the collaborating institution prior to the enrollment of subjects; (5) any substantive modification by the collaborating institution of sample consent information related to risks or alternative procedures is appropriately justified; and (6) informed consent is obtained from each subject in compliance with HHS regulations.

7.2 If no, what is the location of the coordinating site?
If there is no coordinating site, indicate N/A

8.1. Are you or the institution receiving any financial support for the conduct of this study?
(Yes/No)

The IRB needs to know how you will pay for all research procedures. The IRB must ensure that there is sufficient funding to complete the study and follow-up procedures for all subjects and that the costs to the subjects are properly disclosed in the informed consent. “Financial support” refers to money you receive from external sources (government agency, foundation or nonprofit organization) or internal sources (department, School, or institution funds) to pay for the conduct of the research.

At HSC: If you receive financial support from industry, the funds must be deposited with HRA. If you receive financial support from foundations, private sources, or from federal, state, or local government, the funds must be deposited with USC Contracts & Grants.

8.2 If the funding source has undergone separate review by the IRB (for example, cooperative group grants, umbrella grants, multi-project/program grants, or center grants), please try to select it from the list using the "Add" button. If the funding source is not displayed in the list, enter the information in question 8.3.
If you previously submitted the grant or other type of award that is funding this study under the “Grant/Contract Only” review mechanism in iStar, it should appear in the list when you click the “Add” button. If the grant or other award does not appear, enter the information requested in section #8.3.

8.2.1. If the grants selected in question 8.2 fund multiple studies, please attach the specific pages of the grant that are relevant to THIS study.
Please do not attach the entire multi-project grant. Attach only those pages of the grant that describe the human subjects research submitted for review in this iStar application.

 
8.3. Please add any funding source that is not listed in question 8.2. You will need to click the “Add” button for each funding source for this study.
Provide all the budget information requested in sections #8.3.1 - #8.3.8. If funding for your study comes from more than one source, click “Add” and enter the information for each funding source separately.

8.3.1. Name of Sponsor:

8.3.2. Named Principal Investigator:

8.3.3. Institution awarded the grant award:
If your award is a subcontract from another institution, add the name of the institution awarded the main award.

8.3.4. Grant-award number provided by the Sponsor:

8.3.5. Title of the Funding Project, if applicable:

8.3.5.1. If this funding project has been assigned an IRB number, please list it here:

8.3.6. Type of Funding

8.3.6.1. If Other type of funding is selected, please specify:

8.3.7. Attach a budget sheet or copy of the proposal/contract/grant with the project budget. If this is a subcontract, also attach a copy of the institution’s IRB approval:
Attach your study budget here. The following template budget sheets are available to assist you:

·         NIH Budget Form

·         HRA Budget Form (Click on “Detailed Budget Template” and save the spreadsheet to your computer; the password is “HRA”)

If your study is funded by a subcontract, you must attach the IRB approval letter from the institution that awarded you the subcontract.

Note: All study personnel listed in the iStar application has access to this information..

8.3.8. (HSC ONLY) Please indicate where the funds will be deposited and the amount:
Investigators at HSC must complete this section. Identify where the funds will be deposited by checking the appropriate box. Add the total amount of funds from all sources to be deposited at that location.

8.4 (HSC ONLY) Attach a copy of the Contract/Study Consistency Checklist completed by HRA.  
This is a checklist that Health Research Association (HRA) fills out when examining the study contract. Please upload a copy of the HRA checklist here.

9.1. Social – Behavioral Procedures (check any or all that apply):
Check all the procedures that apply to your study. If none of these procedures apply to your study, check the box for “None of the above.” You must check at least one of the boxes in order to continue with the application. This is NOT an all-inclusive list of methods and procedures for social-behavioral research. The list includes procedures for which the IRB needs additional information to ensure protection of research subjects and compliance with regulations. Checking the box for any of these procedures triggers additional questions later in the application.  

9.2 Medical Procedures/Considerations (check any or all that apply):
Check all the procedures that apply to your study. If none of these procedures apply to your study, check the box for “None of the above.” You must check at least one of the boxes in order to continue with the application. This is NOT an all-inclusive list of methods and procedures for medical research. The list includes procedures for which the IRB needs additional information to ensure protection of research subjects and compliance with regulations or procedures that require approval from other review committees. Checking the box for any of these procedures triggers additional questions later in the application. 

9.3 Data Collection Types (check any or all that apply):
The following definitions may be helpful in understanding the different types of data collection in section #9.3:

Prospective Study: A prospective study is one in which the data or specimens will be collected in the future. The data or specimens do not currently exist. Prospective studies may involve an intervention, but they may also be purely observational or involve only the collection of data.

Repository: a collection of human tissue to be used for research purposes; repositories collect, store, and distribute human tissues under IRB-approved procedures.

Retrospective Study: A retrospective study is one in which the data or specimens already exist at the time the study is proposed. A typical retrospective study involves a review or analysis of previously collected information such as birth or death certificates, medical records, school records, or employment records.

Check all the procedures that apply to your study. If none of these procedures apply to your study, check the box for “None of the above.” You must check at least one of the boxes in order to continue with the application.

§         Banking of Specimens/Data (Creation of a repository): Check this box only if you are planning to create a repository to store specimens or create a database of data for use in future research projects to be conducted by you or by others. Do NOT check this box if you are collecting specimens or data to be analyzed for this study only.

Examples:

·         As part of your research on hemophilia, you are collecting blood specimens. You ask subjects if you can keep leftover samples for potential future research on hemophilia and related disorders. These samples may be kept in your lab, or they may be sent to a central research repository that is supported by a group of healthcare facilities.

·         You are a therapist at University Mental Health Clinic and you realize you have a valuable database containing psychometric and outcome data on 10 years of interventions with families. You and other therapists would like to be able to use this and future data for a series of research projects looking at the comparative effectiveness of different therapeutic approaches. You decide to set up a database and procedures for the use of this information.

Prospective Collection of Specimens/Data: Check this box if you will be collecting specimens or data during the course of this study.

Examples:

·         You are studying a group of men with hypertension to determine risk factors for progression of hypertension and kidney disease. The men will come to the clinic twice a year for study visits. At each study visit, the men will complete questionnaires, have their blood pressure measured, and provide blood and urine samples.

·         Dental students studying bacteria will collect saliva samples from patients during a routine oral exam.

§         Genetic Specimens: Check this item if you are collecting biological specimens and performing genetic analysis in the study. This may include, but is not limited to:

·         Collection of samples to learn about inheritable conditions or characteristics

·         Gene transfer studies

·         Studies of gene markers or mutations

·         Pedigree studies

§         Audio/Video Recordings or Photographs: Check this item if you are audiotaping, videotaping, or taking any photographs of study subjects.

Examples:

·          You are conducting focus groups to help develop age-appropriate health messages for a diabetes education program. The focus group sessions will be audiotaped and the tapes will be transcribed for evaluation.

·          You are evaluating a new surgical procedure and will be taking full facial photographs of study subjects before and after the surgery.

·          You are studying aggression and photograph facial expressions in response to various stimuli.

·          You are studying behavior patterns in children and videotape them while completing study procedures.

9.4 Does this study involve the use of existing/retrospective data/specimens?

Retrospective Study: A retrospective study is one in which the data or specimens already exist at the time the study is proposed. A typical retrospective study involves a review or analysis of previously collected information such as birth or death certificates, medical records, school records, or employment records.

Select “Yes” if you will analyze retrospective data or specimens in this study. The data or specimens must exist at the time you submit the iStar application to be considered retrospective. Select “No” if you will analyze data or specimens that will be collected in the future and do not exist at the time you submit the iStar application.

If you are reviewing subjects' medical records for the purpose of determining eligibility and this is the only use of retrospective data in your study, select "No." This is not considered analysis of retrospective data.

9.5. Is this project an investigator-initiated drug, biologic, or device study?
Choose “Yes” if you are initiating a study using a drug, biologic, or device and you do not have a sponsor for your study. Answer “No” if your study was initiated by a sponsor.  

9.6. (HSC AND UPC ONLY) If the investigator is considered a sponsor/investigator he or she must complete and attach a USC Sponsor/Investigator Agreement. This must be completed and signed by the Sponsor/Investigator.
A sponsor/investigator is an individual who assumes the responsibilities of both the sponsor (initiating, managing, and financing the trial) and the investigator (conducting the trial). If you are a sponsor/investigator for a clinical trial of a drug, device, or biological, you must complete this form: USC Investigator/Sponsor Agreement. Attach the completed form to the iStar application here.

10.1. What is the maximum number of subjects you plan to recruit for this site (integer values only)?
Enter the number of subjects you plan to enroll at HSC, UPC, and CHLA.

10.1.1. If this is a multi-site study, indicated the projected total subject accrual (integer values only).
If your study will be conducted at one or more other institutions other than USC and CHLA, enter the total number of subjects to be enrolled for the entire study (at all study sites).

10.1.2. Please provide further explanation of accrual goals, if necessary.

Examples:

·         We plan to recruit 100 normal volunteers and 100 subjects with rheumatoid arthritis.

·         We estimate that 50 adult subjects will be enrolled at LAC+USC Medical Center and 20 pediatric subjects will be enrolled at CHLA.

·         We will enroll 20 students in the 12^th grade, and 30 students in the 7^th grade.

10.2 Indicate the inclusion criteria for enrollment. (HSC: refer to specific sections of the protocol/grant, if applicable).
The inclusion criteria describe the characteristics of the subjects you wish to recruit and study. The inclusion criteria may include age range, gender, medical condition, participation in a previous study or program, enrollment at a school, or living in a particular community or location.

Examples:

·         Study subjects must be scheduled to undergo knee surgery, be 18 to 55 years of age, be willing to use local rehabilitation and physical therapy services designated by the surgeon, and be competent to provide informed consent

·         Subjects must be Asian males, over the age of 18, who have agoraphobia. 

For HSIRB submissions only: If a clinical protocol is attached to the application, refer to the section(s) of the protocol that provide this information. If your grant application includes this information, refer to the appropriate section(s). DO NOT RETYPE MATERIAL THAT IS IN THE PROTOCOL OR GRANT APPLICATION.

Example:

·         Please refer to the inclusion criteria found on pages 30-31 of the sponsor's protocol.

10.2.a. If needed, copy-and-paste any tables here and reference in the question above.
If there are existing tables in the research proposal, protocol, or other study document, please refer to the page number or section of the document where the table can be found, rather than copying and pasting them into the application.

10.3. Indicate the exclusion criteria for enrollment (HSC: refer to specific sections of the protocol/grant, if applicable)
The exclusion criteria describe characteristics that make subjects ineligible for participation in the research. Exclusion criteria may include age restrictions, gender, medical conditions, previous treatment, or inability to provide informed consent.

Examples:

·         Study subjects will be excluded if they are younger than 18 or older than 55 years of age, had previous knee surgery on either knee, have degenerative joint disease, have a serious chronic condition that affects overall health and well-being, or are not competent to provide informed consent.

·         Subjects under the age of 18, female, or no known history of agoraphobia will be excluded.

For HSIRB submissions only: If a clinical protocol is included, refer to the section(s) of the protocol that provide this information. If your grant application includes this information, refer to the appropriate section(s). DO NOT RETYPE MATERIAL THAT IS IN THE PROTOCOL OR GRANT APPLICATION.

Example:

·         Please refer to the exclusion criteria found on pages 31-32 of the sponsor's protocol.

10.3.a. If needed, copy-and-paste any tables here and reference in the question above.
If there are existing tables in the research proposal, protocol, or other study document, please refer to the page number or section of the document where the table can be found, rather than copying and pasting them into the application.

10.3.1. If there any age, ethnic, language, or gender-based exclusion criteria, please provide justification.

Age of Adult Subjects:  Subjects should not be excluded from research on the basis of age alone unless there are scientific or medical reasons for excluding them. If enrollment is restricted to certain age ranges, you must justify why you are excluding people on the basis of age.

Examples:

·         We are excluding subjects who are 50 years or older because we are studying healthy joints, and people over 50 are more likely to have age-related arthritis or joint degeneration.

·         We are interested in studying agoraphobia in Asian males over the age of 18 because there is little data on the prevalence of this condition in this ethnicity, gender, and age. 

Age of Pediatric Subjects: Children must be included in all human subjects research conducted or supported by the National Institutes of Health unless there are scientific, medical, and ethical reasons not to include them, and FDA regulations require that pediatric studies be conducted for certain drug and biological products. The participation of children in research, including children of both genders and children from minority groups, is important to assure that they receive a share of the benefits of research. “Children” are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. In California, the legal age of consent is 18 years. Subjects who are 17 years of age or younger are considered children. If you are not including children in your research, you must provide your justification for excluding them.  

Examples:

·         We will not include pediatric subjects because the disease being studied does not occur in people younger than 18 years.

·         We will not include pediatric subjects because our adult clinic does not treat subjects under the age of 18 years.  

·         We will not include pediatric subjects because we are interested in studying drinking and driving habits of college students who are generally over the age of 18.  

Gender of Subjects: When a disease affects both men and women, each gender must form an appropriate proportion of the study population, unless it can be demonstrated that there are strong scientific reasons for studying only a single gender. Equitable inclusion of both men and women in research is important to ensure that they receive an equal share of the benefits or research and that they do not bear a disproportionate burden. Women of childbearing potential and pregnant women should not be routinely excluded from participating in clinical research without justification. If you excluding men or women from your study, you must provide justification for the exclusion.

Examples:

·         We are excluding female subjects because we are studying risk factors for prostate hyperplasia.

·         Because we are studying ovarian cancer, no male subjects will be enrolled.

·         We are excluding female subjects because we are interested in the beliefs of males.

Language of Subjects: If you are enrolling only subjects who speak a particular language, you must provide a justification for excluding people who do not speak that language.

Example:

·         We are excluding subjects who do not read and speak English because the survey instruments have not been validated in languages other than English. 

Racial and Ethnic Origin of Subjects: When a disease affects persons of all ethnic groups, then each must form an appropriate proportion of the study population, unless it can be demonstrated that there are strong scientific reasons for excluding certain racial or ethnic groups. Within the limitations imposed by the eligible study population, your research should include sufficient enrollment of persons of diverse racial/ethnic backgrounds in order to ensure that the benefits and burdens of research are distributed in an equitable manner. If you are enrolling only persons from a particular racial or ethnic group, you must provide a justification for excluding those of other racial or ethnic groups.

Example:

·         Because we are studying the effects of a new blood pressure medication in the African-American population, we will not be enrolling subjects from other racial groups.  Because we are studying illegal substance in Caucasian females, we will not enroll subjects from other racial or ethnic origins.

NOTE: Special subject populations (normal volunteers, employees, students, adults who are not competent to consent, non-English speakers, children, pregnant women, fetuses/neonates, prisoners/detainees, and wards) are addressed in section #22.

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