Getting Started

Covered Entity

Health plans, healthcare clearinghouses and healthcare providers who transmit any health information in electronic form in connection with a HIPAA required standard transaction–typically providers that bill electronically.

De-Identified 

Health information is de-identified if there is no reasonable basis to believe that the data can be used to identify an individual, or if the provider has no reasonable basis to believe it can be used to identify the individual. 

All of the following 18 identifiers must be removed for the data to be considered de-identified: name, all geographic subdivisions smaller than a State including street address, city, county, precinct, zip codes and equivalent geocodes, (except for the initial 3 digits of a zip code if more than 20,000 people reside in the area), all dates including birthdays (other than the year) and ages over 89, phone numbers, fax numbers, email addresses, social security numbers, medical record numbers, health plan beneficiary numbers, account numbers, certificate/license numbers, vehicle identifiers and serial numbers (including license plate #), device identifiers and serial #’s, URLs, IP addresses, biometric identifiers, full face photographic images and any comparable images, any other unique identifier, characteristic or code. Note: Other demographic information, such as gender, race, ethnicity and marital status are not included in the list of identifiers that must be removed.

Intervention 

Intervention includes both physical procedures and manipulations of the living individuals or the living individuals' environments.

Interaction

Interaction includes communication or interpersonal contact between the investigator (or research team) and the living individual.

  • Examples: interviews, questionnaires, surveys, observations, manipulation of subject behavior, diet, or environment, physical measurements, specimen collection (e.g. blood tissue), administration of experimental drugs or devices.

Information is considered Identifiable if (1) the identity of the individual from whom the information was obtained is ascertained or may be readily ascertained by the investigator; or (2) the identity of the individual from whom the information was obtained is associated or may be readily associated with the information.

Limited Data Set

This set of data excludes facially identifiable information, but still includes some identifiable information. As a result, the data is still “identifiable” and may be used for limited purposes, including research, public health or healthcare operations as long as there is a data use agreement with the recipient of the limited data set.

A limited data set must exclude 16 specified identifiers that are listed in the Rule including: name, street address, telephone and fax numbers, email address, social security number, certificate/license number, vehicle identifiers and serial numbers, URL’s and IP addresses, and full face photos and any other comparable images.

The limited data set could include the following identifiable information: admission, discharge and service dates, date of death, age, (including age 90 and older); and the five digit zip code.

Private information

Private information includes information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place or information that has been provided for specific purposes that the individual can reasonably expect will not be made public (e.g., medical record, employee or student records). 

Examples of individual identifiers include the subject's name, address, phone number, social security number, medical record number, student or employee identification number, or in some cases, the combination of data such that they can identify a single individual through deductive reasoning. For example, data about employer, job title, age and gender may not individually identify a subject, but when combined, could in certain cases, identify a specific individual.

Protected Health Information (PHI)

Health information, including demographic information collected from an individual, and (1) is created or received by a healthcare provider, health plan, employer, or healthcare clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual.

Systematic Investigation 

Systematic investigation typically involves a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory. Examples: observational studies, interview or survey studies, group comparison studies, program evaluation, test development, interventional research.

Test article

Any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the Public Health Service Act. Act means the Federal Food, Drug and Cosmetic Act.

Definitions

Covered Entity

Health plans, healthcare clearinghouses and healthcare providers who transmit any health information in electronic form in connection with a HIPAA required standard transaction–typically providers that bill electronically.

De-Identified 

Health information is de-identified if there is no reasonable basis to believe that the data can be used to identify an individual, or if the provider has no reasonable basis to believe it can be used to identify the individual. 

All of the following 18 identifiers must be removed for the data to be considered de-identified: name, all geographic subdivisions smaller than a State including street address, city, county, precinct, zip codes and equivalent geocodes, (except for the initial 3 digits of a zip code if more than 20,000 people reside in the area), all dates including birthdays (other than the year) and ages over 89, phone numbers, fax numbers, email addresses, social security numbers, medical record numbers, health plan beneficiary numbers, account numbers, certificate/license numbers, vehicle identifiers and serial numbers (including license plate #), device identifiers and serial #’s, URLs, IP addresses, biometric identifiers, full face photographic images and any comparable images, any other unique identifier, characteristic or code. Note: Other demographic information, such as gender, race, ethnicity and marital status are not included in the list of identifiers that must be removed.

Intervention 

Intervention includes both physical procedures and manipulations of the living individuals or the living individuals' environments.

Interaction

Interaction includes communication or interpersonal contact between the investigator (or research team) and the living individual.

  • Examples: interviews, questionnaires, surveys, observations, manipulation of subject behavior, diet, or environment, physical measurements, specimen collection (e.g. blood tissue), administration of experimental drugs or devices.

Information is considered Identifiable if (1) the identity of the individual from whom the information was obtained is ascertained or may be readily ascertained by the investigator; or (2) the identity of the individual from whom the information was obtained is associated or may be readily associated with the information.

Limited Data Set

This set of data excludes facially identifiable information, but still includes some identifiable information. As a result, the data is still “identifiable” and may be used for limited purposes, including research, public health or healthcare operations as long as there is a data use agreement with the recipient of the limited data set.

A limited data set must exclude 16 specified identifiers that are listed in the Rule including: name, street address, telephone and fax numbers, email address, social security number, certificate/license number, vehicle identifiers and serial numbers, URL’s and IP addresses, and full face photos and any other comparable images.

The limited data set could include the following identifiable information: admission, discharge and service dates, date of death, age, (including age 90 and older); and the five digit zip code.

Private information

Private information includes information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place or information that has been provided for specific purposes that the individual can reasonably expect will not be made public (e.g., medical record, employee or student records). 

Examples of individual identifiers include the subject's name, address, phone number, social security number, medical record number, student or employee identification number, or in some cases, the combination of data such that they can identify a single individual through deductive reasoning. For example, data about employer, job title, age and gender may not individually identify a subject, but when combined, could in certain cases, identify a specific individual.

Protected Health Information (PHI)

Health information, including demographic information collected from an individual, and (1) is created or received by a healthcare provider, health plan, employer, or healthcare clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual.

Systematic Investigation 

Systematic investigation typically involves a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory. Examples: observational studies, interview or survey studies, group comparison studies, program evaluation, test development, interventional research.

Test article

Any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the Public Health Service Act. Act means the Federal Food, Drug and Cosmetic Act.

Human Subject

A human subject is a living individual, [as well as human embryos, fetuses and any human tissue or fluids], about whom an investigator (professional or student) conducting scientific research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. (45 CFR 46.102(f))  Thus, the scope of "subject" is interpreted broadly. Even if you are "just interviewing" (talking with people), observing behavior or conducting a survey, you are involving human subjects in your research and your research requires IRB review.  If your research involves using identifiable private information about one or more living individuals, even if you never have direct contact with them, your research requires IRB review.

Research

Research is defined by the Department of Health and Human Services as “a systematic investigation, including research development testing and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d)). Systematic investigations range from observing behavior to asking questions to testing drugs to performing surgery. 

Not all data gathering or experimentation is necessarily research; it could be education or therapy. The difference is one of intent or primary goal. For example, if a physician finds a patient developing bad side effects from a drug, the physician may "experiment" using other drugs to see which works best with the fewest negative side effects. So long as the drugs being used are clinically approved (i.e., not themselves experimental), such activity would constitute therapy, not research. Yet, if this same physician decides to try these same drugs on a series of patients to see if the results are the same as they were with the original patient, then this activity is classified as research.

Occasionally, the IRB Office staff determine that an application involves activities that are not considered "research" under the definition because it is, for example, conducted for evaluation purposes for an entity (e.g., a government agency, commercial enterprise, workshop evaluation, or administrative review). 

Existing Data

To qualify as “existing data” the data, documents, or specimens must already be in existence (“on the shelf”) at the time the research begins. If some, or all, of the data are going to be collected by the researcher or another party after the researcher applies for approval to access, they are NOT existing data and do not qualify for this category.

Minimal Risk

“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR 46.102(i)).

Risk

The IRB must decide what degree of risk (if any) is involved. Risk can be social or psychological as well as physical. For example, breach of confidentiality might result in a child being labeled the "stupidest" in an entire school, or a family could be upset by their neighbors' learning that they suffer from a particular disease. Even if confidentiality is not involved, psychological damage may occur. 

For instance, suppose a psychologist wants to induce stress on his subjects to measure resultant changes. To do so, he gives them insoluble problems and psychometric tests which he then announces reveal various mental and emotional deficiencies. This procedure places the subject at risk psychologically and, if not (and even if) given an adequate explanation after the experiment, the participants could remain disturbed for some time.

The IRB realizes that risks are an inevitable and accepted part of life, but the IRB's task is to ascertain whether the proposed research increases risks beyond this normal level. If so, the IRB members must address two questions:

  1. Could the research objective be attained through procedures bearing less risk? For example, could an aversive electric shock be given by batteries rather than by a transformer plugged into a 110 volt wall socket? Could anonymous numbers be used instead of names? Such risk-reducing options would be suggested to the investigator.
  2. If the risk cannot be avoided, is the value of the research sufficient to justify the risk? This is the thorny "risk/benefit ratio" issue. While the regulations do not ordinarily require institutional review boards to concern themselves with the merit of the proposed research, when anything more than minimal risk is involved, the institutional review board must judge merit in order to evaluate the risk/benefit ratio. The benefit, if any, may be to the subject directly, to science, or to society in general.

Vulnerable Populations

“Vulnerable populations” include children (under age 18), fetuses, pregnant women, persons with mental disabilities, prisoners, persons with physical disabilities, and economically or educationally disadvantaged persons.

Does Your Study Require IRB Review?

The question of whether you need to submit is best answered by reviewing the checklist below.

The basic questions are:

Is it research? If your activity involves a predetermined method and contributes to generalizable knowledge, it requires a research submission. 

Does your activity involve Human Subjects? If your activity involves research and human subjects, your activity is subject to the Common Rule and requires a research submission.

Does your activity involve deceased individuals? If your activity involves research with one or more deceased individuals, it requires a research submission.

Does your research involve the FDA? If your activity involves one or more of the following test articles: foods or dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, electronic products, and if the research involves using the test article with one or more participants the research is being done as part of an investigational new drug (IND) or investigational device exemption (IDE) submission, the data may be submitted to the FDA, or the data may be held for inspection by the FDA and your activity is subject to FDA regulations (as defined above), your activity requires a research submission.

If you have any questions after going through this checklist, please contact the IRB Office.

Resources

Pre-Submission Investigator Requirements

Upon reviewing the Checklist for IRB Review and determining that the IRB needs to review your activity, Investigators must complete each of the following tasks before approval of a research study can be granted:

1. Complete the required Collaborative Institutional Training Initiative (CITI) All key team members, (i.e., investigators, coordinators, etc., anyone involved in the design, conduct, or reporting of the research, or having significant interaction with subjects including personnel obtaining informed consent listed on the IU Health Ball Memorial Hospital IRB application) will need to complete CITI human subjects protection training CITI is a web-based tutorial and testing site that is frequently updated to reflect changes in human subject law and regulation. Additionally, CITI meets the Federal Requirement that researchers using human subjects demonstrate the completion of education in the protection of human research participants. There are two educational tracks: Biomedical and Social/Behavioral. Researchers should choose the track that correlates best with their area of interest. If your research involves behavioral and/or social science methods, complete the Social/Behavioral Researcher course. If your research involves biomedical research methods, complete the Biomedical Researcher course.

Basic courses contain approximately 11 required modules, additional modules are optional. The course takes approximately 2 hours to complete. You may find it helpful to take one or two modules at a time, rather than trying to complete the entire course in one sitting.  You may save your work, log out of the system and return at your convenience.

New users can register at citiprograms.org. Click on “New Users Register Here” and complete the instructions. Select “Indiana University/IU Health” under “Organization Affiliation.”

Once you have completed the CITI  basic course, completion of the refresher course is required every 3 years.

Important Note for Principal Investigators of Interventional Clinical Studies: Effective Jan. 1, 2017, Principal Investigators of interventional clinical studies are required to complete the CITI Good Clinical Practice Course.  A refresher course is required every 3 years.

Important Note regarding the “IU Health (formerly Clarian)” Account: This account is NO LONGER active.  Learners who originally completed courses using this account must login to CITI and add “Indiana University/IU Health” as an affiliation, then contact the IRB Administrator to have the Refresher course added to your curriculum

2. Complete the Research-Related Financial Interest Disclosure Form    

3. Provide “Letter of Support” to conduct research As applicable, the investigator must provide written acknowledgement by the Department Manager, Director or Administrator that the study can be conducted on their unit(s)/hospital. The letter must be included with your submission application.

4. For additional requirements, review the Protocol Submission Guidelines.

Submission Process and IRBNet

In order for applications to be reviewed in a timely manner the IRB Office must be able to understand the purpose of the project, what the procedures are and how human subjects are involved (i.e., what the subjects will be asked to do or have done to them).

Investigators are cautioned to avoid using discipline-specific terminology, both in the description of the project and in the consent form. For projects being conducted where instruments and consent forms will be in a foreign language, two copies of the materials must be submitted for final approval; the foreign language version and an English translation.

ALL studies requiring IRB review must be electronically submitted using IRBNet. Forms and templates are located both in the IRBNet Document Library and on this website. Documents must be prepared using the most current edition of our forms.  New IRBNet users must complete a New User Registration.

IRBNet Registration for New Users

  1. Go to irbnet.org.
  2. Click on New User Registration in the upper right of your screen.
  3. Complete the user profile.
  4. Accept terms of IRBnet.org.
  5. Select IU Health Ball Memorial Hospital as your organization.
  6. You will receive an email from IRBNet.
  7. Click on the link in the email to activate your account in IRBNet.

Instructions for Submitting a New Study

  1. Review the Protocol Submission Guidelines to determine which forms and documents are required for your submission. Forms are located in the Forms section of this page and in the IRBNet Document Library.
  2. Open the applicable form(s) and download to your computer.
  3. Complete the submission form(s) and Save to your computer.

When you have all your study documents ready to upload

  1. Log into irbnet.org.
  2. From the menu bar to the left of the screen, select Create New Project.
  3. Fill in the requested information (title, name, PI, etc.) and click Continue.
  4. You are now ready to Assemble Your Document Package. For each document you want to submit to the IRB, click:
    1. Add New Document.
    2. Select the Document Type.
    3. Enter a description.
    4. Use the Browse button to locate the file on your computer.
    5. Repeat this step until all documents are uploaded.
  5. You can now Share This Project with other team members. To the left of the screen, under Project Administration, locate and click on Share This Project.
    1. Select anyone you would like to have access to this research, such as another investigator or research team member.  Indicate the degree of access each user will have.  Users will be automatically notified that they have been granted access to this project. You may also specify additional comments to be included in this notification.  (This is also a useful tool for informing a collaborating department manager or other signatory official that the study is ready for their electronic signature.)
      1. NOTE: To “share” your research with someone, they must be registered in IRBNet.org and have activated their account by clicking the email link sent by IRBNet. 
      2. Depending on your research, this stage may be optional.
  6. You are now ready to Sign This Package. From the menu bar to the left of the screen locate and click Sign This Package. Your “Electronic” signature is accepted as a legal signature. This step is mandatory.
    1. NOTE: Ensure that all forms are signed electronically by the appropriate signatories. Each form will indicate whose signature is required. The appropriate signature must be present before the application will be processed by the IRB Office.
  7. After all signatures have been obtained and you are sure all documents are attached and in final form, click Submit This Package. When the Search for an Organization prompt appears, select IU Health Ball Memorial Hospital from the drop-down menu.
    1. NOTE: Once you “SUBMIT,” the research is “locked” and cannot be edited unless you contact the IRB Office.
  8. To review what has been sent, locate Project Overview on the menu bar to the left of the screen and click.  The study status will be Pending Review until the review has been completed. 
  9. An electronic IRBNet notification will be sent to your email confirming that the IRB has received an electronic copy of your research study.
  10. You will be notified if there are any issues with your submission, i.e., incomplete submission, incorrect information, etc. Once any issues have been resolved and your submission has been approved, you will receive an email notification that the approval documents can be accessed by logging into IRBNet.

Instructions for Submitting Additional Documents for IRB Review

Instructions for Submitting Amendments, Continuing Reviews, Adverse Events, Study Closures and other notifications to IRB Review:

  1. Log into irbnet.org.
  2. From your list of projects, click on the Project Title
    1. DO NOT select “CREATE NEW PROJECT.” (Your Project has already been created and appears in your list.
  3. The menu bar to the left of the screen, select Project History.
  4. From the center of the Project History screen select “CREATE NEW PACKAGE”.
  5. Select “Work in Progress” (appears in green).
  6. Select “Add New Document.” Fill in the requested information. Upload your document, then “Attach.”  Repeat as needed until all your documents are attached.
  7. Sign your package and submit.

In order for applications to be reviewed in a timely manner the IRB Office must be able to understand the purpose of the project, what the procedures are and how human subjects are involved (i.e., what the subjects will be asked to do or have done to them).

Investigators are cautioned to avoid using discipline-specific terminology, both in the description of the project and in the consent form. For projects being conducted where instruments and consent forms will be in a foreign language, two copies of the materials must be submitted for final approval; the foreign language version and an English translation.

Approval Process

Upon submission, a study is first reviewed to determine if it can be considered a "complete submission" eligible to be reviewed. Once deemed "complete," a determination must be made regarding the level of review required, i.e., full board, expedited or exempt.  Submissions determined to require full board review will be sent to the next IRB Full Board meeting for consideration. Expedited and Exempt studies are sent to an IRB reviewer or designee for approval. In the event a submission is deemed "incomplete," the IRB Office will contact the Principal Investigator or identified study contact person to notify him/her as to what is needed and how to proceed. Please note that your submission will not move forward in the process until it qualifies as a complete submission as defined below.

This priority determination will be based on two major factors:

  • Are all investigator requirements completed and all documents necessary for review included?

A complete submission will include the following:

  • Conflict of Interest Disclosure for all team members. Please see the Conflict of Interest section of this for more information.
  • Documented ‘Letter of Support’ to conduct research, as applicable.
  • Completion of the required CITI modules, or other IRB approved training, by each team member. Please see the CITI program page for more information.
  • All pertinent required submission documents for the type of action being submitted.

(For more information regarding what documents are required, please see the Forms section of this page.)

Studies are rarely disapproved by the IRB. However, many studies require additional information for adequate review. Occasionally, the IRB requests investigators to revise their procedures.

When the IRB has approved your project, you will be notified by email. Log in to IRBNet and retrieve your approval documents.

Additional Information

Human Subject

A human subject is a living individual, [as well as human embryos, fetuses and any human tissue or fluids], about whom an investigator (professional or student) conducting scientific research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. (45 CFR 46.102(f))  Thus, the scope of "subject" is interpreted broadly. Even if you are "just interviewing" (talking with people), observing behavior or conducting a survey, you are involving human subjects in your research and your research requires IRB review.  If your research involves using identifiable private information about one or more living individuals, even if you never have direct contact with them, your research requires IRB review.

Research

Research is defined by the Department of Health and Human Services as “a systematic investigation, including research development testing and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d)). Systematic investigations range from observing behavior to asking questions to testing drugs to performing surgery. 

Not all data gathering or experimentation is necessarily research; it could be education or therapy. The difference is one of intent or primary goal. For example, if a physician finds a patient developing bad side effects from a drug, the physician may "experiment" using other drugs to see which works best with the fewest negative side effects. So long as the drugs being used are clinically approved (i.e., not themselves experimental), such activity would constitute therapy, not research. Yet, if this same physician decides to try these same drugs on a series of patients to see if the results are the same as they were with the original patient, then this activity is classified as research.

Occasionally, the IRB Office staff determine that an application involves activities that are not considered "research" under the definition because it is, for example, conducted for evaluation purposes for an entity (e.g., a government agency, commercial enterprise, workshop evaluation, or administrative review). 

Existing Data

To qualify as “existing data” the data, documents, or specimens must already be in existence (“on the shelf”) at the time the research begins. If some, or all, of the data are going to be collected by the researcher or another party after the researcher applies for approval to access, they are NOT existing data and do not qualify for this category.

Minimal Risk

“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR 46.102(i)).

Risk

The IRB must decide what degree of risk (if any) is involved. Risk can be social or psychological as well as physical. For example, breach of confidentiality might result in a child being labeled the "stupidest" in an entire school, or a family could be upset by their neighbors' learning that they suffer from a particular disease. Even if confidentiality is not involved, psychological damage may occur. 

For instance, suppose a psychologist wants to induce stress on his subjects to measure resultant changes. To do so, he gives them insoluble problems and psychometric tests which he then announces reveal various mental and emotional deficiencies. This procedure places the subject at risk psychologically and, if not (and even if) given an adequate explanation after the experiment, the participants could remain disturbed for some time.

The IRB realizes that risks are an inevitable and accepted part of life, but the IRB's task is to ascertain whether the proposed research increases risks beyond this normal level. If so, the IRB members must address two questions:

  1. Could the research objective be attained through procedures bearing less risk? For example, could an aversive electric shock be given by batteries rather than by a transformer plugged into a 110 volt wall socket? Could anonymous numbers be used instead of names? Such risk-reducing options would be suggested to the investigator.
  2. If the risk cannot be avoided, is the value of the research sufficient to justify the risk? This is the thorny "risk/benefit ratio" issue. While the regulations do not ordinarily require institutional review boards to concern themselves with the merit of the proposed research, when anything more than minimal risk is involved, the institutional review board must judge merit in order to evaluate the risk/benefit ratio. The benefit, if any, may be to the subject directly, to science, or to society in general.

Vulnerable Populations

“Vulnerable populations” include children (under age 18), fetuses, pregnant women, persons with mental disabilities, prisoners, persons with physical disabilities, and economically or educationally disadvantaged persons.

Does Your Study Require IRB Review?

The question of whether you need to submit is best answered by reviewing the checklist below.

The basic questions are:

Is it research? If your activity involves a predetermined method and contributes to generalizable knowledge, it requires a research submission. 

Does your activity involve Human Subjects? If your activity involves research and human subjects, your activity is subject to the Common Rule and requires a research submission.

Does your activity involve deceased individuals? If your activity involves research with one or more deceased individuals, it requires a research submission.

Does your research involve the FDA? If your activity involves one or more of the following test articles: foods or dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, electronic products, and if the research involves using the test article with one or more participants the research is being done as part of an investigational new drug (IND) or investigational device exemption (IDE) submission, the data may be submitted to the FDA, or the data may be held for inspection by the FDA and your activity is subject to FDA regulations (as defined above), your activity requires a research submission.

If you have any questions after going through this checklist, please contact the IRB Office.

Resources

Pre-Submission Investigator Requirements

Upon reviewing the Checklist for IRB Review and determining that the IRB needs to review your activity, Investigators must complete each of the following tasks before approval of a research study can be granted:

1. Complete the required Collaborative Institutional Training Initiative (CITI) All key team members, (i.e., investigators, coordinators, etc., anyone involved in the design, conduct, or reporting of the research, or having significant interaction with subjects including personnel obtaining informed consent listed on the IU Health Ball Memorial Hospital IRB application) will need to complete CITI human subjects protection training CITI is a web-based tutorial and testing site that is frequently updated to reflect changes in human subject law and regulation. Additionally, CITI meets the Federal Requirement that researchers using human subjects demonstrate the completion of education in the protection of human research participants. There are two educational tracks: Biomedical and Social/Behavioral. Researchers should choose the track that correlates best with their area of interest. If your research involves behavioral and/or social science methods, complete the Social/Behavioral Researcher course. If your research involves biomedical research methods, complete the Biomedical Researcher course.

Basic courses contain approximately 11 required modules, additional modules are optional. The course takes approximately 2 hours to complete. You may find it helpful to take one or two modules at a time, rather than trying to complete the entire course in one sitting.  You may save your work, log out of the system and return at your convenience.

New users can register at citiprograms.org. Click on “New Users Register Here” and complete the instructions. Select “Indiana University/IU Health” under “Organization Affiliation.”

Once you have completed the CITI  basic course, completion of the refresher course is required every 3 years.

Important Note for Principal Investigators of Interventional Clinical Studies: Effective Jan. 1, 2017, Principal Investigators of interventional clinical studies are required to complete the CITI Good Clinical Practice Course.  A refresher course is required every 3 years.

Important Note regarding the “IU Health (formerly Clarian)” Account: This account is NO LONGER active.  Learners who originally completed courses using this account must login to CITI and add “Indiana University/IU Health” as an affiliation, then contact the IRB Administrator to have the Refresher course added to your curriculum

2. Complete the Research-Related Financial Interest Disclosure Form    

3. Provide “Letter of Support” to conduct research As applicable, the investigator must provide written acknowledgement by the Department Manager, Director or Administrator that the study can be conducted on their unit(s)/hospital. The letter must be included with your submission application.

4. For additional requirements, review the Protocol Submission Guidelines.

Submission Process and IRBNet

In order for applications to be reviewed in a timely manner the IRB Office must be able to understand the purpose of the project, what the procedures are and how human subjects are involved (i.e., what the subjects will be asked to do or have done to them).

Investigators are cautioned to avoid using discipline-specific terminology, both in the description of the project and in the consent form. For projects being conducted where instruments and consent forms will be in a foreign language, two copies of the materials must be submitted for final approval; the foreign language version and an English translation.

ALL studies requiring IRB review must be electronically submitted using IRBNet. Forms and templates are located both in the IRBNet Document Library and on this website. Documents must be prepared using the most current edition of our forms.  New IRBNet users must complete a New User Registration.

IRBNet Registration for New Users

  1. Go to irbnet.org.
  2. Click on New User Registration in the upper right of your screen.
  3. Complete the user profile.
  4. Accept terms of IRBnet.org.
  5. Select IU Health Ball Memorial Hospital as your organization.
  6. You will receive an email from IRBNet.
  7. Click on the link in the email to activate your account in IRBNet.

Instructions for Submitting a New Study

  1. Review the Protocol Submission Guidelines to determine which forms and documents are required for your submission. Forms are located in the Forms section of this page and in the IRBNet Document Library.
  2. Open the applicable form(s) and download to your computer.
  3. Complete the submission form(s) and Save to your computer.

When you have all your study documents ready to upload

  1. Log into irbnet.org.
  2. From the menu bar to the left of the screen, select Create New Project.
  3. Fill in the requested information (title, name, PI, etc.) and click Continue.
  4. You are now ready to Assemble Your Document Package. For each document you want to submit to the IRB, click:
    1. Add New Document.
    2. Select the Document Type.
    3. Enter a description.
    4. Use the Browse button to locate the file on your computer.
    5. Repeat this step until all documents are uploaded.
  5. You can now Share This Project with other team members. To the left of the screen, under Project Administration, locate and click on Share This Project.
    1. Select anyone you would like to have access to this research, such as another investigator or research team member.  Indicate the degree of access each user will have.  Users will be automatically notified that they have been granted access to this project. You may also specify additional comments to be included in this notification.  (This is also a useful tool for informing a collaborating department manager or other signatory official that the study is ready for their electronic signature.)
      1. NOTE: To “share” your research with someone, they must be registered in IRBNet.org and have activated their account by clicking the email link sent by IRBNet. 
      2. Depending on your research, this stage may be optional.
  6. You are now ready to Sign This Package. From the menu bar to the left of the screen locate and click Sign This Package. Your “Electronic” signature is accepted as a legal signature. This step is mandatory.
    1. NOTE: Ensure that all forms are signed electronically by the appropriate signatories. Each form will indicate whose signature is required. The appropriate signature must be present before the application will be processed by the IRB Office.
  7. After all signatures have been obtained and you are sure all documents are attached and in final form, click Submit This Package. When the Search for an Organization prompt appears, select IU Health Ball Memorial Hospital from the drop-down menu.
    1. NOTE: Once you “SUBMIT,” the research is “locked” and cannot be edited unless you contact the IRB Office.
  8. To review what has been sent, locate Project Overview on the menu bar to the left of the screen and click.  The study status will be Pending Review until the review has been completed. 
  9. An electronic IRBNet notification will be sent to your email confirming that the IRB has received an electronic copy of your research study.
  10. You will be notified if there are any issues with your submission, i.e., incomplete submission, incorrect information, etc. Once any issues have been resolved and your submission has been approved, you will receive an email notification that the approval documents can be accessed by logging into IRBNet.

Instructions for Submitting Additional Documents for IRB Review

Instructions for Submitting Amendments, Continuing Reviews, Adverse Events, Study Closures and other notifications to IRB Review:

  1. Log into irbnet.org.
  2. From your list of projects, click on the Project Title
    1. DO NOT select “CREATE NEW PROJECT.” (Your Project has already been created and appears in your list.
  3. The menu bar to the left of the screen, select Project History.
  4. From the center of the Project History screen select “CREATE NEW PACKAGE”.
  5. Select “Work in Progress” (appears in green).
  6. Select “Add New Document.” Fill in the requested information. Upload your document, then “Attach.”  Repeat as needed until all your documents are attached.
  7. Sign your package and submit.

In order for applications to be reviewed in a timely manner the IRB Office must be able to understand the purpose of the project, what the procedures are and how human subjects are involved (i.e., what the subjects will be asked to do or have done to them).

Investigators are cautioned to avoid using discipline-specific terminology, both in the description of the project and in the consent form. For projects being conducted where instruments and consent forms will be in a foreign language, two copies of the materials must be submitted for final approval; the foreign language version and an English translation.

Approval Process

Upon submission, a study is first reviewed to determine if it can be considered a "complete submission" eligible to be reviewed. Once deemed "complete," a determination must be made regarding the level of review required, i.e., full board, expedited or exempt.  Submissions determined to require full board review will be sent to the next IRB Full Board meeting for consideration. Expedited and Exempt studies are sent to an IRB reviewer or designee for approval. In the event a submission is deemed "incomplete," the IRB Office will contact the Principal Investigator or identified study contact person to notify him/her as to what is needed and how to proceed. Please note that your submission will not move forward in the process until it qualifies as a complete submission as defined below.

This priority determination will be based on two major factors:

  • Are all investigator requirements completed and all documents necessary for review included?

A complete submission will include the following:

  • Conflict of Interest Disclosure for all team members. Please see the Conflict of Interest section of this for more information.
  • Documented ‘Letter of Support’ to conduct research, as applicable.
  • Completion of the required CITI modules, or other IRB approved training, by each team member. Please see the CITI program page for more information.
  • All pertinent required submission documents for the type of action being submitted.

(For more information regarding what documents are required, please see the Forms section of this page.)

Studies are rarely disapproved by the IRB. However, many studies require additional information for adequate review. Occasionally, the IRB requests investigators to revise their procedures.

When the IRB has approved your project, you will be notified by email. Log in to IRBNet and retrieve your approval documents.