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New Research Submission

What Are My Responsibilities?Slice

Before beginning with a new research submission, investigators must complete the Pre Submission Investigator Requirements.

New research submissions to the IRB require specific forms for review. The question of what forms you need to submit is best answered by considering the type of review.

Investigators

Principal Investigators are the responsible leader of a team of investigators (and research team), who have the ultimate responsibility for the conduct of the research.

Faculty Sponsors (for research originating from a university) are full or part-time faculty who engage in classroom instruction, supervise on or off campus internships, clinical experiences or practica, or mentor students who are conducting independent projects.

  • What do I do as a first time, principal investigator?

All key team members (i.e., investigators, coordinators, 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 Collaborative Institutional Training Initiative (CITI) 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. Additionally, principal investigators will need to meet the Pre Submission Investigator Requirements.

  • What do I need to do as a principal investigator?

The Principal Investigator (PI) is responsible for ensuring that research with human subjects is properly conducted such that participants are adequately protected. The environment in which investigators conduct research and the type of research they conduct influence their roles and responsibilities. Competent, informed, conscientious, compassionate and responsible investigators provide the best possible protection for research subjects. Additionally, there are many regulatory agencies to guide the PI in the proper conduct of research involving human subjects.

  • What do I need to do as a co-investigator? 

The Principal Investigator is ultimately responsible for the adequate conduct of research involving human subjects; however, he/she may delegate research-related responsibilities to other members of the research, provided these individuals are appropriately qualified and trained. Co-investigators who will be responsible for the design, conduct, or reporting of the study; will have access to subjects (i.e., will consent subjects, conduct parts of the study); will be making independent decisions about the inclusion or exclusion of participants; or will have access to identifying and confidential information will need to meet the Pre-Submission Investigator Requirements.

Conflicts

  • Do I need to declare any conflicts?

IU Health Ball Memorial Hospital has set forth policy on the avoidance, disclosure, management and resolution of financial conflicts of interest. This Policy applies to all persons at IU Health Ball Memorial Hospital who are key personnel on the study team. Key personnel is anyone who participates in designing research, collecting research data or performing other substantive research activities, or reporting research; and anyone who participates in designing, conducting or reporting with respect to a sponsored program.

What Are My Responsibilities?

Before beginning with a new research submission, investigators must complete the Pre Submission Investigator Requirements.

New research submissions to the IRB require specific forms for review. The question of what forms you need to submit is best answered by considering the type of review.

Investigators

Principal Investigators are the responsible leader of a team of investigators (and research team), who have the ultimate responsibility for the conduct of the research.

Faculty Sponsors (for research originating from a university) are full or part-time faculty who engage in classroom instruction, supervise on or off campus internships, clinical experiences or practica, or mentor students who are conducting independent projects.

  • What do I do as a first time, principal investigator?

All key team members (i.e., investigators, coordinators, 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 Collaborative Institutional Training Initiative (CITI) 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. Additionally, principal investigators will need to meet the Pre Submission Investigator Requirements.

  • What do I need to do as a principal investigator?

The Principal Investigator (PI) is responsible for ensuring that research with human subjects is properly conducted such that participants are adequately protected. The environment in which investigators conduct research and the type of research they conduct influence their roles and responsibilities. Competent, informed, conscientious, compassionate and responsible investigators provide the best possible protection for research subjects. Additionally, there are many regulatory agencies to guide the PI in the proper conduct of research involving human subjects.

  • What do I need to do as a co-investigator? 

The Principal Investigator is ultimately responsible for the adequate conduct of research involving human subjects; however, he/she may delegate research-related responsibilities to other members of the research, provided these individuals are appropriately qualified and trained. Co-investigators who will be responsible for the design, conduct, or reporting of the study; will have access to subjects (i.e., will consent subjects, conduct parts of the study); will be making independent decisions about the inclusion or exclusion of participants; or will have access to identifying and confidential information will need to meet the Pre-Submission Investigator Requirements.

Conflicts

  • Do I need to declare any conflicts?

IU Health Ball Memorial Hospital has set forth policy on the avoidance, disclosure, management and resolution of financial conflicts of interest. This Policy applies to all persons at IU Health Ball Memorial Hospital who are key personnel on the study team. Key personnel is anyone who participates in designing research, collecting research data or performing other substantive research activities, or reporting research; and anyone who participates in designing, conducting or reporting with respect to a sponsored program.

Application SponsorshipSlice

Some research involving human subjects must be sponsored by a responsible investigator; for example, student research, fellows, etc. Sponsorship is more than simply a signature, and carries two responsibilities:

  1. Supervision of the research
  2. Assistance in preparing the application for IRB review. While the Research Department and the IRB Administrator are able to offer assistance in how to complete the IRB application, it cannot take the place of the sponsor.

When an individual (student, fellow, etc.) is working on a project that already has IRB approval and is active with a current approval, and that individual will use some of that data to fulfill a course or degree requirement, such as honor's thesis, first-year project, master's degree, or dissertation, the original principal investigator must submit an amendment to the IRB Office requesting that they be added as a co-investigator on his/her project for the stated purpose.

In all other situations student/fellow -initiated research must be submitted as an independent project, NOT as an amendment to an already approved protocol.

Application Sponsorship

Some research involving human subjects must be sponsored by a responsible investigator; for example, student research, fellows, etc. Sponsorship is more than simply a signature, and carries two responsibilities:

  1. Supervision of the research
  2. Assistance in preparing the application for IRB review. While the Research Department and the IRB Administrator are able to offer assistance in how to complete the IRB application, it cannot take the place of the sponsor.

When an individual (student, fellow, etc.) is working on a project that already has IRB approval and is active with a current approval, and that individual will use some of that data to fulfill a course or degree requirement, such as honor's thesis, first-year project, master's degree, or dissertation, the original principal investigator must submit an amendment to the IRB Office requesting that they be added as a co-investigator on his/her project for the stated purpose.

In all other situations student/fellow -initiated research must be submitted as an independent project, NOT as an amendment to an already approved protocol.

Types of IRB ReviewSlice

The type of review required for a study is initially determined by the investigator, but ultimately, the IRB decides the appropriate level of review.

There are checklists and applications available to help you decide which type of review is applicable for your research. The checklists and applications are located on the Forms section of this page.

Once you have determined your type of review, you must submit the appropriate forms related to that review type.

Following is a list of the types of reviews, as well as a brief description of the types of review:

Exempt Review Research activities that (1) present no more than minimal privacy, psychological and/or physical risk to human subjects, and (2) involve only procedures listed in one or more of the categories on Exempt Research Checklist. Federal regulations mandate that someone other than the researcher determine whether research is exempt. Therefore, the Exempt Research Checklist and Application must be submitted to Human Subjects Office for review.

Expedited Review Research activities that (1) present no more than minimal privacy, psychological and/or physical risk to human subjects, and (2) involve only procedures listed in one or more of the categories on the Expedited Research Checklist may be reviewed by the IRB through an expedited review procedure. 

NOTE: The activities listed on the checklist should not be deemed to be of minimal risk simply because they are included on the list.

Full Board Review Any study involving greater than minimal risk, involving human subjects from certain vulnerable populations, or which does not fit into the categories on the Expedited Research Checklist requires full board review -- that is, review by the convened IRB, which meets monthly. Submissions must be received by the meeting deadline, typically 3 weeks before the meeting for new projects and 2 weeks before the meeting for ongoing projects.

Non-human subjects research Research involving data on Decedent PHI, a limited data set, de-identified health information, or coded private information or biological specimens may be eligible for review as Research Not Subject to FDA or Common Rule Definitions of Human Subjects Research.

Types of IRB Review

The type of review required for a study is initially determined by the investigator, but ultimately, the IRB decides the appropriate level of review.

There are checklists and applications available to help you decide which type of review is applicable for your research. The checklists and applications are located on the Forms section of this page.

Once you have determined your type of review, you must submit the appropriate forms related to that review type.

Following is a list of the types of reviews, as well as a brief description of the types of review:

Exempt Review Research activities that (1) present no more than minimal privacy, psychological and/or physical risk to human subjects, and (2) involve only procedures listed in one or more of the categories on Exempt Research Checklist. Federal regulations mandate that someone other than the researcher determine whether research is exempt. Therefore, the Exempt Research Checklist and Application must be submitted to Human Subjects Office for review.

Expedited Review Research activities that (1) present no more than minimal privacy, psychological and/or physical risk to human subjects, and (2) involve only procedures listed in one or more of the categories on the Expedited Research Checklist may be reviewed by the IRB through an expedited review procedure. 

NOTE: The activities listed on the checklist should not be deemed to be of minimal risk simply because they are included on the list.

Full Board Review Any study involving greater than minimal risk, involving human subjects from certain vulnerable populations, or which does not fit into the categories on the Expedited Research Checklist requires full board review -- that is, review by the convened IRB, which meets monthly. Submissions must be received by the meeting deadline, typically 3 weeks before the meeting for new projects and 2 weeks before the meeting for ongoing projects.

Non-human subjects research Research involving data on Decedent PHI, a limited data set, de-identified health information, or coded private information or biological specimens may be eligible for review as Research Not Subject to FDA or Common Rule Definitions of Human Subjects Research.

What Forms are Required?Slice

The question of what forms you need to submit is best answered by first considering what type of review is required for your study. Once your type of review has been determined, you can download the appropriate forms for your review.

You must complete the Exempt Research Checklist or the Expedited Research Checklist when you submit for review. The checklists and applications are located in the Forms section of this page.

What Forms are Required?

The question of what forms you need to submit is best answered by first considering what type of review is required for your study. Once your type of review has been determined, you can download the appropriate forms for your review.

You must complete the Exempt Research Checklist or the Expedited Research Checklist when you submit for review. The checklists and applications are located in the Forms section of this page.

​How and When Do I Submit My Study?Slice

All projects must be submitted to the IRB Office using the online program IRBNet.

Upon submission, a study is first reviewed to determine if it can be considered a "complete submission" eligible to be reviewed. Once deemed "complete," submissions will be processed for review, and then sent to either the IRB Full Board or the Expedited/Exempt Reviewer(s) 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 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:

  1. Are all investigator requirements completed and all documents necessary for review included?
  2. A complete submission will include the following:
    1. Conflict of Interest Disclosure for all investigators. Please see the Conflict of Interest section of this page for more information.
    2. Documented ‘Letter of Support’, as applicable.
    3. Completion of the required CITI modules by each key team member. Please see the CITI program page for more information.
    4. 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.)

​How and When Do I Submit My Study?

All projects must be submitted to the IRB Office using the online program IRBNet.

Upon submission, a study is first reviewed to determine if it can be considered a "complete submission" eligible to be reviewed. Once deemed "complete," submissions will be processed for review, and then sent to either the IRB Full Board or the Expedited/Exempt Reviewer(s) 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 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:

  1. Are all investigator requirements completed and all documents necessary for review included?
  2. A complete submission will include the following:
    1. Conflict of Interest Disclosure for all investigators. Please see the Conflict of Interest section of this page for more information.
    2. Documented ‘Letter of Support’, as applicable.
    3. Completion of the required CITI modules by each key team member. Please see the CITI program page for more information.
    4. 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.)

​What Happens After Submission?Slice

Beginning your research

Research may not begin until final written approval is received from the Institutional Review Board. This means that there can be no collection of data and no recruitment of and/or contact with human subjects until the investigator has received written notification of approval. The regulations governing research involving human subjects and IU Health Ball Memorial Hospital’s Letter of Assurance with the federal government prohibit granting retroactive approval.

IRB Actions

Approve The IRB may approve a research study or study action when it finds that no additional changes are needed and it meets the standard criteria for approval.

Conditional / Provisional Approval The IRB may provisionally approve a research study or study action when specific revisions requiring simple concurrence by the investigator can be stipulated. In this case, subsequent review by the convened IRB is not required. The IRB Chair or his/her designee may approve the investigator’s response on behalf of the IRB. 

However, any substantive changes must be reviewed at a convened IRB meeting.  The research may proceed only after the convened IRB has reviewed and approved the required changes to the research.

Table (for studies reviewed by the convened IRB only) The IRB may table a research study or study action when substantive clarifications or modifications regarding the protocol or informed consent document that are directly relevant to the determinations required by the IRB are necessary. In this case, subsequent review by the convened IRB is required.

Disapprove If the IRB disapproves a research study or study action, written notification will be provided to the investigator, which will include the reasons for the determination.

Approval Period When the IRB approves a new research study, it must determine the study’s approval period, which is set at intervals appropriate to the degree of risk, but not less than once per year. In some circumstances, a shorter review period (e.g., biannually, quarterly, or after accrual of a specific number of subjects) may be required. The IRB will require review more frequently than annually for those studies deemed “high risk."

Suspend/Restrict/Terminate Approval The IRB may also suspend, place restrictions upon, or terminate approval of research that is not being conducted in accordance with IRB requirements or that have been associated with unexpected serious harm to subjects.

​What Happens After Submission?

Beginning your research

Research may not begin until final written approval is received from the Institutional Review Board. This means that there can be no collection of data and no recruitment of and/or contact with human subjects until the investigator has received written notification of approval. The regulations governing research involving human subjects and IU Health Ball Memorial Hospital’s Letter of Assurance with the federal government prohibit granting retroactive approval.

IRB Actions

Approve The IRB may approve a research study or study action when it finds that no additional changes are needed and it meets the standard criteria for approval.

Conditional / Provisional Approval The IRB may provisionally approve a research study or study action when specific revisions requiring simple concurrence by the investigator can be stipulated. In this case, subsequent review by the convened IRB is not required. The IRB Chair or his/her designee may approve the investigator’s response on behalf of the IRB. 

However, any substantive changes must be reviewed at a convened IRB meeting.  The research may proceed only after the convened IRB has reviewed and approved the required changes to the research.

Table (for studies reviewed by the convened IRB only) The IRB may table a research study or study action when substantive clarifications or modifications regarding the protocol or informed consent document that are directly relevant to the determinations required by the IRB are necessary. In this case, subsequent review by the convened IRB is required.

Disapprove If the IRB disapproves a research study or study action, written notification will be provided to the investigator, which will include the reasons for the determination.

Approval Period When the IRB approves a new research study, it must determine the study’s approval period, which is set at intervals appropriate to the degree of risk, but not less than once per year. In some circumstances, a shorter review period (e.g., biannually, quarterly, or after accrual of a specific number of subjects) may be required. The IRB will require review more frequently than annually for those studies deemed “high risk."

Suspend/Restrict/Terminate Approval The IRB may also suspend, place restrictions upon, or terminate approval of research that is not being conducted in accordance with IRB requirements or that have been associated with unexpected serious harm to subjects.