IU Health Ball Memorial Institutional Review Board

Overview

Effective Jan. 1, 2017

• New Good Clinical Practice (GCP) training requirement for Principal Investigators of interventional clinical studies
• New IRB fee structure for industry sponsored research

IRB Registration & Compliance

The Indiana University Health Ball Memorial Hospital Institutional Review Board (IRB) complies with all federal requirements for IRB as defined in DHHS regulations 45 CFR Parts 46 and 164 and Food and Drug Administration regulations 21 CFR Parts 50 and 56.

What is the IRB Office?

The IRB Office provides support to the IU Health Ball Memorial Hospital Institutional Review Board (IRB) which is responsible for reviewing all research involving human subjects, ensuring the protection of human subjects in research conducted by researchers at the hospital (including non-IU Health Ball Memorial Hospital researchers using subjects at IU Health Ball Memorial Hospital hospital), and overseeing the hospital’s compliance with the federal regulations and guidelines.

Why Do You Need Approval?

Under Federal regulations and hospital policy, all researchers who conduct research that involves human subjects or materials of human origin must submit an application to the IRB. Approval of the research protocol must be in place BEFORE the research begins. This includes data collection, which refers to any gathering of information from or about living human beings.

Research includes not only physicians, but also, fellows, nurses, pharmacists, research conducted for master theses and doctoral dissertations, and may include undergraduate, staff and postdoctoral research as well.

What Records are Kept?

The IRB Office maintains the following files:

• Federal regulations and communications, as well as letters of assurance.
• Minutes of the IRB meetings.
• Protocols and correspondence sent to, and received from, investigators.
• Protocols from which approval has been withheld and for which suitable remedial action has not yet been taken.

All protocols are kept for a minimum of three years after completion of the research and then may be destroyed.

Mission

Indiana University Health Ball Memorial Hospital Institutional Review Board (IRB) is the body that is designated by IU Health Ball Memorial Hospital to review, approve the initiation of and conduct periodic review of all research involving human subjects under the auspices of this institution.

The Board is charged with protecting the rights and welfare of human research subjects recruited to participate in research activities and ensuring compliance with applicable IU Health Ball Memorial Hospital policies and state and federal regulations.

The board is responsible for reviewing all research projects involving human subjects that are conducted at this institutions' facilities or properties; is sponsored by this institution; is conducted by or under the direction of any employees or agents of this institution in connection with their institutional responsibilities; or involves the use of this institutions' non-public information to identify or contact human research subjects or prospective subjects. In addition, the IRB may be asked by organizational officials to review research protocols on behalf of other institutions with which they have formal affiliation agreements.

IU Health Ball Memorial Hospital IRB is guided by the ethical principles set forth in the report titled: “Ethical Principles and Guidelines for the Protection of Human Subjects Research”, also known as “The Belmont Report”.

IU Health Ball Memorial Hospital IRB has pledged that this institution and all investigators will follow the U. S. Department of Health & Human Services (DHHS) regulations (45 CFR Parts 46 and 164) and Food & Drug Administration (FDA) regulations at 21 CFR Parts 50 & 56 for protecting human research subjects.

Explore the pages linked below to learn the six basic steps to fulfill the Indiana University Health Ball Memorial Hospital research with human subjects requirements:

• Does Your Study Require IRB Approval
• Pre-Submission
• Types of Review
• Submission to the IRB
• Ongoing Actions After IRB Approval
• Study Closure

1. Getting Started
2. New Research Submissions
3. Existing Research Submissions

Conflict of Interest

Review the following Conflict of Interest policies and form:

• IRB Conflict of Interest Policy
• IU Health Ball Conflict of Interest Policy
• Conflict of Interest Disclosure Form

HIPAA

If you are conducting human subject research and can answer ‘Yes’ to any of the following questions, then HIPAA requirements apply to you.

• Are you using any health information or information that can be linked to or used to identify and individual (e.g., name, address, social security number or other identifier) and pertains to an individual’s past, present or future physical or mental health?
• Was the health information obtained as part of clinical care or obtained by someone who normally cares for patients?
• Are you conducting a retrospective medical chart review?
• Are you conducting research using existing biological samples?
• Are you conducting research using existing research or clinical data?
• Are you consenting or re-consenting subjects in an existing research protocol that involves health information after April 14, 2003?

Links

Federal Regulation Links

• DHHS OHRP Policy and Guidance Library
• DHHS Regulations on the Protection of Human Subjects (45 CFR 46)
• FDA Regulation on the Protection of Human Subjects (21 CFR 50)
• FDA Regulation on Institutional Review Boards (21 CFR 56)
• FDA Regulations on Investigational New Drug Application (21 CFR 312)
• FDA Regulations on Investigational Device Exemptions (21 CFR 812)

Other Resources

• The Belmont Report
• Comparison of FDA and DHHS Human Subjects Protections Regulations

Education

Human Subjects Requirement

All principal investigators, co-investigators, research team members (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 training before the submitted protocol will be approved.

• CITI training is required for New Study submissions submitted after October 1, 2012.
• CITI training is required if you are being added as a co-investigator to an existing study for all co-investigator updates submitted after October 1, 2012.

This requirement applies to both affiliated and non-affiliated research team members.

Resources

CITI Human Subjects Training

Meeting Dates

The IRB meets on the fourth Tuesday of each month with the exception of the December meeting which will be held on the third Tuesday of the month. The IRB meets at 7:30 a.m. in the Maria Bingham Boardroom.

The deadline for new projects requiring full board review is 3 weeks before the IRB meeting. The deadline for all other projects requiring full board review is 2 weeks before the meeting. Projects not requiring full board review can be submitted at any time.