Institutional Review Board

1. Is it human subjects research?

Research + Human Subject = IRB Review

Research is defined as "a systematic investigation, including research, development, testing and evaluation, designed to develop or contribute to generalizable knowledge." 45 CFR 46.102(d)

Human Subject means a living individual about whom an investigator conducting research obtains:

1. Data through intervention or interaction with the individual
2. Identifiable private information

• Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
• Interaction includes communication or interpersonal contact between investigator and subject.
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

2. Research subject to oversight by the Food and Drug Administration (FDA)

If the research involves any of the following, FDA regulations 21 CFR 50 & 56 apply and require IRB approval prior to implementation:

• Any use of a drug in research other than the use of an FDA approved drug in the course of medical practice;
• Any use of a medical device in studies where the purpose is to determine the safety or effectiveness of the device; or
• Data will be submitted to or held for inspection by FDA as part of a marketing permit.

At CHNw the IRB Office determines whether a project qualifies as human subjects research. If you do not believe your activity meets either of the above definitions for human subjects research please complete the Non-Human Subjects Research Determination Form and submit it to IRB@ecommunity.com. Please note that no activity can begin until a determination letter is received from the IRB office.

It is the policy of Community Health Network (CHNw) Institutional Review Board (IRB) to protect the safety and welfare of all subjects involved in human subjects research.

The CHNw IRB requires that all key study personnel engaged in human subjects’ research must complete Collaborative Institutional Training Initiative (CITI) training.

This requirement applies to all human subjects research regardless of the level of risk, the institutional affiliation of the personnel and/or the source of funding.

The CHNw IRB requires that all personnel complete the Biomedical and Conflicts of Interest modules prior to engaging in any research involving any Community Health Network patients or data or submitting any applications to the CHNw IRB.

For detailed instructions on how to register with CITI or transfer credits from another institution see:

• Instructions for mandatory CITI training

The CHNw IRB uses the iRIS electronic submission system for all IRB submissions and reviews. Community employees with an eCommunity.com email address can request access to the iRIS system at any time by visiting iris.eCommunity.com.

Visit iRIS

For researchers who are not affiliated with Community or who do not have an eCommunity.com email address please contact the IRB at IRB@eCommunity.com to request access to the system.

For further instructions on submitting a new study in iRIS please contact the IRB office at 317-355-5675 or see instructions below.

Instructions for Submitting to iRIS

The following SOPs are available for review. To request an SOP please contact IRB@eCommunity.com.

Section 1 - General SOPs

• SOP 1-1 Purpose, Authority, Scope
• SOP 1-2 Conflicts of Interest
• SOP 1-3 SOPs
• SOP 1-4 Signatory Authority 

Section 2 - IRB Review of Research

• SOP 2-1 Determination of Activities that Need IRB Review
• SOP 2-2 Criteria for IRB Approval
• SOP 2-3 Full Board Review
• SOP 2-4 Expedited Review
• SOP 2-5 Exempt Review
• SOP 2-6 Continuing Review of Research
• SOP 2-7 Amendment
• SOP 2-8 Study Close Out
• SOP 2-9 Suspension-Termination of IRB approval
• SOP 2-10 Medical Device Clinical Investigations, Compassionate Use, and Treatment IDE
• SOP 2-11 Expanded Access Program (EAP) for Drugs
• SOP 2-12 Humanitarian Use Device
• SOP 2-13 Emergency Use
• SOP 2-14 Certificates of Confidentiality
• SOP 2-15 Vulnerable Populations

Section 3 - Site Responsibility and Reporting

• SOP 3-1 Investigator Responsibilities
• SOP 3-2 Principal Investigator/Key Study Personnel Training
• SOP 3-3 Data Safety Monitoring Plan
• SOP 3-4 Unanticipated Problems. SAE reporting
• SOP 3-5 Protocol Deviation Reporting
• SOP 3-6 IND Safety Reports
• SOP 3-7 Informed Consent
• SOP 3-8 HIPAA

Section 4 - IRB Administration

• SOP 4-1 IRB Membership
• SOP 4-2 IRB Member and IRB Staff Training and Education
• SOP 4-3 Conduct of IRB Meetings
• SOP 4-4 IRB Meeting Minutes
• SOP 4-5 Record Keeping
• SOP 4-6 Appeal of IRB Decisions
• SOP 4-7 Noncompliance

Section 5 - Work with Outside Parties and Reporting

• SOP 5-1 Facilitating Inspections by federal regulatory agencies
• SOP 5-2 Directed On site Review
• SOP 5-3 Utilizing the NCI CIRB
• SOP 5-4 Research Collaborations
• SOP 5-5 Subject Complaints
• SOP 5-6 Mandatory Reporting
• SOP 5-7 Radiation Safety Review