Institutional Review Board
What is the IRB?
An Institutional Review Board (IRB) is a federally mandated entity that oversees the protection of human subjects in research. IRBs help protect subjects by mitigating potential risks to participants, including their physical and psychological well-being, confidentiality and privacy, and autonomy.
The CHNw IRB oversees human subjects research conducted at Community Health Network. The Human Subjects Office within the Office of Research Administration provides administrative support for the IRB.
At Community Health Network (CHNw), the IRB must review all research involving human subjects, and the research cannot begin until the IRB has provided a written determination. This is true even if a researcher perceives there are no risks to participants in his or her research. If a researcher believes that his or her project does not qualify as human subjects research, the researcher is still responsible for obtaining a written concurrence from the Human Subjects Office before beginning any project.
Note: External IRBs are not allowed without explicit permission from ORA and legal department for studies in areas under the FWA, including all network entities except Anderson.
Below you'll find answers to frequently asked questions about IRB review requirements, submissions and training.
If you have questions, or need to report a concern, please don’t hesitate to contact us at IRB@eCommunity.com or 317-355-5675.
Protection of Human Subjects
Community Health Network IRB’s mission is to ensure that research is conducted ethically according to the principles of the Belmont Report and the Declaration of Helsinki, in compliance with all federal regulations, international (ICH) guidance, and institutional policies and to ensure that the rights and welfare of human subjects are protected.
The IRB recognizes that Indiana laws impose additional requirements on the protection of human subjects in research. To ensure that the applicable requirements are met the IRB members or staff will consult with the CHNw legal office for guidance on additional legal requirements under Indiana Law.
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:
- Data through intervention or interaction with the individual
- 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:
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.
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.
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
Contact the IRB
|Director, Research Compliance and Regulatory Affairs
Attn: Human Subjects Office
7229 Clearvista Drive
Indianapolis, IN 46256
7330 Shadeland Station
Indianapolis, IN 46256
IRB Metrics/Sponsor Information
FWA #: FWA00001713
IRB Registration #: RB00001979
IRB Statement of Compliance
Recent IRB Inspections
The Community Health Network IRB was most recently inspected by the FDA in 2017. The inspection concluded on May 31, 2017 and there were no findings. The final report indicated that the inspection revealed no deviations from applicable regulations.
Prior to the 2017 inspection the Community Health Network IRB was inspected by the FDA between March 29, 2016 and April 4, 2016. At the conclusion of that inspection a FDA Form 483 was issued listing 6 observations. These observations related to expedited reviews, membership rosters, meeting minutes, electronic records and IRB correspondence.
The Community Health Network IRB is scheduled to meet every Wednesday at 7:30 am. All full board submissions must be submitted one week prior to the scheduled meeting in order to appear on the agenda for the following week's meeting.