Institutional Review Board | Community Health Network

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 Community Health Network 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 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.

Do You Need IRB Review?

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.

Non-Human Subjects Research (NHSR) Form

Required Training Prior to IRB Submission

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.

At minimum, the IRB requires completion of the HSR-SBE modules OR the HSR-BioMed modules. Completed curriculum must be affiliated with CHNw by CITI. Please complete any additional modules required by your specific department.

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

Instructions for Mandatory CITI Training

How to Submit to the CHNw IRB

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

Policies and Procedures

Institutional Review Board Policies and Standard Operating Procedures (SOPs) may be requested by emailing IRB@eCommunity.com.

Contact the IRB

Mindy Whisnant
Manager, Institutional Review Board

Email: IRB@eCommunity.com
Phone: 317-355-5675
Fax: 317-355-8747

Mailing address:
Attn: IRB
6626 E. 75th St., Suite 400
Indianapolis, IN 46250

Legal address:
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.

Meeting Schedule

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.