IRB Frequently Asked Questions
The following questions/answers provide details about Community Health Network's procedures and requirements for clinical research. For more information, please contact the IRB:
Community Health Network Institutional Review Board
c/o Medical and Academic Affairs
7330 Shadeland Station, Suite 200
Indianapolis, IN 46256
An Institutional Review Board, or IRB, is comprised of people (physicians, laypersons, and administration) who review research to assure that patients or populations in a study are aware of and consent to any physical or psychological risks.
The primary role of an IRB is to protect research participants from physical or psychological risks. The Community Health Network IRB was established to review, approve, require modifications to, or disapprove human subject research conducted under the auspices of the Network.
A series of ethical failures in research (most notably the Tuskegee Syphilis Study and theThalidomide Tragedy in the 1960s) gave birth to the modern IRB system, which is required across the country and around the world. Each institution conducting research is required by law to have its own IRB or contract the services of another IRB.
Sometimes the line between clinical care and research is blurry – the IRB Office is here to help you make that determination. Our goal is to provide all Community Health Network researchers with information, guidance, forms, and related materials needed to secure IRB approval for human subject research.
IRBs are subject to the Department of Health and Human Services (HHS) regulations in Title 45 Part 46 of the Code of Federal Regulations as well as the Food and Drug Administration (FDA) regulations (Title 21 Part 50 and Title 21 Part 56) when any FDA-regulated product (drug, device, or biologic) is reviewed.
Community Health Network has committed to provide full compliance with the regulations via a written document called a “Federalwide Assurance” (FWA). If for any reason Community Health Network fails to follow the regulations, HHS can revoke our FWA which would result in our inability to receive any federal funding for research in any area of the network. Our FWA Number is 00001713.
Human subject research means any activity that meets the FDA or HHS definition. Research may include surveys, new patient care procedures, or even observations about patient care.
45 CFR 46.102(d) defines “research” as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
The FDA defines “research” as any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]
- “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act” means any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
- “Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act” means any activity that evaluates the safety or effectiveness of a device. [21 CFR 812.2(a)]
- “Any activity in which results are being submitted to or held for inspection by FDA as part of an application for a research or marketing permit is considered to be FDA-regulated research. “[21 CFR 50.3(c), 21 CFR 56.102(c)]
While that may seem obvious, a “human subject” must meet specific definitions according to the HHS and the FDA.
45 CFR 46.102(f) defines a “human subject” as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
- “Intervention” defined by HHS regulations means 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. [45 CFR 46.102(f)]
- “Interaction” as defined by HHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]
- “Private information” as defined by HHS regulations means 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). [45 CFR 46.102(f)]
- “Identifiable information” as defined by HHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).
“Human Subject” as defined by FDA regulations means an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3(g), 21 CFR 56.102(e)] A human subject includes an individual on whose specimen a medical device is used. [21 CFR 812.3(p)]
NOTE: Secondary analysis of existing datasets where participants are individually identifiable should be reviewed by the IRB.
All human subject research, regardless of funding source, must be reviewed and approved by the Community Health Network IRB before initiation where:
- The research is sponsored by Community Health Network.
- The research is conducted or directed by any employee or trainee of the Network in connection with his or her Community Health Network responsibilities.
- The research involves Network faculty, staff, and/or students.
- The research involves access to any property or facility of the Network at the following locations:
- Community Hospital East
- Community Hospital North
- Community Hospital South
- Community Rehabilitation Hospital
- Community Westview Hospital
- Indianapolis Osteopathic Hospital, Inc.
- Community Surgery Center North
- Community Surgery Center East
- Community Surgery Center Hamilton
- Community Endoscopy Center
- Hancock Surgery Center
- Center for Neurological Rehabilitation
- Community Health Network Foundation
- Community Heart and Vascular
- Community Home Health
- Community Physician Network (formerly Community Physicians of Indiana)
- Community Regional Cancer Center
- Gallahue Mental Health Center
- Specialty MRI Center
In lieu of a membership list, the following information pertaining to membership is provided: The Community Health Network IRB meets the IRB membership requirements as set forth in 45 CFR 46.107 and 21 CFR 56.107, including that no IRB member may participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB [45 CFR 46.107(e) and 21 CFR 56.107(e)].
Research studies involving more than minimal risk to human subjects as defined by 45 CFR 46.102(i) are required by federal regulations to be reviewed by the fully-convened IRB.
Minimal risk is “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
Research that is considered minimal risk may also be referred to the full board for review in the following situations:
- The research study involves vulnerable populations, sensitive topics, or a complex research design that would benefit from a review by the breadth of expertise represented at the full board.
- The study has obtained an NIH Certificate of Confidentiality (CoC) that protects subject data from compelled disclosure. The CoC does not, however, protect sensitive data from accidental or malicious disclosure which may pose more than minimal risk to subjects.
- The study is referred to the full board by an expediting reviewer. For example, a reviewer may seek guidance from the full board in determining whether a study meets the regulatory definition of minimal risk or when the scientific question posed by the PI exceeds the expertise of the identified expediting reviewer pool.
A study previously reviewed by the full board may subsequently be reviewed by expedited review in the following situations:
- An amendment to the study that proposes minor changes to the previously approved research.
- Continuing review of research where:
- The research is permanently closed to the enrollment of new subjects; all subjects have completed research-related interventions; and the research remains active only for long-term follow-up of subjects or
- No subjects have been enrolled and no additional risks have been identified, or
- Remaining activities are limited to data analysis.
- Research previously reviewed by the full board and deemed to be minimal risk. The IRB may vote to return a minimal risk project to expedited review for subsequent reviews.
Some types of research may not require a review by the fully-convened IRB. Generally, these are research activities that present no more than minimal risk to the subject.
45 CFR 46.102(i) defines minimal risk as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met:
- Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
- Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
- From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
- From other adults and children, considering the age, weight, and health of the subjects, the collection procedures, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
- Prospective collection of biological specimens for research purposes by noninvasive means.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Continuing review of research previously approved by the convened IRB as follows:
- where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
- where no subjects have been enrolled and no additional risks have been identified; or
- where the remaining research activities are limited to data analysis.
- Continuing review of research, not conducted under an investigation new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Both HHS [45 CFR 46.101(b)] and FDA [21 CFR 56.104] regulations include categories of research which are exempt from the regulations. Although the category is called "exempt," at Community Health Network the determination of exemption must be made by the IRB Office. Exempt projects are different from Expedited or Full Board review in that they are not assigned an expiration date, do not have to undergo continuing review. (IRB review and approval is still required for any study alterations).
IRB applications are accepted, triaged, and scheduled for review as they are submitted to the IRB office through our electronic submission system. Initial applications requiring full board review must be submitted no later than seven (7) days prior to the scheduled meeting. Continuing Review applications must be submitted no later than 30 days prior to the study expiration date.
45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1) require the IRB to ensure that investigators promptly report “any unanticipated problems involving risk to subjects or others” (UPIRTSO) to the IRB. UPIRTSOs in which the Community Health Network IRB is the IRB of record must be reported within five (5) days of first learning of the event, even if it is not resolved, using the IRB Reportable Event form.
The standard expectation is that all subjects will sign a document containing all the elements of informed consent. A Waiver of Consent may be granted if specific criteria are met and the Waiver is approved by the IRB. Please contact the IRB Office for more information if a Waiver is requested.
The informed consent process gives potential subjects a description of the study that is clear and complete enough for the individual to judge whether she or he wants to participate. The consent form should provide readily understandable information in an amount appropriate to the level of risk in participating.
Please see the Community Health Network IRB Operations Manual.
The following are REQUIRED elements of an Informed Consent as set forth in 45 CFR 46.116:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
- A description of any reasonably foreseeable risks or discomforts to the subject;
- A description of any benefits to the subject or to others which may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
When appropriate, one or more of the following elements of information shall also be provided to each subject:
- A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
- Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
- Any additional costs to the subject that may result from participation in the research;
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
- A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
- The approximate number of subjects involved in the study
Absolutely! The Privacy Rule defines conditions where certain health information may be used or disclosed in research activities. These regulations define conditions where “authorization” to use Protected Health Information (PHI) must be obtained from the subject. The use of PHI for research purposes requires documented Authorization from the individuals whose PHI will be used unless an IRB or Privacy Board waives the requirement for authorization.
Please contact the IRB Office if you have any questions or refer to the IRB Operations Manual if you need further guidance on HIPAA in research settings.
Community Health Network has determined that all individuals involved in research with human subjects, including investigators (principal investigators and co-investigators) as well as members of the research team must complete the appropriate Human Subjects Protection Training curriculum.
For more information, please see the IRB Training Requirements page.