Institutional Review Board FAQ
Does my research require IRB review and approval?
Research is defined as a systematic investigation. Systematic investigations include development, testing, and evaluation that is done with the goal to develop or contribute to generalizable knowledge. A project requires IRB review if it
- meets the definition of research
- involves interaction or intervention with human subjects
- collects and handles participants’ private identifiable information.
Members of the IRB will make a final determination as to whether a project constitutes human subjects research. The information researchers provide to the IRB will be assessed in making this determination.
What is “systematic investigation”?
Systematic investigation involves a predetermined method for answering specific questions, testing a specific hypothesis, exploring a topic or developing or testing a theory. Scholarly activity that involves setting objectives, developing procedures that help the researchers achieve the objectives, and utilizes quantitative, qualitative, or mixed methodology to collect and analyze data is considered a systematic investigation. Examples of systematic investigations include but are not limited to interventional research, group comparison studies, test development, interview or survey studies, clinical studies, observational studies. Examples of non-systematic investigations include but are not limited to oral histories, phenomenological activities, journalism. Program evaluations can be considered in both categories and thus need to be presented to the IRB to make a determination.
What is “generalizable knowledge”?
Generalizable knowledge includes findings that are intended to have a theoretical and/or practical impact in a discipline. If you disseminate information with the goal of influencing practice, behavior, future research, and/or theory, you are contributing to the generalizable knowledge.
What is a “human subject”?
A human subject is a person who is participating in research. The participation can take many different forms from answering survey questions, participating in an experiment, providing biospecimens and many others.
When a human subject is providing data through physical procedure or if there is a manipulation of one’s environment, we say there is intervention. Interaction includes personal or interpersonal communication between the researcher and human subjects. The interaction can be face to face or remote (e.g. online survey). The interaction can be confidential OR anonymous.
Private information is information about a human subject (either personal information that identifies the subject or information about their behavior that occurs in a research setting) that an individual can reasonably expect will not be made public. Such information can include identifiable information such as names, addresses, age as well as other information such as medical record, answers to the surveys, biospecimen results.
Some activities are not classified as human subject research. They include certain public health activities, legal research, literary criticism, historical research as well authorized operational activities in support of homeland security, defense and other national security missions. Such activity must be determined and authorized by respective government agencies.
What is informed consent?
The informed consent process is a basic ethical requirement that reflects the ethical requirement of beneficence or respect for persons. This requirement and other ethical requirements are described in the Belmont Report. In essence, informed consent is an education process between the researcher(s) and human subject(s) and this process continues throughout the study. Informed consent process ensures that potential participants will understand what the research seeks to accomplish and can make a decision to participate in research knowledgeably and voluntarily. The elements of informed consent are mandated in the regulations at 45 CFR 46.116, 38 CFR 16.116, and 21 CFR 50.25
A subject’s consent is considered informed if a person has a reasonable understanding of that to which he/she is consenting.
The consent process should:
- Provide complete information about the nature of the research and the subject’s participation
- Ensure adequate comprehension on the part of potential subjects
- languages if your human subjects are not fluent English speakers
- Allow the subject’s voluntary choice to participate
To ensure adequate comprehension of potential participants, human subjects should be presented with a consent document written at the 8th-grade reading level. Moreover, human subjects should be presented with information in a language they understand. If subjects do not speak, understand, or read English then consent documents must be translated into a language they can understand.
The IRB may waive the requirement to obtain a signed informed consent form if it finds that either:
- The only record that links the subject to the research is the consent form and the most serious risk would be a breach of confidentiality; and
- The research involves no procedures for which written consent is normally required outside of the research context and the procedures carry no more than minimal risk.
Unless waived by the IRB, consent from subjects must be obtained freely and without coercion and/or undue influence.
What are the required elements of informed consent?
The following information MUST be provided to potential research subjects.
1) A statement that the study involves research, an explanation of the purposes of the research; the expected duration of the subject’s participation, a description of the procedures to be followed and identification of any procedures which are experimental.
2) A description of any reasonably foreseeable risks or discomforts to the subjects.
3) A description of any benefits to the subject or to others which may reasonably be expected from the research.
4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
6) For research involving minimal risk, an explanation as to whether any medical treatments or compensation are available if injury occurs and, if so, what they consist of or where further information may be obtained.
7) An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research-related injury to the subject.
8) A statement that participation is voluntary and refusal to participate will not involve penalty or loss of benefits to which the subject is otherwise entitled, that the subject may discontinue participation at any time without penalty or loss of benefits to which he/she is otherwise entitled, and that the subject will receive a copy of the signed informed consent.
The consent templates on the IRB page include these required elements. The researcher must adequately address each required element in their informed consent document. If the required elements are not adequately stated in the consent document, the IRB will be unable to grant approval for the research. Once approved, only the versions that were included in the approved protocol should be used. Any changes to approved consent documents require IRB approval.
Please refer to the IRB policy for more information. You can also contact the Caldwell University IRB at email@example.com