What is the IRB?
The Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects.
The primary purpose of the IRB is to protect the rights and welfare of the human subjects.
What research has to be reviewed by the IRB?
The IRB reviews and monitors human subjects research conducted at Albion College or in the community.
What is research?
Research contributes to generalizable knowledge. Research is designed in advance. Research utilizes a systematic approach.
What is a human subject?
A human subject is defined by Federal Regulations as "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."
What about student research or class projects?
Some student work is clearly research and requires IRB approval but other student class activities present a challenge to know if they fall under IRB governance.
Institutional Review Board (IRB) approval for research with human subjects. This applies whether the research is conducted by faculty or students, by individuals or a group. Failure to obtain proper approval in advance may jeopardize your data, prevent you from publishing the results.
Many class projects are conducted for educational purposes and not as research, and will not require IRB approval.
IRBs do not have the option of granting "retroactive" approval after research is done; you should err on the side of submitting or consulting with the IRBs if there is any doubt.
IRB approval is required for research activities that result in undergraduate honors theses. IRB approval is generally required if human subjects are involved, either directly or through use of identifiable data.
How do I apply?
Do I have to get consent from study participants?
The standard expectation is that all subjects will sign a document containing all the elements of informed consent. 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. Some or all of the elements of consent, including signatures, may be waived under certain circumstances.
What information must be included in a consent form?
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 that 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 that may be reasonably 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 the records identifying the subject will be maintained; For research involving more than minimal risk, an explanation as to whether any compensation and/or 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 subject's rights, and whom to contact in the event of a research related injury to the subject, if relevant. Typically, questions concerning a research project should be referred to the PI for that project, whereas questions concerning the rights of human subjects should be referred to the IRB. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Other requirements may apply.
How do I obtain consent from Non-English speaking participants?
Consent forms should be prepared in the language understandable to potential subjects.
Researchers should be fluent in the subject's language or an interpreter should be available during the consent process and throughout the subject's participation as needed. When unexpected circumstances arise (e.g. single subject who does not speak/read English), it may be appropriate to consider use of a Short Form of Consent. This form has specific requirements that should be discussed with the IRB prior to use. Researchers should take great care when obtaining informed consent from individuals who do not speak English or whose understanding of the language is limited.
What are the exceptions to informed consent requirements?
The IRB may waive the requirement for written consent if the consent document is the only link between the subject and the research and the principal risk of harm would come from a breach of confidentiality.
The IRB may waive consent if: The research involves no more than minimal risk to the subjects; The waiver will not adversely affect the rights and welfare of the subjects; The research could not practicably be carried out without the waiver; If appropriate, the subjects will be provided with additional information after participation.
Consent may also be waived for some types of research regarding public service programs.
What happens after submission?
Your study will be assigned an IRB number that should be used on all correspondence relating to the study until the study is closed.
What kinds of IRB review are there?
There are three levels of IRB Review (full board, expedited, and determining if exempt from continuing review), determined by the nature of the protocol, level of potential risk to human subjects, and the subject population. The determination of level of review applicable to a particular study is made by the IRB. Regardless of the kind of review, all applications use the appropriate submission form.
Convened IRB review (full board)
Any study involving greater than minimal risk requires a review by the convened IRB. This includes studies with vulnerable populations and sensitive questions as well as studies with the possibility of physical risk. Check the deadline schedule through Submitting a Proposal in the IRB website. Studies assigned to full board review are reviewed by members ahead of time, and then discussed at the meeting. The Committee then votes on whether or not to approve the study.
What are the possible outcomes of a review?
A study may be approved; approved with stipulated changes; disapproved; deferred; or it may be deemed exempt from continuing review.
Approval of research
Research may proceed on receipt of written documentation of IRB approval.
Stipulated minor changes or clarifications required prior to approval
It is common for the IRB to request some changes to the consent form or protocol prior to approval. These are called "stipulated changes." If there are stipulations, you will receive a communication from the IRB with details. You should respond to the communication in writing. If your response is acceptable, your project will be approved and you will receive an approval letter.
Deferral (full board action only)
Sometimes the IRB, in a full board review, determines that substantive changes must be made before approval may be granted. Full board review is required for responses to deferral.
How long does it take?
The chair of IRB will contact you if changes are needed within two weeks. Please allow a month until for all the necessary changes to be made and the committee gives final approval. The PI has a significant influence on length of time between submission and approval. Well prepared applications result in fewer requests for stipulated changes. Rapid response by the PI to requests for changes speeds the approval process.
You have a responsibility to report unanticipated problems or adverse events that may occur during the research to the IRB. "Adverse event" or "adverse experience" (AE) is an undesirable and unintended, though not necessarily unanticipated, injury or physical or emotional consequence to a human subject.
All projects are subject to renewal, usually annually.
No approval is for longer than one year from the initial review. If the research is continuing or data analysis is not yet completed, request renewal of approval to (please include your IRB number and title of your study. Projects are subject to continuing review through the data analysis phase. At completion of this phase, inform the IRB that your project is completed at .
What if I want to modify the study?
Once the project is submitted to the IRB, you may not make changes to the study until the IRB has completed the approval process for your original submission. Once your study is approved, you may submit modifications. All protocol changes must be approved by the IRB prior to implementation. All changes to documents used with subjects (consent forms, questionnaires, recruitment materials, etc.) must be approved by the IRB prior to use. The review of the amendment request may be expedited or may require full board review.