FAQ

The Institutional Review Board (IRB) is a committee established to review, approve and monitor research involving human participants conducted by Albion College faculty, students, staff, or members of the Albion community. The primary purpose of the IRB is to protect the rights and welfare of the human subjects.

The IRB reviews and monitors human subjects research conducted at Albion College or in the Albion community.

Research contributes to generalizable knowledge. Research is designed in advance. Research utilizes a systematic approach.

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.”

• Some student work is clearly research and requires IRB approval, but other student class activities may or may not qualify as research, if in doubt whether an IRB review is needed contact the committee chair for clarification
• Many class projects are conducted for educational purpose only and not for research purposes and will not require IRB approval
• Institutional Review Board (IRB) approval for research with human subjects is required regardless of 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, preventing you from publishing the results
• The IRB committee does not have the option of granting “retroactive” approval after research is done; if there is any doubt about whether you need IRB approval you should contact the chair of the IRB committee for clarification
• IRB approval is required for research activities that result in an undergraduate honors thesis or a FURSCA sponsored project. IRB approval is generally required if human subjects are involved, either directly or through use of identifiable data.

Submit a Research Proposal.

The standard expectation is that all participants will sign a document containing all the elements of informed consent. The informed consent process gives potential participants 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.

• 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 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

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.

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.

Within 24 hours of receiving your proposal, you will receive an email with your assigned proposal number that should be used on all correspondence relating to the study. Reply to the message and electronically attach your proposal documents. Once your electronic version is received, your study will be reviewed by members of the IRB committee.

There are two categories of IRB review involving human participants:

• Expedited review

• Convened review

The determination of which level of review is appropriate for a particular study is based on the nature of the protocol, level of potential risk to human participants, and the participant population. Institutional Review Board (IRB) approval for research with human subjects is required regardless 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, preventing you from publishing the results. If there is any doubt about whether you need IRB approval you should contact the chair of the IRB committee for clarification.

A study may be approved; approved with stipulated changes; disapproved; deferred; or it may be deemed exempt from continuing review. Proposal decisions can generally be anticipated within a two-week turnaround time.

Approval of research: Once a final decision on the proposal has been made, you will receive official confirmation by email from the committee chair.

Stipulated minor changes or clarifications required prior to approval: Normally the IRB will request some changes to the consent form and/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 electronically respond to the communications. If your corrections are acceptable, your proposal will continue through the review process. Revision submissions generally extended the approval turnaround.

Deferral (full committee action only): Sometimes the IRB, in a full review, determines that substantive changes must be made before approval may be granted. Full committee review is required for responses to deferral. Once a final decision on the proposal has been made, you will receive official confirmation by email from the committee chair.

The chair of IRB will contact you if changes are needed within two weeks. Please allow a month for all the necessary changes to be made and for the committee to give 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 also speeds up the approval process.

You have a responsibility to report unanticipated problems or adverse events that may occur during the research to the IRB chair. “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.

Immediately report any unanticipated problems to [email protected].

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 [email protected] (please include your IRB number and title of your study). Projects are subject to continuing review through the data analysis phase.

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.