The Fall 2020 IRB meetings will be held virtually on an as-needed basis.
The IRB accepts applications for approval of research involving human subjects between the first and last day of class of each semester.
Investigators must submit research proposals a week in advance of an IRB scheduled meeting. The meeting dates are listed on the IRB website and under “IRB Meeting Dates” noted earlier in this document. Investigators should allow one week for an expedited review decisions and up to three weeks for full review decisions.
Applications received during the winter or summer break will be reviewed at the beginning of the following semester. Upon notice to the IRB Chair before the end of the semester, an exception may be made for student-faculty research projects conducted through the Summer Research Program. Exceptions for other summer or winter research may be granted only under unusual circumstances. For almost every research project, applicants should expect the IRB committee to review applications only during each semester.
An administrator or staff member will initiate research reviews and facilitate meetings during the winter and summer breaks according to the policy for accepting applications during these periods, as stated in the committee description. During these periods, the IRB chair or, when the chair is unavailable, a sufficiently qualified faculty member appointed by the Dean of the College will write and sign official IRB letters of approval or disapproval.
Based on the action of the convened IRB, the Chair will provide notices of action to investigators regarding their proposals. A notice of action will include
Once a proposal is submitted and reviewed by the IRB, it will designated as approved, not approved, or approved with conditions.
The Chair will email the investigator a dated approval letter. It will state that the investigator should promptly report changes to project procedures or personnel, and any unanticipated problems or adverse events encountered during the study. The letter will include the category of review designation and the duration of the IRB approval, which will end one year to the date of the initial approval. If the project goes beyond a year, the project must be re-approved through the IRB. The investigator must submit an End of Project Report Form at the completion of the study.
The investigator is responsible for implementing all minor changes suggested by the IRB (e.g. change a word in a survey, clarifying terminology in an informed consent document, etc.). The Board will not monitor progress on any of its suggestions for expedited projects or suggestions that do not affect the risk of the study. In this case, the IRB comments or suggestions are meant to draw attention to ways in which a project may be made even less stressful to the human participants.
If the Board does not approve a project or grant an exemption, it will provide justification and suggest ways in which the project might be revised to meet approval. In this case, the revised proposal must be resubmitted with a new Human Subjects Research Proposal.
The IRB may “approve with conditions” research proposals, consistent with OHRP guidelines. By IRB approval with conditions, OHRP means that at the time when the IRB reviews and approves a research study (or proposed changes to a previously approved research study), the IRB requires as a condition of approval that the investigator (a) make specified changes to the research protocol or informed consent document(s), (b) confirm specific assumptions or understandings on the part of the IRB regarding how the research will be conducted, or (c) submit additional documents. The investigator must provide the IRB with a letter or email stating specifically how the conditions will be met before the project begins. The IRB Chair will respond as to whether the conditions have been satisfied and include a final approval letter with the conditions noted in “approved” above. Normally, in this case, a re-submission of the original proposal will not be required. The investigator must submit an End of Project Report Form at the completion of the study.
Any changes to the research activity including research plans, consent process and form, co-investigators, other research personnel, and/or methods of subject recruitment, after IRB approval of the research study must be submitted to the IRB Chair for re-approval before continuing with the project. An exception includes the necessity to eliminate apparent immediate hazards to the subjects. Generally, a minor amendment (such as the addition of a new, related question to a survey) can be approved by the expedited process. A new proposal with any changes in research should be submitted at least one week prior to beginning data collection.
In order for the IRB to focus its attention on the protection of human subjects, the IRB delegates to its Chair the authority to approve minor changes to previously reviewed research. The Chair shall communicate approval to the investigator in written (usually email) form. Examples of minor changes include small changes in the wording of questions on surveys, the correction of minor errors (such as listing an incorrect phone number or email address), the correction of a reference or citation, etc. As noted above, the Chair is also authorized to review and approve changes made in accordance with the conditions of approval made by the IRB.
It is the policy of Randolph College that students may be permitted to be investigators of research activities. A faculty advisor is required to oversee student research even if the student is the investigator. While faculty advisors and the IRB will review and take action on proposals, students who are investigators are responsible for the protection of the human subjects of their research. Student-led investigations may require a faculty advisor to serve as a co-investigator in research projects that are deemed more than minimal risk. “Minimal risk” means that 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,” according to the Department of Health and Human Services Code of Federal Regulations 45 CFR 46.102(i). A proposal that collects information on illegal activity is more than minimal risk and likely would require greater faculty advisor oversight. Other examples of factors that could increase the risk level beyond minimal risk include threats to reputation, financial standing or employability. Questions that elicit responses to life events that are so upsetting that they may cause significant distress might also increase the level of risk.
All requests from external researchers are subject to administrative review as well as needing Randolph College IRB approval. Studies originating from other schools must first receive approval from their own human subjects review board before seeking permission to use Randolph College students or employees as research subjects. A letter of approval from the home institution’s IRB should be submitted with a project proposal to the Board.
Randolph College investigators should obtain IRB approval from Randolph College and all institutions where students would be engaged in the project. In the absence of an IRB, approval from an Executive Director (or synonymous position) is required. Student investigators must have a Randolph College faculty advisor.
The IRB recognizes that internet-based or online surveys complicate issues such as the documentation of consent, the identification of underage participants, and other matters. The IRB encourages investigators (especially students) to conduct only minimal risk research when using internet surveys. The IRB does not recommend the use of open-ended responses on minimal risk surveys because of the risk of subjects providing information that could raise the risk level of the research. The IRB will generally disapprove any internet research involving the use of personally identifiable information because confidentiality cannot be guaranteed. For minimal risk research, the IRB will allow investigators to certify age and consent by including the basic elements of consent in a statement at the beginning of the survey. The required elements of consent can be found in the guidelines for informed consent found in the Procedures for Submitting a Proposal above.
An investigator, or any person with knowledge of unanticipated problems, must immediately report to the IRB Chair, or another member of the IRB if the Chair is not available, the unanticipated problems as well as any adverse events that involved physical and psychological harm to a participant. The Chair will convene the IRB, if necessary, to appropriately address serious unanticipated problems. Protecting against further adverse events to participants in the research protocol is of utmost importance.
If there is an adverse event that occurs during the research project, investigators must complete an Adverse Events Report Form for Primary Investigators, and every involved participant must complete an Adverse Events Report Form for Research Participant.
When reviewing a report of an adverse event, the IRB should consider whether the affected research protocol still satisfies the requirements for current IRB approval, or if a change of review type is warranted for the research. The IRB Chair will inform the Vice President for Academic Affairs who subsequently will notify any necessary supporting agency official, as well as notifying proper authorities at the Office for Human Research Protections.