- Does my research require IRB review?
- Is there an application deadline?
- What is expedited review and does my research qualify?
- How do I sign up for the Mandatory Ethics Training?
- What will the IRB committee look for when reviewing my research proposal?
- What if I need to revise an approved research protocol?
- What should I do if my research study extends for longer than the one-year IRB approval deadline?
- What is informed consent?
- Is there anything I need to report upon completion of my project?
- How long should I keep my research records upon completion of my project?
*Note that throughout the answers provided below you will frequently encounter references to the acronym CFR, which refers to the Code of Federal Regulations. The CFR is published in the Federal Register, a publication of the Federal Government that codifies the general and permanent rules of executive departments and agencies.
All research that includes human research subjects are subject to IRB review. Research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. A human subject is defined as a living individual about whom an investigator obtains data through intervention or interaction, or identifiable private information. For more detailed definitions see 45 CFR ş46.102. In short, if your research does not fit the definition of human subject research, then there is no requirement for IRB review. If your investigation does fit the definition of human subject research then it always requires some level of IRB review. The types of review are exempt , expedited, full, or continuing review. For more information on how to apply for IRB review visit the application page.
The IRB committee accepts applications year round. However, applications must be received at least 14 days prior to the next scheduled IRB meeting to be included in the agenda. Also note that the committee does not normally meet during June and July. View list of upcoming meeting dates.
Expedited review is a procedure for certain kinds of research involving (1) no more than minimal risk (2) minor changes in approved research (3) procedures listed in one or more of the categories outlined in the human subjects guidance 63 FR 60364-60367. "No more than 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." Expedited review does not negate or modify the policies of the college or the HHS regulations (i.e. a full application is still required). Expedited review means that one or more experienced members of the IRB (often the chair) can review the study without it being considered at a convened meeting. When conducting expedited review, the chair may exercise the same authority of a full IRB committee except he/she cannot disapprove the research study. The IRB chair makes the determination of whether an application and protocol qualify for expedited review under 45 C.F.R. ş46.110.
Saint Anselm College offers several online ethics training courses through the Collaborative Institutional Training Initiative (CITI), inlcuding the following two courses that are most relevant to the IRB:
- IRB Protection of Human Subjects (required of all individuals conducting research with human subjects)
- Responsible Conduct of Research (required of all individuals with externally funded research)
For information on how to register for either online course download/view the CITI registration guide (Word/33KB).
The objective for the IRB committee when reviewing your human subject research will be to ensure that it is in compliance with federal standards and that it is consistent with the policy and procedures of Saint Anselm College. To that end, there are few specific questions that reviewers will keep in mind when reviewing your research. These same questions are therefore useful for you to consider while writing your research plan:
- Have the risks to subjects been minimized using procedures that are consistent with sound research design?
- Are the risks reasonable in relation to anticipated benefits?
- Is the selection of subjects equitable?
- Are adequate procedures in place to ensure privacy and confidentiality?
- Is there a plan to monitor the data and safety of the subjects, if necessary?
- Will informed consent be sought and appropriately documented? Do proposed alterations or waivers of informed consent meet the criteria for approval?
- Are safeguards in place to protect vulnerable populations?
The IRB must review and approve all amendments to study protocols before the researchers can implement them. Amendments are reviewed the same way a new study is reviewed, that is, by the convened IRB or by expedited review, depending on how the changes affect the protocol. Minor modifications - those changes that are minimal risk and do not significantly alter the risk/benefits balance or other study elements - may be reviewed under the expedited review process. Major modifications, requiring full IRB review, are those that might increase the risk to participants or otherwise represent a substantive change, such as the inclusion of a vulnerable population, or change in treatment. Investigators seeking to amend their research protocol should provide the committee with a written explanation of the proposed changes, including justification as to why the modification is necessary and reasonable given the overall study design.
Continuation of a research study beyond the approval period (12 month maximum) requires submission of a request for continuance to the IRB. It is the investigator's responsibility to submit a status report (Word/143KB), and if appropriate, a request for continuance (PDF/83KB) in a timely manner. Additional information on continuing review can be found at the DHHS website.
It is federal policy that no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. See CFR §46.116 for general requirements for informed consent and a list of basic elements that are included in standard informed consent forms, and CFR §46.117 for directions on the documentation of informed consent. Please note that recruitment of subjects is part of the consent process because it begins the disclosure process. All recruitment strategies such as fliers, e-mail messages, newspaper ads, phone calls, and so on must be reviewed by an IRB before they are used.
Institutional Review Board (IRB) approval is granted for one year or the completion date of the project. Upon completion of a project investigators must submit a brief summary report of 1-2 paragraphs that includes the following:
- Date of completion
- Short narrative description of research activity
- Number of human subjects that took part in your study
- Description of any reported or adverse effects to human subjects
Investigators are responsible for retaining signed consent documents, IRB correspondences, and research records for at least 3 years after the completion of the research activity. Additional requirements must be met for FDA-regulated studies as specified in 21 CFR Part 312.62 (c) (PDF).