Research During COVID-19
What research projects need to be approved by the IRB?
Research involving human subjects needs to be approved by the IRB. “Research” is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
A “human subject” is defined as “a living individual about whom an investigator conducting research obtains information or biopspecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens; OR obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.”
Revised federal regulations in effect as of 2018 indicate that the following activities are NOT deemed to be research under these regulations and therefore do NOT need to undergo IRB review: “Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.”
If you are not sure if your research requires IRB review, please consult with the IRB by emailing a short description of your project (its purpose and your data collection procedures) to firstname.lastname@example.org.
Why have you told me that my project needs to be reviewed?
The St. Mary’s College Institutional Review Board formulated the following two guidelines for the review of research involving human subjects conducted at St. Mary’s College, or conducted by St. Mary’s College faculty or professional staff (February 7, 1986).
- All research involving human subjects must receive an ethics review by the IRB if the subjects are being recruited from outside the instructor’s classroom and the research project is not an in-class demonstration.
- An evaluation of the ethics involved in in-class research demonstrations and experiments remains entrusted with the individual instructor.
What is an expedited review?
How do I get my project reviewed by the IRB?
The eIRB form, instructions for completing the eIRB form, and templates for informed consent can all be found at https://dev.smcm.edu/irb/forms/. The completed eIRB form should be emailed to email@example.com for review.
Where can I obtain the IRB form and instructions?
The IRB form, instructions for completing the form, and templates for informed consent can be found at https://dev.smcm.edu/irb/forms/. The completed form should be emailed to firstname.lastname@example.org for review. Questions about completing the form can be sent to email@example.com, but most commonly asked questions are answered in the instructions document.
How do I submit an IRB proposal?
To submit an IRB proposal, complete the IRB form by editing the Microsoft Word file.
Important: Make sure to include any appendixes (e.g., consent form(s), debriefing statements, copies of surveys, list of interview questions, and other materials being presented to participants) at the end of the file, include a page break between each appendix and attach ONE file to an e-mail message and send it to firstname.lastname@example.org. Your IRB proposal is NOT complete if it does not contain your consent form(s) and other relevant information!
What kinds of ethical issues does the IRB consider?
Criteria for IRB approval of research:
- risks to subjects are minimized;
- risks are reasonable in relation to anticipated benefits;
- selection of subjects is equitable;
- informed consent is sought from each subject;
- informed consent is appropriately documented.
Additional criteria where appropriate:
- data collection is monitored to ensure subject safety;
- privacy and confidentiality of subjects is protected;
- additional safeguards are included for vulnerable populations
What is informed consent?
Informed consent refers to the voluntary choice of an individual to participate in research based on an accurate and complete understanding of its purposes, procedures, risks, benefits, alternatives, and any other factors that may affect a person’s decision to participate.
Informed consent is typically gathered by having participants sign a hard copy consent form or indicate their consent in an online format. Participants under the age of 18 must have the consent of a parent or guardian and must also give their own assent to participate. Templates for SMCM consent forms are available at https://dev.smcm.edu/irb/forms/ and their use is encouraged to make sure all required elements of consent are present in the consent form. Information about informed consent from the federal guidelines can be found at https://www.ecfr.gov/cgi-bin/text-idx?SID=91137a43527512a23d10a2d56603fdd2&mc=true&node=se45.1.46_1116&rgn=div8
Does the IRB need to review projects that have small revisions?
How long does it take the IRB to review a proposal?
What if some unforeseen risks emerge as the research is being conducted?
Any unforeseen risks or negative response to the research must be reported to the IRB immediately. The researcher should temporarily suspend data collection and promptly inform the chair of the IRB by sending an e-mail to email@example.com and directly to the current Chair.
What should I do if I have other questions about IRB procedures?
Send an email to firstname.lastname@example.org and we will respond to your questions as quickly as possible! If you have questions about completing the IRB submission form, be sure to review the Instructions document on the Forms page for further information about how to complete the forms.