Information

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 irb@smcm.edu.

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).

1. 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.
2. An evaluation of the ethics involved in in-class research demonstrations and experiments remains entrusted with the individual instructor.

An expedited review applies to certain kinds of research involving no more than minimal risk, and to minor changes in approved research. An expedited review is carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. If there is sufficient concern about a proposal during an expedited review, the proposal will be reviewed by the full IRB before a decision is made. For additional information on expedited reviews, see the FDA website.

The eIRB form, instructions for completing the eIRB form, and templates for informed consent can all be found at  https://www.smcm.edu/irb/forms/.  The completed eIRB form should be emailed to irb@smcm.edu for review.

The IRB form, instructions for completing the form, and templates for informed consent can be found at  https://www.smcm.edu/irb/forms/.  The completed form should be emailed to irb@smcm.edu for review.  Questions about completing the form can be sent to irb@smcm.edu, but most commonly asked questions are answered in the instructions document.

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 irb@smcm.edu. Your IRB proposal is NOT complete if it does not contain your consent form(s) and other relevant information!

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

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://www.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

Yes, any substantive revision to a project must be reviewed by the IRB.

The IRB is committed to making quick decisions. In most cases (i.e., expedited proposals), a decision will be returned (via electronic mail) to the investigators within 3-5 working days (weekends and holidays are excluded), however during peak submission times it may take longer. Proposals submitted during summer months and proposals submitted on paper rather than electronically generally require a longer review time. Additionally, if members of the IRB have questions for the researchers, then the review time may be lengthened. Although the IRB has been successful in meeting the goal of 3-5 working days, there is no guarantee. Therefore, investigators should plan ahead and submit IRB proposals early in order to ensure an early initiation of approved projects.

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 irb@smcm.edu and directly to the current Chair.

What should I do if I have other questions about IRB procedures?

Send an email to irb@smcm.edu 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.