Institutional Review Board

Research involving human subjects needs to be approved by the IRB. “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 conducting research obtains data through intervention or interaction with the individual, or identifiable private information.”

For additional information, see:

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102
http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

No, certain types of observational, archival, and educational research do not require IRB review. For example, the following do not require IRB review: research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

For a complete list of exempt research, see:

http://answers.hhs.gov/ohrp/categories/1564

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:

http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.110

In order to have a proposal reviewed by the IRB, the researchers must complete and submit an IRB form. The IRB form contains questions regarding the project procedures as well as ethical safeguards being used in the project. Detailed instructions for completing the form are available at here.

The IRB form can be obtained by downloading the Microsoft Word file named “eIRBForm.doc” from here (use the “forms” link to the left). Instructions and forms also may be obtained through an e-mail request addressed to the IRB at irb@smcm.edu.

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!

If it is impossible to submit the proposal electronically, print and complete “hardIRBForm.pdf” and submit the original form and 4 copies (plus appendixes) to the current IRB chair via campus mail or to his or her office.

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. Complete information on informed consent and how to properly document it can be obtained by following these links:

http://www.hhs.gov/ohrp/policy/ictips.html

http://www.hhs.gov/ohrp/policy/consent/

http://www.hhs.gov/ohrp/policy/consentckls.html

http://answers.hhs.gov/ohrp/categories/1566

http://answers.hhs.gov/ohrp/questions/7247

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.

Promptly inform the chair of the IRB by sending an e-mail to irb@smcm.edu or contacting the current IRB chair Anna Han directly at hahan@smcm.edu .