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 (whether professional or student) conducting research [obtains] information or biospecimens 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." (45 CFR §46.102)
For additional information, see:
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.102
http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
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 here.
You must also submit an informed consent form and complete the online training in research ethics, attaching your certificate of completion of this training to your submission.
The research ethics training, CITI program course Human Subjects Research, can be found at www.citiprogram.org. New users should register for an account and choose Maryland Institute College of Art in the "Select Your Organization Affiliation" field to initiate the registration process.
To register for the course select "View Courses" on the Main Menu / Institutional Courses page. This appears under the heading "Institutional Courses" to the right of Maryland Institute College of Art in the list of affiliated institutions. At the bottom of this next page under the heading Learner Tools for Maryland Institute College of Art select "Add a Course".
You have now navigated to the Select Curriculum page. Here, scroll down to Question 1: Human Subjects Research and select "Social-Behavioral-Educational Researchers". After making this selection, scroll down and click "Submit". You will now be enrolled in the course and will be taken to a page where you can select to begin the modules.
Note: the CITI course is made up of 12 modules requiring approximately 3 hours of cumulative time to complete. You will be quizzed after the completion of each module. An average score of 80% is required to receive certification.
The IRB approves research if:
• 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 may apply 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
Within one week of submission of your application for review, the IRB will contact you to let you know if your submission was complete and to inform you of your application's status (whether your research proposal is considered to be exempt from IRB review, suitable for expedited review, or requiring full review). If your proposed research qualifies for expedited review, you will hear from us within two weeks of submission. If your proposed project requires full review, it will be considered at the next full meeting of the IRB. The IRB meets as necessary during the semester in the first week of the month.
Projects that involve no more than minimal risk (the same risks incurred by normal conversation or day-to-day activity) and do not involve engaging with a high-risk population may qualify for expedited review. An expedited review is carried out by the IRB chairperson and one other member of the IRB.
The decision of whether or not a project is suitable for expedited review rests with the chair of the IRB.