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Institutional Review Board

How to Fill Out an IRB

1. INSTRUCTIONS: GENERAL INFORMATION

Each project must have a unique title. If you are modifying an existing approved IRB proposal, please indicate that here and be sure to reference the original IRB identifier for the existing approval (e.g., FA15_14).

The principal investigator is usually a faculty or professional staff member and must take primary ethical responsibility for the project. If the project is a class assignment, this is usually the course instructor.

The co-investigator(s) are other researchers involved in the project. For a class assignment, this is often the student or students carrying out the project.

If you are receiving external funds to support the project, please indicate this in the “Funding Agency” area. If the research is not funded, please indicate “n/a”

The IRB determines whether the proposal requires an expedited review or a full review. In the case of an expedited review, at least one member of the IRB reviews the proposal and consults the full IRB if necessary. Expedited review is appropriate for research that either 1) involves minor changes in already approved research, or 2) involves minimal risk AND falls into particular categories of research, including but not limited to: research on individual or group characteristics of behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.  For the complete list of research categories that may qualify for expedited review, see http://www.hhs.gov/ohrp/policy/expedited98.html .

“Minimal risk” means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

2. INSTRUCTIONS: OBJECTIVES OF PROPOSED PROJECT 

What are the goals of the research? What are you trying to learn or accomplish? A short list of objectives is usually sufficient for this section.   However, some projects may benefit from having additional context on past research or past methodology here.  This is particularly useful if risks are anticipated, but have been explored in past research.

3. INSTRUCTIONS: DESCRIPTION OF HUMAN PARTICIPANTS

Please provide as much information as possible; for example, number, age, sex, how they will be obtained (including selection criteria and recruitment procedure if applicable), and whether the participants will be students or some other special category. Note that in some research designs (e.g., naturalistic observation, ethnography) it is impossible to specify exactly who the participants will be. In these cases it is appropriate to give a more general description (e.g., people who will interact with a librarian at the circulation desk). In any case, be as specific as possible. Information about the potential participants is very important in how the IRB evaluates the ethical considerations of the research project.  If you plan to use prisoners as your research population, you must indicate that clearly here.  You must also indicate clearly if your research involves the recruitment or use of minors (under the age of 18) which would require the researcher to address parental consent.

4. INSTRUCTIONS: SUMMARY OF RESEARCH AND DATA GATHERING PROCEDURES

Provide a description of your research project in language that a non-expert can understand. Include a detailed explanation of the procedure you will follow in collecting data and interacting with participants.  The IRB should clearly understand the method you will utilize and how the data will be recorded/collected.  It is helpful to the IRB if you make reference to specific appendices as you describe them (e.g, see Appendix A for the consent form; see Appendix B for the survey questions).

5. INSTRUCTIONS: LOCATION OF PROJECT

Provide a brief statement of where the research project will take place. For some research projects a description of that location may be important (e.g., the location of the project influences who participates in the project).

6. INSTRUCTIONS: CONFIDENTIALITY SAFEGUARDS

If participants will be anonymous state that here (and please ensure that it is clear how/why they will be anonymous from your description in part 4).  Anonymous means that it is impossible to identify any particular individual’s data.  Signed consent forms must be collected and stored separately from data to insure anonymity.

If the participants will not be anonymous, describe how the confidentiality of the participants’ responses will be maintained. If confidentiality cannot be safeguarded, please explain. If responses are to be audio or video recorded, this must be clearly described and how those recordings will be gathered, stored, and destroyed should be described.


7. INSTRUCTIONS: DESCRIPTION AND ASSESSMENT OF ANY POTENTIAL RISKS

Assess any potential risks—physical, psychological, social, legal, or other—and assess the likelihood and seriousness of such risks.  If your methodology involves potential risks, describe alternative methods, if any, that were considered and why they will not be used, as well as procedures that will be used to minimize the risks that have been identified (e.g., thorough debriefing, resources provided).


8. INSTRUCTIONS: DESCRIPTION OF CONSENT PROCEDURES

Include how and where informed consent will be obtained.  Attach a copy of the consent form that you will use (see below for more information on consent forms).  A written consent form template and an online consent form template are both available on the IRB website.  If the researcher wants to request a waiver of documented consent or a waiver of consent entirely, based on federal guidelines, justification for the wavier must be clearly stated.

If debriefing procedures will be used, describe them here as well (see below for information on debriefing).

Signed consent forms must be retained by the principal investigator for 3 years from the date of research completion and a copy of the consent form should be provided to the research participant.

See http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117 


9. INSTRUCTIONS: DESCRIPTION OF THE POTENTIAL BENEFITS

This includes benefits to the individual participant, investigator(s), and to society in general which may result from this research.  The benefit of the research is weighed against the risks of the research to determine a cost-benefit assessment of the project.

10. ETHICS TRAINING

Everyone conducting human subjects research at MICA is required to complete this online training session, provided by the National Institute of Health, which focuses on research ethics. Once completed, please download the certificate of completion and append it to your application. The certificate is valid for three years. 

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 "Add a Course"  on the Main Menu / My Courses page. This appears under the heading "My Learner Tools for Maryland Institute College of Art" on this page. On the next page select "Social-Behavioral-Educational Researchers" under Question 1:  Human Subjects Research and click on "Submit". The course will now appear on the Main Menu / My Courses page and you can select it to begin.

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.

 

 

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