1- read the IRB file
2- Please, login to this website and complete the training (7 brief modules). When finished, download a copy of the Completion report, save it and send it to me. If you have difficulties saving and uploading as a .pdf, a screen shot will be acceptable, copy and paste… whatever works.
3- write a reflection on a word document: what kind of review you believe will be necessary for your study. Then, reflect upon what components covered in the training are most relevant to your study. What questions will have to be addressed?
How Early ESOL classes Overcome language and culture Barriers in Schools: Helping Arab
Children Acquire Success in Elementary Schools
-the completion report
What is the role of the Institutional Review Board (IRB)?
The IRB reviews and approves all Marymount University research that involves human subjects, in accordance with federal regulations and University policies. The IRB review ensures that risks to subjects are minimized; risks to subjects are reasonable in relationship to anticipated benefits; selection of subjects is equitable; informed consent is obtained and properly documented; data collected is monitored to ensure safety of subjects; and the privacy of subjects and confidentiality of data are maintained. In addition to approving research, the IRB has the authority to require modifications (in securing approval), disapprove research, conduct continuing reviews, observe/verify changes, and suspend or terminate approval of research.
What research must by approved by the IRB?
Research is defined by federal guidelines as a systematic investigation designed to develop or contribute to generalizable knowledge and should be distinguished from potentially similar activities such as employing innovative teaching techniques and administrative data collection.
Marymount University requires that all research involving human subjects conducted by faculty, students, or staff affiliated with the University be reviewed and approved by the IRB prior to initiation, regardless of the source of funding, and regardless of its federal status as an exempt, an expedited, or a full review project.
What about student research projects?
Student research may qualify for an alternative process for assurance of human subject protection. To qualify, projects must meet all of the following criteria:
1. The primary purpose of the human subject’s data collection is classroom instruction about the research process, not the production of generalizable knowledge that will be shared outside the classroom.
2. The project meets the federal criteria for “exempt” research.
3. A faculty member is directly responsible for overseeing data collection activities. This faculty member has completed the NIH online tutorial on Human Subject’s Protection, and has submitted a copy of the completion certificate to the IRB committee. This certification must be completed every two years.
4. The supervising faculty member reviews each student’s project before initiation of any human subjects involvement and confirms that adequate safeguards are in place. This faculty member continues to monitor human subject involvement during the project. The faculty member is responsible for assuring that human subjects are fully protected.
5. The supervising faculty member informs the IRB committee of the names of the projects and the student researchers with a confirmation that he or she has reviewed the project and can confirm that the student researchers are adequately protecting human subjects.
6. Once the project is completed all individually identifiable data related to the project is destroyed.
What kinds of IRB reviews are there?
There are three federally defined categories of IRB review, which are determined by the nature of the research, level of potential risk to subjects, and the subject population.
I. Full Review Research that requires full review are studies that:
1. Put subjects at more than minimal risk; OR
2. Involve subjects who are vulnerable to coercion or undue influence; OR
3. Cannot assure confidentiality of a subject’s responses (e.g., audio or videotaped interviews, or a “key” that would allow someone to match a set of responses with a particular participant; OR
4. Collect or record behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability, be stigmatizing, or be damaging to the subject’s financial standing, employability, insurability, or reputation; OR
5. Collect information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior); OR
6. Involve as subjects prisoners, fetuses, pregnant women, and the seriously ill or mentally or cognitively compromised adults.
Research projects involving certain warm-blooded animals have additional requirements. Contact the IRB Chair for information.
Full Review Process: Proposals may be submitted at any time during the academic year. Full reviews are conducted by all members of the IRB. These proposals may require 6 weeks for a response.
II. Expedited Review
Expedited review can be approved for studies that involve no more than minimal risk to subjects (for example, blood sampling in minimal amounts, use of noninvasive procedures routinely used in clinical practice, chart reviews, and survey research). The Department of Health and Human Services’ Institutional Review Board Guidebook defines minimal risk as that where “the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
Expedited Review Process: Proposals may be submitted at any time during the academic year. Proposals received by the first workday of each month will receive a response within 30 days. Expedited reviews are conducted by three IRB members. The full IRB will review any proposal that is recommended for denial.
III. Exempt from IRB Review
Research with very minimal risk to human subjects, as determined by regulatory guidelines, may be exempted from continuing review, at the determination of the IRB upon receipt of the proposal.
Exempt Review Process: Exempt reviews are conducted by two IRB members. The full IRB will review any proposal that is recommended for denial.
Criteria for Determining Category of Review
How do I submit an IRB application?
The IRB Committee accepts proposals at any time during the academic year. Exempt and expedited review proposals received by the first workday of each month will be responded to within 30 days. Full review projects may take 6 weeks for response. If you are working on a proposal with a fixed deadline, contact the IRB committee chair EARLY in the proposal preparation process to alert the committee to the proposal and to discuss submission deadlines.
All IRB applications must identify a Marymount University faculty member as the Principal Investigator. Students may be listed as co-investigators and may be the primary persons carrying out the research.
The Chair of the IRB will review each application to be sure it is in the correct review category (full review, expedited, or exempt). Faculty who are submitting applications that involve the use of warm-blooded animals should contact the Chair of the IRB for specific requirements.
Proposals should be submitted electronically to the Chair of the IRB, Dr. Monical Robbers. In addition, one hard copy of the proposal with an original signature page should be forwarded to the Provost and Vice President for Academic Affairs, Rowley Hall.
Application for Review of Research Involving Human Subjects
How do I obtain subject consent?
The IRB expects that all subjects will sign a document containing all the elements of informed consent. Federal regulations require the Informed Consent to meet specific requirements.
Sample Informed Consent
Sample Consent Involving Videotaping
What about HIPAA?
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulates “protected health information.” If a research study either uses or creates protected health information, research subjects’ consent is required.
To make this determination, use the Checklist for HIPAA Requirements.
Who are the IRB Members?
The overall composition of the IRB committee is consistent with federal guideline for Protection of Human Subjects (45 CFR 46). These federal guidelines emphasize the need for committee diversity in terms of professional background and perspective, including at least one individual whose primary concern is “nonscientific” and one person who has no other affiliation with the University. Marymount’s IRB Committee meets these guidelines. Each School recommends at least two faculty members to serve on this committee. The IRB Committee reports to the Associate Vice President for Academic Affairs, who is an ex officio member of the committee.