ÃÛÌÒav is deeply committed to supporting the research activities of faculty and staff. The IRB Committee on Human Subjects Research upholds this commitment by overseeing the review and approval of all research involving human subjects undertaken by faculty, staff, and students. As you plan and prepare for your research protocols, please review the resources provided below.
Exempt: for all exempt applications, one committee member is assigned to review the application. After this review, if the committee member has no questions, the application is approved and research can begin. If the committee member does have questions, these will be sent back to the Principal Investigator (PI) listed on the application. The PI needs to submit a response for review prior to approval being granted.
Expedited: for all expedited applications, two committee members are assigned to review the application. After this review, if the committee members have no questions, the application is approved and research can begin. If the committee members do have questions, these will be sent back to the PI(s) listed on the application. The PI(s) needs to submit a response for review prior to approval being granted. Both committee members must agree and sign off on the application before approval can be granted and the research can begin.
(Exempt and Expedited Protocols are reviewed by the IRB committee on an ongoing basis. Reviews are not based on full committee review meeting dates.)
Full: for all full review applications, the entire committee is sent the application to review prior to the stated meeting date. At the meeting, the researcher(s) involved in the project must be present and will be asked to give a summary of the application and respond to questions by the committee. After the committee has asked all of the questions they have, the researchers are asked to leave the room while the committee deliberates. If all questions have been answered satisfactorily, approval will be given. If there are unanswered questions, the researchers will be given a list of points to clarify and re-submit. These will be discussed with the researchers prior to the ending of the meeting. The submitted responses are sent out to the committee as a whole for review. If all points have been answered satisfactorily, approval will be given. If they have not, the question and response process continues until all issues are resolved. (Please make note of the Full Committee Review meeting schedule.)
The Committee requires 15 business, non-holiday days to review and respond to Exempt or Expedited. As such, these protocols need to be submitted at least three weeks prior to the planned start of the research in order to leave time for comments and revisions, if necessary.
Full Committee reviews require submission at least 15 business, non-holiday days prior to the scheduled IRB meeting date. All listed researchers are required to attend the IRB meeting for full reviews. Researchers who need to follow a modified timeline should contact the IRB Committee Chair to discuss this.
A note about reviews over breaks (Thanksgiving, Winter Break, Spring Break, and Summer): the IRB committee is made up of faculty and therefore we cannot guarantee that applications will be reviewed following the stated timelines above. Please contact Graduate Studies and Research for review requests during these times.
All IRB applications (regardless of level of review, continuations, or amendments) are to be sent electronically through the . This will ensure your application is sent to the appropriate committee member(s) for review.
Exempt and Expedited: All completed protocols certified by a faculty Principal Investigator (PI) are reviewed as they are received. Most protocols will be reviewed for exemption or fall under expedited review. These reviews are ongoing throughout the year.
Full Committee Review: Protocols requiring Full Board review must be received three weeks prior to a meeting. Completed protocols received after the deadline will be reviewed at the following IRB meeting.
It is the researcher’s responsibility to ensure that the approved protocol is followed. Any unanticipated changes or issues regarding the research should be immediately reported to the IRB.
What do I need to do to continue my research past my original IRB approval date?
With the new 2018 Common Rule changes, minimal risk studies reviewed by the IRB after January 21st, 2019 via expedited procedure will no longer require annual continuing review.
Or projects that were reviewed by the full IRB committee: If you intend to continue your research past the original expiration date, you must submit a request to extend the protocol dates through the and it will be sent out to the appropriate committee member(s). Deadlines as outlined above still apply.
What do I need to do to amend a previously approved protocol?
All amendments to the previously approved protocol must be sent through the and approved by the IRB committee prior to any changes being implemented. In Kuali, please select the Amendment Request form which will automatically connect to your existing approved protocol. Deadlines as outlined above still apply.
Student research at ÃÛÌÒav has become one of the distinguishing characteristics of our mission and has brought us national recognition. The SU IRB strongly supports student research so long as it is conceived and carried out in a way that insures the rights of human subjects are protected.
The Committee would like to remind faculty and students alike that any research undertaken by students as part of or related to University courses or activities is subject to review by the committee. That is our charge as mandated by federal statute, the University System of Maryland and our own ethical responsibilities as committee members. (Code of Federal Regulations, Part 46, Title 45 and University System of Maryland Policy on Human Subjects: 105.0 IV-2.10)
In the last several years, the increased number and variety of undergraduate and graduate student protocols involving human subjects and full committee review have greatly increased and have caused some problems both for the students and the committee. Understandably, it takes students time to identify, develop and propose a protocol and it takes the committee a fair amount of time to work through these protocols. This has created a “crunch” often near the end of the semester that has left students and committee members increasingly frustrated.
With these concerns in mind, and in a spirit of cooperation, we would like to make the following recommendations (mostly reminders and suggestions) to faculty members who are working with students engaged in research with human subjects.
Undergraduates are not permitted to be the primary investigator on full committee protocols. This is to protect the subjects, the student researcher, the faculty member and the university. In the case where an undergraduate student is participating with a faculty member on a full committee protocol, the faculty member must be identified as the primary investigator, must be in attendance at the full committee review meeting, and maintains all applicable research responsibility. Graduate students can serve as a primary investigator on full committee reviews.
When students are doing research, they are often learning how to do research in a particular field of study. While we recognize that it takes time for students to come to a topic and develop a protocol, we recommend to faculty that you encourage them to do so as soon into the semester as possible so that the committee will have ample time to receive, discuss, make recommendations and approve. This also gives the committee time to perform its educational function; that is, helping students understand the importance of their ethical responsibilities to human subjects, particularly in the areas of risk, privacy and confidentiality.
Because students’ work frequently does not meet the level of verifiable scientific research, we have to be particularly cautious with protocols that involve sensitive topics or protected populations. We have to look very carefully at protocols that include illegal behaviors (such as drugs and alcohol) or could cause compromises of privacy (such as sexual and bathroom behaviors) or involve vulnerable populations (such as children and prisoners) or forgo prior consent (such as interacting with unwitting subjects). When students chose protocols that are classified as either ‘exempt’ or ‘expedited’ by the federal guidelines, turn around time is much quicker. A number of faculty members have found it beneficial to require students to select research projects that do not involve full committee review.
If a student should choose to develop a protocol which requires full committee review, we ask the faculty member to remind the student early on about our deadlines for submission and counsel the student that the process of approval can be lengthy.
A complaint sometimes voiced about the committee’s operation is that its members get overly involved in the details of research methodology; something which is perceived to be outside of the committee’s mandate. Actually, we try not to be overly intrusive into research methodology but such discussions are within our purview because a faulty methodology can negatively impact the subjects in a protocol. Again, timely submission of protocols will help all of us in our mission to educate our students in the important responsibility they have to their subjects to do good scientific research.
Conclusion
To facilitate its primary mission to protect human subjects in research and to educate our students in the essentials of ethical research, we as a committee stand ready to help faculty and students in any way possible. We welcome requests to come into your classes and to talk with you individually about your research.
Please keep the following points in mind when working on research proposals for IRB review with students:
Feasibility: please be certain that the student research can be conducted within a semester time frame (if applicable). When planning the study, please do not assume that an IRB application submitted close to mid term will be approved in time for the student to complete the research before the end of the semester.
Deadlines: please see the deadlines listed below regarding the submission of IRB applications and their projected processing time. If the research requires a full review, please plan accordingly.
Responsibility: Undergraduate students cannot submit a protocol for a full committee review. Graduate students at the doctoral level can serve as a co-investigator in a full committee review.
For Faculty/Staff Conducting Research with Student Records
All research involving student records from ÃÛÌÒav should be approved through the University Registrar prior to IRB review. IRB protocols requiring access to SU student data must include a letter of support and acknowledgement from the University Registrar.
Required Training
Federal Regulations and ÃÛÌÒav policy require investigators (students, faculty, and staff) to undergo human subject research training to ensure the protection of research subjects.
SU Researchers must complete the Collaborative Institutional Training Initiative (CITI Program) before their protocol is approved.
*ÃÛÌÒav will accept other human subject research trainings (ie. National Institute of Health Training), but training confirmation and certificates must be provided for review.
ÃÛÌÒav’s Institutional Review Board on Human Research (IRB) has provided researchers with sample templates and forms to assist them as they are developing their research protocol applications.
