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Research at Salisbury University

Research Compliance - SU Institutional Review Board (IRB)

For Faculty/Staff Members Supervising Student Research:

Student research at Salisbury University 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.

Recommendations

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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 can serve as a primary investigator in a full committee review.

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Do I need IRB approval?

See decision tree (adapted from Virginia Tech)

I need IRB approval, now what?

What happens at each level of review?

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.

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.

Considerations for Protocols:

What key things are looked for in an IRB review? (this does not guarantee there won't still be questions from the committee)

Here are a few things at which the committee looks closely: checklist

What are the IRB deadlines?

The Committee requires two weeks to review and respond to Exempt or Expedited protocols. 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 three weeks 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. Once contracts end in June, no IRB applications will be reviewed again until contracts begin in August. There are no full committee reviews scheduled during these times. Please plan accordingly.       

To whom do I send my IRB application?

All IRB applications (regardless of level of review, continuations, or amendments) are to be sent electronically through the official IRB email. This will ensure that your application is sent to the appropriate committee member(s).

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Application for Research with Human Subjects (PDF document)

IRB Committee email: humanresearch@salisbury.edu

IRB Committee Meeting Dates for Fall 2017:

09/05/17
 
 
 


**If you have a full committee review, 1) your proposal must be submitted at minimum 14 days before the scheduled meeting, 2) you must attend the scheduled meeting. Failure to comply with either condition will delay review of your proposal**

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