Another excellent source for answers is the FAQ page on human subjects research at the National Science Foundation.
Who should take the MCCCD online training?
All faculty, grants directors, and staff who plan to participate in or submit a research or grant proposal should complete the training. Project directors should also complete the training. Institutional researchers also encouraged, as they may be called upon to assist with data collection and reporting.
Should administrators take the MCCCD endorsed online training on human subjects research?
It would be helpful for Vice Presidents of instruction as well as other administrators and managers to become familiar with human subjects research topics. It provides you with information and tools to work with your faculty and staff as they prepare for research and grant projects on behalf of your college or on joint projects with sister colleges and/or district office. You should take the “Educational Processes Only” training module.
Although I have completed human subjects research training at another institution, do I have the opportunity to take the training noted on the MCCCD website?
Yes, you can take this training. Maricopa has endorsed a particular online training that every principal investigator or project director is asked to complete, prior to submitting their research or grant proposal. This will provide the same basic foundation for Maricopa employees and students.
Which training module do I complete?
You have several modules to pick from, depending on your role. If your students want to learn about this field, they would enroll in the “Undergraduate Research” module. If you are going to conduct social-behavior research or grants projects, or serve as project directors, enroll in the “Social Behavioral” module. If you are only doing pedagogical or institutional effectiveness research or are an administrator just trying to get a sense of what this topic is all about, then you should enroll in the “Educational Processes Only.” Members of the IRB or CRRC need to enroll in the “IRB member” module.
Does this new administrative regulation apply to me and my work?
The regulations cover human subjects research. The two questions you should ask are; is it human subjects, and is it research?
If you plan to conduct research that involves human subjects, you will need to submit an application to do so at MCCCD.
If I plan to conduct a research study or grant project at another institution using their students or employees, and/or they have approved my research at their institution, do I need to get MCCCD IRB approval?
If you will use any Maricopa work time, facility, or resources, or plan to publish or make presentations under your Maricopa college affiliation, you need to get MCCCD IRB approval prior to your research or grant project begins. The IRB reviews multi-year projects each year.
If a colleague at another institution already has approval from their institution to conduct the proposed research or grant, do they need to get MCCCD IRB approval for conducting research at Maricopa?
Yes, all external requests (from individuals, groups or institutions) must be reviewed by the MCCCD IRB.
If a MCCCD employee has joint appointment with another institution, can they just go through the other institution’s IRB?
No, joint appointees must submit their proposals to the MCCCD IRB for review.
I know that the work I do is considered exempt from review in the regulations. Do I need to get IRB approval?
Only the IRB can make the a determination on a proposal (for example, exempt, nonexempt); the investigator or grants project director cannot make the determination.
I am writing a federal grant proposal that does not involve gathering data from human subjects. Do I need IRB approval?
It depends. Many granting institutions now require IRB review before they will consider a proposal. In such a case, the IRB will determine that the project does not involve human subjects research, and you can report that determination in the application so you can move forward with your proposal.
A faculty member is taking a graduate course at ASU. One of their assignments is to interview students at their own institution. The teacher of the class got approval at ASU's IRB for the class. The results will only be used internally (at ASU) as an instructional exercise. Does the graduate student (MCCCD Faculty member) need to first get MCCCD IRB approval to do her class assignment?
Since it is a class assignment and is not research as defined by the regulations, it falls outside of the scope of the regulation. It therefore does not need to document an exemption determination. The fact that both ASU and MCCCD are involved complicates the matter, but the fact that it is not Human Subjects Research places it outside the scope of the federal regulations and our administrative regulation.
Can our students submit human subjects research applications to conduct research?
Yes, a faculty member can submit the proposal as the principal investigator, and then list the student as a co-investigator. A student has no legal standing, thus they cannot submit human subjects research application and research proposals as the principal investigator. If the student seeks to publish or present at professional conferences, they are advised that more and more associations and publications are asking for IRB review, and that this review needs to take place prior to gathering any data.
Does every student in a psychology or sociology course, for example, have to submit a human subject research application to conduct research?
Class projects are typically not considered research and do not fall within the scope of the federal regulations. If an instructor wanted to use the application process as a pedagogical tool and require all students to submit a protocol, then the faculty could prepare one application for each course (e.g., course # 101). If an instructor supervises students who are conducting research as defined above, then their proposals would be submitted individually per the question above.
Do I need to submit my FEP for IRB review?
It depends. Generally, faculty set up the FEP so that it is geared toward self-improvement and as such, do not require IRB review. If you plan to gather data so that you can draw generalizable conclusions you can share with others, then it is research and does require IRB review.
Does my Scholarship of Teaching and Learning (SoTL) project with MCLI need IRB review?
Scholarly Teaching, which is used to improve one’s own pedagogy, is not research and does not need review. SoTL work is explicitly designed to draw generalizable conclusions to share with colleagues, so it is research and does require IRB review. Also, if the faculty seek to publish and/or present at professional associations, more and more of these groups are asking for IRB review.
Students provide varied data about themselves and/or their families when they apply for financial aid. Since the students have already consented to the use of their data for that purpose and I have access to it as an employee, can I just go ahead and conduct my research using their data for my research purposes?
No. Students have consented and provided their data for that specified purpose – to qualify for financial aid of some type. They have not given you permission to use their data for research purposes. You can, however, submit a research proposal for MCCCD IRB review, indicating your intent to incorporate that data into your research and then ensure informed consent.
Students and employees provide data about themselves when they enroll at an MCCCD Fitness Center. Since they have consented to the use of their data accessing the Fitness Center, and I can access their data as an employee, can I just go ahead and use their data in my research project?
No. They have provided their data for a specified purpose. If you wish to use their data in your research project, you will need to submit a research proposal for MCCCD IRB review and ensure informed consent.
Will the IRB prevent me from using student or employee data for research projects?
The IRB exists to ensure that the rights of human subjects are protected. If you submit a research protocol to the IRB that meets the Belmont principles of Beneficence, Justice, and Respect for Persons, then the IRB will likely approve the use of student or employee data for research purposes.
Who can I contact if I believe there is a conflict of interest or ethical breach?
You should contact any or all of the following persons: IRB Chair, IRB Administrator, CRRC Chair at your college, or the non-MCCCD affiliated IRB member. The contact information for all of these can be found at the Contacts section of the IRB website (http://mcli.maricopa.edu/irb/contacts.php)
As an IRB member, when should I recuse myself from the discussion of a proposal?