Note: The additional information available on this site is provided to assist you. However, for specific research questions or issues please contact IRB.
Who should participate in Human Subjects Research (HSR) training?
Q. Who should take the HSR online training?
A. 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 are also encouraged, as they may be called upon to assist with data collection and reporting.
Q. Should administrators take the online training on human subjects research?
A. It would be helpful for Vice Presidents of instruction, other administrators and managers, and executives to become familiar with human subjects research topics. Training 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 the district office.
When is IRB review of proposed research or grants projects needed?
Q. Does this administrative regulation apply to me and my work?
A. The regulations cover human subjects research. The two questions you should ask are; is it human subjects, and is it research?
- Human Subject - As defined by US code 45 CFR 46102(d), a human subject is a living individual about whom an investigator (whether a Maricopa professional or a student) conducting research obtains data through intervention or interaction with the individual or identifiable private information through any means. Intervention means any physical procedures undertaken with the subject or any manipulation of the subject or the subject’s environment for research purposes. If you’re gathering data from or about live people, it is probably human subjects research. Some clear cases which are not “human” are gathering data about people who are dead and gathering secondary data.
- Research - As defined by US code 45 CFR 46102(f), research is gathering information or data in a systematic way to draw generalizable conclusions or otherwise develop or add to a body of knowledge. One way to determine if the project adds to a body of knowledge is if it is going to be published or shared publicly, such as a conference presentation. Publicity does not by itself constitute research though.
If you plan to conduct research that involves human subjects, you will need to submit an application to do so at MCCCD.
Q. 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?
A. 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.
Q. 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?
A. Yes, all external requests (from individuals, groups or institutions) must be reviewed by the MCCCD IRB.
Q. If a MCCCD employee has joint appointment with another institution, can they just go through the other institution’s IRB?
A. No, joint appointees must submit their proposals to the MCCCD IRB for review.
Q. I know that the work I do is considered exempt from review in the regulations. Do I need to get IRB approval?
A. Only the IRB can make the a determination on a proposal (for example, exempt, nonexempt); the investigator or grants project director cannot make a determination. Check with your college IRB representative.
Q. I am writing a federal grant proposal that does not involve gathering data from human subjects. Do I need IRB approval?
A. 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.
Q. 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?
A. 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.
What is the role of students in human subjects research and IRB review?
Q. Can our students submit human subjects research applications to conduct research?
A. 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.
Q. Does every student in a psychology or sociology course, for example, have to submit a human subject research application to conduct research?
A. 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.
How do faculty projects such as FEPS and MCLI SoTL relate to Human Subjects Research (HSR) and IRB review?
Q. Do I need to submit my FEP for IRB review?
A. 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.
Q. Does my Scholarship of Teaching and Learning (SoTL) project with MCLI need IRB review?
A. 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.
How does this review procedure apply to using student or employee data?
Q. 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?
A. 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.
Q. 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?
A. 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.
Q. Will the IRB prevent me from using student or employee data for research projects?
A. 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.
How should I handle a conflict of interest or ethical breach?
Q. Who can I contact if I believe there is a conflict of interest or ethical breach?
A. 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 Contact IRB page.
Q. As an IRB member, when should I recuse myself from the discussion of a proposal?
A. In the following situations:
- When you are a co-investigator or project director on a proposal that the IRB will review.
- Your supervisor (or supervisee) is an investigator or project director that the IRB will review.
- You are the dissertation supervisor for a student who is submitting his/her proposal for review.
Where can I get more information or answers to specific questions?
Another excellent source for answers is the National Science Foundation FAQs on Human Subjects Research. Or contact IRB with further questions.