Frequently Asked Questions

What is the difference between the UREO and the UREC?
The University Research Ethics Office (UREO) is the administrative face of the ethics review process. Directly under the Office of the President, it processes all documents pertaining to the review process (including submissions), provides administrative support (including secretariat functions) to the University Research Ethics Committee (UREC), and conducts training workshops and seminars on research ethics. The UREC is the body that performs the actual ethics review of protocols.

Do all research activities have to go through ethics review?
Only research activities that involve direct interaction with living human participants or derive data or materials (e.g. biological specimens) from living human participants need to go through ethics review. If your study is of the "minimal risk" category and it meets certain criteria (see here), then it can be validated for exemption from the review process.

What actually constitutes "minimal risk?"
We define minimal risk as "the probability and magnitude of harm or discomfort anticipated in the research not being greater than those ordinarily encountered in daily life or during performance of routine physical or psychological examinations." So a study where the potential risk (physical, psychological, emotional, etc.) is comparable to the emotional stress or level or discomfort or even pain experienced on a normal day (such as stubbing your toe!) or to that involved in a routine clinical check-up, including extraction of a small volume of your blood, that is of minimal risk. If the perceived risk is greater, more careful assessment of the protocol is needed and so it cannot be validated for exemption.

So if my study is of minimal risk and is valid for exemption, I don't need to submit it to the UREO?
Validation of Exemption is still part of the ethics review process since it must be applied for with the UREO. The distinction is that Validation for Exemption will be decided on solely by the UREO Director instead of by members of the UREC, which is the case with Expedited and Full Reviews. So as long as your study involves human participants, it must be submitted to the UREO.

Can undergraduates pursue research activities of any risk level?
By virtue of the lack of expertise and extensive training of most undergraduates in more advanced and often delicate research methodologies, undergraduates are allowed to pursue only minimal risk studies. As such, undergraduate researches are reviewed by the Department Research Ethics Committee (DREC) of the students' home Department/Program. Student organizations that are not affiliated with a home Department/Program and wish to undertake research projects that involve human participants may submit their protocols to the UREO for institutional review.

Do classroom or community engagement activities that involve human participants, such as surveys, interviews, or extraction of biological materials (e.g. saliva, blood, skin cells, etc.) have to go through ethics review as well?
Such classroom or community engagement activities do not need to go through the ethics review process UNLESS it is intended that the data derived therefrom will result in the public sharing of information such as through a publication. Regardless, the concerned Department/Program or Office is expected to make sure that ethical principles and practices on engagement with humans, such as the informed consent process and complete voluntariness at the very least, are carried out.

Isn't an Expedited Review supposed to be fast, given the name "expedited?" Why does it take so long?
The term "expedited" may indeed prove misleading; it is not meant to be a statement on the speed of the ethics review process. In fact, Expedited Review may take as many as four (4) to six (6) weeks, depending on the complexity of the study and its ethical implications. The main difference between an Expedited Review and a Full Review is that the former involves review by only two (2) UREC members, unlike the latter, which requires review by the full Committee (at quorum). But generally, an Expedited Review is expected to take a shorter time than a Full Review, which can take more than eight (8) weeks.
The review process often takes some time because reviewers meticulously read all submitted documents, including the protocols and their experimental design. What takes the most time is the assessment of risks and benefits vis a vis the objectives of the study; weighing the risks against the benefits can be an arduous task in more complicated protocols. The allotted time (4-6 weeks for Expedited Review and 4-8+ weeks for Full Review) should already take into account the likely back-and-forth between the principal investigator and the reviewers toward final approval (or rejection) of the ethics clearance. Delays in the process are completely unintended and, thankfully, historically quite rare, since mechanisms are in place to ensure a process that is careful and deliberate but mindful of the temporal nature of research.

Why are ethics reviewers commenting on my experimental design, which has already been evaluated by my adviser and my panelists? Shouldn't they stick to making comments on the ethical aspects of my study?
Unfortunately, even a carefully designed study that satisfies criteria for a good experimental design in the field can overlook certain elements that can potentially increase the potential risk to participants. This is certainly truer of badly designed studies. Consider as examples the following: Is it truly necessary to recruit children (i.e. individuals less than 18 years of age), or can the objectives of the study still be met by recruiting those of age 18 years or above? Are all 500 questions necessary in a survey or can some be combined with each other or removed altogether, especially those that ask for sensitive information? Is the control group receiving the standard for care in this particular context? Ethics reviewers do not comment on experimental designs with the intention of questioning the capability of the principal investigators and their advisers and collaborators. They do so to help the principal investigator come up with the most ethically sound protocol that is scientifically grounded while safeguarding the well-being and dignity of human participants. The traditional practice for Expedited Reviews is to assign a protocol to a researcher in the same field who can expertly assess and comment on the experiment design. The second reviewer is typically from a different field, who will be able to provide perspectives from a different lens and speak on how understandable the protocol is to a general audience. Reviewers' comments on experimental design are often expressed as suggestions more than impositions.

Do studies involving other animals, such as dissections or research involving pets, livestock, and wildlife, require ethical clearance, too?
Studies that involve living non-human vertebrates (i.e. fishes, amphibians, reptiles, birds, other mammals) must undergo institutional review, but not by the UREC. Such reviews are performed by an Institutional Animal Care and Use Committee (IACUC). The University currently does not have an IACUC, but the UREO is working toward establishing one in the near future.