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Advice Topic: Ethics

What You Need to Know about Human Subjects and Animal Subjects for Dissertations

Research involving animals or humans is an essential component of many dissertation research projects. Knowing how to comply with regulations governing human and animal research is critically important to many graduate students. These regulations enhance academic integrity while also protecting research subjects.

The first step: Be advised of compliance mandates

The Graduate School requires submission of a completed “Use of Human and Animal Subjects for UW Graduate Student Theses and Dissertations” form to ensure that students have been advised about the need to comply with UW requirements for research before beginning their dissertation research. These compliance mandates are from the UW Human Subjects Division and Institutional Animal Care Use Committee. The form must be signed by both the dissertation committee chair and the student, and must be kept on file by your program.

Factoring timelines into your planning

In developing timelines for dissertation completion and graduation, be sure to factor in the time necessary to receive approval from the UW Human Subjects Division or the Animal Care Committee, and the need to comply with any other departmental or collaborating institutions’ requirements. Time required for review and approval ranges widely. Allocate enough time for the entire review process, including the possibility of resubmission and reconsideration.

You may NOT proceed with the human subjects or animal care research component of your dissertation until you have a UW approval number. This rule includes approval for exempt, minimal risk, or full review applications. Failure to obtain approval is quite serious, and could jeopardize completion of your dissertation, graduation plans, and any publications derived from the dissertation.

Resources for dealing with human subjects and animal subjects issues

The UW Human Subjects Division website includes many helpful sources of information, including:

  • Introduction to the Human Subjects Review Process, from the UW Human Subjects Division
  • Locations and instructions for completing the human subjects/animal subjects application
  • Helpful links and instructions about specific issues that may arise in your research, including a checklist for preparing a consent form

by Professor Emeritus Melissa Austin, Public Health Genetics; Marina Alberti, professor, Urban Design and Planning; and Woody Sullivan, professor, Astrobiology

Review of Graduate Student Research by the Institutional Review Board (IRB)

What is the IRB?

The IRB is a committee of scientists, non-scientists and community members. At the UW and other universities, the IRB reviews research proposals to protect the rights and welfare of human research subjects who participate in research activities conducted under the auspices of the University.

When is IRB review required?

If the proposed study meets the federal definition of research…

“A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

and…

If the proposed study involves “human subjects,” defined as “a living individual about whom an investigator (whether professional or student) conducting research obtains: 1) data through intervention or interaction with the individual; or 2) identifiable private information.”

Why is IRB review necessary?

IRB reviews help ensure the safety and protection of research subjects, as well as the ethical conduct of research that involves human subjects.

The IRB review must determine that all of the following requirements are satisfied.

  • Risks to subjects are minimized.
  • Risks to subjects are reasonable in relation to anticipated benefits.
  • Selection of subjects is equitable.
  • Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.
  • Informed consent will be appropriately documented, in accordance with, and to the extent required by HSS regulation 46.117.
  • The research plan makes adequate provision for the monitoring of data collected to ensure the safety of subjects.
  • There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons or economically disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

How does the IRB evaluate research proposals?

The IRB reviews and responds to proposals at three levels, depending on the type of research proposed.

Exempt: Six categories of research involving human subjects qualify for exemption from federal regulations governing the protection of human subjects. A determination of eligibility for exemption must be made by the IRB or its designee. Exempt research must also comply with state laws, UW policy, and conform to sound research ethics/principles.

Expedited (minimal risk): An “expedited” review procedure can be used when research has been determined to be of “minimal risk” to subjects (i.e., “poses no more risk to subjects than would be encountered by the average person in his/her daily activities”) and involves only the procedures listed in the federally described categories of expedited review. All federal, state and local regulations must be taken into consideration. The standard requirements for informed consent (or its waiver or alteration) apply.

Expedited reviews may be carried out by the IRB chair, an IRB co-chair, or by one or more experienced reviewers designated by the chair from among members of the IRB.

Full IRB review: Research that does not qualify as exempt or for expedited review must undergo a full review by a quorum of IRB members. The application process is the same as for expedited review; however, it is recommended that researchers allow two to four months from the time of submission until approval. Researchers should also be aware that the initial full review process frequently does not result in an outright approval of the research; minor or major revisions and written clarifications are often requested.

How can I get help?

The Human Subjects Division (HSD) website is designed to help you decide whether or not you need review and has detailed instructions on how to apply.

If you have questions or need additional assistance, you can contact HSD directly.

This Mentor Memo was developed in collaboration with the Human Subjects Division.

The Good Kind of Audit

There is no supervision in the practicum setting of the students in the [redacted] program. Every week, the students have to sign a form to turn into the board, although they did not receive the supervision they have signed off for. Questions are not being answered when they voice their concerns about this. Some people feel this program should be audited because the lack of supervision is only one concern of this program.     —Anonymous

I’m so sorry to hear you’re having to deal with this in your program. While students cannot directly request an audit, you should know that the Graduate School conducts Academic Program Reviews for all departments on a rotating schedule. Without calling out your specific department, it looks like this is your year! Program reviews provide several opportunities for student feedback, including speaking to the review committee during the site visit and also sending written feedback.

Ask the Grad School Guru is an advice column for all y’all graduate and professional students. Real questions from real students, answered by real people. If the guru doesn’t know the answer, the guru will seek out experts all across campus to address the issue. (Please note: The guru is not a medical doctor, therapist, lawyer or academic advisor, and all advice offered here is for informational purposes only.) Submit a question for the column →