Faculty, staff, or students conducting human research, or involved as key personnel in a research or training project including human subjects, should complete an online educational tutorial and certification. This tutorial is accessed through the National Institutes of Health, Office of Human Subjects Research website.
Some projects are designed to have the findings applicable to the local institution (e.g., Quality Improvement, Process Improvement, Quality Assurance or Program Evaluations). These projects may not meet the federal definition of human subjects research as outlined in 45 CFR 46.102 because they are not designed to generalize to other settings:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
If you are doing a project that does not involve research as it is federally defined, you can explain your project on the exempt form. There is a section for Quality Improvement (QI) and Quality Assurance (QA) projects. If you are working with an outside agency, attach a letter or email from that agency stating what the project entails and how the project will help improve agency processes or outcomes. Ideally, your project would be developed in cooperation with leadership at that agency to ensure it is designed to address their needs. In this case, the letter or email can explain how the project was developed in cooperation.
Alternately, instead of a letter, you can document that another IRB has determined the project to be Quality Improvement if you are working with an institution that has an IRB.
According to federal guidelines, Quality Improvement projects can be published. Read more information on the federal guidelines.
"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." - U.S. Department of Health & Human Services §46.102 Definitions (d). For example: Some demonstration and service programs may include research activities.
"HUMAN SUBJECT means a living individual about whom an investigation (whether professional or student) conducting research obtains: 1) Data through intervention or interaction with the individual, or 2) Identifiable private information." - U.S. Department of Health & Human Services §46.102 Definitions (f).
Not all experiments with human subjects, human data and/or human anatomical substances constitute "human research." For example: off-label use of FDA approved medication or using a cheek swab for a PCR experiment, but are not part of research as defined above.
Click here to see the Decision Tree for determining if an activity qualifies as human research.
Before starting a research project at GU, all proposed research using human subjects, human data or human anatomical substances must be evaluated and approved by the Institutional Review Board (IRB). In addition, some classifications of ongoing research are reviewed at least annually or when certain changes are made to the research's scope or activities.
The University requires that all research be conducted within the highest possible legal requirements, federal policies and ethical principles.
Legal requirements to protect human participants apply to a much broader range of research than you may realize. Often, additional ethical standards are applied in many disciplines.
Informed Consent. Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.
While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness. (For more information on Informed Consent click here)
The purpose of Informed Consent is to ensure that human participants are, a) informed of the research process and procedures, b) informed of the risks and benefits, and are c) protected against any possible violation of privacy or confidentiality that could cause harm to themselves or their relatives.
Exempt research does not necessarily require a standard signed consent form. If appropriate, you can use verbal consent and/or provide a simple information sheet with no signature line. You may also use a full waiver of informed consent in some studies. Click here for Informed Consent FAQs.
The OHRP has a section dedicated to researchers working with children. Click here to access further information.
The primary consideration in assessing the use of concealment or incomplete disclosure requires a determination of whether concealment meets the criteria of deception. In such a case, it would be fundamentally wrong to use concealment if it violated the principle of respect for persons/autonomy (note: one can be deceived without a violation to his/her autonomy). This type of violation of principle also includes circumstances in which subjects are wronged without being harmed (in a literal sense).
Generally, you need to keep your research data for 3 years after completion of the research (45 CFR 46.115(b)). However, in some cases, such as with children, it is advisable to retain the data for 7 years after they turn 18.
"If investigators who have been designated to retain records on behalf of the institution leave that institution, the investigators and the institution should identify the successor responsible for maintaining those institutional records, either at the original institution or wherever the records are relocated, for the period of time required under HHS regulations at 45 CFR 46.115(b)." - U.S. Department of Health and Human Services
Gonzaga's Institutional Review Board (IRB) reviews human subjects research to verify that it meets the generally accepted ethical and professional standards for the protection of human subjects. We review protocol submissions that have a signed cover sheet and a protocol form, plus all materials for conducting your research.
The protocol review form shows what we consider as we verify that a protocol meets the following criteria:
- The protocol and method of data analysis answer the research question
- The risks to subjects are reasonable relative to benefits
- Recruitment /informed consent processes are appropriately documented
- Provisions are adequate to ensure the privacy and safety of subjects
International Compilation of Human Research Standards, 2016 Edition
The International Compilation of Human Research Standards enumerates more than 1,000 laws, regulations, and guidelines that govern human subjects research in 120 countries, as well as the standards from a number of international and regional organizations. This Compilation was developed for use by researchers, IRBs, Research Ethics Committees, sponsors, and others who are involved in human subjects research around the world.
Content experts from around the world, listed at the back of the Compilation, provided updates (or confirmations of prior listings), which are reflected in the hundreds of changes entered into this Edition. Seven new countries are featured in the 2016 Edition: Burkina Faso, Côte-d'Ivoire, Cuba, Sri Lanka, Trinidad and Tobago, United Arab Emirates, and Uzbekistan. The 2016 Edition also contains a new category for Clinical Trial Registries. For more information on research abroad click here*.
- If your research requires the participation of an organization or group, (e.g., using their facility; interacting with their employees, attendees, or members; accessing their non-public data, etc.) you must document confirmation of understanding of its role and permission to do the intended research. A letter or email must accompany your protocol submission that provides adequate detail of the organization or group’s involvement and understanding. This must match the information provided in the protocol.
- Specifically, accessing Gonzaga students during a scheduled time requires permission from the relevant authority (e.g., if you will interact with students during class time, you must provide confirmation that the course instructor understands your plan and supports it.)
- Note – working with members of a Gonzaga athletic team or other students under contract may have special stipulations. You are responsible to determine what is required for these students to have permission participate in your research, and you must submit documentation of this permission with your protocol submission.
- If working with an outside organization or institution, (e.g., school, church or business) you are responsible for determining what is required to obtain approval for its role in your research. For example, some organizations may require you to present your research proposal to a committee before they will approve it. Plan enough time for their approval processes before you submit your protocol to the IRB.
If you are cooperating on non-exempt research (e.g., conducting a project at a research hospital or working with another researcher at another University), you have an option. You can obtain both institutions’ IRB approvals and ongoing approvals. Or, Gonzaga’s IRB may be able to establish a reliance agreement with the other institution’s IRB. In this case, you would submit your protocol to the local IRB and the second IRB would complete some paperwork to show that they will accept the first IRB’s decision. This paperwork is called an Interagency Agreement (IAA) form.
Yes, if you will be doing research on Gonzaga's campus, whether in person or via online resources, you will need to obtain IRB approval.
Once you receive your IRB Letter of Determination, you will have up to one year to complete your research or the length of time indicated on your coversheet if less than one year. If you need longer than a year, you will need to submit a Continuing Review form.
Complete information for the 6 research categories for a Exempt protocol can be found here.
The 9 research categories for a non-exempt protocol can be found here.