FAQs

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.

All student research members must complete ethical training prior to submitting a protocol. The two options are:

  1. NIH* Human Subjects Research training within the past 4 years.  *Note that NIH will no longer be accepted after Oct. 1, 2021.
  2. CITI Human Subjects Research training within the past 4 years.  Refresher courses are available if needed

Each investigator in the study should complete CITI's Human Subjects Research Training.

 

Getting Started With CITI Training:

  • Read step-by-step instructions on how to access and begin the CITI training.  Or, watch a 5 Minute Step-by-Step Video on how to access and begin the CITI training.
  • Complete the CITI Training.
  • Gonzaga will be notified when you receive your CITI certificate. You can access it anytime in your CITI account, too.  It's valid for 4 years. 
 

"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.

 

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. 

This table shows key distinctions between QI and research.

According to federal guidelines, Quality Improvement/Quality Assurance (QI/QA) projects can be published. Read more information on the federal guidelines.

Therefore, whether or not you intend to publish or present your project is not part of the criteria for determining whether IRB review is needed or not. 

When determining whether to submit a QI/QA project to the IRB, follow the guidelines below.  Please contact the IRB mailbox (IRB@Gonzaga.edu) if you have a question about whether your project meets the criteria for QI/QA projects and/or whether your project should be reviewed by the IRB. 

Student-led projects

For students who, as partial fulfillment of the requirements for their degree program, are conducting QI/QA projects that involve interactions to obtain information about individuals and/or identifiable private data about individuals, IRB review must be completed before they carry out their QI/QA projects. 

Students, follow these steps:

  • 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.
    • Attend to ethical considerations for protecting humans involved and document your plans on the forms (or with additional attachments as necessary).
    • Provide all materials to carry out the project (e.g., pre and post instrument; detailed plan for obtaining information from academic, medical or personnel records)
  • 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.
  • You may want to use this TEMPLATE for a letter of support that was developed by Nursing faculty for the DNP program.  However, it can be adapted for other programs.
  • 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.

Faculty, staff or administrative projects

Quality improvement projects conducted by faculty, staff or administration may not need to be reviewed by the IRB. Consider the following questions to help determine whether the project is QI/QA, and if so, whether an IRB review is needed or valuable.

•       Is it QI/QA?  If so, the intention is to understand how to serve Gonzaga’s constituents better; therefore, the project design leads to conclusions that do not generalize to a population beyond our constituents.

•       Even if it is QI/QA, will an IRB determination be helpful?  For example, some conference or publications may ask whether an ethical review was conducted as part of the proposal submission process.  In anticipation of this, the IRB will evaluate materials for any project when requested.

•       If it is QI/QA for another entity, what is the role of the faculty, staff or administration?  If partnering with an outside organization to conduct research-like exercises (e.g., designing and implementing data collection, analyzing the subsequent data, and disseminating the findings in professional outlets), it would be prudent to obtain IRB review first.

Here are EXAMPLES to illustrate the above considerations for faculty, staff or administrative projects.

•      One faculty member tries a different technique in one section to see if it helps students learn better while keeping another section of the same class consistent with previous techniques.  The faculty then collects final test scores and compares the two sections using inferential statistics.  The faculty could share the findings at a conference or in a publication, provided it was presented as his or her journey towards improvement (not as generalizable research). This project does not need to be reviewed by the IRB because it is quality improvement.  That is, the intention is for the faculty to understand how to serve his or her students better, and the project design leads to conclusions that do not generalize to a population beyond the students in those classes.

•       Another faculty participates yearly in a conference that asks whether an ethical review was conducted as part of the proposal submission process.  Knowing that she wants to submit a proposal to this conference in subsequent years, the faculty submits materials to the IRB before launching the project. The IRB will evaluate materials for any project when requested, and there are spaces on the exempt form to designate that the project is considered QI/QA.

 

Please contact the IRB mailbox (IRB@Gonzaga.edu) if you have a question about a project you plan to carry out.

 

Follow the instructions on the Forms page and you will be off to a good start! Then move on to the Submission Process page.

There are several learning tools you can access such as a 10 minute video that walks you through how to fill out and submit your protocol.  There is also an Investigator's Manual, a Training Presentation, and Training handouts available.

The entire process is conducted via SharePoint (and via email for outside researchers).  The Submissions page has detailed instructions for submitting through SharePoint.

 

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.

Click here to access the Office For Human Research Protections' (OHRP) Informed Consent form.

 
  • 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.
  • You may want to use this TEMPLATE for a Letter of support that was developed by Nursing faculty for the DNP program.  However, it can be adapted for other programs.

 

 

1. Children can be part of exempt studies, as per https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/children-research/index.html#nodequeue_14-page_2-6 quoted below. 

One of the six exemptions of research involving human subjects is narrowed in scope by Subpart D’s additional protections for research involving children. The other five exemptions apply to research involving children as human subjects in the same way that they apply to research involving adults. 

The narrowed exemption is the exemption at 45 CFR 46.101(b)(2), which generally applies to research involving educational tests, interviews or survey procedures or observation of public behavior, if the data are recorded without individual identifiers, or if disclosure of the recorded responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation.  

Where children will be involved as research subjects, however, the use of survey or interview procedures is eliminated from this exemption, and so is research involving the observation of public behavior if the investigators participate in the activity being observed. 

In other words, the only research activities involving children that may fall under this exemption are those involving educational tests or observation of public behavior where the investigators do not participate in the activity being observed.  

To be exempt, these activities must also meet the condition that the data are recorded without individual identifiers, or the condition that disclosure of the recorded responses would not place the subjects at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation. Otherwise, all the requirements of the human subjects regulations apply. 

 

2.  IRBs can approve low risk research with children, provided there is a 2-step assent/consent process 

§46.404 Research not involving greater than minimal risk. HHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in §46.408.

 

3. Non-exempt research with children need not always be reviewed by the full Board… (quoted directly from https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html, emphasis added )

Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review Procedure [1] 

Applicability:

A. Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. 

B. The categories in this list apply regardless of the age of subjects, except as noted:

· Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.) 

· Collection of data from voice, video, digital, or image recordings made for research purposes. 

· Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.) 

 

The OHRP has a section dedicated to researchers working with children. Click here to access further information.

 

The IRB is tasked with reviewing human subjects research, which is defined in 45 CFR 46 as “a systematic investigation designed to develop or contribute to generalizable knowledge” during which an investigator obtains identifiable private data about living individuals and/or interacts with people to obtain data. Based on this definition, there are 3 considerations discussed below:  publicly-available data or public records, de-identified data, and coded research sets with a separate key.

Publicly-available data

First, publicly-available data or data in public records do not qualify as human subjects research.  So no IRB review is need for data accessed from public websites or through public records requests.  Data are considered to be publicly available if no employee or membership credentials need to be entered to access the information.

Data That is Not Identifiable

Second, any project involving data with no identifying information (i.e. no variables with which the identity of the respondents could reasonably be determined) does not meet the definition of human subjects research, as per the federal definition.  So no IRB submission would be needed

Guidance from HIPPAA about de-identifying information is pasted below. If you want to read the complete regulations, they are available at https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html#standard

(2)(i) The following identifiers of the individual or of relatives, employers, or household members of the individual, are removed:
(A) Names
(B) All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP code, and their equivalent geocodes, except for the initial three digits of the ZIP code if, according to the current publicly available data from the Bureau of the Census:
(1) The geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people; and
(2) The initial three digits of a ZIP code for all such geographic units containing 20,000 or fewer people is changed to 000
(C) All elements of dates (except year) for dates that are directly related to an individual, including birth date, admission date, discharge date, death date, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
(D) Telephone numbers
(L) Vehicle identifiers and serial numbers, including license plate numbers
(E) Fax numbers
(M) Device identifiers and serial numbers
(F) Email addresses
(N) Web Universal Resource Locators (URLs)
(G) Social security numbers
(O) Internet Protocol (IP) addresses
(H) Medical record numbers
(P) Biometric identifiers, including finger and voice prints
(I) Health plan beneficiary numbers
(Q) Full-face photographs and any comparable images
(J) Account numbers
(R) Any other unique identifying number, characteristic, or code, except as permitted by paragraph (c) of this section; and
(K) Certificate/license numbers
(ii) The covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.

To reiterate, if those identifiers (or any additional points of information that might flag individuals in a particular context because of low sample size) are not included in the data sets, then the IRB need not review the project because it does not meet the federal definition of human subjects research.

Coded Data or Specimens

Third, in some cases, data or specimens are coded such that a link exists that could allow the source of the data/ specimens to be re-identified (i.e., key available to decipher the code).  Then one of the following must be true in order to not meet the definition of human subjects:

  • The provider of the data/ specimens will remove the code before sending the data/specimens to the researcher.
  • The holder of the key and the investigator enter into an agreement prohibiting the release of the key to the investigator under any circumstances, until the individuals are deceased.
  • The investigator has documentation of written policies and operating procedures from a repository or data management center that prohibits the release of the key to the investigators under any circumstance, until the individuals are deceased.
  • There are other legal requirements prohibiting the release of the key to the investigator, until the individuals are deceased.

Although technically none of these situations meets the definition of human subjects research, some researchers in situations that involve the last 3 bullets may want to involve the IRB.  If you prefer the IRB to review the agreements regarding the key to the data, submit an exempt protocol and provide a copy of the agreement.  A letter or even an informal email exchange is sufficient to document the agreement.

 

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).

Click here to access more information on concealment and deception.

 

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*.

 

For NON-EXEMPT research, the recent change to the Common Rule (45 CFR 46) included the expectation that multi-site studies would rely on a single IRB, called an sIRB.

 

The regulations define what it means for an institution to be categorically engaged in non-exempt research.  (see https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html)

 

When Gonzaga is categorically involved in NON-EXEMPT research, the following NIH guidance (from https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html) should be followed:

  

The PIs should “submit a plan describing the use of an sIRB that will be selected to serve as the IRB of record for all study sites.  The plan should include a statement confirming that participating sites will adhere to the sIRB Policy and describe how communications between sites and sIRB will be handled.”

 

“Participating sites are responsible for meeting other regulatory obligations, such as obtaining informed consent, overseeing the implementation of the approved protocol, and reporting unanticipated problems and study progress to the sIRB. Participating sites must communicate relevant information necessary for the sIRB to consider local context issues and state/local regulatory requirements during its deliberations.  Participating sites are expected to rely on the sIRB to satisfy the regulatory requirements relevant to the ethical review.”

 

When faculty, staff, students, or administrators are involved in EXEMPT research involving personnel from several sites with IRBs:

  • The regulations defining what it means for an institution to be categorically engaged in research only pertain to non-exempt research. 
  • But Gonzaga’s IRB is responsible for determining that research conducted by our faculty, staff, student, or administration has had ethical review.  So our IRB can review the research (with a completed cover sheet, exempt protocol form, and materials needed to conduct the research).  This would be especially important if Gonzaga were the lead site. 
  • If another site is the lead, Gonzaga’s IRB need only receive the other IRB’s determination of exemption and a cover sheet, which will state who is involved in the research.  These can be emailed directly to IRB@gonzaga.edu.

 

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.

 

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
 

Please do three things when your project has been completed (and/or when you discontinue the project):

1. Close the study

When you have finished your data collection and analysis, please notify the IRB that the study is closed.  You may notify Gonzaga’s IRB via email at IRB@gonzaga.edu. Please include the Protocol Number.

2. Follow the data management plans as approved in your protocol.

Retain the following for at least 3 years.  Students must work with their advisors to ensure this occurs.

    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.

    3. Transfer data if necessary

    "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

     

    For EXEMPT research or Quality Improvement/Quality Assurance (QI/QA) projects: 

    • After receiving an IRB Letter of Determination, you may conduct the study according to the approved protocol without further review for up to 3 years.
    • If the study extends beyond 3 years, email the IRB prior to the expiration date. Through an email exchange, the project can be approved for another 3-year period.

     

    For NON-EXEMPT research:

    •  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.
     

    For EXEMPT research or Quality Improvement/Quality Assurance (QI/QA) projects:

    If you are considering a change to the approved procedures, please email the IRB.  Through an email exchange, the IRB will verify that the proposed changes adhere to privacy regulations (e.g., HIPAA, FERPA), follow any existing Data Use Agreements, and do not affect the level of risk.  

    • Any changes with potential impacts on privacy (e.g., HIPAA or FERPA regulations), Data Use Agreements, or level of risk must be submitted to the IRB on an Amendment or Modification of Protocol form.  Do not implement these changes until the Request for Amendment form has been approved by the IRB.  (The Amendment or Modification of Protocol form is available online at Gonzaga’s IRB webpage for forms.)

    • Note that changes to an existing Data Use Agreement must be processed separately with the facility named in the Agreement. Be sure the changes submitted to our IRB match the changes approved by the facility named in the Data Use Agreement.

     

    For NON-EXEMPT research:

    Any changes to the approved procedures must be submitted to the IRB prior to implementation.  Use the Request for Amendment form is available online at Gonzaga’s IRB webpage for forms.

     

    When submitting an Amendment or Modification of Protocol form, you will be asked to submit the following:

    • Your approved protocol form with the amendments/modifications marked using track changes in Microsoft Word (or equivalent, such as highlighting).
    • Your approved consent documents and other attachments.  Again, highlight or otherwise track any amendments/modifications being requested.
     

    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

     

    Research is EXEMPT when it fits into one of the 6 federally-defined categories.  Complete information for the 6 research categories for an Exempt protocol can be found here.

    Federal Categories of Exempt Research:

    CATEGORY 1 EXAMPLE:

    • Research will be conducted in established educational settings on normal educational practices

    CATEGORY 2 EXAMPLES:

    • Use educational tests with children or adults
    • Use surveys with adults on non-sensitive topics
      • To be exempt, disclosure of responses outside the research must NOT reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
    • Use interviews with adults on non-sensitive topics
      • In exempt research, interviews can be audio-recorded but not video-recorded
      • Disclosure of responses outside the research must NOT reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
    • Involve observation of public behavior of adults
    • Involve observation of children
      • The researcher can not be a participant in the activities being observed

    CATEGORY 3 EXAMPLES:

    • Benign manipulations of individuals or their environment
      • To be exempt, disclosure of responses outside the research must NOT reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
      • Benign behavioral interventions must be “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing”

    CATEGORY 4 EXAMPLE:

    • Uses data originally collected for non-research purposes – does not need to exist prior to the start of the study

    CATEGORY 5 EXAMPLE:

    • Focus on public benefit or service program

     

    Other Requirements For Exempt Research

    • The research holds out no more than minimal risk to subjects

    • Selection of subjects is equitable

    • Recruitment involves no undue influence or coercion, and recruitment materials are appropriate

    • Adequate provisions are in place to protect confidentiality of data and the privacy of the subjects

    • If there is interaction with subjects, the consent process or information sheet will disclose (as appropriate):

     -- A statement that the activities involve research

    -- The purpose of the research

    --  A description of the procedures to be performed

    --  A statement that the participation is voluntary

    --  A statement about confidentiality

    --  Name and contact information for the investigator and for the GU IRB

     

    In Section II of the Exempt form please indicate the category (or categories) your research falls into by placing a checkmark into the appropriate box(es).

     

     

    The 9 research categories for a non-exempt protocol can be found here.

     

    Here are two links to additional information about human research