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Human Subjects

Human Subjects - Institutional Review Board

University of Wyoming Human Subjects Research Policies

University of Wyoming Human Subjects Research Forms

Biomedical Research Forms and Templates

If you plan to submit a biomedical protocol please consult Ken Robertson, MD at 307-760-1000, or KenR@Ivinsonhospital.org at least 2 months prior to your desired submission date. This medical pre-review process will greatly facilitate the IRB review and approval process

Helpful Templates

Is My Project Research?

Some projects, by definition, are not “research” and therefore do not require an IRB prior to the start of the project.  We have put together several documents describing the differences between “research” and projects like quality assurance, quality improvement, and/or program evaluation.  These documents are intended to provide a basic overview of these different types of projects, but ultimately the decision of whether a project requires IRB approval or not is made by the UW IRB, not the researcher.  These guidance documents are provided to educate the researcher on the types of projects that may not require IRB approval, but we highly encourage you to contact the IRB at IRB@uwyo.edu prior to starting any project, in order to ensure that it has been correctly categorized as research or QA/QI/PE.


Trainings

Additional Resources

Please review the research determination tool on the IRB webpage for initial guidance on whether your project falls into the category of human subjects research. Please contact the IRB with any questions and note that the IRB will make the final determination on whether your project requires a proposal submission.

No research-related activities may begin until the IRB has given your research project full approval- meaning that all revisions or conditions are complete and the researcher has received an official approval letter.

Visit the UW human subjects research webpage and follow the instructions for   completing the CITI training. The IRB requires documentation of completion of   the appropriate CITI training.

Studies that meet the definition of (regulated) research under the Common Rule may fit within one or more categories of “exempt” research. This does not mean that such studies do not need IRB review and approval. In order for a research study to be deemed "exempt", investigators will need to submit an application to the IRB, along with study-related materials (e.g., consent forms, surveys,   questionnaires, interview scripts, etc.). Please note that the determination of exemption must be made by IRB staff. No research may begin until the researcher receives a letter of approval.

 

  A thorough review of exempt research may be found here.

The IRB may use an expedited review procedure when the research involves no more than minimal risk to the subjects and where the only involvement of human subjects will be in one or more of the expedited categories. Expedited protocols are still carefully reviewed by the IRB, and approval times vary depending on the submission quality and required review time.

Research practica are class projects or assignments designed to provide students an opportunity to practice various research methodology such as performing interviews, conducting surveys, observing subjects, holding focus groups, or analyzing data. Research practica are intended to provide students in the class with a learning experience about research. They are not intended to create new knowledge about the participants, to result in generalizable information, or to lead to scholarly publication. Research practica generally do not require an IRB proposal, but the faculty member must submit the “Classroom Research Information Sheet” on the Research Office webpage.

A single case report is a medical/educational activity that does not meet the US Dept. of Health & Human Services definition of “research”, which is: "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge“.  Therefore, the activity does not have to be reviewed by the UW IRB.

 

  However, a case report for IRB purposes is a retrospective analysis of one, two, or three clinical cases.  If more than three cases are involved in the analytical activity, the activity will constitute “research.”

 

  Compliance with HIPAA is required; consult with UW General Counsel, the IRB,   and here for more information.

  Classroom Practica/Projects: While an IRB proposal is generally not required for classroom projects, the faculty or staff member must complete and submit to the IRB the “Classroom Research Information Sheet” on the Research Office webpage.

 

  If a class assignment moves from the category of “non-research” into the category of “regulated research”  the faculty member and  student must submit a full IRB proposal for approval prior to taking this next step. Any data obtained under research practica may not be used for research purposes.

 

  Research Projects-Directed or Independent: Any research conducted by undergraduate students, graduate students, or faculty that does not fall under the definition of a research practicum is considered a research project.  A research project that uses human subjects and is intended to contribute to generalizable knowledge must be reviewed and approved by the IRB.  This research includes, but is not limited to, independent undergraduate research projects and honors theses, masters’ theses, and doctoral dissertations. 

  Informed consent must be obtained by the investigator for all research participants age 18 and over prior to commencing research. There are required elements of informed consent as outlined in the informed consent template on the IRB webpage.

 

  (Child) assent must be obtained for minors under the age of 18, in addition to informed consent by their legally authorized representative. See the child assent template on the IRB webpage.

An individual’s participation in a research project can be described as anonymous when no one, including the research team, can identify her or him as a participant.

 

  An individual's participation is considered confidential when the research team knows the individual's identity but is obligated not to disclose that information to others outside of the team (except as clearly described in the research protocol and consent document).

Personal identifiers

  For most human subjects research purposes at UW, personal identifiers include   the following:

  • names
  • photographs
  • audio or video recordings
  • social security numbers
  • student ID numbers
  • email addresses
  • codes that link unidentifiable data to identifiers

 

  Information is also considered identifiable if there is enough information being collected to allow a subject's identity to be deduced.

 

  Indirect identifiers

  There are instances where an investigator may not be collecting any direct identifiers, such as names, but will be collecting enough indirect information about a group of people that a person familiar with the group could potentially identify subjects, or that information could be combined in such a way as to ascertain subjects' identities.

 

  For example:

 

  • A researcher collects both academic department and ethnicity at a university with a small number of ethnic minorities.
  • A researcher collects demographic information about a group of employees at a small company.
  • A researcher records the age, rank, and years of service of a group of Marines who served in a small base in Afghanistan in 2012.

 

  No identifiers

  If no identifiable information (including audio and video recordings) is being collected, then the research is considered anonymous and respondents' identities are protected.

  A waiver of informed consent is a waiver of the requirements to obtain informed consent or a waiver or alteration of some of the required elements of informed consent.

 

  The UW IRB may waive the requirement to obtain informed consent, or it may approve a consent procedure that alters some of the elements of informed consent described above. Before the UW IRB does so, the researcher must include sufficient information in the research protocol for the IRB to determine that the waiver requirements have been met. The researcher must show that:

 

  • The research presents no risks of harm, considering probability and magnitude, greater than those ordinarily encountered in daily life or during the performance of routine examinations or tests; and
  • The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
  • The research could not practicably be carried out without the waiver or alteration; and
  • When appropriate, the subjects will be provided with additional pertinent information after participation;

  OR

  • The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
  • Programs under the Social Security Act, or other public benefit or service programs;
  • Procedures for obtaining benefits or services under those programs;
  • Possible changes in or alternatives to those programs or procedures; or
  • Possible changes in methods or levels of payment for benefits or services under those programs.

 

Waiver of Parental Permission

 

  Alternatively, parental permission may be waived based on the above, or under 45 CFR §46.408 (c) if the IRB determines that parental or guardian permission is not a reasonable requirement to protect the subjects, such as in cases of neglected or abused children. In these cases, an appropriate mechanism for protecting the children must be substituted. Note: Under normal circumstances, enrollment of minors as subjects requires consent by the parent or legal guardian as well as assent by the minor.

Check out these tip sheets if you are planning to conduct research online. SACHRP  Internet Research “Investigators and IRBs should remember that the Belmont Report’s fundamental principles of respect for persons, beneficence, and justice are as applicable to Internet research as they are to any other form of human subjects research. Regardless of how the regulations may be interpreted in individual studies, adherence to these fundamental principles is important to encourage public trust in the ethical conduct of Internet research.” Online Survey Guidelines Private Sites Guidelines Public Sites Guidelines Virtual World Guidelines

 

We prefer that you do not use students from your own class because it is difficult to avoid giving the perception to your students that they have an obligation to participate. In other words, there is a potential for a conflict of interest. However, it can be done if recruitment is done in such a way that there is no hint of undue influence. The students shouldn't be made to feel pressured to participate, and if they refuse, their refusal shouldn't influence their grades for the course. Alternatives to research participation should be used in the consent form.

All proposals may be submitted at any time. However, full board proposals must be received by the due dates listed on the current IRB meeting schedule on the IRB webpage to be reviewed at the next meeting. The due dates are approximately one month prior to the next meeting. Full board proposals received after the due date will be reviewed at the next month’s meeting.

The time it takes to process your proposal depends on the completeness of the application, the complexity of the research, and the volume of protocols already under review at the time your application is received. Proposals are reviewed according to type and date received. The following are estimates only:

 

  • Exemption Requests: 3-5 weeks
  • Full Protocols (Expedited Review): 6-8 weeks
  • Full Protocols (Full Board Review): 6-8 weeks + IRB meeting scheduling
  • Continuing Review: 2-4 weeks
  • Updates/Modifications: 3-5 weeks

 

  We recommend allowing ample time for IRB review and responding promptly to IRB feedback. Final approval/exempt determination is dependent on your timely and sufficient response to comments.

If your study was reviewed and approved under Expedited or Full Board status, then annual/continuing review is required. Exempt studies (so long as no changes have been made to the study) are exempt from further IRB review although investigators will be required to update the status of their exempt studies every three years by submitting an annual review form.

 

  Please submit your annual update form ~30 days before the date of IRB expiration.  Please note that the IRB Staff will review the continuing review documents shortly after they are submitted but that an approval letter will not be sent out until within days of the expiration date so as to keep the approval dates consistent from year to year.

Once a study receives IRB approval, any changes to the research project must be approved by the IRB before implementation. For instance, changes to the study title, principal investigator, informed consent document, and study design all require prior authorization from the IRB. Please submit the protocol update form found on the IRB webpage.

Yes, however you must submit a separate protocol update form and annual review   form.

  Stop all research-related activities immediately. There is no grace period. Only if the IRB determines that the continuation of the subjects in the research activity (i.e., medical or psychological treatment/intervention) presents a prospect of direct benefit, may individual subjects continue in the research as the investigator seeks IRB re-approval for the study (contact the IRB office).

 

  If your IRB approval lapses, you can:

  (a) do nothing so long as you do not intend to use the data you collected during the time of IRB approval lapse. The IRB automatically terminates your study if it has not received a submission by your studies IRB expiration date.

  (b) If you plan to continue research, then you must apply for IRB approval by submitting a Continuing Review Form.

No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data were collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), IRB approval can be sought for the data analysis going forward.

It is not possible to “transfer” an approved protocol from another institution. If you have collaborators at the approving institution, we may establish an IAA (institutional authorization agreement) to “rely” on that institution’s review and approval processes. Alternatively, you may need to submit a new proposal at UW. Contact irb@uwyo.edu with questions.

Due to the time and resources required to review a proposal, we can only review proposals that are submitted by a UW affiliate.

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