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Institutional Research Board

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Part I: Research Subject to Institutional Review Board (IRB) Review

 

A. Scope of IRB Review

The scope of the IRB's charge is broad. Generally, any research involving living humans, human tissues or specimens, or humans' records or data that is conducted by any faculty, staff, student, employee or agent of Viterbo University (VU), or otherwise conducted at or sponsored by VU, requires IRB review, irrespective of the risks, scope, funding, or location of the research. Specifically, IRB review is required for any human subjects research that:

  • is conducted by VU faculty, staff, student, or visiting researchers (including but not limited to intern, postdoctoral, and sabbatical researchers);
  • is sponsored by VU;
  • is performed with or involves the use of facilities or equipment belonging to VU;
  • involves VU faculty, staff, or students as part of the research team;
  • satisfies a requirement imposed by VU for a degree program; or
  • is certified by a dean or department head to satisfy an obligation or a faculty appointment at VU.

B. VU IRB Review and Affiliated Researchers

Researchers employed by another institution who have a partial University appointment ("Affiliated Researchers") must submit their proposed research to the VU IRB committee for review when the University is "engaged" in human subjects research (see OHRP Guidance on Engagement of Institutions in Human Subjects Research [October 2008]). In other words, Affiliated Researchers are not required to submit the research to the VU IRB committee simply because they have a partial University appointment. If the research is sponsored by VU, involves VU facilities or participants, or is certified by the University as satisfying obligations of a faculty appointment, VU IRB committee approval is required.

Generally, the University will be engaged in human subjects research under any of the following circumstances:

  1. The research is funded, in whole or in part, through or by the University.
  2. University employees or students (other than the Affiliated Researchers) will intervene or interact with the human subjects for research purposes by:
    1. Performing non-invasive or invasive procedures;
    2. Manipulating the environment (e.g., controlling environmental light, sound, or temperature; presenting sensory stimuli; and orchestrating environmental events or social interactions);
    3. Engaging in protocol-dictated communication or interpersonal contact with the subjects, such as conducting interviews or administering questionnaires;
    4. Obtaining the informed consent.
  3. University employees or students (other than the Affiliated Researchers) will obtain or have access to identifiable private information or identifiable biological specimens. Obtaining identifiable private information or identifiable specimens includes, but is not limited to:
    1. Observing or recording private behavior;
    2. Using, studying, or analyzing for research purposes identifiable private information or identifiable specimens provided by another institution;
    3. Using, studying, or analyzing for research purposes identifiable private information or identifiable specimens already in the possession of the investigators.

Private information or specimens are considered individually identifiable when they can be linked to specific individuals by the investigator either directly or indirectly through coding systems.

If any of these conditions applies to a research protocol, the PI must submit an IRB application to the VU IRB Web page. Affiliated Researchers are urged to contact the VU IRB committee if they have any questions about this requirement.

C. Projects for which the Researcher is a Consultant

When the VU researcher is a consultant, he or she is deemed to be "conducting" research and IRB approval is required, unless all three of the following are true:

  1. the VU researcher/consultant consults or is hired on his or her own time,
  2. the VU researcher/consultant holds no rights in the work (including publication) and
  3. neither the VU researcher/consultant nor VU retains any data.

D. Research Conducted in Courses

HUMAN PARTICIPANTS RESEARCH AND CLASS ASSIGNMENTS

Learning how to conduct ethical research is an important part of a student’s educational experience. Research activities that are designed as part of a course requirement and involve human participants MAY not require IRB review and approval if all of the following conditions are true:

  • The activity is a class assignment designed for learning purposes only and is not designed to develop or contribute to generalizable knowledge. Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations). However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.
  • Results of the research are viewed only by the course instructor and students for teaching purposes and discussed within the classroom for teaching and learning purposes.
  • Results of the research are not made public through presentation (outside of the classroom) and are not published in paper or electronic format (e.g., cannot be made available on the Internet, cannot be published in a journal, etc.)
  • Research procedures are no more than minimal risk. A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
  • Vulnerable populations are not targeted (e.g., children under age 18, prisoners, persons who are cognitively impaired, persons with mental illness, pregnant women, etc.).
  • Data collected are recorded in such a manner that the subjects are not identifiable. (Images in videotapes and photographs and voices on audiotape are identifiable.)
  • When appropriate, an informed consent process is in place.

Responsibility of the Course Instructor: The course instructor is responsible for communicating to the students the ethics of human subjects research, for ensuring the protection of human subjects (including a process is in place for obtaining voluntary informed consent from research subjects when appropriate), and for monitoring the students’ progress.

When designing a project, students should be instructed on the ethical conduct of research and on the preparation of the IRB application when such is required. In particular, instructors and students should:

  • Understand the elements of informed consent;
  • Develop appropriate consent documents;
  • Plan appropriate strategies for recruiting subjects;
  • Identify and minimize potential risks to subjects;
  • Assess the risk-benefit ratio for the project;
  • Establish and maintain strict guidelines for protecting confidentiality, and
  • Allow sufficient time for IRB review (if necessary) and completion of the project.

In making a determination of whether or not a class research project requires IRB review, the instructor is encouraged to err on the side of caution and to contact the IRB office for assistance (irb@viterbo.edu or 608-796-3722). Viterbo University policy and procedures, forms, and related information may be found on the VU IRB website at www.viterbo.edu/irb/.

E. Individual Research Projects Conducted by Students:

Independent study projects, senior theses, undergraduate research projects, masters and advanced degree research, and similar exercises must be independently submitted for IRB review if the work is considered human subjects research. The responsible principal investigator must be a non-visiting VU faculty member or staff who is serving as an advisor or mentor to the student and will directly oversee the research. It is important to keep in mind that any human subjects research activity that will ultimately contribute to part or all of a thesis, dissertation, or other type of publication or presentation must go through the IRB review process prior to enrolling subjects and collecting data. IRB review cannot occur after a study has begun. Students and advisors should contact the IRB Office (irb@viterbo.edu or 608-796-3722) with any questions.

Student Projects might use mixed methods, whereby research activity is combined with Quality Improvement projects. In these cases federal guidelines state “most quality improvement efforts are not research subject to the HHS protection of human subjects regulations. However, in some cases quality improvement activities are designed to accomplish a research purpose as well as the purpose of improving the quality of care and in these cases, the regulations for the protection of subjects in research (45 CFR part 46) may apply.” http://answers.hhs.gov/ohrp/categories/1569

Class Projects involving Practicum Agencies:

1. CLASS PROJECTS or PRACTICA that involve direct interaction (e.g., in        person, via mail, email, web surveys, or telephone), but where the purpose is training, an educational exercise, or professional development, and not research. The project or practicum is not "research" even if students ask people questions as part of learning how to conduct interviews or surveys, take histories, administer assessments, or perform "in-house" evaluations as requested by the practicum site. 

Exception: If a student decides after the completion of a practicum activity to pursue additional activities with the same information for a master’s project or paper, then an IRB application describing research use of secondary data should be submitted for approval, as above. 

No IRB action required (neither approval nor determination of human research status) but may be requested if instructor or students are unsure, or if documentation is required by gatekeepers (e.g., schools, businesses) for access to participants.  Class instructor is responsible for providing the necessary training in respecting the privacy of the individuals and the confidentiality of any resulting information, along with training in the relevant professional ethics. Instructor provides information about the assignment for the students to distribute to people who participate in these class projects. List the instructor as the appropriate contact person should questions arise. 

2. CLASS PROJECTS or PRACTICA that involve direct interaction or secondary analyses of private identifiable data and are undertaken as both an educational experience and as research (e.g. results of these activities will be presented publicly or otherwise disseminated, or the data will be stored and used by the students or others as research data). 

Submission tip: Such projects may be very similar to one another. For example, each student may interview one or more persons for a group of oral histories, or conduct telephone surveys as part of a yearly poll, but all in the class follow the same general script or guidelines. If class projects follow different protocols, a table or chart can describe these more individualized activities, under the umbrella of a single IRB application.

IRB approval required: When there are several students in a class doing similar projects, a single IRB application may be submitted by the course instructor as PI, listing all students will be involved. If projects vary greatly, then it may be preferable to submit individual IRB applications with the student(s) as PI. The PI must have research ethics certification. Taking into account the sensitivity of the information to be collected, the instructor can require that students complete the CITI online course, or the instructor may provide comparable training, with the approval of the IRB.

F. Research Conducted at non-VU Sites

Irrespective of the research site, any human subjects research conducted by any VU employee or agent requires IRB review and approval. In general, VU investigators planning to conduct research at non-VU sites must obtain approval from the VU IRB committee. There may be some exceptions to this rule. When investigators plan to conduct research at or plan to collaborate in research activities at other institutions with a Federalwide Assurance (FWA), the VU IRB or the IRBs at these institutions may, under specific situations, enter into a formal agreement between the institutions allowing the review to be carried out by just one institution. Researchers should contact the VU IRB committee for specific information.

When investigators plan to conduct or collaborate in human research at an institution or entity that does not have an FWA, VU IRB approval is required. If no IRB or IRB-like committee exists at a given institution, researchers should consult the VU IRB office on how to document the outside institution's approval. Researchers might be required to provide formal, written assurance that the research will be conducted according to ethical standards. VU’s approval of off-campus research is made contingent on outside institutions' approvals and assurances.

Off-campus research at sites that are not formally affiliated with an institution, government, or other agency (e.g., in foreign countries or remote locations) must still receive approval from the VU IRB committee. The research may also need to be approved by the local equivalent of an IRB for the off-campus site or, where there is no equivalent group, by local experts or community leaders. Appropriate permissions must be documented.

G. Research in Multicenter Clinical Trials

National level approval of a research proposal is not sufficient to bypass VU IRB approval. Researchers who conduct multicenter clinical trials sponsored by the National Institutes of Health (NIH) or the National Cancer Institute (NCI), for example, should include protocols and consent forms approved at the national level with their IRB applications. Although the documents will be identified as having been approved by a national IRB, the VU IRB committee must review the material as it would any other submission.

H. Pilot and Feasibility Studies

Pilot and feasibility studies, regardless of the number of subjects, require the same scrutiny as full-scale research projects and must be submitted for IRB review and approval. Pilot and feasibility studies should be identified as such in the IRB application. Subjects should be told that the study is a pilot.

I. Research involving a Secondary Use of Data

Projects that use previously gathered human subjects data, and that meet the definition of human subjects research, require IRB review.

J. Research using "Waste" or "Extra" Material

Research conducted on waste or extra human tissues or fluids must be submitted for IRB review.

Waste material is material originally collected for clinical or diagnostic purposes but that is no longer needed for that purpose.

Extra material is material collected during a clinical or diagnostic procedure but, solely for investigative purposes, in quantities above and beyond what was needed for the procedure.

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