Protecting Human Subjects Guide

2. What Is Subject to Review?

The scope of the Institutional Review Board's (IRB) charge is broad. Generally, any University research that uses humans, human tissue, surveys of human subjects, or human subjects' records requires IRB review, irrespective of its funding source. The IRB's charge extends to research in the social and behavioral sciences as well as research in the health and biological sciences.

2.1 Scope of review

IRB review and approval is required for any research involving human subjects that:

• is conducted by University faculty, staff, students, Fairview Employees or Gillette Children's Specialty Healthcare Employees; 
• is performed on the premises of the University, Fairview Health Services or Gillette Children's Specialty Healthcare; 
• is performed with or involves the use of facilities or equipment belonging to the University; 
• involves University patients, students, staff, or faculty;
• involves Fairview Health Services or Gillette Children's Specialty Healthcare patients and/or patient data
• satisfies a requirement imposed by the University for a degree program or for completion of a course of study; or
• is certified by an institutional official to satisfy an obligation of a faculty appointment at the University, including clinical or adjunct appointments.

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2.2 Research conducted at partner institutions

Research involving human subjects conducted at Fairview must meet the requirements set down by the Fairview "Research Involving Human Subjects Policy"

See more Fairview research policies related to subject protection on their Web site.

Researcg involving human subjects conducted at Gillette Children's Specialty Healthcare must meet the requirements set by Gillette Research Administration.

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2.3 Research conducted by "affiliated faculty"

Research conducted by "affiliated faculty"--faculty members who hold clinical or adjunct appointments--is subject to the University's guidelines for research on human subjects and must be submitted for IRB review. Any research project that is conducted by or under the direction of any employee or agent of this institution, in connection with his or her institutional responsibilities, requires IRB approval.

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2.4 Research projects in which the researcher is a consultant

University IRB review is required unless the researcher has a strict consulting relationship in which:

• the researcher is hired on his or her own time, 
• the researcher holds no rights in the work, and 
• neither the researcher nor the University retains any data.

All three of these criteria must be met, or the IRB will need to review the project. If you have questions, then call the IRB at 612-626-5654.

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2.5 Research conducted by students--the faculty responsibility

Independent class projects, senior theses, undergraduate research projects, master's projects, and similar exercises must be independently submitted to the IRB by the student-researcher. However, when students conduct research as part of a course of study, a faculty member ultimately is responsible for the protection of the subjects, even if the student is the primary researcher and actually directs the project. Academic advisors shoulder the responsibility for students engaged in independent research, and instructors are responsible for research that is conducted as part of a course. 

During the design of a project, academic advisors and faculty members should instruct students on the ethical conduct of research and help them prepare applications for IRB approval. In particular, students should:

• understand the elements of informed consent, 
• develop a readable consent form following the sample, 
• plan appropriate recruitment strategies for identifying subjects, 
• establish and maintain strict guidelines for protecting anonymity and confidentiality, and 
• allow sufficient time for IRB review and completion of the project.

As assurance that the University's guidelines will be followed, the academic advisor or instructor is required to sign the student's application for IRB approval.

After IRB approval, faculty members should take an active role in ensuring that projects are conducted in accordance with the IRB's requirements. Meeting periodically with students to review their progress is one way to meet this responsibility.

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2.6 Research conducted in university courses

See section 3.6 Class Protocols for Research Methods Courses

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2.7 Research conducted at another institution

An agreement allow the University of Minnesota Institutional Review Board to formally delegate research review responsibilities to the respective IRB for projects where:

• University faculty or staff hold joint appointments
• All research subjects are recruited and seen at that facility
• Funding arrangements are not managed through University of Minnesota Sponsored Projects Administration.

This form registers activities on projects where the review was conducted through the researcher's respective IRB, eliminating the duplicity of a review conducted by both review boards.

Affiliated Research Registration Form

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2.8 Research that is part of multicenter clinical trials

Approval of a proposal document at the national level is not sufficient to bypass approval at the local level. 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 applications to the University IRB. Although the documents should be identified as having been approved by a national IRB, the local IRB must review the material as it would any other submission. (OHRP Report Number 93-01).

Only the local IRB is vested with the authority to review and approve projects to be conducted at a given institution familiar with the particular circumstances of its research setting and is able to weigh critical considerations such as state and local laws, professional and community standards, institutional policies, and the needs of different patient and subject populations.

If changes are made to documents approved by the national IRB, the investigator must notify that IRB. The University IRB will rarely make substantive changes in the protocol or study plan and more likely to request that the wording of a consent form be changed to reflect local standards or to include specific language required by the University.

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2.9 Research in foreign countries

Research conducted by University investigators in foreign countries remains under University purview and guidelines. While we cannot impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct or consent process

While human subjects in foreign countries merit the same level of protection as subjects in the United States, acceptable practices vary from place to place. Different mores, traditions, and institutions may require different research protocols, particularly in informed consent, recruitment practices, and documentation. Special attention should be given to local customs and to local cultural and religious norms in drafting written consent documents.

Research projects must have been approved by the local equivalent of an IRB before they are presented to the University IRB. Where there is no equivalent board or group, investigators must rely on local experts or community leaders to provide approval. The IRB requires documentation of this "local approval" before it gives approval. Researchers should describe what if any, knowledge or experience they possess regarding the language and culture of the country in question.

The Office for Human Research Protection (OHRP) can provide guidelines on procedures followed by foreign institutions which affords protections that are at least equivalent to U.S. regulations (45 CFR 46 101 [h]). Under this provision, OHRP reviews the foreign country's guidelines for human subjects research, and if the foreign guidelines are found to be equivalent to U.S. regulations, the investigator is permitted to substitute those foreign procedures.

Researchers proposing international research should allow additional time for this review process.

OHRP on International Research

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2.10 Research at a pilot or feasibility stage

Pilot studies and feasibility studies, including those involving only one human subject, require the same scrutiny as full-scale research projects. Pilot studies should be identified as such in applications to the IRB. The informed consent process must must explaine to subjects that the research is a pilot study.

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2.11 Research involving secondary use of data

Projects that use data on human subjects gathered in earlier projects require IRB review.

If the data are gathered by someone who has legitimate access to the records and who gives the investigator only "blinded" or de-identified data (so that the investigator is unable to identify the subjects), the level of risk is lowered.

If you have questions, then contact the IRB at 612-626-5654.

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2.12 Research using "waste" and "extra" material

Research that is conducted on "waste" or "extra" human tissue or fluids must be submitted for review.

"Waste material" is material that is collected originally for clinical or diagnostic purposes only but is no longer needed. "Extra material" is material that is collected above and beyond what is needed for a clinical or diagnostic procedure. It is collected during the same procedure, but solely for investigational purposes.

The IRB may determine that research on waste material qualifies as exempt from full review. If the subject's consent to the clinical procedure outlines research use of the material as well, a separate consent form may not be required. Collecting and using "extra material" requires subjects' written consent and full IRB review.

Related OHRP Guidance

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Next Section: 3. How to Apply for Review