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pictureRole, Authority, Actions, and Jurisdiction of the Alverno IRB


IRB Role

The primary responsibility of the Alverno College Institutional Review Board (IRB) is the review of research for the protection of human subjects who are participants in research. Review by an IRB is the cornerstone of an institution’s program for the protection of human subjects participating in research. IRBs are responsible for ensuring that the rights and welfare of the participants in research are adequately protected. IRB means an institutional review board established in accord with and for the purposes expressed in Office for Human Research Protections policy (45 CFR 46.102(g)).

INSTITUTIONAL REVIEW BOARD: A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research. [Federal Policy 45 CFR 46.102(g), &.108, &.109]
HUMAN SUBJECTS: Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. [Federal Policy 45 CFR 46.102(f)]
RESEARCH: A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge [Federal Policy 45 CFR 46.102(d)].

Note: the IRB only holds jurisdiction over Human Subjects Research.

To minimize risks, the IRB ensures that the ongoing conduct of the research protects subjects at Alverno College and at other sites as negotiated through Federal Assurances. These protections ensure that human subjects participate in research only after providing legally effective, fully informed consent when consent is required by law for the ethical and legal conduct of the research. The IRB operates under the rules of conduct established from the Code of Federal Regulations, most frequently 45 C.F.R. § 46 subpart A (PDF), as well as Wisconsin state laws, and policies established by Alverno College. The IRB’s decisions are based on the ethical principles in the Belmont Report.

COMMON RULE: The common federal policy for protecting human subjects, promulgated in regulation and contained in the CFR, that outlines the provisions regarding the review and approval of research, is generally referred to as the "Common Rule." It was signed by 17 federal agencies, including the VA, which are thus bound by it. The DHHS "Common Rule" is found at 45 CFR 46 Subpart A. Comparable regulations for the VA are found at 38 CFR 16 & for FDA are 21 CR 50 and 56. See also: "Federal Policy" and "CFR."
ASSURANCE: A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved [Federal Policy 45 CFR 46.103].

The IRB reports directly to the Alverno College President, who officially serves as the Institutional Official (IO) with oversight of the Alverno IRB and Human Research Protections Program. The IRB exercises full autonomy in deciding whether human subjects research reviewed under its auspices meets ethical requirements.

AUTHORIZED INSTITUTIONAL OFFICIAL: An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research. The Alverno President has assumed this designation.

IRB Authority

The IRB is constituted by the IO and is registered with Department of Health and Human Services, Office for Human Research Protections (OHRP) under Alverno College’s Federal Wide Assurance (FWA#FWA00012561). The IRB has the following authority:

  • to approve research, require modifications to research protocols in order to approve research, or disapprove research;
  • to require progress reports or other information from investigators in order to effectively oversee the conduct of the research and the informed consent process;
  • and to place restrictions on, suspend, or terminate the approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to subjects.

IRB Actions

The IRB ensures the adequacy of human subject protections by taking the following actions:

  • Conduct the initial and continuing review of research protocols;
  • Report the IRB’s determinations and decisions, in writing, to investigators and the research sponsor;
  • Determine which research protocols require review more frequently than once per year;
  • Determine which research protocols require verification from other sources, other than the investigator, that no material changes have occurred since the most recent IRB review and approval;
  • Require that proposed changes in research are promptly reported;
  • Require that changes in approved research are not initiated without prior IRB review and approval, except, when necessary to eliminate apparent immediate hazards to subjects;
  • Require that any unanticipated problems involving risks to subjects or others be promptly reported to the IRB Chair and, when appropriate, by the IO to pertinent federal agencies;
  • Require that any serious or continuing noncompliance with Alverno College’s Human Research Program Protection Policies and/or federal regulations, or the requirements or determinations of the IRB, be promptly reported to the IRB and, when appropriate, via the IO to pertinent federal agencies; and
  • Report any suspension or termination of IRB approval to the IO and, when appropriate, via the IO to pertinent federal agencies.
RISK: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk."
REVIEW (OF RESEARCH): The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis. [Federal Policy 45 CFR 46.108(e)]
PROTOCOL: The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.
CONTINUING REVIEW: An IRB review of a study that occurs within no more than a year of the previous or initial RB approval. May also include explicitly specified continuous monitoring procedures. All research, except for exempt research, is necessarily subject to continuing review. Continuing review address, among other things, risks, potential benefits, informed consent, and safeguards for human subjects. In particular, the review addresses whether any new information has emerged that could alter the IRB’s previous determinations, especially with respect to risk to subjects.

IRB Jurisdiction

The IRB has jurisdiction only over the following categories of research when that research involves the use of human subjects or identifiable data or tissues derived from human subjects:

HUMAN SUBJECTS: Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. [Federal Policy 45 CFR 46.102(f)]

RESEARCH: A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge [Federal Policy 45 CFR 46.102(d)]. Note: the IRB only holds jurisdiction over Human Subjects Research.

  • Research performed on the premises of Alverno College or using equipment owned by Alverno College.
  • Research conducted on an identified population of students, employees, staff or other affiliated members of Alverno.
  • Research to satisfy a requirement imposed by Alverno College for the award of a degree or the completion of a course of study.
  • Research conducted by faculty, staff, and others affiliated with Alverno College or under Alverno College’s auspices.

For research conducted on Alverno premises or on an identified population of Alverno students, faculty, or staff, Alverno College is the local IRB and, accordingly, acts as an IRB of record with its required approval of the final design of the research protocol and its specified procedures for the protection of human subjects, unless the Alverno College IRB Chair provides a written letter that officially delegates this authority (or some portion of it) to another IRB. Alverno has articulated policies that address circumstances when multiple IRB’s have shared jurisdiction. These policies may assist a researcher to avoid unnecessary duplication of effort. However, Alverno affiliated students should always begin with the Alverno IRB’s standard submission forms and processes.

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