Standard Operating Procedures - Chapter 4

IRB AUTHORITY

4.1	IRB Scope
4.2	IRB Authority
4.3	Authority of Institutional Officials

4.1 IRB Scope

The IRB must review and approve all funded human participants research carried out at UMASS, or under its auspices, regardless of sponsorship.

Funded research is conducted in accordance with the Federal Wide Assurance (FWA) filed with the Office of Human Research Protections (OHRP) in which a UMASS IRB is designated as the IRB of record.

Unfunded research involving human participants may be reviewed at the local level if a local board is available. Local boards currently exist in the following areas: Anthropology, Communication, Education, Linguistics, Nursing, Psychology, Public Health (including Exercise Science and Nutrition), and Sociology. Unfunded projects are reviewed by the IRB where a local board is not established.

Definition of Research

Research is defined as any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Definition of Human Participant

A human participant is a living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information. Private information includes information that an individual can reasonably expect will not be public, and information about behavior that an individual can reasonably expect will not be observed or recorded. Private information must be individually identifiable. Identifiable means that the identity to the individual is, or may readily be ascertained by, the investigator or associated with the information.

If a FDA regulated test article is involved, the FDA regulations will also apply. The FDA regulations define research as any experiment that involves a test article and one or more human participants. These regulations define a human participant as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A participant may be either a healthy individual or a patient.

Research Conducted at, or in Cooperation with, Other Sites

The IRB reviews research that is performed by UMASS employees and students at other institutions or sites, and research performed at UMASS by investigators who are not affiliated with UMASS. When research reviewed by the IRB is conducted at, or in cooperation with another entity, all requirements of the UMASS IRB review will remain in effect for that research study. See Section 5.4 for additional information.

Research conducted outside the United States

The IRB must review and approve research conducted outside the United States of America by UMASS employees or students, even if the foreign research receives no U.S. government funding. Such collaborative research activities must meet ethical standards similar to those required at UMASS. The IRB may approve such research, provided it determines that (1) the research conforms to proper codes of ethics (e.g., the Declaration of Helsinki or the Belmont Report) and (2) the research is approved by the local ethical review authority when available. Requirements for the informed consent process will follow the laws and customs of the country in which the research is being conducted. If a U.S. department or agency funds the research, then it is probable that the foreign research site will need to file a Federal Wide Assurance (FWA) application through OHRP. For more information, see http://ohrp.osophs.dhhs.gov. See Roadmap for Success in International Research at http://www.rti.org/pubs/protecting_research_subjects.pdf for more information on international ethics regulations.

4.2 IRB Authority

The authority conveyed to UMASS IRB includes the following:

• Review all funded research studies involving human participants before the involvement of human participants may begin;

• Require from investigators revisions in research studies and informed consent documents as a condition for initial or continuation approval;

• Approve new research studies and the continuation of previously approved studies;

• Disapprove the initiation of new research studies, if necessary;

• Monitor the activities of approved studies, including regularly scheduled continuing review at least once every 365 days and verification of compliance with approved research studies and informed consent procedures;

• Develop mechanisms for prompt reporting to the IRB of any planned changes in approved studies prior to the implementation of those changes;

• Develop mechanisms for prompt reporting to the IRB of any unanticipated problems involving risks to participants occurring in approved studies, or in other studies related in context to the approved studies;

• Suspend or terminate a previously approved study, if necessary;

• Restrict aspects of a research study for the purpose of participant protections, if necessary; and

• Review and monitor the use of test articles (investigational drugs, biologics and devices) for the purpose of treating serious or life-threatening illnesses.

4.3 Authority of Institutional Officials

The institutional official has the authority to review decisions of the IRB. In the case of an approval decision, should the institutional official conclude that a study does not fully comply with policies or obligations of UMASS or for other reasons, the study may be disapproved, suspended, or terminated on behalf of the institution. In the case of a decision by the IRB to disapprove, suspend, or terminate a study, the institutional officials or any other officer/agency of UMASS, state government, or federal government has no authority to override or reverse the decision.