Compliance

Research Integrity

The Office of Research Integrity works with OSU faculty, staff, and students to help assure proper conduct of research in areas pertaining to the use of human subjects, and non-human vertebrate animals. The office also works with faculty and Academic Affairs to identify and appropriately manage issues that could be perceived to present financial conflicts of interest. A wide array of research activities are governed by federal and state laws and regulations. OSU manages these through a number of compliance committees.

Faculty should be aware that non-compliance can result in severe penalties to the institution, and, in some instances, to the individuals involved. It is the responsibility of all members of the university community to be familiar with OSU policies as related to these research compliance areas. The following are some regulated areas that are commonly identified with certain research activities of faculty and staff.

Animal Care - IACUC

Institutional Animal Care and Use Committee (IACUC)

All research and/or teaching activities that involve the use of vertebrate animals require prior review and approval by the Institutional Animal Care and Use Committee (IACUC).

The IACUC performs semiannual inspections of all animal facilities associated with the university and provides reports of these inspections to federal regulatory agencies.

Chemical Safety

Chemical Safety

Issues regarding chemical safety in the laboratory and the disposal of chemical wastes are key concerns of the Chemical Safety Committee (CSC). The CSC provides oversight of projects using chemical carcinogens and highly toxic materials, oversight of the campus chemical inventory and hazardous waste programs, and guidance regarding chemical safety training that is required for students, staff, and faculty who work in laboratories using hazardous chemicals. Research projects involving the use of chemical carcinogens are reviewed by the CSC to ensure compliance with current regulations. The CSC is also charged with reviewing the campus Chemical Hygiene plan, which governs safe use of chemicals in laboratories. The web site provides access to the Chemical Hygiene plan and other procedures for waste and chemical safety.

http://oregonstate.edu/dept/ehs

Biosafety - IBC

Biosafety

The Biological Safety Committee (BSC) has been established to assist Principal Investigators and the university in meeting the requirements mandated in the NIH Guidelines for Research Involving Recombinant DNA (rDNA) and to have oversight of all projects involving rDNA; biohazardous agents (a pathogen capable of replication and a disease causing organism in humans, animals or plants); and human blood, body fluids or tissues. The BSC is also responsible to see that the CDC Select Agents rule is enforced. A Biological Safety Manual has been adopted that outlines the Biosafety program.

http://oregonstate.edu/dept/ehs/biological.php

Chemical Safety

Chemical Safety

Issues regarding chemical safety in the laboratory and the disposal of chemical wastes are key concerns of the Chemical Safety Committee (CSC). The CSC provides oversight of projects using chemical carcinogens and highly toxic materials, oversight of the campus chemical inventory and hazardous waste programs, and guidance regarding chemical safety training that is required for students, staff, and faculty who work in laboratories using hazardous chemicals. Research projects involving the use of chemical carcinogens are reviewed by the CSC to ensure compliance with current regulations. The CSC is also charged with reviewing the campus Chemical Hygiene plan, which governs safe use of chemicals in laboratories. The web site provides access to the Chemical Hygiene plan and other procedures for waste and chemical safety.

http://oregonstate.edu/dept/ehs

Conflict of Commitment

Conflict of Commitment

content

Conflict of Interest

Conflict of Interest

A conflict of interest may occur when an employee is in a position to make a decision in his or her capacity as a university employee that may result in personal or family gain, financial or otherwise. These conflicts often arise as a result of the employee’s external activities that are related to their research, teaching or outreach activities. The OSU policy recognizes that the potential for conflicts exist. The intent is to identify when such relationships exist and to appropriately manage the relationships in order to maintain the integrity of actions of all individuals. Disclosing a potential conflict of interest in no way suggests an inappropriate action by an employee but is instead a necessary management process within the University.

Human Subjects - IRB

Institutional Review Board (IRB)

The mission of the IRB is to:

If the proposed research activity is a systematic investigation designed to develop or contribute to generalizable knowledge and it involves human participants, then the activity will require review and approval by the OSU IRB before any recruitment or research activities may begin.

Human Research Handbook & Guidance

Oregon State University Institutional Review Board

Table of Contents

 

Institutional Review Board (IRB)

IRB Review

Principal Investigator (PI) Responsibilities

Educational Requirement

Initial Application

Types of Research Projects

Recruitment / Advertising

Informed Consent

Race / Ethnicity of Subjects

IRB Continuing Review

Records Retention

Additional Protections for Special Populations

Definitions

Institutional Review Board (IRB)

Institutional Review Board (IRB)

Safeguarding the rights and welfare of humans in research is a general institutional policy of Oregon State University, with oversight delegated by the Vice President for Research to the Institutional Review Board (IRB), as mandated by federal regulation (45 CFR 46.103(b)(2)). The OSU IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human subjects. The IRB is concerned with justifying the participation of humans in research and protecting their welfare, rights, and privacy.

The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.

The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board will also include at least one member from the local community and one member who is not a scientist. The IRB has several Special Advisors who advise the Board and are periodically involved in protocol review.

Projects that Require IRB Review

Projects that Require IRB Review

 

For research involving humans, Oregon State University is guided by the ethical principles set forth in the Declaration of Helsinki and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research's Ethical Principles and Guidelines for the Protection of Human Subjects of Research: The Belmont Report. In addition, the IRB follows the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations.

Determining whether a project must be reviewed by the IRB is a two-step process: first, is the activity research, and, second, does it involve the participation of humans? To answer these questions, one must refer to the federal definitions of "research" and "human subjects," which are presented below. If the answer on both counts is "yes," then the project must be reviewed and approved by the IRB before subject recruitment is initiated, and the research staff must have completed training in the ethical use of humans in research.

  • Defining Research

As defined by the Code of Federal Regulations (45 CFR 46), research is "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." If there is a possibility that a project using human subjects might be published or disseminated outside of the OSU community, then the faculty member (and student, if a student project) must obtain IRB approval before starting the project or recruiting human subjects. In addition, pilot research work or methodological development that involves the participation of human subjects must also receive IRB review and approval because this work constitutes "research development" as described in the federal definition. Research that involves human subjects that is being done to fulfill thesis or dissertations requirements must receive IRB review and approval. An example of a project that would not be submitted for IRB review is a student's project that is conducted as a class assignment and that will not be communicated beyond the class.

  • Defining Human Subject

The CFR defines human subject as "a living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information." Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject, such as interviews, surveys and questionnaires. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., medical records).

All research (including interviews, surveys, and questionnaires) involving human subjects must be reviewed by the IRB. Approval must be obtained when the experimental plans are complete and before human subjects are involved in the project.

Prior to commencing any aspect of human subjects research, including recruitment of any sort, IRB review and approval is required. The results from studies conducted without obtaining IRB approval may not be published, presented, or the results otherwise distributed, nor can such data be used to satisfy honors thesis, master’s thesis or doctoral dissertation requirements. It is, therefore, in the investigator's best interest to consider carefully the likelihood that the data will be published or used to fulfill thesis or dissertation requirements, and to err on the side of inclusion and seek IRB approval prior to commencing the work.

The IRB reviews projects by one of three methods: Exempt from Full Board review, Expedited review, and Full Board review. The investigator may recommend the review category, but final determination of the category will be made by the IRB. A project may be subject to more comprehensive review at the discretion of the IRB. The first page of the IRB application provides details on the review timelines for each level of review.

Exempt from Full Board Review

Exempt from Full Board Review

Certain categories of research qualify for Exempt from Full Board review. These applications and protocols are reviewed and approved by the Human Protections Administrator, as authorized by the IRB. Work with human subjects (including recruitment of any fashion) may not begin until full approval has been issued.

Research involving the following cannot be reviewed at the Exempt from Full Board level:

  • Audio-taping or video-taping
  • Vulnerable populations (e.g., children, prisoners, pregnant women)

Research activities in which the only involvement of human subjects will be in one or more of the following categories qualify for review under the exempt category (45 CFR 46.101(b)):

  1. "Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods."
  2. "Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation."
  3. "Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under category 2 of this section, if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter."
  4. "Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects."
  5. "Research and demonstration projects which are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs."
  6. "Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed or (b) if a food is consumed that contains a food ingredient, or agricultural chemical or environmental contaminant at or below the level and for a use found to be safe, by the Food and Drug Administration and approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture."

Occupational Health

Animal Handler Occupational Health and Safety Program

Mandated by federal requirements, the primary goal of the OSU Animal Handler Occupational Health and Safety Program is to evaluate and, if necessary, address potential risks to you that may be associated with your use of animals in the research environment. Enrollment in this program is mandatory for all personnel for whom OSU has responsibility and who have substantial animal contact, including faculty, classified staff, faculty research assistants, research associates, technicians, graduate students, post-doctoral students, undergraduate students, visiting faculty, and others involved with animals.

Visit the web site: Occupational Health Services, Animal Handler Medical Surveillance

Radiation Safety

Radiation Safety

 

All research and teaching activities at Oregon State University that require the possession and/or use of radioisotopes or radiation-emitting machines are governed by the provisions of a license and/or regulations issued by the State of Oregon. The Radiation Safety Program, established by the President of the university, provides for these uses under the applicable laws and regulations of federal, state, and local agencies. Furthermore, the Program ensures that no risk from ionizing radiation shall be incurred except where justified by benefits from the activity and that radiation exposure shall be maintained As Low As Reasonably Achievable. All uses of ionizing radiation must be specifically authorized by the Radiation Safety Committee and the authorized user has primary responsibility for all safety aspects of work under the program. This includes familiarity with and adherence to all regulations, personnel training, and the conduct of safe operations with the assistance of Radiation Safety.

http://oregonstate.edu/dept/radsafety/

Responsible Conduct of Research

Oregon State University Procedures for Handling Allegations of Research Misconduct

11/3/89, addendum 8/29/95, revision 12/20/01, revision 03/10/06

I. PREFACE

It is the purpose of these procedures to set forth guidelines for efficient disclosure and resolution of accusations of research misconduct in a manner that (1) protects the public from the results of misconduct, (2) protects innocent scientists and scholars from harassment or interference with their academic freedom, and (3) protects from retribution the individual who unmaliciously presents evidence of misconduct. These procedures apply to all research endeavors whether or not federally funded.

The Oregon State University Procedures for Handling Allegations of Scientific and Scholarly Misconduct were originally developed during 1989 to comply with federal requirements. They have been amended periodically since that date. These Procedures for Handling Allegations of Research Misconduct supersede the 1989 procedures and apply to OSU faculty and other investigators.

Scuba Diving/Small Boat

Diving Control Board

Research that requires diving as a research tool is regulated by the University Diving Officer and Diving Control Board. A university employee, or anyone conducting research under university auspices, must demonstrate previous diving experience and/or skill, as well as meet other recognized standards as outlined by the Dive Control Board.