Policy on Protection of Human Subjects in Research

Section I. Item 3.

Northern Illinois University has the responsibility to protect the rights and welfare of human subjects involved in research activities conducted at, or in affiliation with, NIU, whether or not the activity is independently funded, and regardless of the source of any funding. NIU is guided by the ethical principles regarding all research involving human subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled "Ethical Principles and Guidelines for the Protection of Human Subjects of Research" (the "Belmont Report").

In compliance with U.S. Department of Health and Human Services regulations, NIU has established an Institutional Review Board (IRB) to review all research involving the use of human subjects and to set forth institutional policy regarding such research. The Office of Research Compliance has been created within the Graduate School to assist the IRB in achieving and maintaining compliance with the Department of Health and Human Services (DHHS) regulations for the Protection of Human Subjects (45 CFR 46, as amended).

The IRB has developed a university policy governing research involving the use of human subjects at NIU, based on the federal guidelines. Copies of the policy are available from the Office of Research Compliance.

IRB members are appointed by the Vice President for Research and Dean of the Graduate School (Vice President/Dean), subject to concurrence by the University President, for renewable terms of three years. The membership shall consist of at least five members, including:

  • At least one member whose primary concerns are in scientific areas.
  • At least one member whose primary concerns are in nonscientific areas.
  • At least one member who is not otherwise affiliated with NIU, nor a part of the immediate family of a person affiliated with NIU.

A quorum of the IRB is a simple majority of voting members; formal committee action requires a majority of those voting. Meetings are held monthly during the academic year and as needed during the summer.

All research projects involving human subjects must be initially screened for ethical considerations and for scientific merit by the investigator's department chair or director of graduate studies, who shall also make a preliminary designation of the level of IRB review needed. If the initial designation indicates the project is "exemptible," the investigator may begin data collection subject to ratification of that designation by the IRB chair. All other projects must be reviewed and approved by the IRB prior to the start of data collection.

The IRB review shall determine whether human subjects will be placed at risk in the described project and, if so, whether:

  1. Risks to subjects are minimized.
  2. Risks are reasonable in relation to the anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result from the project.
  3. Selection of subjects is equitable, taking into consideration the purpose(s) of the research, the setting in which it will be conducted, and the population from which the subjects will be recruited.
  4. Informed consent will be sought from each subject or the subject's legally authorized representative. In addition, minor subjects capable of giving assent must do so.
  5. Informed consent will be appropriately documented and retained for a minimum of three years following completion of the research.
  6. Where appropriate, adequate precautions are taken to protect the privacy of subjects and to maintain the confidentiality of data.

For the purpose of this policy, "research," "human subject," and "informed consent" are defined as follows:

Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Research encompasses questionnaires, surveys, interviews, tests, observations, and other experimental procedures regardless of the content or routine nature of the subject and even if the project is preliminary in nature. Research extends to any systematic collection of data from human subjects that occurs in conjunction with classroom projects, demonstrations, and "service" programs.

Human Subject: A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Informed Consent: Voluntary agreement to participate in research obtained by the use of a consent form that complies with the provisions of 45 CFR 46 (as amended), written in language understandable to the subject or representative after sufficient opportunity to consider whether to participate.

It is the responsibility of each human-subjects researcher to know and comply with the review procedures of the IRB. Any faculty member, other employee, or student of Northern Illinois University who wishes to undertake research involving human subjects must file an "Institutional Review of Research Involving the Use of Human Subjects" form, complete with copies of any written instruments to be used, with the Office of Research Compliance. The review forms are available from the departmental office as well as from the Office of Research Compliance. If the proposed activity involves a sensitive subject population such as children, pregnant women or prisoners, additional precautions must be taken. Revisions of approved projects must be reviewed and approved before implementation, and each investigator has a continuing obligation to inform the Vice President/Dean within 48 hours, in writing, of any harm to a human subject as a result of the research activity.

Projects deemed exempt by the IRB do not require review unless changes in the protocol are anticipated. All non-exempt research must be reviewed annually, although unchanged projects can be approved by an expedited procedure for two additional years. Any non-exempt project that will last beyond three years must undergo full review, even if the protocol is unchanged.

It is the responsibility of the Vice President/Dean, assisted by the IRB and the Office of Research Compliance, to assure compliance with all operative federal, state, and NIU policies regarding activities involving human subjects. To assure appropriate institutional procedures, the Vice President/Dean will:

  1. Provide staff support for the IRB, maintain official copies of all records required by NIU and Department of Health and Human Services (DHHS) policies, and refer all proposals involving human subjects to the IRB for review.
  2. Provide review forms and guidelines, support facilities and advice to investigators and departmental representatives regarding human-subjects activities.
  3. Work with the Office of Sponsored Projects to provide certification for funded projects as required by the funding agency.
  4. Ensure that any problems, including adverse reactions to research protocols, are reported promptly to the DHHS, and act upon the recommendation(s) of the IRB regarding any incident of noncompliance with this policy or with state or federal regulation of activities involving human subjects.

Approved by Graduate Council, May 3, 1993
Editorial change, September 16, 2003