Purpose
The purpose of this policy is to provide guidance on the protection of human subjects in research.
Definitions
Governors State University (GovState) has adopted the following definitions included in the federal regulations to guide researchers and other interested parties in determining the necessity for review.
1. Human subject: a living individual about whom an investigator (whether professional or student) conducting research:
  1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
2. Intervention: includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
3. Interaction includes communication or interpersonal contact between investigator and subject.
4. 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
5. Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
6. An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
7. Institution means any public or private entity, or department or agency (including federal, state, and other agencies).
8. Institutional Review Board (IRB) means an institutional review board established in accord with and for the purposes expressed in this policy.
9. IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
10. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
11. Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:
  1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
The Policy
1. Scope
  This policy applies to research involving human subjects under the oversight of the GovState IRB.
2. Rationale
  1. The purpose of the IRB is to ensure the protection of human research subjects. Federal regulation, Title 45, Code of Federal Regulations, Part 46, requires that all institutions receiving federal funds and conducting research using living humans as subjects establish and operate an IRB.
  2. Projects involving human subjects are subject to review and approval by the GovState IRB.
  3. IRB review shall determine:
    1. that the rights and welfare of the subjects involved are adequately protected;
    2. that the risks to an individual, whether physical, psychological, or social, as a consequence of any activity which goes beyond the application of accepted routines necessary to meet his/her needs, are outweighed by potential benefits to the individual and/or to society; and
    3. that legal, informed consent is obtained by methods that are appropriate and adequate.
  4. IRB approval or a determination that the project is exempt from IRB review must be obtained before any research involving human subjects is initiated.
  5. All faculty, students, and staff must adhere to the procedures established by the IRB. These procedures are available from the Office of the Provost.
3. Ethical Principles
  1. GovState is guided by 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 (also known as the Belmont Report). The three primary principles for protection of human subjects established in the Belmont Report are:
    1. Respect for Persons: Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.
    2. Beneficence: Protecting them from harm, but also by making efforts to secure their wellbeing. The term “beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do no harm, and (2) maximize possible benefits and minimize possible harms.
    3. Justice: An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are:
      1. to each person an equal share,
      2. to each person according to individual need,
      3. to each person according to individual effort,
      4. to each person according to societal contribution, and
      5. to each person according to merit.
  2. Other principles that may guide GovState in protecting the rights and welfare of human subjects are found in the existing codes of federal, state, and local agencies, and in the codes of conduct of professional organizations, including, but not limited to:
    1. Title 45 Code of Federal Regulations Part 46, Department of Health and Human Services Regulations for the Protection of Human Subjects, Final Regulations, Subparts A-E, as well as those of other applicable federal, state, and local agencies;
    2. 21 CFR Parts 16, 20, 50, 312, 809, and including 812 Medical Devices;
    3. 34 CFR Part 97 (Basic ED Policy for Protection of Human Research Subjects).
4. Institutional Policy
  1. The University will establish and maintain an IRB.
  2. The IRB will review all research involving human subjects and will approve only those research protocols that comply with its requirements for approval.
  3. All of the following research activities involving human subjects are subject to the review and approval of the IRB. This includes research that is:
    1. sponsored by the University, or
    2. conducted by or under the direction of any employee, agent, or student of the University in connection with their university responsibilities, or
    3. conducted by or under the direction of any individual or agent using the property, facilities, or electronic communications of the University.
  4. Projects being conducted on GovState premises but not directed by a GovState employee must be sponsored by a GovState faculty or staff member and approved by the GovState IRB.
  5. The IRB will establish and implement procedures for the review of research involving human subjects. These procedures will detail the processes to be used for:
    1. the initial review of a newly proposed research protocol, including the classification of that protocol (i.e., exempt from, expedited, or full) and the manner for its review by the IRB;
    2. the review of proposed modifications to approved research protocols;
    3. the consideration of requests for the continuation of and/or extension to approved protocols nearing the end of their approval periods;
    4. the investigation reports of possible harm to human subjects and/or possible noncompliance by any person covered by this policy, including the suspension or termination of approved protocols and reporting to necessary offices/agencies; and
    5. procedures and forms for Human Subjects Research constructed in compliance with federal regulations.
5. Review
  1. An IRB review may result in one of the following:
    1. “Approved” means that neither minor nor major errors or difficulties were detected in the application; the Principal Investigator/Project Director may proceed with the research study.
    2. “Deferred,” means additional information or clarifications are needed before a final determination can be made.
    3. “Disapproved,” means a study is found to be unethical, without scientific or scholarly merit, and/or not meeting the criteria for approval. Written notification from the IRB of a decision to disapprove a protocol is accompanied by the IRB’s reasons for the decision and an invitation for reply by the Investigator. Research can only be disapproved at a full board review meeting. The Principal Investigator/Project Director may resubmit an entirely new application.
    4. “Minor Stipulations,” means minor corrections in the text of the application or revisions in the recruitment and consent documents are required. Under this scenario, further review of the research by the convened IRB may not be necessary. The IRB may designate the Chair to review the written response from the Investigator, determine whether the conditions for approval have been met, and, when they are met, approve the research. The date of approval is the date when the Chair (or designee) determines the conditions for approval have been met.
  2. A review may be “pending” for specific changes, as requested by the IRB and/or for further clarification. The “pending” review status needs to be resolved before moving to a determination status.
  3. A review may end with the IRB making determinations about the project’s exempt status, the University’s engagement in research, and other determinations, as needed, including possible disapproval of research.
  4. For full board reviews, the Principal Investigator/Project Director may be asked to be present for clarification.
  5. The University General Counsel is available to clarify the reading of applicable laws pertaining to the research that is being reviewed.
6. Investigation and Reporting Responsibilities
  1. The IRB will have the authority to and will, at its discretion and for any reason whatsoever, investigate any activity, persons, or records covered by this policy.
  2. The IRB will investigate all unanticipated problems involving risk and/or injury to human subjects.
  3. The IRB Chairperson, or their designee, may:
    1. interview Principal Investigator/Project Director, co-investigator(s), subject or any other person connected with research involving human subjects;
    2. examine the research records involving human subjects, including informed consent documents and collected data; and
    3. inspect any facilities, laboratories, equipment, or supplies used in human subjects research.
  4. The IRB will prepare and maintain adequate records of its activities.
  5. The IRB will report promptly to the GovState Provost and, if appropriate, the federal Office for Human Research Protections (OHRP) or other state or federal office(s), knowledge of:
    1. any serious or continuing noncompliance with the requirements of the IRB;
    2. any suspension or termination of IRB approval of a research protocol;
    3. injuries to human research subjects; and
    4. any changes in the membership of the IRB to agencies with which the University has filed an assurance.
  6. The IRB will require investigators to:
    1. promptly report all unanticipated problems involving risks or injury to human research subjects or others;
    2. initiate no changes to a research protocol, as previously reviewed and approved by the IRB, without requesting and receiving an IRB review and approval for those specific modifications;
    3. maintain complete records of all research activities involving human subjects research; and
    4. file a final report with the IRB.
7. Institutional Review Board (IRB) Membership
  1. The IRB is delegated by the Provost/Vice President for Academic Affairs and convened by that office as defined by statute.
  2. The IRB shall consist of at least seven members, who are individuals with various experiences and skills, which are defined by statute, in evaluating human research and its institutional, legal, scientific, and social implications.
  3. There shall be at least five faculty members appointed by the Faculty Senate, one shall be from each of the four academic colleges and one shall be from the Library or Student Affairs. The members of the IRB shall be appointed for three-year renewable terms. The Chair of the IRB will be elected by IRB members every three years. Consecutive terms are allowable.
  4. The IRB shall include at least one member whose primary concerns are in a scientific discipline, and at least one member whose primary concerns are in nonscientific areas.
  5. Each IRB shall include at least one member who is not affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. The Office of the Provost shall appoint this person upon recommendation from the IRB.
  6. IRB membership will be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
  7. GovState requires that each current member of the IRB have on file a current resume or curriculum vitae attesting to their personal education and experiences.
  8. Each member of the IRB is required to maintain an active IRB Board Member Certification through the CITI Training Website. New appointees must have initial training completed by the first full-board meeting of the academic year.
8. Meetings
  1. Regularly scheduled meetings of the IRB will be held monthly or as needed, but with no fewer than two meetings per year, to conduct the timely review of proposed human subjects research.
  2. A special meeting of the IRB may be called by the Chairperson (or their designee in their absence) to consider any matter related to the protection of the rights and welfare of human research subjects.
  3. A quorum shall be 50% of the members of the committee plus one. A quorum must be present at a meeting for any action to be taken by the IRB. A part of the quorum must be at least one member whose primary concerns are in scientific methods and one member whose primary concerns are in nonscientific methods in attendance.
  4. A majority of those present at any meeting at which a quorum is present is necessary for the IRB to approve any action.
9. University Responsibilities
  1. The University will provide adequate administrative support and oversight for the activities of the IRB, including the preparation and maintenance of adequate documentation of IRB activities. This includes, but is not limited to:
    1. copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects;
    2. minutes of IRB meetings which will be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the notes on these actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution;
    3. records of continuing review activities;
    4. copies of all correspondence between the IRB and the investigators;
    5. a list of IRB members containing the details required by federal regulations; and
    6. written procedures for the IRB.
    Research records must be retained for at least three (3) years after the completion of the research, regardless of whether subjects were enrolled.
    Records for research with a HIPAA authorization or a waiver of HIPAA authorization must be retained for at least six (6) years after completion of the research, regardless of whether subjects were enrolled.
    Records for sponsored research must be retained for the period required by the sponsor.
    IRB administrative documentation is retained for a period of five (5) years after the expiration of its administrative value.
    All records will be accessible for inspection and copying by authorized representatives of the federal Office for Human Research Protections (OHRP) or other state or federal office(s) at reasonable times and in a reasonable manner.
  2. The University will provide adequate meeting space for the IRB.
  3. The University, with the assistance of the IRB, will provide mechanisms and support for education and training regarding human research policies and procedures.