Human Subjects Institutional Review Board Policy and Procedures

Loyola University New Orleans Human Subjects Institutional Review Board Policy and Procedures

I. INTRODUCTION
Loyola University has adopted certain policies and procedures regarding the rights and welfare of human subjects involved in research activities, including those supported by grants and contracts from federal government agencies providing funds to support investigations involving human subjects. The Human Subjects Institutional Review Board shall determine whether subjects will be placed at risk and, if risk is involved, whether:

  • The risks to the subjects are so outweighed by the sum of the benefit to the subjects and the importance of the knowledge to be gained as to warrant a decision to allow the subjects to accept the risks;
  • The rights and welfare of any such subjects will be adequately protected;
  • Legally effective informed consent will be obtained by adequate and appropriate methods in accordance with provisions of applicable law, if necessary; and
  • The conduct of the activity will be reviewed at timely intervals.

II. DISCHARGE OF RESPONSIBILITIES FOR PROTECTION OF THE RIGHTS AND WELFARE OF HUMAN SUBJECTS

In the discharge of its responsibilities for protecting the rights and welfare of human subjects Loyola University New Orleans adopts the ethical principles of the Belmont Report and regulations incorporated in the National Research Act (Public Law 93-348), the Code of Federal Regulations, "Federal Policy for the Protection of Human Subjects," 45 CFR 46.

Additional guidance can be found in the “Institutional Review Board Guidebook” issued by the Office for Human Research Protections (OHRP). For purposes of IRB review the Loyola University Human Subjects IRB shall apply the definitions of the federal government listed in the “Institutional Review Board Guidebook.” “Research is defined by the regulations as ‘a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge’.” “Human subjects are defined by the regulation as ‘living individual(s) 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’.”

III. COMMITTEE STRUCTURE
The Loyola University Human Subjects IRB shall consist of at least seven members. Committee membership shall be consistent with 45 CFR 46 and it will be broadly representative of those academic disciplines in the university likely to use human subjects in research or teaching, or disciplines with ethical insights into issues involving the use of human subjects. The Human Subjects IRB will be sufficiently qualified through the maturity, experience and expertise of its members and diversity of its membership to ensure respect for its advice and council for safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific activities, the IRB must be able to ascertain the acceptability of applications and proposals in terms of institutional commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes. All IRB members shall be appointed by the Provost of the University or his/her designate. The IRB shall have a Chairperson and Vice-Chairperson elected by the majority of committee members present.

Human Subjects Institutional Review Board Committee Members: David Boileau, Anthony Decuir, Patrick Hugg, George Capowich (Chair), and Janet Ruscher (Tulane University)

IV. COMMITTEE PROCEDURES
The Loyola University Human Subjects IRB will meet as required to review studies or proposed studies involving human participation. A quorum of the IRB for conducting official review actions shall be a majority of the members, including at least one member principally concerned with non-scientific and ethical issues. The majority of the members present is required to approve a proposal. If appropriate, the IRB will be guided by the recommendations of consulting expert individuals, or other special applications for research projects involving human subjects. No member of the Human Subjects IRB shall be involved in review of an activity in which he/she has a conflicting interest, except to provide information requested by the Committee. When the grant, contract or study involves the use of drugs or the administration of medical treatment, at least one physician must be used as an expert consultant or as a voting member. Every effort shall be made to insure that members reviewing proposals have scientific and other competencies pertinent to the judgments that need to be made.

No project involving human subjects at greater than minimal risk will be approved unless evidence is presented that legally effective informed consent to participate in the study has been given, in accordance with federal regulations. "Informed Consent" means the knowing consent of an individual or his/her legally authorized representative, so as to be able to exercise freedom of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion. The Committee will employ the following basic elements of information regarding such consent:

  1. A fair explanation of the procedures to be followed, and their purpose, including identification of any procedures which are experimental;
  2. A description of any attendant discomforts and risks reasonably to be expected;
  3. A description of any benefits reasonably to be expected;
  4. An offer to answer any inquiries concerning the procedures; and
  5. An instruction that the person is free to withdraw his/her consent and to discontinue participation in the project or activity at any time without prejudice to the subject.
  6. An example of an Informed Consent Form can be found in Appendix B below.

After an initial review and approval, continuing projects will receive at least an annual review, and when the element of risk sufficiently warrants, more frequent reviews and additional information will be requested of the project director or others at the discretion of the Committee. The frequency of review (either annual or more frequently) will be decided by the committee during its review meeting. Likewise the committee shall determine whether a given project requires additional information from sources other than the project director in order to determine that no material changes have occurred, by considering the level of risk exposure to subjects. The IRB shall report its findings and actions through written notification sent to project directors, its members and, when appropriate, university officials. The IRB notification of findings and actions sent to project directors requires the project directors to report and request action on any proposed changes in research activity. Through distribution of information concerning the review, Loyola University New Orleans encourages a continuing constructive communication between the IRB and project directors.

The Chair of the IRB, or an IRB member designated by the Chair, may conduct an expedited review of projects which present no more than minimal risk to human subjects in accordance with federal government regulations. Normally, an expedited review will consist of the Chair, or another member, making a determination that the project is exempt from full committee review and advising members of the project approved under this procedure.

For cooperative projects involving the use of human subjects, the Loyola University IRB may accept the decision and procedural requirements of another duly constituted IRB, provided that the project director provides the Loyola University IRB with satisfactory documentation. A "cooperative project" is one in which (1) at least one project director is not a Loyola University employee and other researchers or human subjects are Loyola University employees or students, (2) a Loyola University employee or student proposes to conduct research using human subjects who are employees, students, patients, or clients at another institution, or (3) Loyola University is identified in any way as being a sponsor of, a participant in, or a site of a proposed project.

Records of all meetings and notifications shall be kept in the office of the Chair of the IRB. The records of each Committee meeting shall be available for audit at any time by federal government officials. All records, directives and recommendations shall also be made available to federal government officials and the Provost and President of Loyola University or a designate.

V. APPLICANT'S PROCEDURES
Principal Investigators (including Project Directors and faculty supervising research projects of students) who use human subjects must submit their research protocols to the Human Subjects IRB, using "Instructions to Principal Investigators/Project Directors", Appendix A, as a guide in preparation of protocols submitted for review. An activity is required to be reviewed by the IRB if it meets the test of “Research” and “Human Subject”, as defined above (see Section II) and below (see Appendix A). However, the IRB makes the final determination of whether an activity must be subjected to IRB review, not the Principal Investigator.

The applicant is to submit materials to the IRB well in advance of the deadline for submission of a grant proposal. By so doing, the applicant will have the benefit of the review prior to the final preparation of the proposal, thus insuring that procedural revisions which might be indicated by the IRB can be incorporated in the proposal.

The Project Director (Principal Investigator) must report to the IRB any problems or proposed procedural changes not included in the original submission. No changes, except those necessary to eliminate apparent immediate hazards, shall be made without prior approval by the IRB.

In those instances when an applicant is not satisfied with the IRB's decisions, the applicant may again appeal to the Human Subjects IRB or to the President who may, if he wishes, request a special hearing for reconsideration by the full IRB membership. As specified in federal government regulations, the President may not override the IRB's decision, except for adding restrictions to an approved project.

Project Directors (Principal Investigators) and "Key Personnel", or "all individuals responsible for the design and conduct of the study," are required to have completed education on the protection of human research participants as specified in federal government regulation. Additional requirements may be added in accordance with federal regulation. As the educational program for various categories of Project Directors may differ, each Project Director wishing to submit a protocol to the IRB must contact the Chair of the IRB for instructions on an educational program and any proof of satisfactory completion to be submitted to the IRB.

The Project Director shall be responsible for promptly reporting to the IRB any incidence of an adverse event, unanticipated problems involving risks to subjects or others, or deviation from an approved research protocol. The IRB shall, at its discretion and in accordance with human subject regulations, report any of the above, or any instances of continuing noncompliance with human subjects requirements or IRB determinations, or a suspension or termination of IRB approval to university officials, a sponsoring department or government agency.

VI. SUBJECT'S PROCEDURES
If a study subject wishes to voice complaints or concerns, the subject should first contact the Principal Investigator, followed by the Chair of the Human Subjects Institutional Review Board. If not satisfied with the IRB's opinion, the subject may refer concerns to the Provost or President.
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APPENDIX A

INSTRUCTIONS TO PRINCIPAL INVESTIGATORS/PROJECT DIRECTORS
You are required to submit your research protocol to the Loyola University Human Subjects IRB if you may expose any human subject to risk. The definition of "risk" follows, along with a format for your submission to the committee.

I. SUBJECTS AT RISK:
Any individual who may be exposed to the possibility of injury, including physical, psychological or social injury, as a consequence of participation as a subject in any research, development, or related activity which departs from the application of those established and accepted methods necessary to meet his/her needs, or which increases the ordinary risks of daily life, including the recognized risks inherent in a chosen occupation or field of service.

II. RESEARCH:
Research that is undertaken by faculty solely as a classroom exercise to serve only pedagogical ends does not require submission to the IRB for approval, unless the activity involves minors or poses greater than minimal risks to participants (human subjects).

Research that is undertaken by faculty, students, staff or others that meets any of the following conditions requires IRB approval,

  • The research seeks to develop or contribute to generalizable/theoretical knowledge in the researcher’s field,
  • The research results will be published or submitted for publication,
  • The research results will be presented in a public forum (e.g. conference, competition), and
  • The research results will be used by a third party.

III. PROTOCOL:

When applying to the Human Subjects IRB for approval of a project involving human subjects send one copy of a research protocol to the Chairman of the IRB. (A grant proposal may be included as additional information, but is not a substitute.) The protocol must include all information on how you will use human subjects in your project. Please use the outline below. If any item below does not apply to your project, please indicate with "DNA" or "NA".

Page 1

RESEARCH PROTOCOL

Title of Research Project_________________________________________________________
Principal Investigator _________________________________ (signature)_________________

_________________________________(signature)________________

_________________________________(signature)________________

Faculty Supervisor (if student PI) ________________________ (signature)________________

Granting Organization funding the project________________________________________
Grant proposal deadline____________________
Project start date _______________________
Project end date ________________________

Abstract: In 2 to 4 sentences describe the research topic, subjects, methods and data (questionnaires, inventories). Example Abstract: Fifty college students (eighteen years of age or older) will be recruited in psychology classes and will be asked to participate in a study on memory. It is hypothesized that students with a more positive emotional state will be able to remember more information. Subjects will be asked to recall information connected with the following activities: puzzle solving, reading, watching television, responding to questions, describing thought processes, and describing emotional states. The “Beck Depression Inventory” will be administered.

Page 2 through Page n

  1. Study Objectives and Hypotheses
  2. Subject Selection: Population (students, prisoners, children, mentally ill, medical students, disease group, etc).
  3. Describe sampling strategy. Subjects selected shall contain, to the best of the investigator's knowledge, representation from all racial/ethnic/gender groups.
  4. Subject Exclusions: age, sex, childbearing potential, and other
  5. Number of Subjects
  6. Method of Study
    a.) Where (If the project will use Human Subjects at another institution, the principal investigator must provide a letter from a responsible official at that institution giving permission. Such evidence must be attached to the protocol. b.) When (Proposed start and end dates of data collection from or on human subjects.)
  7. Drugs and Dosages
  8. Animal safety data
  9. Human safety data
  10. Phase of investigation
  11. Measurements or measurement techniques
    a) Risks of measurement techniques
    b) Biochemical, hematological, and physiological safety data
    c) If survey instrument or instruments, please attach copies. It is the responsibility of the researcher to make sure that the use of any instruments, images, or other documents is legally obtained. By attaching copies of these documents to your research protocol, you are giving the IRB an assurance that you have obtained permission or will have obtained permission to use the documents before commencing your research.
    d) If public use data or data collected for another study will be used, provide complete information and documentation.
  12. Procedures described in detail
  13. Risk-gain balance. (Compare the risks to the benefits to society and/or individual subjects.)
  14. Describe how you have satisfied the education requirement on the protection of human subjects.
    a.If you are a student and the Chair of the IRB or your Professor has conducted training in your course (and you were present) give the course name and date of the presentation. Otherwise, you must complete the National Cancer Institute on-line training course entitled, “Human Participant Protections Education for Research Teams” located on the web at (http://cme.nci.nih.gov/). Please attach a copy of the on-line certificate provided at the conclusion of the course. If access to the on-line training course is a problem, a third, but less preferred option is to view the “Protecting Human Subjects” video on reserve in the Monroe Library. If you choose this option, you must provide your professor with a synopsis of the video to verify your completion of viewing the video.
    b.If you are a faculty member or Project Director you must provide documentation of having completed one of the following training options: 1) A training course offered by a professional organization. List the name of the organization, title and dates of the course, and attach a certificate or other documentation, if available.
    2) The National Cancer Institute on-line training course entitled, “Human Participant Protections Education for Research Teams” located on the web at (http://cme.nci.nih.gov/). Please attach a copy of the on-line certificate provided at the conclusion of the course. 3) View the “Protecting Human Subjects” video on reserve in the Monroe Library. 4) If you are neither a Loyola student nor faculty member, please provide documentation of having completed The National Cancer Institute on-line training course entitled, “Human Participant Protections Education for Research Teams” located on the web at (http://cme.nci.nih.gov/). Please attach a copy of the on-line certificate provided at the conclusion of the course.

IV. INFORMED CONSENT
Any investigator proposing to place any subject at risk is obligated to obtain and document legally effective informed consent. No such informed consent, oral or written, shall include any exculpatory language through which the subject is made to waive, or to appear to waive, any legal rights, including any release of the institution or its agents from liability for negligence.

For a sample Informed Consent Form, click here.  The sample cannot be considered an appropriate template for all research projects. Please contact the IRB Chair, if you wish to consult other sample consent forms.