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

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

Beginning January 2019 all institutional review boards must comply with the new common rule. See this link for more information.

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INTRODUCTION

COMMITTEE STRUCTURE AND MEMBERS

COMMITTEE PROCEDURE

APPLICANT PROCEDURES AND EXCLUSION DOCUMENTS

COOPERATIVE PROJECTS

PARTICIPANT CONCERNS

PROTOCOL PROCEDURES/FORMS AND CONSENT PROCEDURES/ FORMS

CITI TRAINING

 

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 consists of at least seven members from Loyola University, two of which are co-chairs, and one member from Tulane University. Committee membership is consistent with 45 CFR 46 and broadly represents academic disciplines of the university that uses human subjects in research or teaching, or disciplines with ethical insights into issues involving the use of human subjects.

IRB members possess a sufficient and diverse experience and expertise that will help to safeguard the rights and welfare of human subjects. IRB members must also 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. The provost appoints all IRB members, and currently co-chairs share the responsibility of initial protocol review. 

Human Subjects Institutional Review Board Committee Members:

Dr. Erin Dupuis (Primary Co-Chair): Psychological Sciences, Loyola University

Dr. Michele Ellis (Secondary Co-Chair): Nursing, Loyola University

Dr. Kelly Frailing: Criminology & Justice, Loyola University

Dr. Kathleen Murphy: Music Therapy, Loyola University

Dr. Jonathan Peterson (Ethics): Philosophy, Loyola University

Dr. Frankie Weinberg: Business Management, Loyola University

Dr. Kim Mix: Biological Sciences, Loyola University

Dr. Michele Adams: Sociology, Tulane University

IV. COMMITTEE PROCEDURES
The Loyola University Human Subjects IRB will meet as needed to review applications involving human participation. A quorum of the IRB is needed for officially reviewing applications, including at least one member principally concerned with non-scientific and ethical issues. 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 or she has a conflicting interest, except to provide information requested by the committee. When a grant, contract, or study involves the use of drugs or the administration of medical treatment, at least one physician will be used as an expert consultant or as a voting member. Every effort shall be made to ensure 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. See “IRB Applications” for what elements should be included in an informed consent.

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 will be decided by the committee during its review meeting. In addition, the committee shall determine whether a given project requires further information from sources other than the principle investigator 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 the principle investigator, its members, and university officials when appropriate. The IRB notification of findings and actions sent to principle investigators requires them to report and request action on any proposed changes in research activity. Through distribution of information concerning the review, Loyola University New Orleans encourages continuous communication between the IRB and the principle investigators.

The co-chairs of the IRB, or an IRB member designated by the co-chairs, 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 a co-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. All studies involving vulnerable or protected populations (e.g., minors, prisoners, pregnant women) will undergo full committee review.

Records of all meetings and notifications shall be kept in the office of the co-chairs 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).

Before submitting an application to the IRB, we encourage the principle investigator to consider if their project meets the definition of research, if they are in fact using human subjects in a way that requires review, and if they might qualify for exempt status. A designated member of the IRB makes the final determination of whether an activity must be subjected to IRB review, not the Principal Investigator; however, if the principle investigator suspects his or her study qualifies for any of the above they should first submit one of the following:

 

·      Non-Research Application

 

·      Human Subjects Exclusion Application

 

·      Exemption Application

 

 

If your study meets the definition of research, you are using human subjects, and you do not qualify for exempt status, you must submit an IRB application (see protocol template below). Dr. Erin Dupuis handles all applications that come from the College of Arts and Sciences, the College of Business, and the University as a whole and Dr. Michele Ellis handles all applications that come from the College of Nursing and Health and the College of Music and Fine Arts.

 

Please allow for at least a two-week turnaround time for your application to be reviewed. Depending on the nature of your study, the IRB co-chair might decide to expedite the review process or decide to bring it to a full IRB review. If you suspect your study will require a full review, please allow for at least a six-week turnaround time.

 

If you are submitting for a grant proposal, please submit your IRB application well in advance of the deadline for submission of a grant proposal. Then you 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 Principal Investigator must report to their IRB co-chair 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.

If you are not satisfied with the IRB's decisions, you 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.

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 Principal Investigators may differ, each Principal Investigator wishing to submit a protocol to the IRB must contact their IRB co-chair for instructions on an educational program and any proof of satisfactory completion to be submitted to the IRB.

The Principle Investigator must report to their IRB co-chair 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.

Cooperative Projects Between Loyola and Other Institutions: 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 principle investigator provides the Loyola University IRB with satisfactory documentation. A "cooperative project" is one in which (a) at least one principle investigator is not a Loyola University employee and other researchers or human subjects are Loyola University employees or students, (b) a Loyola University employee or student proposes to conduct research using human subjects who are employees, students, patients, or clients at another institution, or (c) Loyola University is identified in any way as being a sponsor of, a participant in, or a site of a proposed project. If the non-Loyola researcher wishes to utilize Loyola faculty, staff, or students as participants on a larger scale, they should first gain the permission of the Office of Institutional Research and Effectiveness. Permission of the OIRE must be supplied to the Loyola IRB.

VI. PARTICIPANT PROCEDURES
If a study participant wishes to voice complaints or concerns, the participant should first contact the Principal Investigator, followed by the Primary Chair of the Human Subjects Institutional Review Board. If not satisfied with the IRB's opinion, the participants may refer concerns to the Provost or President.
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PROTOCOL INSTRUCTIONS AND CONSENT FORMS

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 appropriate Co-Chair 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".

USE THIS PROTOCOL DOCUMENT. ALL SECTIONS MUST BE COMPLETED.

 

IV. INFORMED CONSENT

All research studies that use human subjects require a legally effective informed consent to give to their subjects. 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.

Informed consent letters require a number of statements to be included. Please see the template to learn more about what to include in your informed consent letter. Submit a copy of your informed consent letter along with your IRB protocol.

USE THIS INFORMED CONSENT TEMPLATE

 

IRB Co-Chairs:

Erin Dupuis: Colleges of Arts & Sciences, the College of Business, University as whole, and general questions
Michele Ellis: College of Graduate & Professional Studies and the College of Music and Fine Arts 

If you are submitting a proposal for review, please direct your proposal to the relevant co-chair. 

 
Per federal guidelines, any individual conducting human subjects research must obtain approval from the Institutional Review Board. Part of this approval requires that all individuals involved in data collection participate in human subjects training. This training used to be available through the National Institutes of Health; however, NIH closed its free training program and previous certificates are no longer available. As such, the University has purchased a CITI program institutional training license. If you have a certification from NIH, you may still use this certificate. All certifications must be renewed within three years from the date they were issued. CITI program training has been updated to reflect New Common Rule regulations with a compliance date of January, 2019 and includes shorter three year refresher courses.

To receive HSR training access CITI and click on “register”. From there, you will choose Loyola University New Orleans from the institutional selections and create an account using your Loyola credentials. Most individuals will choose the Behavioral-Social-Educational course; however, individuals in the sciences may choose the Biomedical course. CITI also gives nurses, psychologists, and other relevant individuals the option to purchase additional CEUs.