Introduction
Loyola University follows federal 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.
- The conduct of the activity will be reviewed at timely intervals.
Watch this video: What does the IRB do?
Please note, IRB submissions over the winter and summer breaks may only processed if they are exempt status. Expedited and Full-Committee IRBs should be submitted at least two weeks prior to end of the semester so that the entire IRB committee is available.
- Step 1: Complete required Citi Training (see section below for login information)
- Step 2: Have your documentation ready before you start (CITI certificates for all researchers involved in study, copies of measures, consent form, assent form if using minor participants, etc...)
- Step 3: Find the appropriate protocol template. We have templates for traditional review, exempt review, and non-research review. See "Investigator Instructions" section to determine which template you need.
- Step 4: Use the consent form template which includes all of the information you need in order to meet federal guidelines. See the "Consent" section.
- Step 5: Aggregate all materials into one document - such as, protocol, consent, measures, CITI certificates.
- Step 6: Determine your contact person - see "Contact Information" section.
- Step 7: Submit and wait. It may take up to two weeks for expedited review and longer for full review. You may also need to make edits. Unless your study is exempt, there is also a one-week waiting period between when you receive your approval and when you can start. Give yourself plenty of time before your anticipated study start date.
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.
Dr. Michele Ellis handles all applications that come from the College of Nursing and Health, College of Law, and the College of Music and Media.
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’.”
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 (Co-Chair and Research Integrity Officer): Psychological Sciences, Loyola University
Dr. Michele Ellis (Co-Chair): Nursing, Loyola University
Dr. Edward McClellan: Music Education, Loyola University
Dr. Jonathan Peterson (Ethics): Philosophy, Loyola University
Dr. Frankie Weinberg: Business Management, Loyola University
Dr. Kim Mix, Biological Sciences, Loyola University
Dr. Elizabeth Rainey: Assistant Provost, Loyola University
Dr. Michele Adams: Sociology, Tulane University
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 a secured drive, available only to IRB members. 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.
INSTRUCTIONS TO PRINCIPAL INVESTIGATORS/PROJECT DIRECTORS
You are required to submit your research protocol to the Loyola University Human Subjects IRB if you are engaging in any regulated human subjects research. The IRB then determines the level of risk involved. The definition of "risk" follows, along with a format for your submission to the committee.
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.
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.
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 protocol template 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. Please note, this link will take you to the document on Google drive. Do NOT request access to edit the document. You must save a copy to your own computer or drive.
All studies that seek to recruit participants via social media must have a script included with their protocol. See the FAQs section for an example script.
All research team members must complete CITI training. Please see that information link on this page to get started.
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 the appropriate template, provided below. An activity is required to be reviewed by the IRB if it meets the test of “Research” and “Human Subject."
Before submitting an application to the IRB, we encourage the principle investigator to consider if their project meets the definition of research, and if they are in fact using human subjects in a way that requires review.
Research
Research is now defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (46.102[1]). So, your research study has to be both systematic (quantitative and qualitative methods are systematic) and your results have to generalize to a larger population.
Human Subjects
The definition of a human subject is “a living individual about whom an investigator 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.” (46.102(e)(1))
Using human subjects does not automatically require IRB approval. A designated member of the IRB makes the final determination of whether an activity must be subjected to IRB review, not the Principal Investigator.
If your study meets the definition of research, and you are using human subjects, you must submit an IRB application (see protocol templates above). All protocols (even if expedited or exempt) will use the full-application template listed above.
Non-Research Activities
Quality improvement projects generally seek to improve processes and reduce waste to impact outcomes. QI projects may use established methods, or new methods may be developed that are individualized to the organization, but projects are not designed for the results to generalize to other populations or organizations. The methods used may be systematic, but they are not designed to test hypotheses or interventions.
Evidence-based practice (EBP) projects seek the best current evidence to solve or manage a clinical problem. EBP also integrates clinical knowledge/experience and patient preferences into the project. Project evaluation for both QI and EBP projects is site-specific: did it work for this organization/population?
In addition, four other types of activities do not meet the definition of research.
1. Scholarly and journalistic activities that focus directly on the specific individuals
about whom the information is collected,
2. Public health surveillance activities limited to those necessary to identify, monitor,
assess, or investigate conditions of public health importance.
3. Collection and analysis of materials for criminal justice purposes,
4. Authorized operational activities for national security purposes. (46.102[1])
If your project meets the definition of a Non-Research Activity, submit the Non-Research Application for IRB review.
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. The IRB follows the University procedures on "Misconduct in Sponsored Research" (regardless of whether the research is supported by federal funds).
Consent Forms
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.
Citi Training
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. 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.
Recruitment of Loyola Community Members
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. Generally these projects require a reliance agreement between all involved institutions.
If a 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.
If a study participant wishes to voice complaints or concerns, the participant should first contact the Principal Investigator, followed by the associated Co-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.
*Misconduct in Sponsored Research will follow that University protocol.
When a protocol deviation or incident of noncompliance becomes known to a researcher, they must immediately report this deviation/incident to the Chair of the Institutional Review Board. It is expected that researchers and research staff promptly self-report protocol deviations or incidents of noncompliance regardless of whether the incident is minor, sporadic, serious, or continuing.
Allegations or reports of protocol deviations and incidents of noncompliance may be identified via monitoring visits or via communication by someone other than the researcher through telephone calls, letters, e-mails, or any other method of communication and may be made to the IRB Chair or to the Research Integrity Officer (these may be the same person). The identity of individuals making a report will remain confidential unless the individual provides permission to disclose his/her identity.
The IRB Chair (or the co-chair of the IRB responsible for the particular researcher in question) reviews allegations of noncompliance. The IRB Chair makes a determination as to whether the alleged practices appear to (1) cause injury or any other unanticipated problems involving risks to participants or others, or (2) constitute serious or continuing noncompliance with IRB determinations or federal regulations. In such cases, the IRB Chair shall notify the Provost (or designated Institutional Official) and suspend the study procedures pending a timely investigation and review.
Investigations of allegations of noncompliance brought to the IRB focus on the protection of study participants and human subjects protocols. In cases that involve allegations of other research misconduct, the IRB Chair contacts the Provost (or designated Institutional Official) for further action. This does not preclude the IRB Chair or any member of the IRB from independently contacting the Research Integrity Office about any allegation of research misconduct. Inquiries or investigations into research misconduct do not preclude IRB review and actions. Depending on the nature of the incident, an investigation may be warranted and procedures will follow the Loyola policy on Misconduct in Sponsored Research.
Listed below are the procedures for resolving alleged noncompliance:
- When made aware of a potential problem, the Research Integrity Officer compiles information and presents concerns to the IRB Chair. Alternatively, information may be given directly to the IRB Chair.
- The IRB Chair determines whether to pursue the matter with the PI via telephone call, e-mail, memorandum, or in person.
- The purpose of such contact is fact-finding, i.e., to determine whether the problem is intentional, unintentional and/or the result of mistake or oversight.
- Care is taken to maintain confidentiality when leaving messages for the PI via voice mail or with secretarial and support staff.
- The IRB Chair documents the outcome of any and all communications and discussions in writing, by either e-mail or memorandum with a copy to the IRB files. Such documentation should be factual and objective, and include timelines for resolution (e.g., meeting dates, response deadlines).
- When the initial inquiry does not result in resolution of the matter, a meeting with the PI is scheduled as soon as possible
- Any discussions and effort to achieve resolution are documented in the IRB files, and presented to the IRB by the IRB Chair.
- When a review of relevant documents and meetings as described above do not lead to resolution, the IRB Chair schedules a review by the full IRB at the next available meeting.
- If a quorum of IRB members are present, and after discussion, the IRB shall determine appropriate actions.
- The IRB has the authority to suspend or terminate IRB approval of protocols that are found to be non-compliant with institutional policies and procedures, state laws, and/or federal laws or regulations.
- Other sanctions recommended to the Provost by the IRB may include, but are not limited to the recommendation of routine compliance audits, letters of reprimand, and restrictions on serving as an investigator on human participants protocols.
- The Provost sends written notification of actions taken to the PI with copies to the IRB and Dean of the College.
How Long Will Review Take?
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. Please note, IRB submissions over the winter and summer breaks may only processed if they are exempt status. Expedited and Full-Committee IRBs should be submitted at least two weeks prior to end of the semester so that the entire IRB committee is available.
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.
Social Media Recruitment
If you are using any type of social media to recruit participants, you must provide us with a script. We recommend the following:
I am conducting a study on (give brief study details). If you are interested in participating and you are a Loyola student (or change to your participant group) at least 18 years of age and... (add any other qualifiers) please click the link! Please do not comment on this post regarding your participation in the study or lack thereof. Sharing of this study link is voluntary and any risks associated with sharing of this link are assumed by any individuals who choose to do so.
Gifts Card & Compensation
Participant compensation may be taxable. Students should never be responsible for the collection of W-9s! This responsibility, when needed, would be the responsibility of the PI. Do not collect W-9s without first checking with the IRB and/or finance regarding whether this is a necessary step. For compensation below $20 a W-9 is generally not required. When a W-9 is required all necessary steps should be taken to ensure sensitive information is protected, thus email is not usually a reliable method for the collection of W-9s.
For either a small cash disbursement or a gift card, the following must be obtained. The compensation should be kept to a $20 maximum.
1) The Loyola faculty or staff member initiating the study may need to request a cash advance.
2) If distributing cash or gift cards, a sign-in sheet must be kept that each participant who receives compensation must sign or initial. If compensation is electronic, an e-acknowledgment of receipt of gift card is allowed instead of a sign-in sheet. Detailed procedures for ensuring participant anonymity will be needed.
3) To close out the advance, the following must be submitted to Financial Affairs within 10 days of disbursement of the compensation:
a) If gift cards are disbursed, a receipt for the gift cards purchased and the sign-in sheet.
b) If cash disbursed, the sign-in sheet.
4) If tangibles are purchased through the usual university purchasing process, no sign-in sheet is required for items under $75/ea. There is a different process if the tangible item costs above $75.
Under revision...check back soon.