The IRB has adopted the definitions used by the U.S. Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP), and the 45 CFR 46:

45 CFR 46: Code of Federal Regulations: Title 45 Public Welfare, Part 46 Protection of Human Subjects is a federal policy that guides the conduct of research involving human subjects.

Federal-wide Assurance (FWA): The FWA is documentation of an institutional commitment to comply with federal regulations and maintain adequate programs and procedures for the protection of human subjects. It is the principal mechanism for compliance oversight by OHRP.

Human subject: A human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains:

• Data through intervention or interaction with the individual, or
• Identifiable private information

Institutional Review Board (IRB): The IRB is a specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.

Minimal risk: 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.

Research: Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Federal-wide Assurance (FWA)

The FWA is required for all Department of Health and Human Services (DHHS) funded research involving the use of human subjects. It is a formal commitment made by an institution to provide for the protection of human subjects. Any institution with an FWA agrees to and is responsible for protecting human subjects. The FWA is not required for research that has not received federal funding, but an institution may make the decision to hold all research involving human subjects to the standards listed in the FWA. Saint Augustine’s University has agreed to hold all research to these federal standards.

The FWA includes the following important components:

1. Saint Augustine’s University assures that all research involving human subjects, regardless of funding source, will be guided by the ethical principles in The Belmont Report, published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report lays out the basic ethical principles and guidelines to consider when conducting research involving human subjects.

The three ethical principles, as defined in the Belmont Report, include:

Respect for Persons – Individuals should be treated as autonomous agents and human beings. Persons with diminished autonomy are entitled to additional protections.

Beneficence – Persons are treated ethically not only by respecting their decisions and protecting them from harm but also by making efforts to secure their well-being.

Two key features of this include:

• • Do not harm
  • Maximize possible benefits and minimize possible harms

Justice – The burden and benefits of research shall be distributed equitably.

The University will be guided by these ethical principles and use them as a foundation for all research conducted with human subjects.

2. Saint Augustine’s University assures that it will apply Title 45 Code of Federal Regulations Part 46 and all of its subparts (A, B – additional protections for pregnant women, human fetuses, and neonates, C – additional protections for prisoners, and D – additional protections for children) to all human subject research. Whereas the Belmont Report discusses ethical principles, 45 CFR 46 discusses the federal rules for conducting research involving human subjects.

Two additional sections of the FWA describe institutional oversight of the human protections program at Saint Augustine’s University and list the individuals responsible for such oversight.

• The Signatory Official, according to the Office of Institutional Research and Planning (OIRP), is responsible for “setting the tone for an institutional culture of respect for human subjects”. The designated Signatory Official is Dr. Linda Gunn-Jones, Director of Title III Funding/Office of Sponsored Programs.
• The Human Protections Administrator is the primary contact for DHHS OHRP and has administrative responsibility for SAU Human Protections Administration which includes ensuring that human subjects involved in research are adequately protected and that SAU remains in compliance with regulations. The Human Protections Administrator shall be the Director of the Office of Research and Sponsored Programs, Dr. Linda Gunn-Jones, or their designee. The human protections program is guided through the SAU Office of Research and Sponsored Programs, also directed by Dr. Linda Gunn-Jones.

All research involving human subjects must be submitted to the IRB for review prior to initiation. To determine if your proposed work must be submitted for review, please consider the following:

1. Are you conducting research?
   The federal definition of research is “a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” If you are not conducting research, your work does not have to be reviewed by the IRB; however, if you have any doubt about your study, please contact the Office of Research and Sponsored Programs.
2. What is a systematic investigation?
   A systematic investigation usually attempts to answer a question or attempts to support or disprove a proposed hypothesis.
3. What is “contributing to generalizable knowledge”?
   This statement applies to sharing the information/data/results that you obtain in your investigation with others in the classroom setting, at a poster presentation, in a publication, or at a conference. If you are unsure about your plans to share your results at a time in the future, you should submit an IRB application for review.
4. What is a human subject?
   A human subject is a living individual 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.

All personnel who will work on research projects are required to complete training in the Responsible Conduct of Research (RCR) involving human subjects. Personnel must be retrained every two years.

The Office of Research and Sponsored Programs requires all research personnel to successfully complete one of the following before submitting a new IRB application for review:

• S. National Institutes of Health, National Cancer Institute, Human Participant Protections Education for Research Teams online training module.
• Collaborative IRB Training Initiative (CITI). SAU, currently, does not have a license for this course, but some researchers have completed the course through their collaborations with other institutions. This is the gold standard.
• Attendance at a seminar where the main purpose is to discuss the responsible conduct of research involving human subjects.

A CERTIFICATE OF COMPLETION FOR ANY OF THE ABOVE SHOULD BE SUBMITTED WITH YOUR IRB APPLICATION.

All research investigators and their key personnel must comply with the following guidelines:

1. Responsibilities Before IRB Approval

• All investigators must obtain IRB approval for each research protocol involving human subjects prior to initiating the study.
• The principal investigator is required to prepare the “New Protocol Application Form” and provide to the IRB:
  • the research proposal
  • the informed consent form(s)
  • study instruments
  • recruitment materials
  • focus group questions (if applicable)
  • any other relevant documentation

The principal investigator and/or faculty advisor may request or may be asked to attend a full board meeting when his or her protocol is under review.

Please note:

• The principal investigator and all key personnel working on the research project must complete the required human subjects’ protections educational training prior to beginning the research. Proof of training in the form of a certificate must be supplied to the IRB with the application. IRB applications from investigators who have not completed the required education will be returned without review. Faculty advisors of student investigators must also complete the training.
• Research activities involving institutions and agencies outside of Saint Augustine’s University must receive written approval from the appropriate official within the agency. The written approval must be submitted with the IRB application.

2. Responsibilities After IRB Approval

• Investigators must provide a copy of the IRB-approved and stamped informed consent form to each participant at the time of consent. All documentation must be stored as outlined in the IRB application in a secure location for a minimum of three years after the completion of the study.
• Principal investigators must promptly report proposed modifications to approved studies to the IRB using the “Modification to a Previously Approved Protocol Form”. No changes to the study should be initiated without prior IRB review and approval. Some modifications may require full IRB review.
• Principal investigators must inform their co-investigators from cooperating institutions that any change in a previously approved protocol must be submitted to the appropriate IRB and approved before implementing the change.
• If findings are developed during the course of the research that may have an effect on participant’s willingness to continue in the study, principal investigators must report the findings to both the IRB and study participants.
• Principal investigators must report all adverse events and unanticipated problems that involve risks to study participants immediately to the IRB using the “Adverse Event Reporting Form”.

The IRB will send a letter to the principal investigator two months before the expiration of a study as a reminder that the study will expire soon. Principal investigators are required to submit the “Continuation or Termination of an Approved Protocol Form” indicating if they will continue the study or terminate the study. In general, the IRB grants approvals for no more than one year. Some studies may be approved for a shorter time depending on the nature of the research. If an IRB approval has expired, research activities must cease.

(45 CFR 46.111)

In order to approve research covered by this policy, the IRB shall determine that all of the following requirements are satisfied:

Risks to subjects are minimized:
(i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
(ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

Selection of subjects is equitable. In making this assessment, the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.

Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116.

Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.

When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.