Institutional Review Board

Institutional Assurances of Compliance

Institutional Assurance of Compliance is documentation of an institutional commitment to comply with DHHS regulations for the protection of human subjects.

The Institution bears full responsibility for all research involving human subjects covered under its Assurance.

For all DHHS-conducted or supported research, all of the requirements of the DHHS Regulations at 45 CFR Part 46, Subpart A, as well as Subparts B through D, must be met.

• Developing policies and procedures for effective and efficient administration of the Human Research Protections Program (HRPP).
• Ensuring that Assurances are in place and certifications of IRB review are submitted to the appropriate authorities for all DHHS-sponsored research, not only for themselves, but also for collaborating performance sites for which the institution has agreed to accept oversight responsibility.
• Implementing appropriate oversight mechanisms to ensure compliance with DHHS regulations and effective administration of the HRPP.

Institutions are responsible for ensuring that all institutions and investigators engaged in its DHHS supported human subject research operate under an appropriate OHRP-approved Assurance for the protection of human subjects. In some cases, one institution may operate under an Assurance issued to another institution with the approval of DHHS and the institution holding the Assurance. Union University's Institutional Review Board operates as an OHRP-approved entity.

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Institutional Review Board (IRB)

The primary role of the IRB is to safeguard the rights and welfare of all persons who volunteer as participants in research studies proposed by faculty, staff, or students at Union University. The IRB Committee has the authority to approve, require modification to, or disapprove all research activities covered by the DHHS and FDA Protection of Human Subjects Regulations. Following initial approval, the IRB must conduct periodic reviews of such research. In addition, it is responsible for ensuring that research with human subjects is consistent with the principles set forth in the Belmont Report (1979) which specifies respect for persons, beneficence, and justice. IRB review and approval is required for any research involving human subjects that is (a) conducted by Union University faculty, staff or students; and (b) performed with or involves the use of facilities or equipment belonging to the University. If human subject data is collected, aggregated, analyzed, or summarized, whether inside or outside the University and regardless of funding or publication, it requires IRB review and approval.

IRB committee membership is composed of at least 12 Union University faculty members from diverse academic backgrounds, and at least one representative from the community having no affiliation with the institution.

The committee is convened by a committee chair who is appointed, along with committee members, by the Provost of the University. The Provost is the academic officer of record, maintaining oversight and ultimate responsibility for the IRB Committee.

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Importance of Our IRB Members

IRB members strive to work interactively with research investigators to assure that research design is appropriate, that risks are minimized and expected benefits are maximized, and that consent procedures are adequate.

IRB members bring diverse skills, insights, and perspectives to the responsibility of reviewing research activities involving humans.

Although the IRB system is not perfect, conscientious IRBs reassure the public that the rights and welfare of human subjects are seriously considered by people who do not have a vested interest in the outcome of the research.

By exercising their responsibilities, IRBs promote the protection of human subjects. IRB approval provides an affirmation of the scientific and ethical soundness of the research, and therefore offers important validation to the research investigator and the research institution.

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IRB Review

Does the Activity Need IRB Review?

You need to answer the following two critical questions.

1. Is the activity in which you will be engaged RESEARCH?
2. Will the activity involve HUMAN SUBJECTS?

Answering these questions will help you determine if IRB review of the research is required.

Is the activity RESEARCH?

Research is a systematic investigation, including protocol development, testing, and evaluation, designed to develop or contribute to generalized knowledge. An intent to publish the results of the study nearly always means that the activity is research.

When might the activity not be considered research?

1. Quality Assurance
   • All actions taken solely to ensure that standards and procedures are adhered to and that delivered products or services meet performance requirements.
   • Activities conducted solely for the intent of maintaining or improving quality of services provided by an institution are not considered research activities. However, if the data collected are generalizable and are to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research.
2. Journalism - the periodical collection and publication of current news
3. Oral History
4. Exercises Performed Solely Within a Classroom without intent to publish*
5. Marketing and Assessment Surveys without intent to publish*
6. Educational Assessments without intent to publish*

* If you intend to publish, the results will be 'generalized knowledge' and the exercise is RESEARCH.

HUMAN SUBJECTS are defined as living individuals about whom the investigator obtains (1) data through intervention or interaction with the individual; or, (2) indentifiable private information.

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Standards for IRB Review

IRBs review research from the vantage point of protecting the rights and welfare of human research subjects and are required to evaluate proposed research activities using the following criteria:

• The design of the study is consistent with sound scientific principles, ethical guidelines, and legal requirements.
• Risks to subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk.
• The necessary elements of informed consent and HIPAA authorization, when applicable, have been met and documented.
• Additional appropriate safeguards have been provided if potentially vulnerable subjects are to be studied (e.g., children, prisoners).
• Subject selection is equitable with attention to the inclusion of minorities and both genders in study populations so that research findings can be applied to all persons at risk for the disease, disorder or condition under study.

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Types of Committee Reviews

All research projects are categorized into one of four categories for the IRB review process. Each category is different in the level of scrutiny and submission procedures. It is important to understand the differences, However the IRB will be responsible for making the final decision of which category a research project falls under.

• Full
• Expedited
• Exempt
• Class Project

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Full Review

The full board reviews the complete protocol. A primary and secondary reviewer will be assigned to a protocol and will summarize the study for the Committee at a convened meeting and answer questions during the discussion. All committee members are provided the opportunity to review any or all documentation related to the study.

Any research that involves more than minimal risk requires review by the full board.

Further, research involving the following requires full board review:

• Research that involves vulnerable populations (i.e. children, prisoners, pregnant women, mentally disabled person, or economically or educationally disadvantaged persons)
• Research that involves experimental drugs or devices
• Research that involves invasive procedures
• Research that involves deception

For protocols that are complicated or pose a high degree of risk to the subject or others, the principal investigator is encouraged to attend the convened meeting to address questions or concerns.

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Expedited Review

Expedited review consists of review by the IRB chairperson or by one or more experienced reviewers designated by the chairperson. Protocols which meet specific criteria, may qualify for an expedited review.

Generally, expedited review may be used for research activities that achieve ALL items below:

• Present no more than "minimal risk" to human subjects. The definition of minimal risk is 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.
• Involve only those research procedures outlined in the federal regulations:
  • Clinical studies of drugs and medical devices that do not require investigational new drug or investigational exemption application.
  • Collection of blood samples by finger stick, heel stick, or venipuncture.
  • Prospective collection of biological specimens for research purposes by noninvasive means (e.g., hair and nail clippings, sputum specimen collected after saline mist nebulization, to name a few).
  • Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving X-rays or microwaves (e.g., body weight, electrocardiograph, ultrasound, moderate exercise when appropriate).
  • Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as for medical treatment or diagnosis). Note: some research in this category may be exempt from DHHS regulations for the protection of human subjects. This listing refers only to research that is not exempt.
  • Collection of data from voice, video, digital, or image recordings made for research.
  • Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior), research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Note some research in this category may be exempt from the DHHS regulations for the protection of human subjects. This listing refers only to research that is not exempt.

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Exempt Review

Exempt status is determined by the IRB chairperson or by one or more experienced reviewers designated by the chairperson. If the project is declared exempt by the IRB, a letter approving the basis for the exemption will be sent to the investigator. If the project is declared non-exempt, the protocol will be sent for expedited or full board review. An IRB approval document must be obtained prior to initiating the research. Any changes to the protocol must be submitted and approved by the IRB.

Research using existing or archived data, documents, records, or specimens only may be exempt from Federal regulations. The data, documents, records, or specimens must be recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Research using educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, observational procedures and questionnaires may be exempt from Federal regulations. (Note: exemption is not allowed in surveys or interviews with children.) Information obtained must be recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects; and any disclosure of the human subject's response outside the research must not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.

Other examples of research that may be exempt from Federal regulations are:

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
   1. research on regular and special education instructional strategies, or
   2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
   1. Public benefit or service programs;
   2. procedures for obtaining benefits or services under those programs;
   3. possible changes in or alternatives to those programs or procedures; or
   4. possible changes in methods or levels of payment for benefits or services under those programs.
3. Taste and food quality evaluation and consumer acceptance studies,
   1. if wholesome foods without additives are consumed or
   2. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

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Class Project Review

This type of review is to be used for class projects that are conducted for educational purposes only and not as research. By identifying the work as a class project, the following must apply:

• The results and data will not be made available to the public beyond those involved in the class.
• The results and data will not be disseminated without further IRB approval.
• The results and data will not be presented at any conference, poster session, or public presentation without further IRB approval.
• Vulnerable populations (prisoners, pregnant women, persons lacking capacity to give consent) or minors are not used.
• Risk is no more than "minimal risk." Minimal risk is when the probability and magnitude of harm or discomfort 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.
• Deception will not be used.
• No use of videotaping.

(If the instructor decides at a later date that the data collected for the project could be used for research/dissemination purposes, the IRB must be notified and the appropriate forms completed to permit this change in purpose to take place.)

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IRB Review Outcomes

In exercising its authority, the IRB may approve, withhold approval pending clarification, table or disapprove research protocols. IRBs are not obligated to approve any protocol that does not meet the ethical standards previously presented.

Most often, the IRB approves a research protocol pending required changes. Research may not begin until the changes have been reviewed and approved in writing by the IRB.