Institutional Review Board

The three major concerns of the IRB are:

• whether legally informed consent is obtained from research participants;
• whether the benefits of the research outweigh the risks to the participant; and
• whether the participants are deceived.

The principles governing the IRB are primarily derived from the following sources:

• Institutional Review Board Services
• National Institute of Health’s Regulations and Ethical Guidelines
• US Department of Health and Human Services’ Office for Human Research Protections (OHRP)
• National Cancer Institute’s Protecting Participants in Clinical Trials

The IRB assesses the ethical aspects of human subjects research proposed by its students, faculty, and staff.  More specifically, the IRB ensures that the benefits of the research outweigh the risks to the participants in that research, that the participants are in no way deceived during the research process, and that participants indicate their informed consent to such research by signing (and/or having a parent or legal guardian sign) a suitable consent form.

IRB Structure

The IRB is composed of at least four “core” members taken from several of the academic divisions of the College. The IRB Chair must have served at least two years as a core member. Core positions are held by individuals who are involved in research or have firsthand knowledge of human subjects research.

A member’s knowledge of such research is defined as having an understanding of procedural issues involved in human subjects research or having experience adjudicating human subject applications. At least one additional member must be from a discipline not typically involved in human subjects research (e.g. fine arts, literature, mathematics, physics, etc.). At least one member of the Board must be from the local community. Additional members are selected to maintain a minimum of eight (8) board members.

The Chair and core members of the Board are selected by the Provost. The other members are selected by the IRB  Chair in consultation with the Provost.

IRB Training

Investigators new to human subjects research are encouraged to go over the training modules available at the following websites.

• US Department of Health & Human Service
• Collaborative Institutional Training Initiative

Before submitting documents to the IRB for review, obtain a certificate of completion of the “Investigator Responsibilities & Informed Consent” training.

IRB Review Procedures

Title 45 Part 46 of the HHS Policy for Protection of Human Research Subjects outlines the IRB procedures for review of research. Using the above as guidelines, the YHC IRB has established three levels of review Exempt, Expedited and Full review.

1. Exempt

Research dealing with the following are exempt from IRB review. Nevertheless, investigators do need to submit the “Application for Exempt Status” form. The final decision that a certain research is exempt rests on the IRB.
a. Research on regular and special instructional strategies or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
b. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), voluntary survey procedures, voluntary interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participant; and (ii) any disclosure of the human participants’ responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.
c. Research involving the use of educational tests (cognitive, diagnostic, aptitude. achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under (2) above if: (1) the human participants are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
d. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in a manner that participants cannot be identified, directly or through identifiers linked to the participants.
e. Research and demonstration projects which are conducted by or subject to the approval of State or Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (1) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs, (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
f. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level 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.

The IRB chair will notify the principal investigator about the outcome of the exempt application which would be either:

• Exempt “As submitted”
• Exempt with modifications
• Not exempt- a non-exempt application must be submitted

The IRB chair will notify the PI about the necessary changes.

2. Expedited

If an application fails to qualify as exempt, the PI needs to seek IRB approval using the non-exempt application form. The research may qualify for expedited review if
a. Minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
b. Collection of: hair and nail clippings, in a nondisfiguring manner; deciduous teeth; and permanent teeth if patient care indicated need for extraction.
c. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
d. Recording of data from participants 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the participant or an invasion of the participant’s privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (e.g., x-rays, microwaves).
e. Collection of blood samples by venipuncture, in amounts not exceeding 450 ml in an eight-week period and no more often than two times per week, from participants 18 years of age or older and who are in good health and not pregnant.
f. Collection of both supra- and subgingival plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
g. Moderate exercise by healthy volunteers
h. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
i. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate participants’ behavior and the research will not involve stress to participants.
j. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
As with the exempt case, the expedited application may be approved as submitted, approved with changes or may be considered for full review. The IRB chair will notify the PI of the results of the expedited application and the next course of action.

3. Full Review

If the application fails or does not qualify for the expedited review, it will be considered for full review by the IRB committee. The application will be considered at the following IRB meeting, unless the next meeting is within a week of the receipt of the application. If it is the latter case, the application would be considered at the meeting after the next. The application could be approved as submitted, with modifications or in the extreme case, may be denied by the IRB if it fails to meet the standards of ethical research.

Policy Regarding Appeals and Non-Compliance

In situations where an application has been denied by the IRB on the ground that it fails to meet the ethical standards of research, the PI could reappeal to the IRB regarding such a decision. Such requests should be made in writing to the IRB chair with two weeks of the IRB decision. The request should justify why the PI thinks that such a decision is necessary and may supply additional documents. The IRB would deliberate on the issue at its next meeting. The PI may be asked to be present at this meeting to clarify any issues.

The IRB reserves the right to monitor research by YHC faculty, staff and students. If there is a report of non-compliance or if the committee has sufficient reasons to believe that a certain research is being carried out without the proper ethical guidelines the following would occur.

• The IRB would intervene and try to resolve the issue such that it follows the guidelines established by the IRB for ethical research.
• If the above fails, the matter would be reported to the academic advisor, chief of staff or dean of faculty for students, staff and faculty respectively.