Background: The AUS IRB was established in fall 2005. It is composed of at least six members—at least five from with in AUS and one external community member. Members are from varying professions, and include both men and women. At least one member has a primary career in science and one is concerned with non-science areas.

Appointed by the Vice Chancellor for Academic Affairs, IRB members, in so far as possible, serve during two or more academic years. The IRB holds regular monthly meetings, and the chair of the IRB calls for ad hoc meetings as required.

The Office of Research provides institutional support for the work of the IRB. The Coordinator of Research serves as an ex officio member of the AUS IRB. The qualifications of current IRB members can be obtained from the Office of Research.

Purpose: The AUS IRB has the institutional responsibility for review and annual monitoring of all research involving humans carried out at AUS to assure the protection of the rights and welfare of all research participants, including volunteers.

All research conducted by AUS investigators (faculty, staff and students) and involving humans, regardless of its source of financial support, must be approved by the AUS IRB and must conform to IRB policies and principles. Self-funded research involving humans must also receive IRB review and approval before being undertaken.

If an AUS researcher conducts research in a host institution, the host institution’s IRB has jurisdiction—if the host institution’s IRB meets or exceeds the standards established by the AUS IRB. Additionally, the AUS researcher is required to provide copies of his/her research protocol, IRB application and signed approval and consent forms to the AUS IRB through the Office of Research.

Individuals from outside AUS wishing to conduct research within AUS must have an AUS sponsor who is willing to function as the principal investigator responsible for the research. This research must also receive AUS IRB review and approval.

The AUS IRB reviews all research proposals and protocols involving human participants before the research is conducted to determine and ensure that all ethical issues have been fully addressed in the protection of humans who participate as subjects in research studies.

The ethical principles guiding the AUS IRB are consistent with the Declaration of Helsinki of the World Health Organization and The Belmont Report.

The AUS IRB also operates according to the rules and regulations of the US Federal Policy for the Protection of Human Subjects (56 FR 28003; often referred to as the “Common Rule”), the US Department of Health and Human Services (DHHS) (45 CFR Part 46) and the Food and Drug Administration (FDA) (21 CFR Parts 50 and 56).

To fulfill this responsibility, the AUS IRB is guided by three principles:

• Protecting autonomy of participants. That is, subjects must be informed about the nature, details and potential consequences of the study, and their participation must be completely voluntary.
• Ensuring beneficence. The benefits of the research must outweigh risks, must not put the person at serious risk and must not violate human rights.
• Promoting fair procedures in selecting participants. The risks and benefits of research should be evenly distributed among the possible subject populations.

The AUS IRB reviews all protocols for research using human participants, weighs ethical issues raised, assesses potential benefits against risks and ensures that appropriate recruitment and consent procedures are used. Through this process, compliance with the spirit and letter of US federal, State of Delaware (where AUS is registered as an institute of higher education) and university policies are achieved.

All IRBs, including the AUS IRB, consider the following:

• Are risks to participants minimized using appropriate procedures?
• Are risks justifiable considering anticipated benefits to participants and/or others? And are serious risks avoided?
• Is the selection of subjects equitable?
• Has adequate provision been made for confidentiality of data and anonymity of participants in any published record?
• Has adequate provision been made for the rights and welfare of all participants, especially those who are mentally, physically, economically or educationally disadvantaged?
• Has adequate provision been made for obtaining informed consent of participants, including those who may not be literate

The rights of human participants in research are eloquently discussed in The Belmont Report prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979 (http://ohsr.od.nih.gov/mpa/belmont).

The AUS IRB reviews projects involving human subjects by one of three methods:

• Exempt
• Expedited
• Full Board Review

These categories of review are briefly explained below. For additional information, contact the Coordinator of Research.

Exempt

Review Certain categories of research may qualify for exempt review. This means exempt from full board review—not exempt from review.

Potentially exempt proposals and protocols are reviewed and certified by the Office of Research, which will provide a copy of the IRB application and research protocol to the chair of the IRB. Allow one to two weeks for exempt reviews.

Research activities in which the only involvement of human subjects will be in one or more of the following categories generally qualify for review under the exempt category:

• Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to the participants; and (b) any disclosure of the human participants’ responses outside the research could reasonably place the persons at risk of criminal or civil liability or be damaging to the persons’ financial standing, employability or reputation. (There are also special considerations required when children are involved.)
• 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 the above if: (a) the human subjects are elected or appointed public officials or candidates for public office or (b) federal statute(s) require(s) with out exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
• 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 such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
• Research and demonstration projects conducted by or subject to the approval of department or heads within public agencies, and designed to study, evaluate or otherwise examine: (a) public benefit or service programs;(b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.
• Research conducted collaboratively with one or more other institutions whose IRBs have reviewed and approved the research project and AUS assists with activities fully covered by that approval. If the AUS role results in new activities not fully covered by the collaborating institutions’ IRBs approvals, or if AUS actions require informed consent not provided for under procedures established by the collaborating institution, the activity is not eligible for exempt review by the AUS IRB.
• Taste and food quality evaluation and consumer acceptance studies (a) if wholesome foods without additives are consumed or (b) if a food is consumed that contains a food ingredient at or below the level, and is found to be safe for a use, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration and approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the US Department of Agriculture. Where stricter requirements have been established by appropriate Emirati agencies, these will be observed to ensure that safe levels are observed.

Expedited Review

Expedited reviews do not require a convened meeting of the full IRB. The Coordinator of Research will forward the application to the IRB chair, who will choose a limited number of board members to review the proposal or protocol.

IRB members will return their comments to the chair, who will notify the Coordinator of Research of the results of the review. The Coordinator of Research will then notify the principal investigator. Allow two to three weeks for an expedited review.

Research activities involving no more than minimal risk and in which the only involvement of human participants will be in one or more of the following categories generally are reviewed through the expedited review procedure:

• Collection of hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction
• Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery and amniotic fluid at the time of rupture of the membran prior to or during labor
• Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed at clinical practice. This includes the use of physical sensors 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 subject or an invasion of the subject’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 (for example, x-rays, microwaves). There are special considerations required when children and/or pregnant women are involved.
• Acquisition of blood samples by finger pricking for collection of blood droplets or smears from subjects 18 years of age or older and who are in good health and not pregnant
• Collection of both supra- and sub-gingival dental 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
• Voice recordings made for research purposes such as investigations of speech defects
• Moderate exercise by healthy volunteers
• Study of existing data, documents, records, pathological specimens or diagnostic specimens
• 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 subjects’ behavior and the research will not involve stress to subjects
• Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required

Full Board Review

The IRB schedules meetings as needed to review all proposals that do not fall into the exempt or expedited categories. Principal investigators may be invited to attend the meeting to discuss their proposals. Allow one month for full board review.

Applications to the IRB are submitted through the Office Research before research involving human participants is undertaken.

All IRB applications must follow the required format as included in this guide as Appendix 2. The required form at for IRB applications is also posted on the Research website. Included in Appendix 2 is a sample consent form that may be consulted when developing the consent form administered to potential research participants.

You may contact the Office of Research for assistance in preparing your IRB application.

The time required for the AUS IRB to review a search protocol depends on the category of review required by the proposed research. Generally, the following schedule of review applies: