II. Definitions

A. There is the question of whether a planned activity is 'research' and therefore needs IRB review. The Code of Federal Regulations defines research as "...a systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalized knowledge." Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and services programs may include research activities. Other criteria which may be of use in determining whether a planned activity is research include:

• the collection of data with the intent to report it in scientific publications;

• use of a standard procedure or medication if it is influenced by any consideration other than direct welfare to the patient, even if both therapies seem equal to the physician in charge; and

• use of experimental drugs or devices.

B. Student research, as part of a class, would not require IRB approval if it meets ALL of the following criteria:

• it is a project which is a normal part of the student's coursework;

• it is supervised by a faculty member;

• it has, as its primary purpose, the development of the student's research skills;

• it does not present more than minimal risk to the participants or to the student investigator; AND

• it is not genuine research which is expected to result in publication or some other form of public dissemination.

Any student research project not meeting ALL of the above criteria must follow all IRB procedures.

Graduate students completing the thesis, practicum, or project requirement involving human subjects must submit an application to the IRB. The approval notification from the IRB must be included in the appendix of the thesis. Academic units may require the approval notification in the appendix of the practicum or project document.

III. IRB Membership

IRB membership shall be consistent with regulation ¤46.107 of the Code of Federal Regulation 45 CFR 46. Membership consists of at least five persons including one member who is not otherwise affiliated with Armstrong Atlantic State University, and one member from an area not normally associated with research involving human subjects. Membership must constitute a mix of both men and women. Members shall be appointed by the Vice-President and Dean of Faculty. The Chair will be the Dean of the School of Graduate Studies. Other members shall be the Assistant Deans of Arts and Sciences, Education, and Health Professions, and the Director of the Office of Sponsored Programs. The IRB may invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available to the IRB. These invited individuals may not vote with the IRB.

The IRB Chair and Vice-Chair

The IRB Chair shall be the Dean of the School of Graduate Studies with a degree at the doctoral level. Duties of the Chair are described throughout the remainder of this document.

The IRB Vice-Chair shall be AASU faculty member of the IRB with a degree at the doctoral level. This person shall have all associated responsibilities and obligations of the Chair, whenever the Chair is incapable of serving in that capacity and when the Chair is an investigator on a research project being reviewed or considered by the IRB. The duties and responsibilities of the Vice-Chair are the same as for any IRB member, except when in the authorized capacity of acting chair.

In the event that neither the Chair or Vice-Chair are available to preside at a meeting of the IRB, the IRB members present shall appoint a member to act as chair for that meeting. This person shall have all the responsibilities and duties associated with the office of Chair for that meeting.

Nominations of candidates for Vice-Chair may come from any member of the IRB. Self-nomination is allowed. Nominations are taken from the floor during the first regular IRB meeting of the academic year. Election shall stem from a majority vote of these IRB members present and voting at that meeting. The Vice-Chair shall serve for a period of one year and may be considered for reelection at the end of each term of office.

Removal of IRB Members Before Expiration of Appointed Term

In the unlikely event that a member of the IRB should conduct him-herself in a manner inviting consideration for a request for removal from the IRB, such a member of the IRB can be removed from the Board with the direct approval of the Chair of the IRB and no fewer than three additional members of the IRB.

The IRB Vice-Chair can only be removed from office by a majority vote of the full IRB. Anyone removed as Vice-Chair retains regular IRB membership for the duration of his/her term.

IV. Administrative duties

Research protocols involving human subjects shall be presented to the Chair of the IRB for evaluation and categorization as EXEMPT, EXPEDITED REVIEW, or FULL REVIEW according to procedures detailed in this document.

The primary function of the IRB is to evaluate and review proposals which fall into EXPEDITED REVIEW or FULL REVIEW categories, described below. Duties of the IRB Chair extend into review of all research as well as additional duties described below.

V. Initial categorization and review of protocols

The Chair of the IRB shall review all protocols and requests for review to determine which of the following three categories of review is appropriate:

• A -- EXEMPT; the investigator is so notified within five (5) working days of protocol submission and the IRB Chair acts to monitor EXEMPT research.


B -- EXPEDITED REVIEW; the protocol is reviewed by at least the Chair of the IRB, or Vice-Chair where appropriate, and one other member of the IRB. Additional members may be asked by the Chair to participate in an expedited review, where such participation is deemed appropriate.

The designated reviewers must vote unanimously for approval of an expedited review protocol. If there is no unanimous vote for approval, the protocol is automatically considered by the full IRB at the next scheduled meeting of the IRB. A protocol cannot be disapproved by expedited review procedures.

Investigators will be notified of the findings of an expedited review within fifteen (15) days of protocol submission.

C -- FULL REVIEW; see the following section (Full Review Procedures).

VI. Full Review Procedures

Quorum

In order to effectively and legally review proposed research not in an EXEMPT or EXPEDITED category, there shall be a majority of the IRB members present, including at least one member whose primary concerns are in nonscientific areas.

Meeting Procedures

The IRB will meet once a month, if needed. If additional meetings are needed, members shall be informed at least five (5) working days in advance. Special meetings may be called on shorter notice, but such a meeting must have a majority of IRB members present in order to be official. The Chair shall prepare the agenda and direct the meeting.

Review and Consideration of Protocols

Wherever possible and desirable, the Principal Investigator (or designee) shall be present at that portion of the meeting in which his/her proposal is under consideration, in order to clarify relevant portions of the protocol and project.

Members of the IRB are authorized to ask any questions pertaining to the study in order to reach a conclusion regarding risks, benefits, safety, and protection of human subjects.

Criteria of IRB Approval of Research

In order to approve research, the IRB shall determine that ALL of the following requirements are satisfied:

• A. Risks to subjects are minimized;
• (1) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk;


(2) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

B. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and to the importance of the knowledge that may reasonably be expected to result.

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 from the research (for example, the possible effects of the research in public policy) as among those research risks that fall within the purview of its responsibility.

While it is not in the realm of IRB authority to evaluate the scientific, social, or political worthiness of any research project, issues of project design are an appropriate area of concern as the risk through participation increases. An IRB member must consider design of the research in determining approval if such design either directly or indirectly places the participant at undue risk. The level of risk involved should be considered when the design of the research and procedures involved cannot be expected to yield meaningful data. If the protocol introduces an element of risk that is not outweighed by direct benefit to participants an IRB member may consider design in arriving at a decision.

C. Selection of subjects is equitable given the purposes and setting of the research.

D. Informed consent will be obtained from each prospective subject or the subject's legally authorized representative in accordance with Federal regulations (45 CFR 46.116) E. Informed consent will be appropriately documented (in accordance with 45 CFR 46.117). Informed consents are required to be written in "lay language" (Language on the seventh grade level) in accordance with federal regulations (45 CFR 46.116) which states that "The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. For example, the amount of blood drawn may be stated in milliliters (ml) or cubic centimeters (cc), but must also be stated in teaspoons, cups or pints." (Refer to the sample informed consent form.)

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

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

H. Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged, or persons who are institutionalized, or minors, appropriate additional safeguards have been included in the study to protect the rights and welfare of these subjects.

I. The use of deception is sometimes necessary in research involving human participants. In such instances, the researcher is to consider alternative design and procedures before introducing a deceptive element to the research. In addition, participants are to be provided a debriefing which clarifies any deceptive elements of the research as soon as possible. Each proposal to the IRB should contain an explanation of the need of deception and a clearly written debriefing statement that participants will receive at the end of participation.

Voting Procedures and Options

After an adequate period of discussion of the research protocol, the Chair may call for a "motion to consider" at which point any IRB member may move for one of the following:

• Following the "motion to consider," there will be opportunity for further discussion and clarification. The motion can then be seconded and voted upon.


In order for the reviewed research to be approved, it must receive the approval of a majority of those members present. Tied votes are considered not approved and will be deferred for alterations and modifications necessary to obtain approval.

VII. Notification of IRB findings

The IRB Chair shall notify investigators in writing within seven (7) days of the IRB review, of the findings and actions regarding their protocol.

If APPROVED, the investigator may begin the proposed research project. If CONDITIONALLY APPROVED, the investigator shall be notified of the specific changes to the protocol and/or consent form necessary to proceed with IRB approval of the research protocol. The Chairperson of the IRB shall communicate, in writing, the findings of the IRB and the necessary modifications. Until the investigator convincingly demonstrates, in writing, that all required changes have been made to the IRBÕs satisfaction, the project CANNOT begin.

• If the investigator does not respond to the IRBÕs notification of required changes within thirty (30) calendar days of receiving CONDITIONAL APPROVAL, the proposed project must be resubmitted for full review consideration at the next regularly scheduled IRB meeting.


The letter of notification to the investigator will convey these stipulations and the time limit.

If DEFERRED, the investigator will be notified in writing that the project as described provides insufficient information to reach a decision for approval or disapproval. The investigator will be asked to resubmit for a later regularly scheduled meeting. In addition, the findings of the IRB that resulted in such a decision will be conveyed to the investigator.

If DISAPPROVED, notification and the findings of the IRB resulting in such a decision will be conveyed, in writing, to the investigator.

In some cases, modifications or alterations to protocol(s) and/or consent form(s) will be required for approval of a research project. Such details will be made in writing at the time of notification. It is up to the investigator to comply with these requested changes in order to obtain approval. Every responsible effort will be made to assist the investigator in bringing a non-approved project into compliance with IRB regulations in order to be approved. However, meeting deadlines and time demands is entirely the responsibility of investigators submitting proposals.

VIII. Minutes of IRB meetings

The minutes shall include, among other things:

• 1. a record of those members present and voting, as well as an account of business conducted and announcements made;


2. an accounting of those voting for/against motions, as well as relevant discussion regarding proposals being reviewed.

These minutes shall serve as IRB records of full review proceedings. All remarks, commentaries, opinions, and votes of board members are eligible to become part of the official record of the meeting.

A copy of the minutes and other official IRB records will be kept in the Office of the Dean of Graduate Studies.

IX. Annual reports

All approved ongoing research projects involving human subjects shall undergo an annual review.

• Occasionally, selected projects will be reviewed more often than annually. Such projects are:


1. any research involving fetuses,

2. any research involving human subjects for which there have been reports of injury or unanticipated problems as a consequence of participating in the research,

3. any research for which the IRB has specifically required more than annual review at the time approval was granted,

4. any research project the IRB deems appropriate for review on a more-than-annual basis, including projects not in any of the above categories.

"More-often-than annual" reviews shall follow the same reporting and review procedures as indicated for annual reports, with the appropriate changes in reporting intervals and deadlines.

Reporting procedure

Annual Reports from investigators are due one year after the project approval date, or as specified by the IRB.

Investigators will be informed of impending Annual Review dates with a memorandum distributed ten (10) months after approval date (or previous annual review for longer term projects). At that time reporting forms will be made available to relevant investigators.

Complete reports must be submitted to the IRB Chair within twelve (12) months following approval date, or as designated by the IRB.

Failure to file Annual Report

If no Annual Report is filed within a thirty (30) day (grace) period from the Annual Report due date, the investigator will be notified in writing that the approval for the indicated research project has expired. The investigator is prohibited from further experimentation involving human subjects in that research project.

This termination notice/memorandum shall be signed by the Chair of the IRB and is effective from the date of the written notification.

In order to re-establish that research project, the investigator must file a new and complete "Request for Review."

X. Changes in protocol and/or consent forms

Investigators shall file with the IRB via the IRB chairperson ANY substantive changes in protocol or consent forms. A copy of the revised protocol and/or consent form, along with a letter of clarification shall be forwarded to the IRB Chair no less than 14 days prior to the implementation of such change. If the proposed change requires FULL or EXPEDITED review, additional time may be required. In any case, the proposed change(s) cannot go into effect until IRB approval has been obtained.

EXCEPTION :

• A protocol may be changed without prior IRB approval where necessary to eliminate apparent immediate hazards to the subject. However, the IRB Chair must be notified IN WRITING of such a change within 72 hours and review is required immediately.
• All required records will be retaied for at least three years after completion of the research.

XI. Report of injury and/or unanticipated problems

Investigators must report to the IRB within 72 hours of its occurrence, ANY injury or unanticipated problem involving risks to subjects or others as a consequence of the research project.

Investigators should use their best judgment regarding the nature and degree of a reportable injury or unanticipated problem. In general, anything serious enough to warrant medical or psychiatric intervention is reportable, as are verbal or written complaints of subjects in which they proclaim that participation presents substantial discomfort, risk, and/or endangerment beyond that explained to them, or otherwise stated in the consent form.

Reports of injury and/or unanticipated problems must be filed with the:

• Office for Protection of Research Risks National Institutes of Health Department of Health and Human Services Bethesda MD 20205

Such reports must be signed by the IRB Chair and filed as soon as possible from the date of occurrence.

XII. Consequences of non-compliance

All research involving human subjects MUST have IRB review and approval before such research can be initiated. Research that is conducted without IRB approval must be terminated immediately. Investigator(s) associated with such research must file for IRB review and approval before restarting the research project.

Investigators who continue non-approved research should note that such non-compliance will be reported to the appropriate administrators.

Failure to comply with IRB directives, regulations and procedures including annual reports, changes in protocol, consent forms, and other requests for information or compliance emanating from the IRB Chair will result in the following:

Project termination : Investigators and their staff and assistants are prohibited from involving human subjects in that research project until formal IRB approval/reinitiation is obtained. Such approval may be sought at the next available regularly scheduled meeting of the IRB, or at a special meeting called at the discretion of the IRB Chair.

Interruption of Research Support : An additional consequence of non-compliance can be the interruption of grant funds (internal or extramural in origin) allocated to that research project. Such "freezing of funds" will continue until the project and its investigators are in compliance according to regulations as determined by the IRB.

Report to Appropriate Federal Agencies : In some cases, the university is required to report to the Office for the Protection of Research Risks (OPRR) any termination of a project due to non-compliance with IRB regulations and directives. Further, such non-compliance is reportable to the Federal Agency supporting the non-compliant research project.

XIII. Investigatory Rights

In order to determine that all substantive and relevant changes in protocol and/or consent documents are being reported, and in order to verify compliance with IRB regulations, the IRB shall have the authority to physically inspect any research premises or review non-confidential research documents relating to the protocol and procedures being used in human subject experimentation. Generally, the investigator will be asked to provide copies of relevant and necessary documents for IRB review. Such document requests are in addition to those generated in an annual review process. In most cases, this will only occur when there is an indication that a substantive change is in effect which has not been reported. Failure to comply with such an IRB request for information may result in suspension or termination of IRB approval of research.

XIV. Suspension or termination of IRB approval of research

According to 45 CFR 46.113 :

• "An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's actions and shall be reported promptly to the investigator, appropriate institutional officials, and the Secretary (of OPRR)."

XV. Appeal procedures

There are no formal appeal procedures associated with IRB review. The IRB is not a judicial body, but a review board embodied to consider and uphold the rights, welfare and protection of human subjects in research. IRB approval for research which has been suspended or terminated can be reinstated with a demonstration that the protocol/project can secure IRB approval. Similarly, a disapproved project need only be altered so that it can secure approval. An appeal process assumes that the decision of the IRB can be overturned by another group. An IRB ruling is not subject to appeal nor can it be overturned by another group or person(s).

(Please note that IRB approval only means that the IRB rules that the potential risks to the subject are, in its opinion, acceptable. IRB approval DOES NOT mean that a project has departmental or institutional approval, and the proper procedures for obtaining such approvals should be followed).

Only the IRB can alter its previous determination. According to 45 CFR 46.112 :

• "Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB."

XVI. Adoption of the Ten Ethical Principles of the APA

In addition to the preceding policies and procedures the AASU Institutional Review Board also adopts the ten ethical principles of the APA regarding the conduct of research with human participants and the ongoing responsibilities of all investigators.

• A. In planning a study the investigator has the personal responsibility to make a careful evaluation of its ethical acceptability, taking into account these Principles, for research with human beings. To the extent that this appraisal, weighing scientific and human values, suggests a deviation from any Principle, the investigator incurs an increasingly serious obligation to seek ethical advice and to observe more stringent safeguards to protect the rights of the human research participant.


B. Responsibility for the establishment and maintenance of acceptable ethical practice in research always remains with the individual investigator. The investigator is also responsible for his ethical treatment of research participants by collaborators, assistants, students, and employees, all of whom, however, incur parallel obligations.

C . Ethical practice requires the investigator to inform the participants of all features of the research that reasonably might be expected to influence willingness to participate and to explain all other aspects of the research about which the participant inquires. Failure to make full disclosure gives added emphasis to the investigator's responsibility to protect the welfare and dignity of the research participants.

D. Openness and honesty are essential characteristics of the relationship between investigator and research participant. When the methodological requirements of a study necessitate concealment or deception, the investigator is required to ensure the participant's understanding of the reasons for this action and to restore the quality of the relationship with the investigator.

E. Ethical research practice requires the investigator to respect the individual's freedom to decline to participate in research or to discontinue participation at any time. The obligation to protect this freedom requires special vigilance when the investigator is in a position of power over the participant. The decision to limit this freedom increases the investigator's responsibility to protect the participant's dignity and welfare.

F. Ethically acceptable research begins with the establishment of a clear and fair agreement between the investigator and the research participant that clarifies the responsibilities of each. The investigator has the obligation to honor all promises and commitments in the agreement.

G. The ethical investigator protects participants from physical and mental discomfort, harm, and danger. If the risk of such consequences exists, the investigator is required to inform the participant of that fact, secure consent before proceeding, and take all possible measures to minimize distress. A research procedure may not be used if it is likely to cause serious and lasting harm to participants.

H. After the data are collected, ethical practice requires the investigator to provide the participant with a full clarification of the nature of the study and to remove any misconceptions that may have arisen. Where scientific or human values justify delaying or withholding information, the investigator acquires a special responsibility to assure that there are no damaging consequences for the participant.

I. Where research procedures may result in undesirable consequences for the participant, the investigator has the duty to detect and remove or correct these consequences, including, where relevant, long-term aftereffects.

J. Information obtained about the research participants during the course of an investigation is confidential. When the possibility exists that others may obtain access to such information, ethical research practice requires that this possibility, together with the plans for protecting confidentiality, be explained to the participants as a part of the procedure for obtaining informed consent.

XVII. Enactment

These procedures and policies are considered to be in effect immediately upon approval by authorized university officials and remain in effect and enforceable until otherwise amended or repealed.