Policies and Guidelines

Section 1.0. University Institutional Review Board Mission

The Clayton State University – University Institutional Review Board (IRB) will process all proposals that require human subject participation. The IRB will also encourage and promote faculty, students, staff and administration to conduct all types of research.

In all deliberations, the IRB will adhere to the Belmont guidelines, and require that research on human subject participation be conducted to protect the rights of individuals against harm. The IRB will maintain a federally registered IRB status to ensure compliance with federal statutes and regulations, and to encourage federal research as well as state, local, and privately supported research.

Section 2.0. University Institutional Review Board Structure

The IRB will be comprised of the following individuals:

One Chair: An individual nominated by the IRB members who will serve for one year.

One Vice Chair: An individual nominated by the IRB members who will serve for one year and act as Chair elect. The Vice Chair term is one year followed by a year as Chair.

Members: Two members from each of the respective schools and colleges of Clayton State University as indicated directly below, will be IRB members. The IRB members will be elected from each school and college as either a three or two year term member for the initial term, with subsequent terms to be three years for all members. Thus a staggered term will occur for all members from each school and college. The colleges and schools determine respective election procedures. Individuals may serve one consecutive term after their initial term. A previous member who served one or two terms must wait one term before serving another term. One individual from the University IACUC will be a member, and one representative from administration will be a member. Both the IACUC and administration member will serve three year terms. There will also be one non-scientist member elected by the staff council or list of librarians who serves for a three year term, with potential for one consecutive term of three years.

School, College and Staff IRB Member Composition:

College of Arts and Sciences: Two members

School of Business: Two members

College of Information and Mathematical Sciences: Two members

School of Nursing: Two members

College of Professional Studies: Two members

Staff Council or Librarians Representative: One member who must be a non-scientist member

External Members: At least two but not more than three individuals will be members from external sources. A list of external members will be maintained by the IRB Chair and Vice Chair to help with IRB review. External members will serve not more than five year terms, with a possibility for one consecutive term. A previous external member who served one or two terms must wait one term before serving another term. External members are considered ad hoc members and are called when needed.

Ex-Officio Members: The President and Provost are ex-officio members with no term limits.

Advisor: The Chair will serve a one year term as advisor after being Chair.

[Human Protection Administrator: Associate Provost who is not a member of the IRB]

Section 3.0. Scheduled and Called Meetings

The IRB will be required to meet at least monthly unless no activity is before the IRB whereby the Chair or Vice Chair may cancel the meeting. A called meeting by either the Chair or Vice Chair may occur beyond the monthly meetings. All meetings are under the guidelines of Roberts Rules of Order.

All meeting agendas and minutes will be forwarded to the Human Protection Administrator for permanent storage in the Provost’s office. At least four members of the IRB must be present to constitute a quorum and conduct IRB business.

Section 4.0. IRB Organizational Policy

The IRB members will report their decisions to the Human Protection Administrator. The IRB Chair or Vice Chair will converse with the Human Protection Administrator on IRB agenda items and pending policies/procedures changes at an IRB meeting. As a faculty driven committee, the IRB Chair and Vice Chair will ensure that all agenda items and meeting minutes are approved by a majority of the IRB members. The President and Provost will serve as ex-officio members, without voting rights on IRB decisions except in their capacity as voting members at Graduate Council meetings. It is noted that the President and Provost make final decisions on grants or contracts, but not on IRB decisions unless appealed. Appealed IRB decisions may be overturned by the Graduate Council, as noted in the specific procedures below.

Section 5.0. Policy on Research Endeavors Requiring IRB Review

It is the policy of Clayton State University that all research endeavors requiring human subject participation must be reviewed by the IRB, with the exception of studies approved and conducted by the following at the Category 1 level (See Section 7.3 below): 1. Institutional Research area in the Provost’s Office, and 2. Faculty Members as part of a course objective or curriculum development process that does not lead to potential publication.

All exceptions are at a Category I level as indicated below, and all potential participants will have the opportunity to not participate or withdraw from the study without recrimination of any type. Any exception area conducting a Category 2 or above must receive IRB approval unless requested by the University System of Georgia Board of Regents.

No research on any human, including faculty, students, staff or administration will be allowed without an IRB review at Clayton State University, unless conducted under the purview of the exceptions noted directly above. There may be severe penalties for studies conducted by any faculty member, student, staff or administrator who does not comply with this policy. Penalties include a step by step process including a verbal warning, written reprimand from the IRB committee that will be placed in the respective individual’s personnel or student file, and potential suspension of research endeavors for a defined period of time depending on the severity of the infraction. Egregious situations may warrant higher level penalties without a step by step process. Appeals may be requested as indicated in the IRB Bylaws. Any individual found to be out of compliance with the IRB policies will be forwarded to the Provost and their respective supervisor for the penalties indicated.

Studies on human subject participation by individuals employed at Clayton State University that have received an IRB approval from another University System of Georgia college or university are deemed to have met the Clayton State University IRB approval. However, the previous IRB approval from another University System of Georgia college or university must be sent to the IRB for file.

Studies on human subject participation by individuals employed at Clayton State University that have received an IRB approval from an external source other than another University System of Georgia college or university may use the external IRB forms to submit to the Clayton State University IRB for approval. Approval from an external source other than another University System of Georgia college or university does not automatically indicate Clayton State University IRB approval, but all due diligence will be provided to the previous IRB approval.

Section 6.0. Policy on IRB Encouragement, Education and Processing of Requests

In conjunction with the mission of the IRB, a website will be maintained by the IRB to help ensure an effective and efficient means of IRB requests, including the education on and procedures required to conduct an IRB request. Individuals requesting an IRB review will be directed to an online request process. Hardcopy IRB requests are also available. Individuals requesting an IRB review are encouraged to complete a federal level research certification as provided by the links to those certifications by the IRB website.

As a means of ensuring an efficient and effective IRB review, forms will be created that are as succinct as possible, but also maintaining a rigorous and parsimonious review of the respective study. All research reviews will be in accordance with federal, state and local statutes/regulations and in compliance with respective HIPAA guidelines if appropriate. Specific IRB review procedures are specified in the IRB Bylaws.

Section 7.0. Specific IRB Research Requests -- Policies And Procedures

Clayton State University is obliged to ensure that all research conducted by or under the direction of persons who are employed by or serving as agents for the University or by persons using University property, facilities, or information complies with federal, state, and local laws and regulations. The specific procedures used to process IRB proposal are specified in the IRB Bylaws. In particular, the University must ensure that research conducted on human subjects complies with regulations promulgated by the U.S. Department of Health and Human Services and that research conducted on laboratory or research animals (other than and in addition to humans) complies with the U.S. Public Health Services Policy on Humane Care and Use of Laboratory Animals. All animal research is reviewed by the IACUC committee with specific procedures on review provided by that committee.

Section 7.1. Research on Human Subjects

Clayton State University requires that research on human subjects be conducted so as to protect the rights of self-determination, privacy, anonymity and confidentiality, fair treatment, and the right to protection from harm of unwarranted discomfort. To that end, the University requires that any member of the University who is planning to conduct research on human subjects submit a formal proposal to do so and, further, that the proposal be reviewed by a designated official of the IRB or an IRB committee and be approved prior to the research commencing. All forms are found at the IRB website and may be submitted online or in hardcopy to the current IRB Chair or Vice Chair if the Chair is unavailable, as indicated on the website.

Section 7.2. Assessment of Risk

Proposals for research on human subjects must address the likelihood and extent of risk to those persons who participate as subjects. The University recognizes five (5) categories of risk and will, upon full review and final approval, permit research to be undertaken which entails risk in Categories 1, 2, and 3 (below).

Section 7.3 Category 1 – Research Involving NO RISK to Human Subjects

Category 1 research is of such a nature as to entail neither positive nor negative physiological or psychological effects on subjects. Examples of such research include:

· research conducted in conventional educational settings and involving normal educational practices, such as research on instructional strategies or comparisons among instructional techniques or curricula;

· research in which educational tests, surveys, interviews, or observations of public behavior are used, unless information obtained is recorded in such a manner as to permit the identification of human subjects and/or to disclosure of subjects’ responses outside the research could place subjects at risk of criminal or civil liability or damage the subject’s financial standing, employability, or reputation;

· research in which educational tests, surveys, interviews, or observations of public behavior are used and the human subjects are elected or appointed public officials or candidates for public office or in circumstances for which federal statues require that the confidentiality of the information associated with a specific human subject be maintained in perpetuity;

· research in which existing data, documents, records, or specimens are used and these data are publicly available or can be recorded in such a manner as to eliminate the possibility of identifying individual subjects;

· research and demonstrations which are undertaken by or are subject to the approval of unit heads, and which are intended to study or evaluate (a) public benefit of 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 of services under those programs.

Section 7.4 Category 2 – Research involving MINIMAL RISK to Human Subjects

This research will cause subjects to experience minimal and temporary discomfort comparable to that which would be encountered in daily life. Examples of this type of research include:

· the collection of nail and hair clippings, excreta and external secretions;

· the recording of data from subjects 18 years of age or older using non-invasive procedures;

· the collection of blood samples by venipuncture and from subjects 18 years of age or older and in good health;

· voice recordings made for such purposes as the study of speech defects;

· moderate exercise by healthy volunteers;

· the analysis of existing data, documents, records, or specimens;

· the study of group or individual behavior where the investigator does not manipulate the subject’s behavior and the research will involve minimal stress to subjects;

· research on drugs or devices for which an investigational new drug or device exemption is not required.

· Surveys of harmless behaviors/thoughts/emotions, such as television viewing, amount of time spent studying, anxiety surrounding final exams

· Standardized assessments of intelligence, personality

· Observation of normal behaviors (e.g., studying, eating behaviors)

· Interviews about television viewing

· In-depth interviews of thoughts/experience with particular fashion garments

Section 7.5 Category 3 – Research involving MODERATE to SUBSTANTIAL RISK to Human Subjects

This type of research causes subjects to experience unusual discomfort that would not ordinarily be experienced in daily life. The discomfort occurs during and after the research and the discomfort is a direct result of the research. The discomfort would be described by the subject as severe and long lasting. Examples of such research include:

· studies involving minor surgical procedures or requiring that subjects recall an unusually traumatic or painful experience

· research involving vulnerable subjects such as prisoners, children, or the mentally or physically disabled.

· all research conducted on pregnant women

· Clinical interview of history of psychological disorders

· Surveys that require recall or experience negative emotions, emotions

· Surveys/interviews that require disclosure of risky behaviors

· In-depth interviews of experience with domestic violence

· Focus groups of experience with alcohol or adult victims of child abuse

Section 7.6 Category 4 – Research involving RISK OF PERMANENT DAMAGE

This type of research has a risk of causing permanent damage including both physiological and psychological harm. It may be in the nature of a questionnaire or a physical related basis such as extensive minor surgery. No research of this nature will be conducted at Clayton State University. However, individuals employed by Clayton State University and conducting category 4 research at another institution must file their external IRB approval with the Provost’s office.

Section 7.7 Category 5 – Research involving CERTAINTY OF PERMANENT DAMAGE

This type of research has the highest risk with a known outcome of permanent damage either physiologically or psychologically. It may be in the nature of a questionnaire or a physical related basis such as major surgery. No research of this nature will be conducted at Clayton State University. However, individuals employed by Clayton State University and conducting category 5 research at another institution must file their external IRB approval with the Provost’s office..

Section 7.8 Informed Consent

Proposals for research on human subjects must demonstrate that prospective participants will be apprised fully and in advance of the nature of the research in which they are being asked to participate as subjects. Prospective subjects are considered to be autonomous agents and are assured that they may choose voluntarily to participate or not to participate in research and, further, that they have the right to terminate participation in a study at any time without penalty of any type.

Proposals for research on human subjects must include a copy of the Informed Consent Form to be used in the research. Such a form must be worded at a level of understanding appropriate to the prospective subject. Furthermore, the form may not include a statement or statements which waive or which appear to waive a prospective subject’s legal rights, including release of the University or its agents from liability for negligence. An Informed Consent form must contain the following:

Category 1: A short paragraph summarizing the information in areas a through i below.

Category 2 and 3: Specific information on the following information requested:

a. the heading Informed Consent Form;

b. an explanation of the duration of the project, procedures to be followed and their purposes, including identification of any procedures which are experimental;

c. evidence that the subject will be able to exercise free power of choice to participate or not to participate as well as to withdraw consent and to discontinue participation in research at any time without prejudice and that no element of coercion or constraint will be used in obtaining consent to participate;

d. a description of any attendant discomforts and risks that may be reasonably expected as a result of participation in the research;

e. a description of any benefits that may be reasonably expected to accrue from participation in the research;

f. a statement pertaining to the security and, hence, the confidentiality of information associated with the research, especially as it relates to specific individuals;

g. a statement on the availability of compensation in the event of physical injury and how to obtain more information;

h. an offer to answer any inquiries concerning the research procedures, including a telephone number and address of a contact person;

i. a place for the subject (or guardian, in the case of minor) to sign and date the form.

Section 8.0. Proposal Review for Grants and Contracts

See the Office of Grants and Contract Programs for Specific Review of Grants and Contracts – their official website is located at http://adminservices.clayton.edu/grants/default.htm. Grants and Contracts review may occur in conjunction with an IRB review, or immediately before or after an IRB review.

Please note that the IRB does not approve Grants or Contracts and that the Grants and Contracts review does not equal an IRB review. Further, not all IRB reviews require a Grant and Contract review, but all Grant and Contract reviews with human subject participation require an IRB review.

Section 9.0. IRB Review Process

Any CSU research activity, with the exceptions noted above, involving the use of humans for research purposes must be reported to or submit the appropriate forms to the IRB.

Application For Approval of Research
Application for Exempted Expedited Study
Required Format Consent Form
Student Application to Engage in Course-Directed Human Subjects Activity

Proposals will be reviewed in a timely fashion and acted upon as soon as a completed Research on Human Subjects Proposal Form is received. Research may not commence until the IRB Committee provides formal approval, and in cases of grants and contracts with the commensurate approval of respective individuals noted in the website directly above. Specific responsibility for the review and approval/disapproval of a proposal is determined by the category of risk associated with the proposed research (see above). Specific procedures on the review process are indicated in the IRB Bylaws.

Section 9.1 Category 1 Review Process

Category 1 (no risk) research proposals will be reviewed and approved/disapproved by the IRB Chair or Vice Chair. If approved, the proposal will be so noted and a copy distributed to the principal investigator, the faculty or agency sponsor. A copy of the approved proposal will be maintained on file and available for inspection in the Provost’s office in a locked environment.

If the IRB Chair or Vice Chair disapproves a Category 1 research proposal, the principal investigator may appeal that determination to the full IRB Committee. The full IRB Committee at this level will be comprised of at least six internal IRB Committee members and one external IRB Committee member (if available) as called by the IRB Chair or Vice Chair. If any called committee member has a comment or question, then the applicant must appear before the called committee members. If the appeal is approved, the proposal will be so noted and a copy distributed to the principal investigator and respective faculty members. A copy of the approved proposal will be maintained on file and available for inspection as noted above.

If the full IRB Committee sustains the disapproval, the principal investigator may appeal that determination to the Graduate Council membership, whose decision is final.

Note: All appeals must be in hardcopy.

Section 9.2 Category 2 Review Process

Category 2 (minimal risk) research proposals will be reviewed, approved or disapproved by at least six internal IRB Committee members and one external IRB Committee member (if available) as called by the IRB Chair or Vice Chair. If any called committee member has a comment or question, then the applicant must appear before the called committee members. If approved, the proposal will be so noted and a copy distributed to the principal investigator and respective faculty members. A copy of the approved proposal will be maintained on file and available for inspection as noted in Category 1 procedures above.

If the IRB called committee disapproves a Category 2 proposal, as indicated in a non-majority vote, the principal investigator may appeal that determination to the full IRB Committee, that must consist of at least 10 members, and at least two external members (if available). If approved, the proposal will be so noted and a copy distributed to the principal investigator and respective faculty members. A copy of the approved proposal will be maintained on file and available for inspection as noted above.

If the full IRB Committee sustains the disapproval, the principal investigator may appeal that determination to the Graduate Council, whose decision is final.

Note: All appeals must be in hardcopy.

Section 9.3 Category 3 Review Process

Section 9.3. Category 3 Review Process

Category 3 (moderate to substantial risk) research proposals will be reviewed, approved or disapproved by the full IRB Committee including all members as well as at least three external members (if available). If approved, the proposal will be so noted and a copy distributed to the principal investigator and the faculty or staff sponsor. A copy of the approved proposal will be maintained on file and available for inspection as noted in Category 1 procedures above.

If a Category 3 proposal is disapproved, the principal investigator may appeal that determination to the Graduate Council. The Graduate Council decision is final.

Note: All appeals must be in hardcopy.

Section 9.4 Annual Review of Approved IRB Requests

All approved IRB requests with durations of more than one year are required to have an annual review. On a case by case basis, the IRB may request a more frequent review.

After an IRB request is approved, it is the responsibility of the principle investigator to report immediately to the IRB any significant changes or unanticipated problems in the study. Failure to report changes or problems is considered an infraction of Section 5.0. above.

Section 9.5. Conflict of Interest in Appeal Process

Individuals who serve on the IRB as well as the Graduate Council, will recuse themselves from a Graduate Council IRB appeal process.

Section 9.6. Doubt or Disagreement on Level of Review Process

In the event that there exists doubt or disagreement with respect to which category of risk should be associated with a particular proposal, the proposal will be treated as the next higher Category and be subject to those review procedures

Section 9.5 Conflict of Interest in Appeal Process

Individuals who serve on the IRB as well as the Graduate Council, will recuse themselves from a Graduate Council IRB appeal process.

Section 9.6 Doubt or Disagreement on Level of Review Process

Section 10.0 Doubt or Policy on Multiple Studies and Timeline for IRB Review

To obtain information relevant to IRB concerns, the IRB asks that those wishing to use human research participants complete an application form for each study they intend to perform (this form is titled “Application for Approval of Research with Human Research Participants” and is available on the IRB website in online or hardcopy form).

Since the review process typically requires specific protocols, please note the typical minimum and maximum review timelines:

[Appeals may require longer duration than the times noted]

Category 1 review; A minimum of two weeks and a maximum of four weeks without appeal

Category 2 review; A minimum of four weeks to a maximum of six weeks without appeal

Category 3 review; A minimum of four weeks to a maximum of eight weeks without appeal

All individuals with IRB requests should allow ample time for approval of projects prior to the intended research start. If serious ethical concerns are involved, the process may take longer. In cases of appeal, the time is on a case by case basis that may be longer than the maximum noted above.