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The IRB reviews each application with consideration for the rights and welfare of the individuals involved, the balance of risks and potential benefits of the study, and the methods used to secure informed consent. There are three levels of review, as determined by the degree of risk to subjects. Applicants may require full review, expedited review, or be screened for exemption. The level of review is determined by the IRB. Please allow up to two weeks for a response to an exempt or expedited review (does not require full board review). Full board protocols must be submitted three weeks prior to the meeting date, otherwise it will be reviewed at the next scheduled meeting time. The reviewer will categorize the editorial comments apart from comments concerning human subject concerns. The review process will cease if there are gross grammatical errors and the protocol will be returned. Research may begin only after IRB approval.

Levels of Review

• First Level – Full Board
  Any research that involves more than minimal risk, vulnerable populations, experimental drugs or devices, invasive procedures, or deception is subject to full board review. Meetings are scheduled on an as needed basis, and investigators are encouraged to attend.
• Second Level – Expedited
  Certain kinds of research involving no more than minimal risk as defined by federal regulations may be subject to expedited review. Expedited review consists of review by the IRB chairperson or by one or more experienced reviewers designated by the chairperson. A study may begin only after IRB approval.
• Third Level – Exempt Status
  There are certain categories of research which are exempt from the requirements of the IRB. The rationale behind these categories of exemption is that, while the research involves human subjects, it generally does not pose physical, social, or ethical risks to human subjects. A study may begin only after the IRB has confirmed that it is exempt.
• Continuing Review
  Research that presents significant physical, social or psychological risks to subjects is subject to continuous review at least every 12 months. Continuing review will not be required in instances where such review does little to protect subjects (e.g., where data collection is complete and only data analysis is still being performed). An is scrutinized at the same level as the initial review.

Applications

Students must first submit applications online to their faculty advisor for review and approval. If approved, the faculty advisor will electronically sign the application and submit it to the Institutional Review Board to begin the review process.

What to submit (if applicable):

• Copy of consent document(s), cover letter(s), or script
• Copy of survey, questionnaire, interview guide/script (include documentation of permission to use/adapt a survey or questionnaire (if applicable)
• Copy of any recruitment advertisements

In addition to the application, the IRB requires that the researcher complete the Institutional Review Board Tutorial.  Once you have completed the tutorial, it will be logged into our database.  The tutorial takes about 30-45 minutes to complete. IRB approval must be obtained before submission of a research request to a school system. Once approval is received from the school system, a copy of the approval document should filed with the IRB Office. If you have any questions concerning the application process, please contact Suzanne Barham, IRB Compliance Officer, at 731-661-5580.

Any application approved for research using human subjects will require that the approved consent form include a stamp from the IRB giving the protocol number and the date approved. This will ensure that the correct, approved version is being used.

Â鶹ÊÓƵ University, in accordance with its Multiple Project Assurance (MPA) filed with the Department of Health and Human Services, and 45 CFR part 46 establishes the Institutional Review Board for the Protection of Human Subjects (IRB).

The IRB is responsible for reviewing research involving human subjects to ensure that such research is consistent with the principles of (1) respect for persons, (2) beneficence, and (3) justice, as set forth in the Belmont Report (1979). Additionally, the IRB follows all applicable Federal, state, and university regulations. These include but are not limited to 45 CFR Part 46, 21 CFR parts 50 and 56 and the Â鶹ÊÓƵ University Multiple Project Assurance (MPA) for research involving human subjects.

Non-compliance

In accordance with 45 CFR 46, the IRB is required to report instances of serious or continuing non-compliance, and any suspension or termination of IRB approval to the Vice Provost for Research, the Federal Office for Protection from Research Risks OPRR, and, in the case of Federally supported research projects, the appropriate Department or Agency head.

Additionally, non-compliance with this policy by faculty/staff members may result in one or more of the following:

• Official reprimand
• Removal from graduate faculty status
• Suspension of research privileges at Â鶹ÊÓƵ University
• Termination of employment

Non-compliance with this policy by students may jeopardize awarding of the degree being sought.

Â鶹ÊÓƵ University, in accordance with its Multiple Project Assurance (MPA) filed with the Department of Health and Human Services, and 45 CFR part 46 establishes the Institutional Review Board for the Protection of Human Subjects (IRB).

Surveys for Class Project and Research Projects: Content and Distribution Method Policy

Faculty, staff and students wishing to begin research at the university must begin the process with the IRB.

Surveys will not be approved if the distribution methods and content of the survey are outside the university context and culture. Stated differently, IRB Protocol Approval does not guarantee automatic access to our student population.

After IRB approval, distribution methods to faculty, staff and students at the university must be approved by the Office of the Dean of Students.

Below are common distribution avenue requests and the protocol for each:

• Distribution in academic hallways. May be approved. Begin the process with the Office of the Dean of Students.
• Facebook/Twitter/Social Media: Facebook can be used as a method for distribution. Please see note regarding Qualtrics* below.
• Residence Life: Students going door to door in the residence complex must begin with approval from the Dean of Students office, and must follow visitation guidelines.
• Personal E-mail requests: Once approved by the IRB, students may send the survey to e-mails they have personally collected. Please see note regarding Qualtrics* below. University officials will not generate lists of currently enrolled students for research purposes.

* It is recommended that survey administrators send respondents to a link. (Qualtrics is similar to Survey Monkey but has more robust features. Access to developing a free online Qualtrics survey begins with a university Qualtrics account manager. The name of the account manager for your discipline can be found by calling the Respective Academic Dean’s office for the Qualtrics account manager.

Any application approved for research using human subjects will require that the approved consent form include a stamp from the IRB giving the protocol number and the date approved. This will ensure that the correct, approved version is being used. It will also serve as a reminder of when the protocol must be reviewed again.

Â鶹ÊÓƵ University institutional data will not be released to internal, external, graduate or undergraduate students at this time.

The Principal Investigator determines that research will involve human subjects. The PI completes and submits an application to the Institutional Review Board (IRB) who then determines what level of review is needed (exempt, expedited, full) and initiates the appropriate review process for that level. The Institutional Review Board communicates the results of the review to the PI (exemption, approval, recommendations, etc).

If applicable, the PI provides progress report at the time of continuing review, which is due at intervals no less often than 12 months.

The IRB Office maintains record of all protocol approvals, disapprovals, continuing reviews, and other actions of the IRB, as well as Federal and institutional written policies and procedures.

Â鶹ÊÓƵ University assures compliance of Federal regulations by all collaborators in human subject research.

The IRB shall report to appropriate University and federal government officials:

1. any unanticipated problems involving risks to subjects or serious or continuing noncompliance with IRB requirements and
2. any suspension or termination of IRB approval of research.

New findings are unexpected problems whose nature, severity, and frequency are not described in the information provided to the IRB or to participants. Examples include unexpected complications in a subject, missteps in the consent documentation, or breaches of confidentiality. Adverse events should be reported to the IRB within 10 working days using the Adverse Events Form. Sometimes a study must be suspended to ensure subjects’ safety.

The report of the event should discuss:

• the facts of the case, including the date and a description of the subject;
• whether the event is related to the study’s procedures or drugs or to the subject’s underlying disease or condition;
• the steps that have been taken to address the problem;
• whether the event is likely to recur; and whether the event provides new information about the study’s risks that should be conveyed to participants, in a revised consent form.

These reports usually receive expedited review, but in some cases the full IRB is involved.

The University’s policies on adverse events are based on Food and Drug Administration regulations. According to the FDA, a “serious adverse drug experience” with respect to human clinical experience includes “any experience that suggests a significant hazard, contraindication, side effect, or precaution,” including “any experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose.” An “unexpected adverse experience” is any adverse experience whose nature, severity, and frequency of risk are not described in the information provided for IRB review or in the consent form. (See 21 CFR 312.32 [4-1-92])

All research that involves human subjects must be reviewed and approved by the Institutional Review Board (IRB) prior to initiation.

Q. What ethical principles guide the IRB in the protection of human subjects?

A. Three basic principles of ethics are particularly relevant to the protection of human subjects in research. They are:

• respect for persons: recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy;
• beneficence: obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm; and
• justice: fairness in the distribution of research benefits burdens.

Q. What are the components of IRB Review?

A. In reviewing research the IRB gives proper consideration to the following:

• risks to the subjects
• anticipated benefits to the subjects and others
• importance of the knowledge that may be reasonably expected to result from the research
• consent process to be employed

The IRB reviews research involving human subjects if one or more of the following apply:

• the research is sponsored by Â鶹ÊÓƵ University regardless of the location of the project
• the research is conducted by, or under the direction of, any staff, faculty, student, or other agent of Â鶹ÊÓƵ University in connection with his or her institutional responsibilities
• the research is conducted by or under the direction of any employee or agent of Â鶹ÊÓƵ University using any property or facility of Â鶹ÊÓƵ University
• the research involves the use of Â鶹ÊÓƵ University’s non-public information to identify or contact human research subjects or prospective subjects

Special consideration is required for research involving fetuses, pregnant or lactating women, human ova in vitro fertilization, prisoners, children, persons with cognitive impairment, or other potentially vulnerable groups.

Q. What is the difference between the three levels of IRB review (minimal, expedited, and full board)?

A. Research in the minimal review category is exempt from applicable federal regulations, although review by the IRB is still required. Minimal review research must be anonymous and at least one of the following:

• commonly accepted educational settings involving normal education practice
• educational tests if the information is taken so that subjects cannot be identified
• (does not apply to children) surveys or interviews that do not deal with sensitive aspects of the subject’s own behavior (such as drug use, sexual activity, or criminal activity), or in which the subject’s responses would not place the subject at risk of liability, or threaten financial standing or employability
• (needs not be anonymous) surveys or interviews of elected or appointed public officials or candidates for office
• (does not apply to children) observation of public behavior that does not deal with sensitive aspects of the subject’s own behavior or in which the subject’s responses would not place the subject at risk of liability or threaten financial standing or employability
• collection or study of existing data, documents, records, or biological specimens as long as they are publicly available
• research or demonstration projects of programs under the Social Security Act or other public benefit or service programs

Research in the expedited category is that which poses no more than minimal risk to the subject involving no more than:

• collection of hair, nail clippings, baby teeth or teeth in need of extraction
• collection of excreta, sweat, saliva, placenta and amniotic fluid at delivery
• non-invasive recording of data from subjects 18 years of age or older using routine clinical procedures (not including x-rays and microwaves)
• collection of blood samples of limited volume and frequency from subjects 18 years of age or older
• collection of dental plaque via routine scaling of teeth using accepted techniques voice recordings for research purposes (e.g., of speech defects)
• moderate exercise by healthy volunteers
• study of existing data, records, or specimens
• research where the researchers do 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

Research which is neither minimal nor expedited requires the full board category of review.

Q. What happens to my protocol after it is submitted to the IRB?

A. The IRB Compliance Officer processes the submitted protocol, inputs necessary information into the database, and assigns the protocol a unique number and determines appropriate level of review. Investigators are notified as soon as possible of the decisions relating to the protocol (i.e., request for revisions or approval).

Q. What kind of timeline should I expect for being able to begin data collection?

A. Remember, no research may begin until IRB has given your research protocol full approval with no revisions. The review process for protocols submitted for minimal or expedited review takes at least two weeks. The review process for protocols submitted for full board review can take up to a month or longer to complete. You should expect at least a few minor revisions. Many of these can be considered by the IRB Chair alone. To speed the review process when revisions are required, please highlight the changes.

A sizable number of protocols at the full board level of review must be returned for revisions. Why? Typically these protocols were not prepared with care, and they require substantial revisions and additions. It is safe to say that the less conscientious the initial preparation, the longer it takes to receive final approval. The IRB cannot approve applications in which critical information is missing or poorly articulated.

Q. The site where I intend to conduct my research has its own IRB. Does my protocol have to be reviewed by the site IRB and the Â鶹ÊÓƵ University IRB? If so, how do I do this?

A. Some sites of research activity, such as hospitals, community mental health organizations, and other universities, have IRBs to review the research conducted at that site. Each IRB must approve your project prior to implementation. You may submit your protocol for review to both boards simultaneously or to each board consecutively, whichever you prefer. Each board may request different revisions based on interpretations of the federal regulations. Remember that it is your responsibility as the investigator to notify each board of the decisions of the other board. You must also remember to submit any revisions to both boards and you must receive approval from both boards before implementing any aspect of the research.

Q. What about changes in the protocol once it has been approved?

A. All changes in a research protocol must be approved before the change is incorporated into the protocol. These should also be submitted to the IRB in memo form, including the protocol number to speed processing.

Q. What are the responsibilities of the Principal Investigator?

A. The principal investigator is responsible for:

• the compliance of all co-investigators, student investigators, and research associates with the IRB decisions, conditions, and requirements
• reporting to the IRB any changes to the research protocol (e.g., research design of the study, recruitment procedures)
• requesting re-approval when contact with subjects will extend beyond the approval termination date
• reporting to the IRB chair any unanticipated adverse reactions or unanticipated events associated with the conduct of this research
• seeking clarification and advice from the IRB regarding ethical aspects of the research

Resources available on the Internet

Websites pertaining to copyright and using published instruments

Resources available from the IRB Office