Institutional Review Board Policies and Procedures

It can be very difficult to determine what constitutes human subjects research. The common rule offers the following definitions as guidance for determining human subjects research. The definitions are intentionally broad to include a wide range of research. These definitions are the starting point for anyone attempting to determine whether their research requires IRB review.

The first question to ask is "Does my project involve human subjects?"

Human subject means a living individual about whom the investigator conducting research obtains (a) data through intervention or interaction with the individual or (b) identifiable private information (45 CFR 46.102F).

Investigator is any faculty, staff, or student member of any Northeastern State University campus who engages in any research activity involving the use of human subjects.

Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

The idea of interaction with a human being is perhaps key in determining whether or not the human being is a subject with respect to the regulations. All forms of interaction are included by the regulatory definitions. Among the most common types of research interaction are:

• Mailed or Internet questionnaires or surveys
• Personal interviews, structured or unstructured, with or without recognized instruments
• Personal (i.e. face-to-face) surveys
• Telephone interviews and surveys
• Classroom instruments, evaluations or exercises
• Examination of private records (e.g. medical, psychological, or school records)
• Observation of public behavior by identifiable individuals (e.g. in a classroom)

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by and individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

The second question to ask is, "Is my project actually research?"

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge. Activities meeting 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, or called development, demonstration, instruction, or another term. For example, some demonstration and service programs may include research activities (45 CFR 46.102d).

If the answer to both questions is yes, then you need IRB approval to conduct research. Otherwise you need to ask these questions:

• Does the activity involve the use of a drug (including an approved drug or an over-the-counter drug), other than the use of an approved drug in the course of medical practice?
• Does the activity involve the use of a medical device (including an approved medical device), other than the use of an approved medical device in the course of medical practice? (Note that medical devices generally include devices intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals, and devices intended to affect the structure or any function of the body of humans or other animals.
• Will data be submitted to the FDA or held for their inspection?

If the answer to one of the above questions is yes, then you need IRB approval to proceed.

The review process and time will vary with the category of review (exempt, expedited, full board), and whether or not submissions are complete. Applications may be submitted at any time. However, applications needing full board review must be submitted by the deadlines listed in the meeting schedule in order to be reviewed at the next meeting. The process is summarized below:

1. The investigators submit an electronic application as an email attachment to irb@nsuok.edu
2. The IRB email account generates an automated confirmation of receipt.
3. The Chair assigns each complete application a unique number and makes a preliminary decision about the category of review (exempt, expedited, or full board).
4. The Chair notifies the investigators of the review category and requests the electronic signatures of all investigators.
5. The Chair assigns the application to IRB reviewers.
6. The Chair verifies that the investigators submitted all signatures and supporting documentation.
7. The Chair notifies the investigators in writing of the IRB's decision: approve, require modifications (to secure approval), or disapprove. If the IRB decides to disapprove an application, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

The IRB Chair will make a preliminary determination regarding whether the proposal is exempt, expedited or qualifies for full review.

Exempt Review

Applications for exempt research are sent are sent by the IRB Chair to one IRB member for review to certify exemption.

Expedited Review

Expedited research applications are sent by the IRB Chair to two (2) IRB members for review. The reviewers are selected based on expertise: however, applications are not reviewed by a member from the originating department.

Exempt and Expedited proposal reviewers will review the research in accordance with the requirements of this policy, obtain additional information from the investigators if necessary, obtain other expert opinions if necessary, then report his/her findings to the IRB Chair. If favorable, the Chair shall notify the investigators that the research has been approved for the use of human subjects. If unfavorable, the research shall be reviewed by the full IRB for final disposition. IRB members conducting exempt or expedited reviews may not disapprove the use of human subjects in proposed research; only the full IRB may disapprove proposed research involving the use of human subjects. Each IRB member conducting exempt or expedited reviews shall report on his/her actions to the full IRB at the next meeting. This report shall include the names and departmental affiliations of the investigators, a short synopsis of the proposed research, and any substantive issues concerning human subjects that the research presented.

Full Board

Proposals needing full board review will be sent to IRB members prior to the meeting so that each member will have adequate time to review the proposal. Prior to the IRB meeting the reviewers may correspond with the investigator(s) to resolve any questions. Furthermore, any IRB member may contact the investigator, co-investigators, other IRB members, or outside sources as necessary to insure a thorough evaluation of risks and benefits of the proposed research.

The IRB meets at announced times to review and discuss each proposal. The proposals undergoing initial review are presented and discussed individually by the IRB, as well as those proposals undergoing continuing review. Primary reviewers of exempt and expedited proposals will report recommendations regarding the proposals they reviewed. After complete and individual discussions, each proposal is voted upon for one of four possible dispositions. The Board may vote to approve, disapprove, table, or approve with explicit conditions. The IRB accepts and endorses without reservations approved studies. Studies approved with explicit conditions, the IRB accepts and endorses provided the investigator concurs with the explicit changes and recommendations. A study may be tabled because the Board did not have sufficient time, expertise, or appropriate personnel present to vote on the study, or because the Board needed substantive clarification or modifications regarding the protocol or informed consent documents to determine whether to approve or disapprove the study. A study may be approved with explicit conditions when the convened IRB is able to stipulate specific revisions that require simple concurrence by the investigator. If the IRB approves a study with explicit conditions, then the IRB member or another member designated by the Chair may approve the revised research protocol under an expedited review procedure to determine whether the investigator has incorporated the specified explicit conditions into his or her project. The potential IRB actions are:

1. Approved Accepted and endorsed as written with no conditions.
2. Approved with Explicit Conditions Accepted and endorsed with explicit minor changes or simple concurrence of the principal investigator. All explicit conditions requested of the PI (IRB sends formal letter) must be completed and documented prior to beginning the research. For these conditions, the IRB Chair or designated reviewer can, upon reviewing the PI's response(s) to stipulations, approve the research on behalf of the IRB. If your study has received approval with Explicit Conditions, return one copy of the corrections to the IRB with any changes underlined or in bold.
3. Tabled Generally, the protocol or consent form has deficiencies that prevent accurate determination of risks and benefits or requires significant clarifications, modifications or conditions that, when met or addressed, require full IRB review and approval of the PI's responses and revisions. The deficiencies will be specified to the PI (IRB sends a formal letter), and on occasion the PI is asked to attend the full board meeting in order to clarify the points in question. If your study was tabled, re-submit revisions to the IRB. Please indicate changes by underlining, bolding, or highlighting.
4. Disapproved The protocol describes a research activity that is deemed to have risks which outweigh potential benefits or the protocol is significantly deficient in several major areas such as safety of subjects, lack of proper informed consent, lack of supervision from a school system, etc.. A principal investigator has the right to appeal the disapproval of his research protocol to the Board and asked to have the decision reconsidered. Investigators may submit a written response to the IRB for a protocol that is disapproved or tabled. The written response will be reviewed by the IRB. The IRB will invite the investigator to the IRB meeting if the IRB has additional questions for the investigator. The IRB will reconsider its decision. The second decision is final.

Following the presentation and discussion of proposals receiving either initial or continuing review, a listing of proposals reviewed and administratively approved for continuation, a listing of proposal modifications, a listing of those proposals approved through expedited review procedures, a listing of exempt proposals and other information relating to ongoing research activities are reported by the IRB chair to the Vice-President of Academic Affairs. The principal investigator is notified of the status of approval within 4 days of the IRB meeting. Letters are sent to the PI through campus mail and by electronic mail as necessary.

There are times when the risks associated with a particular protocol are such that continuing review should take place more frequently than annually. In these cases, the IRB will specify that the PI report to the IRB either at a shorter time interval or after a specified number of subjects (e.g., after each subject or after 3 subjects) are enrolled. The PI's reports must describe the observed effects of the research activities and/or how the subject(s) responded to the research interventions. The determination will be recorded in the IRB minutes and reports forwarded to the IRB, by the IRB office, when they are submitted.

Any research projects which are conducted with an expectation that the results of the research will be made public through any type of publication, including publication in a thesis or dissertation, or presentation at a meeting must be reviewed and approved by the IRB before the project

Exempt Review

Under Federal regulations (45 CFR 46.101(b)), certain categories of activity are considered research but may be exempt from full review by the IRB. This determination must be made by the IRB after review of the research proposal. In other words, even if a researcher thinks the research qualifies as exempt , the exempt proposal must still be submitted for IRB approval. If a study falls into one of the exempt categories, researchers still have ethical responsibilities to protect participants rights.

The following are the five exempt categories as listed in 45 CFR 46.101 (b):

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, UNLESS:
   • Information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to them.
   • Any disclosure of the human participant's responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing, employability, or reputation.
3. 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. The reviewed materials already exist at the time the research is proposed and are not prospectively collected.
4. Research and demonstration projects conducted by or subject to the approval of Federal department or agency heads and designed to study, evaluate or otherwise examine public health benefit or service programs.
5. Taste and food quality evaluation and consumer acceptance studies.

As defined by the National Institutes of Health, a "conflict of interest" arises when an employee is involved in a particular matter as part of his/her official duties with an outside organization with which he/she also has a financial interest, or one which is imputed to him/her, i.e., the employee's spouse, minor children, an organization in which the employee serves as officer, director, trustee, partner, or employee, or a person or organization with which the employee is negotiating for prospective or has an arrangement for prospective employment. Conflicts of interest can arise out of the fact that a mission of the university includes faculty consulting and the commercialization of technologies derived from faculty research. However, an individual's actions or decisions cannot be determined by consideration of personal financial gain.

The federal guidelines and the university's policy apply to persons responsible for the design, conduct, or reporting of research. In some cases, undergraduate or graduate students may be responsible for the design, conduct, or reporting of research, such that they are considered to be an investigator under this policy and may be required to complete disclosure statements. In any situation, it is the responsibility of the principal investigator to ensure that students are not diverted from their primary educational mission.

When does conflict of interest occur?

A PI or Co-PI is said to have a conflict of interest whenever that PI or IRB member, his or her spouse, or dependent child falls under any of the following conditions:

• Is an investigator or sub-investigator on the protocol (IRB members only, not applicable to PIs);
• If the IRB member, the member's spouse, or dependent children are involved in the conduct of research;
• Has entered into a financial arrangement with the sponsor or agent of the sponsor, whereby the outcome of the study could influence the value of the economic interest of the investigator;
• Acts as an officer, director, or agent of the sponsor;
• Has any equity interest in the sponsor that when aggregated for the investigator or member and the investigator's or member's spouse and dependent children exceeds $10,000 as determined through reference to public prices (e.g., NYSE or NASDAQ), any amount if the value cannot be determined through reference to public prices, or 5% of the equity of the sponsor;
• Has received payments or other incentives from any sponsor when aggregated for the investigator or member and the investigator's or member's spouse and dependent children that total in excess of $10,000;
• Has identified him or herself for any other reason as having a conflicting interest.

All investigators are required to disclose any conflicts of interest. In cases of conflict of interest, the IRB will table approval pending review by the University legal staff. Once the University legal staff has made final determination, than the IRB shall review the human subject research proposal in accordance with the Common Rule, and to determine whether the PI has made a compelling reason to conduct research in question.

Research conducted on sites outside of NSU, including public schools or school districts, typically require written approval from an appropriate representative prior to IRB approval. The site approval letter must be on official letterhead and signed by the appropriate representative. Investigators may arrange for the site to fax or mail the letter directly, or obtain the letter from the site and mail it to the IRB Chair. Scanned copies of site permission letters are not acceptable.

Research involving other institutions that have their own Institutional Review Board, including other higher educational institutions and some tribes, typically require approval of their own IRB.