Sponsored Programs (Grants)
Info Revised 12-20-17
Director: Tandy Keenan
Vinson Hall 311
8:00 a.m. - 1:00 p.m.
2:00 p.m. - 5:00 p.m.
Committee Members 2017-18
Dr. James Bell
Ms. Brenda Hood
Ms. Brooke Fuller
Dr. Leslie Collins
Dr. Bo Hannaford
Dr. Wayne McMillin
Dr. Shawn Holliday
Dr. Chandler Mead
Ms. Tandy Keenan
Policies, Procedures & Reports
Policies, Procedures, and Reports: The Use of Human Subjects in Research
The major goal of Northwestern Oklahoma State University is to serve the larger community of the state of Oklahoma by providing opportunities for higher education to students, by broadening their educational horizons, and by helping them develop research skills. In so doing, the rights and privacy of all subjects participating in research projects must be protected. The university willingly undertakes this responsibility while at the same time endeavors not to infringe upon the academic freedom of the members of the university. Thus, as part of this responsibility, the university seeks to protect the rights of individuals involved as subjects in all research projects. This policy was developed in response to the requirements of NSF-207, "Protection of Human Subjects Under NSF-Supported Projects," and applies to all research involving human subjects at Northwestern Oklahoma State University.
The IRB committee shall consist of at least six (6) people; five (5) shall be the current members of Grants Oversight Committee or professionals associated with the university and the sixth a person not otherwise affiliated with the university. All members are appointed by the Vice President for Academic Affairs. At least one must be a non-scientist.
All members of Northwestern Oklahoma State University (undergraduate and graduate students, faculty, and administrators) who wish to conduct research employing human subjects, as well as non-university members wishing to do research in partnership with a member of Northwestern Oklahoma State University or on a NWOSU campus must submit an IRB application and proposal to the Office of Sponsored Programs (OSP). This proposal will describe the study subjects and the parameters of the study. Forms are available under the Sponsored Programs link at nwosu.edu or by contacting the OSP.
The IRB Committee’s approval of the research project shall be contingent on the following: (a) sufficient information given to the potential subjects to enable them to make an informed decision whether to participate, including an explanation of the purposes of the research and a description of any reasonable and foreseeable risks or discomforts, and (b) assurance that these risks will be minimized and are in reasonable proportion to the expected benefits.
It is the ultimate responsibility of the researchers to file their proposal with the Office of Sponsored Programs. Students doing research with human subjects are responsible for filing proposals; however, it is the responsibility of the supervising faculty member to inform students of their responsibility and to review their students' proposals before submission to the OSP. Proposals may be filed at any time but approval must be obtained before the research is initiated. The IRB Committee will review proposals as quickly as possible, but a review time of less than one month cannot be guaranteed. Researchers who fail to file proposals and obtain approval prior to administering any research instrument involving human subjects are violating the rules of the university. Breaches will be reviewed by university administration on a case by case basis.
When is application to the IRB Required?
It is the policy of Northwestern Oklahoma State University that all research involving human subjects conducted by faculty, students, or staff of NWOSU shall be submitted to the NWOSU Office of Sponsored Programs (OSP) for review. If an IRB review is deemed necessary by the OSP, the OSP will initiate the review. The Investigator must have IRB Approval or a notice from the OSP that an IRB review is not necessary before initiating the research. This is true regardless of the research location.
To determine if a researcher’s project requires IRB review, the researcher will need to assess if it meets the definition of research and if human subjects are truly involved.
For purposes of the IRB, research is defined as a systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge (45 CFR 46.102(a)). Any activity that fails to meet either of these criteria is not considered research for the purposes of the IRB. This definition applies regardless of what a funding agency may call the activity. (e.g., demonstration grants).
Generalizable knowledge is determined by whether results are published, presented to the public, or developed for others to build upon. This includes theses, creative components, oral histories, and in‐class research if results may be disseminated outside of the classroom now or in the future. “Creative components” is a broad topic and examples include media/journal articles, films, and books.
A human subject is defined as a living individual about whom an investigator conducting research obtains:
- Data through intervention or interaction with the individual; or
- Identifiable private information, which includes information about behavior that occurs in a context in which an individual can reasonably expect will not be made public (a medical record, for example); private information must be individually identifiable in order for obtaining the information to constitute research with human subjects (45CFR 46.102(f)).
All NWOSU research requires signed Informed Consent from participants unless the PI can justify to the IRB why they should not be included. Research conducted on non-NWOSU properties must obtain written Informed Consent from an authorized facility representative.
Types of Review
All research activity must be approved by exempt, expedited, or full review from the IRB Committee. The levels determine what degree of scrutiny is needed. “Exempt” requires a single person to sign off (Chair), “expedited” requires a review by at least two individuals, and “full review” means a minimum of six committee members must review the project. The level of review required is determined by confidentiality concerns and potential risk to which participants may be subjected.
The federal government has identified certain categories of research involving human subjects that qualify for exemption from federal regulations. Northwestern Oklahoma State University (NWOSU) is authorized by the federal government to determine whether studies thought by the principal investigator (PI) to be exempt from federal regulations actually qualify for exemption. Such determination is made on behalf of NWOSU by the IRB. Only the IRB has authority to make a determination that a study is exempt from federal regulations and from IRB review and approval. When the IRB notifies a PI that a research project is EXEMPT, it also notifies the PI that the research is approved for initiation or continuation. In order to qualify for exemption, a research study cannot place subjects at greater than minimal risk and must fall entirely within one or more of the following six (6) categories for exemption.
The researcher is:
- Using existing data that is publicly available,
- Using existing data from which the investigator records data in such a way that subjects cannot be identified with appropriate collection, storage, and disposal protocols in place to maintain confidentiality,
- Conducting research using educational tests,
- Utilizing surveys exclusively,
- Utilizing interview procedures or observation of public behavior, or
- Collecting data only from public officials or political candidates regarding their office.
These exemptions will not be granted if (1) subjects are identified in, or identifiable from, the data collected; AND (2) any disclosure of subjects' responses could place subjects at risk of criminal or civil liability or be damaging to subjects' financial standing, employability or reputation.
Researchers who are uncertain of whether their research is exempt should seek clarification from the IRB representative for their College/School. Protocols that have been granted exemption from NWOSU IRB Review may still be subjected to review mandated by study sites, schools, or collaborating institutions.
If the research involves prisoners, then it does not qualify for exemption from federal regulations and IRB review.
What Exemption Means: "Exemption" as used in this document means exemption from the requirements set forth in Regulations for the Protection of Human Subjects (Title 45 Part 46 of the Code of Federal Regulations), such as the requirement for a written informed consent document. At NWOSU, determinations of exemption are made by the IRB.
What Exemption Does Not Mean: "Exemption" does not mean that the research activity is exempt from the laws of the state of Oklahoma, and it does not mean that the research need not conform to the canons of sound research ethics.
Exempt reviews may be approved by any one member of the IRB Committee, usually the Director of Sponsored Programs. For additional information regarding Exempt Review categories, see OHRP Decision Charts #2-7 for Exempt Categories.
Expedited review is a procedure through which certain kinds of research may be reviewed and approved by three (3) IRB members rather than the full IRB. Expedited reviews will be conducted by the Office of Sponsored Programs director and two (2) designated members of the IRB.
A list of categories of research has been established in the Federal Register that may be reviewed by the IRB through an expedited review procedure. An IRB may use the expedited review procedure to review either or both of the following:
Some or all of the research appearing on the list of categories of research (established in the Federal Register) and found by the reviewer(s) to involve no more than minimal risk.
Minor changes in previously approved research during the period (of one year or less) for which approval is authorized.
Criteria: The following criteria must be met in order for research to be considered for expedited review:
The research activities must present no more than minimal risk to human subjects. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
All of the research activities involve only procedures listed in one or more of the research categories established in the Federal Register. The categories in this list apply regardless of the age of subjects, except as noted. Categories one (1) through (7) pertain to both initial and continuing IRB review.
Proposals requiring full committee review may fall under one or more of the following criteria:
- Involve data collected from protected populations (e.g., children or adolescents, inmates, pregnant women) or other socially or politically vulnerable groups
- Involve some form of manipulation of research participants
- Allow for potential identification of participants
- Assess issues of a sensitive nature (e.g., sexual behavior, mental illness) or illicit/illegal activities (e.g., drug abuse, binge drinking)
As with other review types, the IRB collaborates via a Shared Folder to review all proposals falling in this category. A majority vote of the six members of the full review committee is required for proposal approval. If modifications to the proposal are required, which is quite common, investigators will be notified of the changes to be made. A final approval email will be sent out by the Office of Sponsored Programs once the proposal has been updated and reviewed by an appointed IRB member.
Because in-person meetings are not feasible for full IRB reviews, all IRB members will have an “IRB Reviews Shared Folder” on their desktop. The Office of Sponsored Programs will work with the IT department to make sure the folder is available to all on-campus IRB members. The non-campus affiliation member will receive the documents for review by email from Sponsored Programs.
When a full review is needed, the Director of Sponsored Programs will notify the IRB by email. The email will include the file name that needs to be reviewed.
IRB members will provide their feedback and save the document. Make sure the file is saved in the Shared Folder.
The Office of Sponsored Programs will request any required edits from the PI (Principal Investigator) and submit changes to the Shared Folder.
No action is needed by members in regards to the Shared Folder unless notified by Sponsored Programs.
The final document will be changed from a Word Document to PDF format. Once each IRB member approves the research, he or she will place a check by their name, sign, date, and save the document.
Note: Once a PDF document has been signed, existing signatures and comments cannot be edited.
The approved documents will be filed in the Office of Sponsored Programs.
The designated IRB members will follow the same protocol for Expedited reviews.