The Review Process
The Principal Investigator:
The researcher, as principal investigator, is responsible for preparing the necessary forms and other required materials as applicable, and for ensuring that these make their way to the Office of Research for review and disposition. The staff in the Office of Research are always available to provide assistance.
All research involving human subjects conducted by students, faculty, and staff at Tennessee Tech require IRB approval
prior to beginning data collection. Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable 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 service programs
may include research activities.
A human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) 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. 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
A systematic study occurs when a researcher implements or uses commonly accepted scientific methods of data collection and analysis. This collection and analysis allow for the researcher to methodically and objectively interpret the results to explore answers to predetermined questions or testing predetermined hypotheses. The approach to a study alone does not determine the need for IRB review. In many cases, people conduct interviews or draw blood for reasons that have nothing to do with research. The statement “designed to develop or contribute” is interpreted as a study that produces results that are intended for dissemination outside of the University via poster presentations, professional or student conferences, any form of publication, or in any online media. Generalizable knowledge is results intended to (1) have predictive value, (2) provide scientific clarity, and (3) be applied to a larger population in order to further scientific knowledge or inform policy. Generalizable knowledge would be applicable to a scientific community beyond the classroom and beyond the participants in the study.
- “Student research” is defined as an activity undertaken by undergraduate or graduate students which meets the DHHS definition of research: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” “Student research” can take place in a class or as a faculty-directed independent study.
- “Student research” meets the DHHS criteria for research; therefore, it is subject to IRB review at the appropriate level.
- Thesis, Graduate Problems, and Dissertation Research: Graduate students conducting research involving human subjects for theses or dissertations must have their projects approved by their aAdvisor and/or Thesis/Dissertation Committee before preparing the Application for Research Involving Human Subjects. The Thesis/Dissertation Advisor/Chair must sign the form certifying that the Thesis/Dissertation Committee has approved the research and application. Under no circumstances can a faculty member be the Departmental Reviewer of a research project that is part of their own research program.
Departmental Review of Research Involving Human Subjects
The department or unit head is responsible for appointing a faculty member or faculty members within the department/unit as Departmental Reviewers. The definition of research, set forth by the OHRP and adopted by the Tennessee Tech IRB, is presented and explained on the Definitions page. Departments that have a high volume of IRB applications may decide to establish a Departmental Review Committee (DRC) consisting of a number of certified Departmental Reviewers. The DRC in the department establishes its own rules and procedures, within the scope of this IRB policy. The DRC reviews proposals for research (by IRB definition) involving human subjects, and determines the level of review to be conducted for each research project.
Student Activities Involving Human Subjects.
“Classroom Projects” and “Student Assignments” are “research-like” activities involving human subjects which do not meet the definition of research according to the OHRP/IRB definition. Such projects include those undertaken by students with faculty oversight and supervision. Responsibility for the ethical conduct of these activities rests with the department head of the sponsoring department or unit. The IRB does not review, monitor, or take responsibility for the conduct of these non-research activities.
Read about procedures for Student Activities Involving Human Subjects.
The substance of concern for research involving human subjects lies in the criteria by which the IRB evaluates proposals. In order to review and approve a project, the IRB must determine that it satisfies the following requirements:
- Risks to Subject: Risks to the subject are minimized by using procedures that are consistent with sound research and that do not unnecessarily expose the subject to risks (e.g., physical, psychological, social or economic) and by using, whenever appropriate, procedures already being performed on subjects for diagnostic and treatment purposes.
- Risks vs. Benefits: Risks to the subject are reasonable in relation to anticipated benefits, if any, to subject, and to the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (as distinguished from the risks and benefits of therapies or services that subjects would receive even if they do not participate in the research). The IRB does not consider the long-range effects of applying the knowledge gained in the research as among those research risks or benefits that fall within its responsibility.
- Subject Selection: The selection of subjects must be equitable. In making this assessment, the IRB takes into account the purposes of the research, the setting in which the research will be conducted, and the population from which the subjects will be recruited. The IRB will be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision- making capacity, or economically or educationally disadvantaged persons.
- Informed Consent: Informed consent must be sought from each prospective subject or the subject's legally authorized representative and will be legally documented. Informed consent will be appropriately documented or appropriately waived.
- Safety, Confidentiality and Privacy: The research plan must provide for monitoring the data collected to ensure the subjects' safety, privacy, and the confidentiality of the data.
- Other Considerations: The IRB also considers the acceptability of the research project
in terms of institutional commitments and regulations, applicable law, standards of
professional conduct and practice, and special vulnerabilities of the subjects.
When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Read more about requirements, procedures, and issues involving INFORMED CONSENT.
PROCEDURES for OBTAINING APPROVAL for a PROJECT
Complete the Application for Research Involving Human Subjects and all supporting material (i.e., copies of all instruments, informed consent form, letter of permission), and obtain approval from a Certified Departmental Reviewer. If an external sponsor funds research, approval must also be obtained from the Tennessee Tech IRB Executive Officer. Consult with your Departmental Reviewer(s) for turn around time on reviews. For externally funded projects, expect a turn around time of one week on exempt research.
The Departmental Reviewer will designate the appropriate level of review: Exempt Status, Expedited Review, or Full Board Review.
Once the Departmental Reviewer signs the application, the entire completed and signed application and all supporting material must be submitted to the Office of Research. It can be hand delivered to Amy Hill in the Office of Research, Southwest Hall, RM 149; submitted via campus mail to Box 5033; or scanned and emailed to email@example.com.
Research Certified as Exempt Status: The Office of Research will process the application and email the PI a letter of approval.
Research Requiring Expedited Review: Once the Office of Research receives and processes the application, it will be sent to the IRB Chairperson. The IRB Chairperson will assign a subcommittee of three Board members to review the application and make a determination to approve, require minor editorial revisions, request that the application be revised and resubmitted, or refer the application to a Full Board Review. The subcommittee will have two weeks from the day they receive the application to make a decision on the application. The PI should anticipate a turnaround time of about three weeks.
Research Requiring a Full Board Review: Once the Office of Research receives and processes the application, it will be added to the agenda for the next IRB meeting. The IRB meets quarterly. The dates of the meetings are published in the University Calendar. Applications must be received at least two weeks before a scheduled meeting to be added to the agenda. The IRB Chairperson will notify the PI of the decision within a week after the scheduled meeting.