The IRB regulates all activity that constitutes research with human subjects, as defined below (see 45 CFR 46.102, Definitions) that (a) is conducted by Texas Tech University personnel in the course of their employment by the university and/or (b) uses Texas Tech University facilities or resources. Generally, this means that Texas Tech University personnel conducting research elsewhere need approval by the Texas Tech University IRB even if the work is approved by another IRB. Work that is conducted on the Texas Tech University campus needs approval by the Texas Tech University IRB even if it has approval by another institution. Individuals who are in doubt about whether an activity constitutes research with human subjects or who have questions about the applicability of this policy to a research project should confer with the IRB Chair, HRPP Manager or a member of the IRB.
In most cases, multi-site collaborative research requires IRB review and approval. If the research activities at Texas Tech involve any interaction or intervention with subjects, then the protocol must be reviewed. In some instances investigators may obtain, receive, or possess private information that is individually identifiable (either directly or indirectly through coding systems) for the purpose of maintaining “statistical centers” for multi-site collaborative research. If the research activities involve no interaction or intervention with subjects, and the principal risk associated is limited to the potential harm resulting from breach of confidentiality, the IRB need not review each collaborative protocol. However, this is still considered research and the IRB must determine and document that the statistical center has sufficient mechanisms in place to ensure that (i) the privacy of the subjects and the confidentiality of data are adequately maintained, given the sensitivity of the data involved; (ii) each collaborating institution holds an applicable Office for Human Research Protections (OHRP) approved Assurance; (iii) each protocol is reviewed and approved by the IRB at the collaborating institution prior to the enrollment of subjects; and (iv) informed consent is obtained from each subject in compliance with Department of Health and Human Services (DHHS) regulations.
Under no circumstances may an investigator undertake research involving human subjects without approval by the full IRB, approval by expedited review, or approval of a claim for exemption. Retrospective approvals and exemptions cannot be granted.
The following definitions from federal regulations apply:
Research means 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.
Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Intervention includes both physical procedures by which data are gathered (for example, 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). 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” (45 CFR 46.102).
Non-research Activities are not subject to review by the IRB and do not have to be certified as exempt from IRB review. Examples of activities that fall outside the jurisdiction of the IRB because they do not have the purpose of contributing to generalized knowledge or are not systematic investigations include, but are not limited to:
Examples of activities that fall outside the jurisdiction of the IRB because they do not involve interaction or intervention with human subjects and the data do not constitute identifiable private information include, but are not limited to:
Identifiable Private Information includes information that can be either directly or indirectly linked to specific individuals. An example of information that could be directly linked to a specific individual would be that person’s social security number. An example of information that could be indirectly linked to a specific individual would be coded information, if a key to decipher the code exists.
However, when the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information pertains, this constitutes non-identifiable information. Examples of non-identifiable information include:
It is possible that some activities such as those above may evolve into research at which time they begin to fall under IRB jurisdiction, and a proposal for IRB approval or a claim for exemption should be submitted. For example, a program evaluation intended solely to aid in improving the performance of a government agency might incidentally yield data that would be of interest to a wider audience through publication. When the intent in analyzing or presenting the data becomes one that involves a contribution to generalized knowledge, an exemption or IRB approval becomes necessary.
Activities that fall outside the purview of the IRB may still involve some of the same ethical issues that confront researchers (e.g., confidentiality). Such issues ought to be considered from the perspective of ethics for teachers, practitioners, clinicians, or other professions or groups whose ethical guidelines or legal authority are relevant to the activity.
When a proposal is received, the HRPP Manager may review proposals in the Exempt category and may prescreen proposals in the Expedited or Full Board categories. Next, a primary reviewer is appointed from among the IRB members to review the proposal. The proposal is generally sent to the designated primary reviewer within three working days of receipt. The IRB Reviewer has 10 working days to complete the review. If the primary reviewer has questions about the proposal, contact is made with the Principal Investigator in an attempt to resolve the issues. Most issues are addressed through email communication.
Principal Investigators will be notified by electronic letter of the action of the IRB. Copies of these letters will be maintained in the IRB office for review by institutional officials.
Pending proposals with no response or communication will be closed after 90 days.
If a project constitutes human subjects research according to the definitions above, there are three types of proposals. Investigators should use the descriptions that follow to determine which category of review is appropriate and check with the HRPP Manager, the IRB Chair, or a member of the IRB if questions remain.
Research in the Exempt category includes research that involves minimal risk and fits certain precisely defined categories such as survey research in which responses are anonymous. The principles of The Belmont Report must still be observed in research in the exempt category.
Expedited proposals involve minimal risk and fit within one of nine precisely defined categories such as research with surveys or interviews.
Research projects involving no more than minimal risk are suited for the expedited category. Projects with children or other vulnerable populations must be approved by two expediting reviewers. Projects that are not suitable for the exempt category or those that raise other than routine ethical issues will, at the discretion of the reviewer, be referred to the Full Board for review. If the reviewer approves a proposal it will be returned to the IRB office. If reviewers have questions about a proposal and cannot approve it in its current form, they will generally contact the Principal Investigator by e-mail or telephone. Only when that procedure is not feasible will the proposal be sent back to the IRB office for rerouting. In any event, investigators will be notified of the final outcome of each review by letter, a copy of which will be maintained in the HRPP office. Expedited proposal review categories are in Appendix D, 63 FR 60364, November 9, 1998.
Research projects involving human subjects that do not qualify for either exempt or expedited categories of review must be reviewed and approved by the full IRB at a convened meeting. The IRB meets on the last Tuesday of the month. A Full Board proposal must be submitted at least two weeks before the scheduled meeting. Investigators are urged to submit earlier in order to allow for the possibility of revisions in the proposal before the meeting of the board.
After a full discussion of a full board proposal, the IRB may take one of the following actions by majority vote:
Approve: The IRB can approve the project as submitted without any changes for no more than 12 months. Projects that involve significant risks can be approved for less than 12 months at the discretion of the IRB. The decision to require a period of approval of less than 12 months is determined in the course of discussion of the proposal and is part of the motion to approve the project. Any specific findings required by 45 CFR 46 such as those needed for approval of research with prisoners (45 CFR 46.305-306), or for waivers of signed consent (45 CFR 46.117) should be documented in the minutes. Motions to approve a proposal may include a finding that the research involves no more than minimal risk, thus making the project potentially eligible for expedited continuing review.
Minor Revisions Required: The IRB may approve a project contingent upon specific, minor modifications by the Principal Investigator. When the revised proposal with the changes incorporated is received by the HRPP Manager, it will be routed to the chair or a member designated in the minutes (usually the primary reviewer) who will compare the modifications received with the actions requested by the IRB. A memo detailing and locating the changes in the proposal should accompany the submission. If the modifications are in compliance with the IRB directives, the chair or the primary reviewer will approve the project for the period of time specified by the IRB. Note: although the approval is not effective and the project may not go forward until the modifications are approved, the period of approval is a maximum of 12 months from the date of the convened meeting.
Defer Pending Resubmission: If the IRB deems that the proposal requires substantial revisions, or if unanswered questions remain, the IRB will require the investigator to resubmit the proposal and attachments with all of the changes required and all of the questions resolved. A revised version of the proposal with the incorporated changes will be reconsidered at the next board meeting following resubmission.
Disapprove: The IRB may disapprove a research project if it has determined that the human subjects are at a greater risk than the benefits to be accrued. This action is taken only after all negotiations with the investigator have failed to result in a resolution of the pertinent ethical issues. Notification will include the reasons for the disapproval. Upon disapproval, the Principal Investigator can submit a revised proposal to the IRB. Federal regulations specify that the administration of the university cannot approve a project which the IRB has disapproved.
Letter and spirit both matter. The IRB cannot approve a proposal that is not consistent with the criteria set forth in 45 CFR 46 or the interpretations of 45 CFR 46 issued by OHRP (see Guidance Documents at http://www.hhs.gov/ohrp/policy/). At the same time, every project is reviewed with consideration of the more general ethical principles of respect for persons, beneficence, and justice described in The Belmont Report. The integrity and good will of investigators is assumed, but the IRB is required not only to ensure the protection of human subjects but also to document that their rights and welfare have been protected. In reviewing proposals, the IRB must determine that each one satisfies the following standards:
Risks to subjects. Risks to subjects are minimized by the use of procedures that are consistent with sound research and that do not unnecessarily expose the subjects to physical, psychological, social, economic, or other risks. In the case of research involving diagnosis or treatment, risk is minimized by the use of procedures already in use for diagnostic and treatment purposes whenever appropriate.
Risks vs. benefits. Risks to the subject are reasonable in relation to anticipated benefits, if any, to subjects, and to the importance of the knowledge that may reasonably be expected to result. In order to assess the importance of the knowledge resulting from the research, the IRB must be satisfied with the soundness of the rationale and the research design. The board’s concern about the scientific validity of research is in direct proportion to the risk involved. 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 did 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. When students are offered course credit for participation, there must be non-research alternatives for earning the same credit for the similar time and effort.
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.
Other considerations. The IRB may also consider the acceptability of the research project in terms of other applicable standards of professional conduct and special vulnerabilities of the subjects.
In virtually all instances, investigators work with the IRB to reach agreement on the best ways to meet human subjects requirements while conducting research. In cases where the investigator and committee reach an impasse, a decision by the IRB to disapprove a project is final. Federal regulations prohibit the university from approving a project which the IRB has disapproved.