Every proposal should be single spaced and printed on one side of the paper only. Pages should be numbered and should not be stapled. Every proposal begins with a Cover Sheet. The Cover Sheet is followed by a Claim for Exemption or Expedited Review Form or Lay Summary in the case of Full Board proposals. The lay summary is a one page non-technical summary of the research. The Cover Sheet, Expedited Review Form, and Claim for Exemption forms are in Appendices G, H, and I. Every proposal follows the same format, found in Appendix J. A description of the required elements of consent, discussed below, can be found in Appendix K. A Reviewer Checklist used to assess the inclusion of all required materials is found in Appendix L.
The IRB proposal must include copies of all materials involved in recruiting subjects. Examples of recruiting materials, consent forms, and assent forms are in Appendices M and N. The IRB proposal must also include copies of all questionnaires, tests, interview materials, etc., that subjects will be asked to complete.
Particular attention should be directed toward the rationale for, and the details of, research procedures that involve more than minimal risk, including the risk of the disclosure of private information that might be harmful to the subject. If these sections of the proposal do not allow the IRB to judge whether risks have been minimized and are reasonable in proportion to benefits, the investigator will be asked for additional information. Where risks are negligible or minimal, particularly when the project falls into one of the categories suitable for exempt review, a brief description of the rationale and procedures may be all that is necessary. Submission of unnecessary, lengthy material, such as a literature review or method sections of a dissertation proposal, will serve only to slow down the processing of a proposal. As detailed in the next section, all expedited or full review proposals must include a copy of a consent form or a request to waive the requirement for a consent form.
Investigators should send their IRB proposals to the HRPP office at the Office of the Vice President for Research, Administration 357, MS 1075. The HRPP Manager prescreens all proposals. As part of the initial screening process, the HRPP Manager may ask the Principal Investigator to revise the proposal to make it suitable for review. A complete proposal packet includes the following in the order indicated:
|Exempt Proposal||Expedited Proposals||Full Board Proposal|
|Cover Sheet||Cover Sheet||Cover Sheet|
|Claim for Exemption||Expedited Review Form||Lay Summary|
|Proposal in 5-Point Format||Proposal in 5-Point Format||Proposal in 5-Point Format|
|Recruitment Materials||Recruitment Materials||Recruitment Materials|
The IRB Program Coordinator will send expedited review proposals to a reviewer. Ten working days should normally be allowed for processing. Proposals involving children or other vulnerable populations must be reviewed by two reviewers, which causes the review process to take longer. Full Board proposals must be received at least two weeks before the Full Board meeting. Full Board meetings are on the last Tuesday of each month at 3:00 p.m.
Data collection may begin as soon as the human subjects research proposal has received approval from the IRB Reviewer or the Full Board. Any proposed changes or extensions of the project must be approved prior to their implementation by submitting new forms or memo describing minor changes.
Recruiting materials must be described and, where relevant, included in the proposal. Examples of recruiting materials are in Appendix N.
Note: “Consent process” and “consent form” are two terms that are used frequently in this section. Although these terms are similar, they are not interchangeable. The consent process is the overall process by which the participant is made aware of the purpose, risks, benefits, etc. of the research. The consent process often includes the use of a consent form, but is not limited to that alone. The consent process also may include a dialogue between the investigator and the subjects to insure that the subject is able to give informed consent. The consent form is the written document that the participant signs indicating consent. All participants should receive a copy of the consent form.
Human subjects research proposals submitted for research in the exempt category do not require a consent form. However, pertinent information materials such as oral scripts, project summary sheets, etc. are required to provide adequate information to the participant to form a decision to participate.
Documentation of informed consent is the most problematic issue in the review of proposals for human subjects research. The required modification of consent forms is the most frequent reason that proposals submitted for expedited or full review are deferred. However, because federal regulations (45 CFR 46.117) and applicable ethical principles from The Belmont Report are reasonably clear about the essential elements required in the consent process, delays in processing many proposals can be avoided by carefully following the guidelines in this section.
Readability is important. The content of the consent form is irrelevant if subjects cannot understand it fully. Therefore, the IRB cannot approve a consent form, even if it contains all the required information, if it will not be fully understood by the individuals expected to read it. Technical material and the purpose of the study must be explained in lay terms. Procedures should be explained from the point of view of what will happen to the subject in the course of the study. The consent form should be written in the second person (“You will…”). A general rule of thumb used by federal regulators is that consent forms aimed at the normal adult should be written at a 7th grade reading level. Research projects involving children require parental consent and generally require assent from the children. The assent form must be written in language understandable to the age level or comprehension level of the child. The assent form allows the child a choice of whether or not to participate, even though the parent has given permission. Both the consent form (for parents) and the assent form (for minors) are required.
Help with readability and language level wording can be found at: http://www.plainlanguage.gov/
Information about a study that includes the elements of informed consent required by 45 CFR 46.116 may be presented in a written consent form that is signed by the subject or a legally authorized representative. The form may be read to the subject or representative, but in any event, the investigator should give either the subject or representative adequate opportunity to read the form before it is signed. When consent is obtained with a full, written consent form that is understood and signed by a competent subject, no witness is required, and the consent form should not contain a space for the signature of a witness or researcher. A copy of the consent form should be given to each participant. The signed consent form should be stored by the researcher for three years after the research is complete.
Appendix N provides examples of consent forms.
Appendix K includes the Required Elements of Consent. There are optional elements that must be included in the consent form if they are applicable to the study.
Information about a study may be presented in a short form written consent document that states that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or a legally authorized representative (e.g., Dr. Researcher told me the purpose of the study; Dr. Researcher told me what the risks of this study are). The short form is most useful when a study is complex and the investigator can’t be sure that a signed written consent is well enough understood to indicate a valid consent process. The short form allows the individual obtaining the consent to talk with the subject to make sure the subject understands what will be involved.
In this case, the following consent process should be followed:
Researchers should provide necessary information to potential subjects to assist in the decision-making process to participate. This could be done electronically by having an email recruitment letter which provides all of the required information before the participant begins and/or a short information paragraph or page before the survey.
In internet research, the consent process must still be followed if the project is Expedited or Full Board.
Sometimes an element of consent can be waived. For example, some research involving deception cannot be done with full disclosure in advance. An element of consent might be waived and not disclosed until the subject’s participation is complete. Here are two regulations that concern the form.
In section III. Procedures of the proposal narrative, the investigators should explain the justification of the request for the waiver or alteration. The investigators will include a blank copy of the “Waiver or Alteration of the Elements of Consent” form with the proposal packet. This form can be found on the www.hrpp.ttu.edu website and a copy is included in Appendix N. The form is for the IRB to document that the conditions specified are satisfied.
Sometimes the IRB can waive the requirement for a signed consent form.
In III. Procedures, the investigators will explain the justification of the request for a waiver. The investigators will also include a blank “Waiver of Written Consent” form with their proposal packet. The form is for the IRB Reviewer to document that the conditions specified are satisfied.
In IV. Adverse Events and Liability of the proposal narrative, when a research study involves no risks beyond those of everyday life or routine physical or psychological tests, the investigators should simply say: “Since there are no risks beyond those of everyday life, no liability plan is offered.”
In V. Consent Forms, the response will usually be “not applicable” for Exempt category proposals and “attached” for Expedited and Full Board proposals.
Texas Tech University’s assurance of compliance with the federal government requires at least annual review by the IRB of all expedited and full review studies involving human subjects research. As part of continuing review, the IRB has regulatory authority to observe, or have observed, the consent process and the research itself and to audit records such as consent forms at any time. When the approval for a project nears expiration, the investigator should respond to the letter sent by the HRPP Manager. The procedures below apply depending on the level of initial review. Except for Exempt category projects, the investigator will be informed by letter of the outcome of continuing review.
Exempt research. Exempt research is not subject to continuing review. Any modifications that (a) change the research in a substantial way, (b) might change the basis for exemption, or (c) might introduce any additional risk to subjects should be reported to the IRB for review before they are implemented. A yearly courtesy letter is sent to the Principal Investigator. A response to this letter informs the HRPP Manager when the exempt research is completed so that the file can be archived.
Timing of review. When a proposal is approved or extended by either expedited or full review, approval normally extends to the last day of the month preceding the anniversary of the approval. The anniversary is determined by the date of final approval (initial or continuing) by an expediting reviewer or the date of the convened full IRB meeting at which approval (including contingent approval) occurs, not the date of final approval of required changes. When continuing review is required for a period of less than a year, the expiration date is determined in a similar manner.
Approximately eight weeks prior to the expiration of the approval, the HRPP staff will send a form, “Notice of Expiration, Progress Report, and Request for Extension” to the Principal Investigator. The progress report requires a report on the status of the project, descriptions of all adverse events affecting the rights or welfare of human subjects, and any changes contemplated in the research protocol and/or informed consent/assent forms. A complete clean proposal is required every three years if the initial proposal has been amended within the three years.
Expedited continuing review. Projects initially approved by expedited review will normally undergo expedited continuing review unless changes to the research are contemplated that might move it out of the expedited category. Because 10 working days should be allowed for processing a proposal and due to the volume of expedited reviews, prompt return of the “Notice of Expiration, Progress Report, and Request for Extension” form is important to ensure that the approval of a project does not lapse. Expediting reviewers will be provided with the Progress Report, the original proposal including the current consent form, any subsequent amendments, and access to the complete file on each project. Criteria are the same as for initial review, but continuing expedited review of research involving children requires review by only one expediting reviewer. At the discretion of the reviewer, independent verification that no material changes have occurred since the previous IRB review may be required.
Full Board continuing review. Projects initially approved by the Full Board will normally not undergo Full Board continuing review unless the progress report identifies additional risks. Prompt return of the “Notice of Expiration, Progress Report, and Request for Extension” form is important to ensure that the approval of a project does not lapse.
For continuing review conducted by the Full Board, a primary reviewer will be designated. When deemed appropriate, protocols requesting Full Board review are distributed to all IRB members and include the Progress Report, current consent forms, prior amendments and the original proposal. The primary reviewer will be provided with the Progress Report, the original proposal, any subsequent amendments, and access to the complete file on each project. Criteria are the same as for initial review. At its discretion, the board may require independent verification that no material changes have occurred since the previous IRB review.
Termination. All Principal Investigators must maintain an active IRB-approved protocol until the project is complete. Once data have been rendered non-identifiable, they no longer constitute identifiable private information and further data analysis does not require continuing approval.
If the HRPP does not receive the request for an extension by the due date noted on the form, IRB approval automatically expires and a letter of termination is sent to the Principal Investigator. By not returning the form or otherwise notifying the IRB that the project has been terminated, the investigator certifies that during the preceding period of approval there were no changes to the protocol or consent form and no adverse events. Projects that continue without IRB approval or projects initiated without IRB approval are out of compliance with federal regulations and with Texas Tech University policy. In such cases a report of non-compliance will be filed with the Vice President for Research for further action. The university is required to inform OHRP of any serious or continuing non-compliance.
If a project is not being conducted in accordance with a protocol approved by the
IRB, if there is harm to a subject, or there is any other failure to conform to the
requirements of 45 CFR 46 and/or these policies and procedures, the Principal Investigator
is required to report the details of these deviations immediately to the IRB Chair.
The Chair may ask the IRB to consider the matter. The IRB has the authority in such
cases to suspend or terminate the research and/or to report them to the Vice President
for Research. Reports to the Vice President for Research will be made as soon as possible.
In the case of serious adverse events or deviations from an approved protocol, Texas
Tech University is required by its assurance of compliance with the
federal government to report such incidents to the federal Office for Human Research Protections. In addition, the university may need to report the events to research sponsors. Thus, the reporting requirement for investigators is an extremely serious one.
Changes to currently approved projects require approval by the IRB. Such modifications may include, but are not limited to, changes which affect the participation of human subjects, changes to informed consent forms and/or assent forms, additional sites for conducting the research, changes in Principal Investigators or key personnel, and the discovery of unanticipated risks to subjects. Substantive changes to projects must not be implemented until approval has been granted. If a project is not being conducted in accordance with the protocol approved by the IRB, the IRB has the authority to suspend or terminate its approval of the research.
The process and distribution of documents for reviewing changes is the same as for initial review. For proposals that have been amended, submission of a complete, clean copy that incorporates the amendments is required at least every three years. The revised copy should be submitted with the request for extension.