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- You need IRB approval, what do you do next?
- How do you apply for approval?
- What if you are not approved?
- What do you need to know about the review process?
- What if you have problems or need to make changes?
You need IRB approval, what do you do next?
What level of review do you need?
Specific criteria for IRB approval of research are discussed in more detail in the IRB policy; however, the following elements are central to IRB decisions. In order to ascertain the level of review, several factors will be considered including whether:
- Risks to subjects are minimized;
- Risks are reasonable in relation to anticipated benefits;
- Selection of subjects is equitable;
- Informed consent is sought from each subject; and
- Informed consent is appropriately documented.
There are five categories of review for projects involving human subjects in research settings. The categories include:
- Full Board Review
- Continuing or annual renewal
- Classroom assignments
Generally speaking, new applications will be submitted as exempt or expedited reviews. A small number of cases might qualify for full board review, but that will be determined by the IRB Committee Chair, not by the applicant. In most cases, if a full board review is required, it will be initiated by the IRB Committee based on an expedited review application. Continuing or annual renewal applications apply only to projects that have previous IRB approval. Classroom assignment applications may only be submitted by faculty members on a limited basis for projects that are not necessarily research in nature but are designed to familiarize students (through assignments) with the process of research.
What type of research is considered exempt?
Any study that uses vulnerable populations such as children, cognitively impaired individuals, incarcerated people, or pregnant women is not eligible for exemption. Research on these populations requires expedited review.
Some limited types of research are exempt from IRB monitoring; however, federal regulations, funding agencies, and UTC policy prohibit investigators from making this determination on their own. Only the IRB Chair or his/her designee is allowed to make that determination, thus researchers must submit an application to ensure that the research meets the criteria for an exemption.
Service projects involving human subjects (including grants and programs that provide services and include an evaluative component that might be determined to be research) are encouraged to contact the IRB Chair and/or submit a proposal to ensure that they are exempt from IRB review. The investigator must receive a letter from the IRB Chair stating that the research is exempt before the proposed research may proceed. There is no such thing as an emergency exemption and no university official other than the IRB Chair may designate research as exempt.
Specific Categories of Exempt Research
According to federal Department of Health and Human Services (DHHS) regulations for protection of human subjects in 45 CFR 46.101, research may qualify as exempt if:
- The research is conducted in established or commonly accepted educational settings, involving normal education practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- The research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or observation of public behavior, unless the information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects or any disclosure of this information outside the research could reasonably place the subject at risk of criminal liability or civil liability or be damaging to the subject's financial standing, employability or reputation.
- The research involves the use of educational tests, survey or interview procedures, or observations of public behavior when the human subjects are elected or appointed public officials or candidates for public office.
- The research involves the use of educational tests, survey or interview procedures, or observations of public behavior and federal statutes require without exception that the confidentiality of the personally identifiable information will be managed throughout the research and thereafter.
- The research involves 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
Research that fails to meet any of these criteria may not be considered exempt.
What type of research is eligible for expedited review?
Federal regulations and institutional policy allow for expedited review of certain types of research that have been determined to place a human subject at minimal risk in a research setting (45 CFR 46.110 and 21 CFR 56.110). Much of the research in the social and behavioral sciences has no more than minimal risk and will be eligible for expedited review. The greatest risk is often a breach of confidentiality. Certain specific medical procedures also are deemed by federal policy to involve only minimal risk (such as gathering blood samples and some other non-invasive methods of specimen collection. Investigators should see the full UTC policy for a list of these specific procedures. In addition, if subjects will be randomized to treatment and control groups, then the study does not qualify for expedited review (and will need a full board hearing.) Expedited review also is prohibited in cases when the identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability; be damaging to the subjects' financial standing, employability, insurability, or reputation; or be stigmatizing unless reasonable and appropriate protections are implemented so that risks related to invasion of privacy and breach of confidentiality are minimal.
What type of research requires full board review?
Any research that involves more than minimal risk to respondents requires full board review. In rare instances, initial applications may require an application for full board review. In most cases, the typical type of research conducted at UTC is eligible for expedited review. Researchers are encouraged to contact the IRB Chair prior to submitting a full board review application. In some instances the IRB Chair or IRB Committee members may feel that an application requires a full board hearing. In those instances, the IRB Chair will notify the principal investigator on the application and request additional information if needed.
What type of research requires annual or continuation review?
IRB Approval is valid for one year. At that time, investigators must file an Annual Review Form noting the project is complete or requesting a renewal for projects that required expedited or full board review. Projects approved under the Full Board Review process require an annual review by the full board committee membership. The annual review date is an anniversary date that is one calendar year later than the date on the original IRB formal letter of approval. IRB Applications that qualified as exempt do not require an annual review.
What type of research qualifies as a classroom assignment?
In some instances, faculty members may wish to require students to complete research projects in order to learn about the process of conducting research. These projects do not meet the definition of research as outlined in the IRB policy; however, there is a need to ensure that these class assignments do not compromise any of the principles outlined in the UTC IRB policy. It also is essential that students be socialized to the ethical and procedural concerns associated with institutional review practices and the need to protect human subjects.
Student research projects may be exempt from IRB review if the assignment meets the criteria outlined below. This procedure applies only to class assignments and does not include independent study projects, honors projects, theses, or dissertations. These types of research require normal review according to the UTC IRB policy.
Faculty members may elect to use the procedure outlined in this section of the policy for student research projects that involve classroom assignments (at both the graduate and undergraduate level) when all of the criteria listed below can be met:
- the assignment is part of a regular class which meets weekly (by any format; i.e., in person or electronically);
- the assignment will be completed during the semester in which the student has registered for the course (and therefore has faculty supervision);
- the purpose of the assignment is for students to learn about the process of engaging in research and not to actually engage in research which would be used for publication, formal reports, or other formal means that would add to the body of knowledge in a particular field;
- the project is eligible for exempt or expedited review (i.e., no project requiring full board approval may be dealt with under this procedure); and
- the instructor has completed the on-line training and has filed their certificate of completion with the Chair of the IRB Board (available at http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp ).
Faculty members who wish to use this procedure must:
- submit a Class Project Form to the Chair of the IRB indicating the course, the assignment, and a copy of their certificate of completion of training. This Form must be approved by the IRB Chair prior to any projects proceeding;
- require students to submit the appropriate Form A or B for approval by the instructor (instead of the IRB Board);
- review and approve the exempt and expedited review forms submitted by the student to the instructor; and
- submit a Form E at the end of these semester which outlines the students name, project title, a short description of the project and certifies that the instructor has ensured that all human subjects protections have been met (including informed consent, anonymity, and minimal risk).
These files must be maintained for no less than three years by the faculty member and may be periodically audited by the IRB Chair and/or his/her designee.
Where do you send your application?
How do you apply for approval?
All non classroom research proposals require the submission of Form A to email@example.com. Upon receipt of Form A, the IRB will determine if the application classifies as exempt or expedited. Annual review and minor changes require a Form B. Classroom assignment applications require a Form C. All applications contain submission directions on the form. All students must have their application approved and signed by their faculty sponsor before submission to the IRB Committee.
If the information on the application seems incomplete or raises any concerns (e.g., regarding eligibility for exempt status, invasion of the subjects' privacy, or confidentiality of research records), the applicant will receive an Action Form from the IRB Chair. The Action Form will outline the concerns that must be addressed in order to continue the review process. It also may indicate that the research does not qualify for the level of review as submitted and ask the investigator to submit a new or revised application.
Exempt and Expedited Applications
All new applications should be submitted as a Form A, the Application for Review of Research Involving Human Subjects. This form requires the investigator to discuss the purpose/objectives of the research; background and rational for the study; the subject population; methods/procedures; incentives; risks and benefits; and privacy/confidentiality. Ensure that all consent forms are submitted with the application. For student projects, faculty advisor approval is required. Submit the application to the faculty advisor first, then he or she can submit it and all applicable attachments to the IRB.
Continuing or Annual Renewal
Investigators who believe their changes involve minor modifications should complete a Certification for Changes Form. Major modification/change requests require that the investigator complete a new Form A noting the modifications to the project. Investigators should email all change requests to firstname.lastname@example.org.
Faculty members who wish to use this procedure must submit a Form C, Student Class Project Application, indicating the course, the assignment, and a copy of their certificate of completion of training. This Form must be approved by the IRB Chair prior to any projects proceeding; faculty also must require that students submit the appropriate application form for approval by the instructor (instead of submitting it to the IRB). At the end of the semester, a Classroom Project Completion Form must be submitted which outlines the student's name, project title, a short description of the project and certifies that the instructor has ensured that all human subjects protections have been met (including informed consent, anonymity, and minimal risk).
What if you are not approved?
Research cannot begin until IRB approval has been granted.
Why did you get an action form and what do you do next?
If the information on the application seems incomplete or raises any concerns (e.g., regarding eligibility for exempt status, invasion of the subjects' privacy, or confidentiality of research records), the applicant will receive an Action Form from the IRB office. The Action Form outlines the concerns that must be addressed in order to continue the review process. It also may indicate that the research does not qualify under the category submitted. Many applications receive an action form because of the failure to address informed consent issues.
The action form will be emailed to the researcher and outline the next steps to be taken. Once the revisions are completed, the investigator should resubmit the application to email@example.com.
What do you need to know about the review process?
When can you start your research?
No research may proceed before the IRB office has notified the applicant that they are exempt or approved. There is no such thing as an emergency exemption/approval and no university official other than the IRB Chair may designate research as exempt or approve an application.
How will you know you are approved?
If there are no questions raised, the IRB office will email a letter of approval to the principal investigator or the faculty advisor noting that the research is approved. A formal approval letter will also be mailed to the investigator or faculty advisor. If the information on the application seems incomplete or raises any concerns (e.g., regarding eligibility for exempt status, invasion of the subjects' privacy, or confidentiality of research records), the applicant will receive an Action Form from the IRB. The Action Form will outline the concerns that must be addressed in order to continue the review process.
How long will it take?
The length of the review process depends on several factors including when the application is received by the IRB, the type of review, and the quality of the application. Researchers should remember that the application requires many review signatures and the IRB processing time cannot begin until the application has made it to the IRB Chair. Exempt reviews generally take about three to five days from the time the application is received by the IRB Chair. Expedited reviews are usually completed within 1-2 weeks of receipt, and full board reviews can take up to 5 weeks. The IRB Chair and Committee at UTC are not full-time staff. As such, submissions received prior to holidays and other times when faculty are very busy (Spring Break, midterms, finals) may experience delays.
Be advised that incomplete applications represent one of the main reasons applications are delayed. Be sure you have fully completed all forms and applications, included appropriate attachments, have required signatures, and request the appropriate level of review.
What if you have problems or need to make changes?
What if you need to make changes?
If substantial changes are planned, the investigator should submit a new IRB application. For minor changes (e.g., a change in principal investigator, minimal changes in wording of a survey instrument, or increasing the sample size from the same sample pool), the investigator must fill out a Change Request Form outlining the modifications. Prior to making any changes that will affect the information given on a previously approved application, the investigator must have approval from the IRB Chair. The IRB Chair will contact the investigator by email if the changes outlined on the application are not acceptable.
What is a minor vs. a major change?
Minor project changes have no impact upon the original goals and protocols outlined in the original application. Minor changes include those that do not adversely alter the overall harm-benefit profile of the study or would not potentially affect the willingness of current subjects to remain or enroll in the study. Examples include: change of project title, minimal changes in wording of a survey instrument, minor grammatical changes to an informed consent and/or child's assent form, addition or deletion of collaborators and/or co-investigators, change in student advisor, adding additional sites for data collection (include a letter from the authorized individual for a new location).
Major changes involve substantial changes to the research protocol including changes in the purpose or process of the research project. Examples might include changes in: sampling population, survey instruments, interview protocols, administration of a treatment of any kind, and/or the informed consent process. Any research, by definition, that increases the level of risk to the participant relative to the initial application MUST assume that the changes are major.
The initial evaluation as to whether an addendum/modification is major or minor starts with the principal investigator, who should assess the degree of change in procedures and risks. The IRB Chair or committee reviewers may change the status of that designation if they deem the designation inappropriate. The investigator must receive a letter from the IRB Chair stating that the proposed changes to the research are approved before any modifications may proceed. There is no such thing as an emergency approval and no university official other than the IRB Chair may grant approval for changes in projects.
What happens if you forget to submit an annual review?
The investigator must receive a letter from the IRB Chair stating that the research is renewed prior to the anniversary date or the research must be suspended pending an approved renewal notice. Projects which are found to be continuing without IRB approval are in non-compliance with UTC policy and federal regulations. In these circumstances a non-compliance report will be sent to the Provost for further action.
What happens if there are problems that result from your study (e.g., injuries to a subject, breach of confidentiality, failure to follow protocol/research design)?
All investigators conducting research on human subjects must report any injuries or adverse events associated with the study procedures and/or problems involving the conduct of individuals associated with the study which occur during the course of their research project. This is called an adverse event and requires a report be submitted to the IRB. More information is available in the policy statement. Failure to report is a breach of the conditions under which IRB approval is given, and could result in suspension or revocation of approval. Suspension or revocation of approval could result in loss of support by funding agencies and loss of right to publish.
What happens if you know that research is being conducted in violation of IRB policy?
Researchers are required to report any possible violations of IRB policy. The IRB will conduct an inquiry following any report of possible misconduct related to human research activities that may come from subjects, study personnel, staff, students, or faculty. If, for instance, a research project is being conducted without IRB approval, or an improper method of recruiting subjects is being used, or undue influence is being placed upon prospective subjects to participate in a study, the IRB has no means of learning about such situations and rectifying them unless it is informed that they are taking place. Thus, in order to fulfill its obligation to protect human subjects in research, the institution depends upon concerned individuals, including investigators, to inform the IRB of any possible misconduct related to research activities of which they become aware.
Such incidents are usually reported by telephone or in writing to the Provost or to the Chair of the IRB Committee. An inquiry is made to the investigator conducting the research activity, maintaining requested anonymity of the individual submitting the report whenever possible. Depending upon the outcome of the IRB's initial inquiry, information about the incident may be forwarded to the Institution Signatory, the Provost, or the Chancellor for appropriate resolution.