Frequently Asked Questions
In most cases, you need IRB approval if your study involves research with human subjects. See Who Needs to Apply for more information.
Research is defined as: "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 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" (Code of Federal Regulations, 45 CFR 46.102d).
A 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" (Code of Federal Regulations, 45 CFR 46.102f).
The intention to contribute to the body of knowledge in a field is key to the definition, whether or not the completed research makes such a contribution or is accepted for publication.
All of the following activities may be considered research:
Pilot studies (research development)
Analysis of existing data
All faculty and staff (both full-time and part-time) using human subjects or identifiable, private information about human subjects to conduct research within the course and scope of their duties are required to have prior approval from the IRB before research is initiated. Projects must be approved regardless of whether or not the research is funded and regardless of the source of funds. This policy also applies to students whose research is conducted under the advisement of a faculty member. All research proposals must be reviewed by the IRB and no individual, other than the IRB Chair, may exempt a proposal from review. Research that is conducted without IRB approval is not in compliance with UTC policy and federal regulations. In these circumstances a non-compliance report may be sent to the Provost for further action.
According to UTC policies, research must be reviewed by the IRB in advance of any involvement of human subjects. This includes research conducted at another institution in this country or research conducted abroad. It includes collaboration with investigators at other institutions, and it includes research in which other institutions or researchers gather the data for a UTC researcher.
There are a few categories of research that may involve human subjects but do not require IRB applications and/or approval. These include the types of research listed below:
UTC teacher and student evaluations;
Program evaluation research to benefit UTC and carried out by UTC administrative officials and/or their designees;
Projects designed to enhance or improve curricula offerings at UTC;
UTC employee performance evaluations;
State of Tennessee mandated program evaluations;
Marketing research (designed to market the institution as a product).
Except for the examples above, all other research involving human subjects MUST complete an application. If the Principal Investigator has any doubt about whether or not their project meets these criteria, it is their responsibility to contact the IRB Chair for clarification. 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. It is preferable to err on the side of caution and to file an application for approval if there is any doubt about the criteria. Any secondary data analyses of these data used for scholarly publication require IRB approval.
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
Generally speaking, new applications will qualify as exempt or expedited reviews. A small number of cases might qualify for full board review. Applications that automatically require full board review involve more than minimal risk to participants. 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.
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.
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). 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.
Any research that involves more than minimal risk to respondents requires full board review. In most cases, the typical type of research conducted at UTC is eligible for expedited review. 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.
IRB Approval is valid for one year. At that time, investigators must file a Form B noting the project is complete or request 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.
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 Form C to the IRB at firstname.lastname@example.org 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 Form A 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 D at the end of the 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.
All research requires informed consent. Voluntary participation and informed consent is at the very core of the need for IRB oversight. How that consent is achieved varies based on the research design and the level of review. Informed consent is a process, not just a form. Information must be presented to enable people to voluntarily decide whether or not to participate as research subjects. It ensures respect for people by providing the opportunity for thoughtful consent to ensure that participation is voluntary. The procedures used to obtain informed consent should be designed to educate the subject population in terms that they can understand to ensure that research participants understand the consent they have provided. As a result, the IRB will seek to ensure that the following general requirements of informed consent are satisfied in all studies:
Informed consent must be prospectively obtained from the participants or their legally authorized representatives;
Information must be conveyed in understandable language;
Subjects must be given sufficient opportunity to consider whether they want to participate;
Consent must be given without coercion or undue influence; and
Subjects must not be made to give up legal rights or be given the impression that they are being asked to do so.
Additional information on this site outlines this issue in more detail and provides a checklist for researchers to consult. Examples of informed consent forms/letters also are included.
Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
The consent form may be either of the following:
- a written consent document that embodies the elements of informed consent (see checklist). This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or
- a written form stating that the elements of informed consent required by this policy have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
Yes. The IRB Committee may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds that:
- the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
- the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
For most anonymous surveys and other exempt applications, no informed consent form is required. In fact, an application that requires a signed consent form in this situation may be rejected since it compromises the anonymity of the research subjects. In this case, however, researchers still have an ethical responsibility to ensure that informed consent occurs. In cases where the documentation requirement is waived, the IRB will normally require the investigator to provide subjects with a written statement regarding the research. The IRB is likely to require use of such a written statement, in the form of an information sheet or cover letter, which includes most or all of the same elements as a consent form, but does not require the signature of the subject.
There also are a few other instances where the IRB may grant an application without a signed, informed consent form. These are outlined in the IRB Policy.
What should I put in a cover letter or document to ensure informed consent when a signed, consent form is not used?
Investigators who are requesting exempt status normally will not need to use a signed informed consent form when the identities of subjects will be completely anonymous if the consent form is not signed and there is minimal risk involved in the study. Investigators in these instances, however, should be conscious of the ethical principles guiding the process of informed consent and ensure that they have provided sufficient information to satisfy the basic elements of informed consent. At a minimum, they should either provide a cover letter or introductory remarks (e.g., at the beginning of a survey) that provide: a reference to UTC and the title of the research project; the identity of the principal investigator(s) and their contact information; an introduction to the study; the aims of the study; a brief summary of the background or reason for the project; a summary of why the individual has been asked to participate in the study; a description of the type of participation requested and any procedures; an outline of any risks; an overview of how confidentiality will be maintained; an discussion of any benefits; a description of any alternatives to participation; a discussion of any costs and/or benefits; and a method of securing additional information or asking questions.
Consent forms should be simple and straightforward so that all subjects will have an easily understood form that outlines the proposed research. For most studies, it is recommended that the consent forms be written at an eighth grade reading level. Unless the subjects are themselves medical professionals, scientific or technical terms should either be replaced with or defined in lay language. Legalistic sounding language should not be used. These phrases interfere with a subject's comprehension of the consent form and lend the appearance of a legal document to the consent form. (Examples include: "You hereby agree," "You certify that," "You, the undersigned, do acknowledge that," "You understand that," "You realize that," "You have been told that," or "It has been explained to you that." )
When constructing a consent from, the investigator should review the following elements and include them when appropriate to ensure they are in compliance with federal law and UTC Policy. Research participants must be told about the purpose, procedures, risks and benefits of a particular study, the subject's rights in participating in research, the freedom to decline to participate without any jeopardy. If applicable, the alternative treatments available will be explained. The individual will also be given the opportunity to obtain further information and answers to questions related to the study. Sample consent forms are available. These elements are outlined in more detail in the UTC IRB Policy. Please see Informed Consent Requirements for further descriptions and sample informed consent forms.
If the study involves subjects who cannot give consent for themselves (e.g., minors, unconscious patients, individuals with Alzheimer's Disease), and the IRB accepts the justification for their inclusion in the study, a separate signature should be obtained for the purpose of third party consent. For studies involving minors, this signature lines will be for parent(s) or guardian(s). In other studies where a legally authorized representative will give consent for the subject, an appropriately labeled signature line should be used. Note that only parents, guardians, conservators or those who have power of attorney for health care are so authorized. If the study involves minors, an assent line also should be included for minors to sign when appropriate. Generally speaking, assent is required only for students in grade 3 and above.
It could be. Please be sure to review the full UTC policy SA0575 on the Safety and Risk Management website and comply with all campus regulations.
Extra Credit: If you plan to award extra credit to students who participate in your research, it is essential that you provide all students with an alternative method of earning extra credit that does not involve participation in research. Otherwise, for a student desperate to earn a passing grade, participation could be seen as essential. Any alternative offered must be approximately equal in both effort and duration.
Gift cards/monetary incentives: If you plan to reward participants with gift cards or monetary incentives and you plan to charge the incentive to a grant account or a university account, you must get approval from Dr. Richard Brown prior to initiating the research. Additionally, there are purchasing, tracking, and distribution guidelines that must be followed in order for the charge to be processed. Please refer to UT Fiscal Policy FI0313.
The Health Insurance Portability and Accountability Act (HIPAA) establishes conditions under which protected health information (PHI) may be used or disclosed by covered entities for research purposes [45 CFR §§ 164.501, 164.508(f), 164.512(i) ]. The Privacy Rule outlined in HIPAA defines the means by which individuals/human research subjects are informed of how medical information about them will be used or disclosed, and their rights with regard to gaining access to information about them when such information is held by covered entities. In the course of conducting research, researchers may create, use, and/or disclose individually identifiable health information. Under the Privacy Rule, covered entities are permitted to use and disclose PHI for research with individual authorization, or without individual authorization under limited circumstances.
The Privacy Rule permits researchers to use and disclose PHI for research when participants authorize the use or disclosure of information about themselves. Typically, a research participant's authorization will be sought for clinical trials and some research involving records. In these instances, specific elements must be included in the informed consent form (see UTC IRB Policy). There are four circumstances that allow researchers to use and disclose PHI for research purposes without authorization by research subjects. These are:
waiver of authorization;
review of PHI preparatory to research;
research involving a decedent's information; and
use involving limited data sets.
All of these situations require IRB approval. Submit a Form G.
HIPPA regulations are quite complex. Researchers using health information should consult the full UTC IRB policy for additional guidance.
Yes. Regulations permit covered entities (usually the agency providing the data) to disclosure health information for research purposes without authorization by the research subject if the use or disclosure involves a "limited data set" and the covered entity enters into a data use agreement with the researcher. A "limited data set" is protected health information that excludes the following direct identifiers of the individual or of relatives, employers, or household members of the individual subjects:
a) names b) postal address information, other than town or city, state and zip code c) telephone numbers d) fax numbers e) email addresses f) social security numbers g) health plan beneficiary numbers h) account numbers i) certificate/license numbers j) vehicle identifiers and serial numbers k) device identifiers and serial numbers l) web universal resources locators (URLs) m) Internet protocol (IP) address numbers n) biometrics identifiers, including finger and voice prints o) full face photographic images and any comparable images
A limited data set may, however include other indirect identifiers, especially dates of birth, treatment, discharge, or death.
Investigators may use a limited data set for research without subject authorization if they have completed a Limited Data Use Agreement with the entity releasing the data. Investigators in this situation should complete a Form K and provide this Form and the Limited Data Use Agreement to the IRB Chair. (Normally, the entity releasing the data should provide the Limited Data Use Agreement; however, if the entity does not have such a form the investigator should contact the IRB Chair for examples of acceptable forms.).
PHI can be released freely if it does not contain "individually identifiable information" as defined in the section above. PHI is not individually identified if the subject is not identified, directly or indirectly, and if the subject has no reasonable basis to believe that the information can be used to identify them.
If an investigator maintains a database containing PHI, then the investigator has an obligation to insure that the use and disclosure of PHI is in compliance with federal guidelines and UTC policy. The investigator is responsible for:
Maintaining applicable security for the database, including physical security and access control;
Controlling and managing the access, use and disclosure of PHI, including verifying appropriate IRB approvals and patient authorizations; and
Any PHI in the database used for treatment or payment purposes must be a duplicate and the original must be included in the patient's medical record.
Databases created prior to April 14, 2003 are grandfathered in and do not have to meet the Privacy Act policies. Studies involving subjects that have enrolled prior to April 14, 2003 will not be required to re-consent. Investigators may continue to collect and use data gathered from these subjects and no new documentation is required.
Each level of the review has a slightly different review process (see policy). Exempt and expedited applications require a Form A. The IRB will determine if the research qualifies as exempt or expedited once the application has been submitted. Annual review and minor changes require a Form B. Classroom assignment applications require a Form C. Applications should be submitted electronically to email@example.com.
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 Office of Research Integrity. The Action Form will outline the concerns that must be addressed in order to continue the review process.
Research cannot begin until IRB approval has been granted.
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 Office of Research Integrity. The Action Form outlines the concerns that must be addressed in order to continue the review process. 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 will outline the next steps. If the changes are minor, the investigator will normally be able to email the requested information to firstname.lastname@example.org.
No research may proceed before the PI has been has notified that he or she is 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.
If there are no questions raised, the Office of Research Integrity will email a letter of approval to the principal investigator or the faculty advisor noting that the research is approved. 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 Office of Research Integrity. The Action Form will outline the concerns that must be addressed in order to continue the review process.
The length of the review process depends on several factors including when the application is received by the Office of Research Integrity, the type of review, and the quality of the application. Exempt reviews generally take about 3-5 days from the time the application is received by the IRB Chair. Expedited reviews are often completed in 7-10 days, and full board reviews are usually completed with 3-5 weeks of receipt. 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 to fully complete all forms and applications, include appropriate attachments, and receive appropriate signatures prior to submission.
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 Form B outlining the modifications. Prior to making any changes that will affect the information given on a previously approved application, the investigator must have a change approval letter from the IRB. The Office of Research Integrity will contact the investigator in writing if the changes outlined on the Form B are not acceptable.
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 Office of Research Integrity 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.
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 may be sent to the Provost for further action.
What happens if there are problems that result from my 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 (Form F). 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.
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 Office of Research Integrity 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.