Frequently Asked Questions
IRB Training Manual -- View and download a PDF of this helpful UTC IRB Guide.
Click here for a Video Presentation on IRB Basics.
- Do I need IRB approval?
- Does the project meet the definition of research with human subjects?
- Do I need approval if the research does not take place at UTC?
- Are there any types of research that do not require an IRB application and/or approval?
- What level of review do I need?
- What type of research is considered exempt?
- What type of research is eligible for expedited review?
- What type of research requires full board review?
- What type of research requires annual or continuation review?
- What type of research qualifies as a classroom assignment?
- Do I need informed consent?
- How do I document informed consent?
- Are there exceptions or situations where a signed, informed consent form is not acceptable?
- What should I put in a cover letter or document to ensure informed consent when a signed, consent form is not used?
- What are the elements of informed consent?
- How do I get consent from minors or others who cannot give consent?
- What do I need to know about the use of health information in research settings?
- What is HIPAA and how does it apply to research?
- Do HIPAA regulations apply to data sets with health information?
- What if I collected data that includes protected health information (PHI)?
- How do I apply for IRB approval?
- What if I am not approved?
- Why did I get an action form and what do I do next?
- When can I start my research?
- How will I know I am approved?
- How long will it take to get approval?
- What if I need to make changes?
- What is a minor vs major change?
- What happens if I forget to submit my annual or continuation review?
- 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)?
- What happens if I know that research is being conducted in violation of IRB policy?
Do I need IRB approval?
In most cases, you need IRB approval if your study involves research with human subjects.
Does the project meet the definition of research with human subjects?
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)
- Interview procedures
- Case studies
- Oral histories
- 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 will be sent to the Provost for further action.
Do I need approval if the research does not take place at UTC?
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.
Are there any types of research that do not require an IRB application and/or approval?
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.
What level of review do I 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; although, researchers should consult the IRB Chair before proceeding with this type of application. Applications that require automatically require full board review involve more than minimal risk to participants. 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. 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). 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 a Form C 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.
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 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.
Do I need informed consent?
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.
How do I document informed consent?
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.
Are there exceptions or situations where a signed, informed consent form is not acceptable?
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.
What are the elements of informed consent?
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. Briefly they include:
A. Heading and Title:Reference to the University of Tennessee at Chattanooga and notification that a research project is being discussed should be included in the heading of all consent forms. The study title also should be included in the heading of the form. For example:
UNIVERSITY OF TENNESSEE AT CHATTANOOGA INFORMED CONSENT FORM
Attitudes toward Cartoon Violence and its Real or Perceived Impact Upon Children
B. Identify Principal Investigator(s):This section should indicate who is conducting the research. The first and last names of the principal investigator(s) should be used and the investigators identified with titles and department and other pertinent contact information at the beginning of the form, so that it is clear who is carrying out the study.
C. Purpose and Background:This section should introduce the study, state the aim of the study, give a brief summary of the background or reason for the project, discuss the number of subjects expected to participate in the study, and explain why the individual has been asked to participate. The reason a person has been asked to participate should be simply but specifically stated (e.g., "because you have tried to quit smoking in the past but have not been successful," "because you are undergoing surgery and will be given a general anesthetic," "because you are a healthy person"). If the study is sponsored research, the sponsor should be named.
D. Procedures:To emphasize the voluntary nature of participation in research, this section should begin with a phrase like, "If you agree to be in this study, the following will happen." For social and behavioral research, this may involve a simple statement such as: You will be asked to complete a short survey, participate in a interview, participate in a focus group.
For health related procedures, each procedure should then be listed, preferably in the order in which it occurs, and discussed. If the study involves screening procedures, these should be mentioned first and identified as tests that will determine eligibility to continue in the study. The Procedures section should clearly state what will be done to the individual as a result of participation in the study, and, where appropriate, how this differs from standard treatment or what would happen to the individual if he/she did not participate in the study.
When a study involves randomization, it should be described as a study procedure, and the term "randomization" explained in lay language. Information about the probability of assignment to each treatment or condition should be given. Other terms, which might not be, familiar to the average layperson (e.g., "placebo") should be defined the first time they are mentioned in the form or use a lay term.
If a standard medical procedure is being done as part of the study, it should not be referred to as "standard" or "routine," since this could easily imply that the procedure would be done anyway for clinical reasons. Rather, what should be conveyed is that this procedure is an extra laboratory test that is commonly done for clinical purposes, but is being done here for research purposes.
If patient records will be reviewed for purposes of the study, this should be listed as a procedure.
Amounts of blood or tissue to be taken for study purposes should be specified, using lay equivalents (e.g., teaspoons, ounces) for metric terms.
The number of times a procedure will be done, the time involved for each procedure, and the total amount of time for participation in the study should be specified. The location(s) where the procedures will be done should also be stated.
E. Risks and/or Discomforts:The risks and/or possible discomforts of all study procedures should be listed and explained in this section. For social science and behavioral research this might include notifying subjects that there is a possibility that they may be upset by the content of the survey or find an interview embarrassing. For medical and health related studies, this might be a discussion of physical discomfort or pain.
It is usually best to describe the risks of each procedure in a separate point. Risks should be arranged and described according to their severity and the likelihood of their occurrence. Where appropriate, it should be indicated what precautions will be taken to avoid certain side effects or outcomes from occurring, and what will be done should they occur. A statement should be included that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject.
To the extent possible, consent forms should characterize the likelihood of risks using words like "likely," "frequent," "occasional," and "rare." The first time these words are used in a form they should be defined using percentages, as follows:
Likely events: Expected to happen to more than 50% of subjects
Frequent events: Will probably happen to 10-50% of subjects
Occasional events: Will happen to 1-10% of subjects
Rare events: Will happen to less than 1% of subjects
For studies involving investigational agents, or experimental doses or combinations of drugs and/or treatments, subjects should be warned that there may be as yet unknown risks associated with the drug/treatment but that they will be advised if any new information becomes available that may affect their desire to participate in the study.
F. Confidentiality:Since one of the risks of participating in research is a loss of privacy, a discussion of confidentiality issues should be included. It should describe briefly how the confidentiality will be protected, i.e., coding of records, limiting access to the study records, not using any individual identifiers in publications or reports resulting from the study.)
For all statements regarding confidentiality of research records, it should be kept in mind that there is no legal privilege between investigator and subject as there is between physician and patient or counselor and client. Thus, a guarantee of complete confidentiality, or "strictest confidentiality," should not be given or implied. One should always state instead that confidentiality will be protected "as far as is possible" or "as far as is possible under the law."
G. Benefits:Any potential direct benefits to the subject should be described first, followed by potential general benefits (e.g., the group of patients to which the individual belongs, to medical knowledge, etc.). It is usually recommended that the description of possible direct benefits be qualified with the phrase, "... but this cannot be guaranteed." If there is no direct benefit to the subject anticipated from the study, this should be stated at the beginning of the section.
The FDA recommends that possible benefits such as medical or societal benefits resulting from a research study be considered separately from payment for participation in the study. Thus, the discussion of payment or reimbursement should be separated from the benefits statement and placed in its own separately labeled section.
H. Alternatives:This section should discuss the various alternatives to participation in the study. This can be a short statement, but it should make clear the possible choices (e.g., no treatment, standard therapy, other experimental treatments, or some or all of the protocol treatment, but without participating in the study) that are available if the individual chooses not to participate in the study. When alternative therapies are available, brief objective descriptions of their important benefits and risks should be included.
When the only alternative is to decline participation in the study (e.g., if the study involves only normal, healthy volunteers), this need not be mentioned in a separate section, since the individuals right to choose not to participate will be made clear in the last section of the form.
I. Costs/Financial Considerations:When there are no costs at all to be charged to the subject, this should be clearly stated in the form. In some medical situations, however, a simple statement that there are no costs is usually not sufficient and could be misleading. The more typical situations are that the subject will have to pay for the usual costs of his or her medical care but will not be charged any extra for participating in the study or the cost of the study medication will be covered by the study but the subject will have to pay all other charges.
When participation in the study may result in any costs whatsoever to subjects, clear information must be provided in the consent form regarding these costs. Special attention must be paid to this issue in studies in which the subjects are also patients. In such cases, where individuals may be undergoing various procedures, tests, or hospitalizations that are part of their clinical diagnosis and treatment, and others that are part of the research study, the costs section of the consent form should clearly distinguish which costs will be charged to the patient or his third party carrier, and which costs will be covered by the study. In addition, when appropriate, a statement should be included, warning subjects that because the therapy is experimental, the insurance carriers may not cover the costs involved.
J. Reimbursement/Payment:When referring to money that subjects will receive in return for participation in a study, either "reimbursement" or "payment" may be used. However, the term "compensation" should not be used, since it is used on consent forms to designate compensation for injury. Investigators should avoid connotations of undue influence to participate or that the subject is being employed by the investigator. Rather, the sense should be that subjects will be reimbursed for their time, travel expenses, and the inconvenience of being a research subject. However, unless the subject has actual receipts (e.g., parking, taxi, babysitting), the person is not being reimbursed in the strictest sense of the word, for either accounting or tax purposes.
This section should state the total dollar amount that the subject will be paid for participation in the study, and should give any other relevant information such as pro-rating if a subject does not complete the study, or bonus payment at the end of the study. If appropriate, a payment schedule should be included in this section. Subjects should not be required to complete the entire study in order to be reimbursed and bonus payments for study completion should be modest. Subjects should be informed how payment will be made (e.g., in cash, by check) and when they will be paid (e.g., immediately after the interview, approximately six weeks after individual completion of the study). Payments for research participation in excess of $600 per calendar year are considered taxable income. If subjects will be paid more than $600, the Reimbursement section should explain that the University will report this income to the IRS.
If there will be no payment or reimbursement of subjects for the study participation, this information should be so stated in this section.
This section should provide contact information for the subject in case of questions about the study. At least one permanent name and telephone number of one investigator, usually the principal investigator, must be typed into this section as submitted. Blank lines to be filled in later may be included for additional contact persons. If the principal investigator is a student, the faculty advisor's name and phone number should be included in this section as subjects often wish to contact the person who is supervising the project.
You also need to include a statement about the IRB approval and contact information. The following wording would be appropriate: "This research has been approved by the UTC Institutional Review Board (IRB). If you have any questions concerning the UTC IRB policies or procedures or your rights as a human subject, please contact Dr. M. D. Roblyer, IRB Committee Chair, at (423) 425-5567 or email email@example.com."
L. Tissue and/or blood banking or storage:Some studies include the option to have tissue specimens or blood stored (or banked) for studies that may come available in the future, future diagnostic testing, or other purposes not yet determined. Subjects should have the option to participate in the study whether or not they agree to tissue banking.
M. Consent:This section should state that the subject has been given (not just "offered") a copy of the consent form.
This section should then state the information that participation in research is voluntary, and explain the individual's right to decline to participate, or withdraw from the study at any time. If the subjects are patients, students, or employees, a phrase may be added indicating that refusal or withdrawal will be without jeopardy to status or care. The investigator may also wish to advise subjects that they may be withdrawn from the study if the investigator deems it in the best interests of the subject or for other reasons that should be specified (e.g., medical interests, failure to keep appointments).
The IRB discourages such wording as "You have read this form and understand it; based on this understanding, I hereby agree to participate," since this does not guarantee an individual's comprehension, legally or otherwise. Rather it is recommended that investigators simply state that if the person wishes to participate in the study, he or she should sign the form; signature will then indicate agreement to participate.
N. Signature Section:
Unless waiver of signed consent is approved by the IRB, this section should include lines for the subject's signature and the date of signature. The consent form also should include a signature line for the specific individual that secured or was present to obtain consent so that subjects have a record of who explained the study to them.
Please see "Informed Consent Requirements" for further descriptions and sample informed consent forms.
How do I get consent from minors or others who cannot give consent?
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.
What do I need to know about the use of health information in research settings?
Research in health settings using health data have some additional considerations to comply with HIPAA regulations.
What is HIPPA and how does it apply to research?
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.
Do HIPPA regulations apply to data sets with health information?
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:
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 12 copies of 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.
What if I collected data that includes protected health information (PHI)?
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;
- Control and manage 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.
How do I apply for approval?
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 applciation has been submitted. Annual review and minor changes require a Form B. Classroom assignment applications require a Form C. All applications contain submission directions on the form. In general, investigators submit their application and other documents to the IRB Chair after it has been routed to the faculty sponsor (if applicable), the Department Head and Dean for signatures.
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.
If an investigator believes his or her study qualifies as exempt from IRB review, a Form A should be completed. Submit a copy of the completed form, consent forms (if applicable), and any research instruments to the IRB for review and approval. The Form A requires the investigator to discuss the purpose/objectives of the research, the subject population, methods/procedures, experimental design/methodology, and justification for exemption.
Investigators who believe their study qualifies for expedited review should complete a Form A. A copy of Form A, consent forms, and any special attachments (including questionnaires or surveys if applicable) must be submitted for an initial, expedited review. The Form A 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.
Full Board Applications
Investigators who believe their study qualifies for full board review should complete a Form A. The IRB will then determine if a full board review is necessesy. A copy of Form A, consent forms, and any special attachments (including questionnaires or surveys if applicable) must be submitted for an initial, full board review. The Form A 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. Any special requirements and/or attachments also must be included. The IRB full-board meets on an ad hoc basis; therefore, investigators should consult the IRB Chair to ensure that they are scheduled for review.
Continuing or Annual Renewal
Investigators who believe their changes involve minor modifications should complete a Form B and submit a copy directly to the IRB.
Major modification/change requests require that the investigator complete a new Form B noting the modifications to the project. Investigators should send four copies of the new Form B to the IRB Chair after routing it through their department head and dean.
Faculty members who wish to use this procedure must submit a Form C to 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;, Faculty also must require that students submit Form A for approval by the instructor (instead of the IRB Board). A Form D must be submitted 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).
What if I am not approved?
Research cannot begin until IRB approval has been granted.
Why did I get an action form and what do I 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 Chair. 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 normally be emailed to the researcher, but a formal copy also will be sent to the principal investigator listed on the application. The action form will outline the next steps. If the changes are minor, the investigator will normally be able to email the requested information to the IRB Chair.
When can I start my research?
No research may proceed before the IRB Chair 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 I know I am approved?
If there are no questions raised, the IRB Chair will send a letter of approval to the principal investigator or the faculty advisor noting that the research is approved. Normally the IRB Chair or his/her assistant will send an email to the principal investigator listed on the form prior to sending the formal letter (when time allows). 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.
How long will it take to get approval?
The length of the review process depends on several factors including when the application is received by the IRB Chair, 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 one to two weeks from the time the application is received by the IRB Chair. Expedited 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. There is a review status spreadsheet on the IRB web page that applicants may consult to track their progress.
Be advised that incomplete applications (including insufficient copies) represent one of the main reasons applications are delayed. Be sure I have fully completed all forms and applications, included appropriate attachments, have required signatures, and request the appropriate level of review.
What if I 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 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 signed Form B from the IRB Chair. The IRB Chair will contact the investigator in writing if the changes outlined on the Form B are not acceptable.
What is a minor vs 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 I forget to submit my annual or continuation 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 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 G). 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 I 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.