Human Research Protection Program FAQs

Researchers are required to complete either the CITI Social & Behavioral Research – Basic/Refresher course OR the Biomedical Research – Basic/Refresher course. Click here to learn more about CITI training.

The Human Research Protection Program (HRPP) requires current CITI training for all Research Personnel listed on a human subjects research application. This includes the Principal Investigator, any Sub- or Co-Investigators, and Research Assistants. Department Review Chairs are also required to have current CITI training.

The Principal Investigator (PI) is ultimately responsible for the protection of the human subjects participating in research they conduct or oversee. The PI is expected to abide by the highest ethical standards when developing a research plan and to incorporate the principles of the Belmont Report. The PI is expected to conduct research in accordance with the IRB approved research plan and to personally conduct or oversee all aspects of the research. In addition to complying with all applicable regulatory policies and standards, PIs must comply with organizational and administrative requirements for conducting research. The PI is responsible for ensuring that all investigators and research staff complete all required training as well as training for their specific responsibilities in any given research study. 

If there are personnel engaged in your research project who are not affiliated with the University of Tennessee, Knoxville, please attach the CITI completion report from their institution to your IRB application in iMedRIS. The completion report should list all modules and courses completed in CITI, so that the HRPP office can compare this training to our required training. If the training is not comparable, we may ask the external researcher to complete additional CITI training.

Individuals who are not affiliated with the University of Tennessee, Knoxville and who have not previously completed CITI training can affiliate with the University of Tennessee, Knoxville on the CITI website and take our required training. Click here to learn more about CITI training.

An individual is considered to be engaged in research when they (1) obtain data about the subjects of the research through intervention or interaction with them, (2) obtain or have access to identifiable private information about the subjects of the research; or (3) obtain the informed consent of human subjects for the research. An individual may share recruitment information about a study without being considered to be engaged in research, as long as they only share IRB-approved recruitment materials and refer all questions about the study to people on the research team. 

 When conducting international research, additional review and documentation is required from both the international site and the University of Tennessee, Knoxville IRB. It is imperative that you start the process early! We encourage researchers who are unfamiliar with the requirements for conducting international research to request a consultation with HRPP staff during the initial planning stages.

In order to conduct international research, the IRB will expect investigators to demonstrate an understanding of the local cultural context and the research ethics guidelines of the host country. See the International Research page for more information.

If you have any questions, you may contact your department liaison or stop by virtual office hours.

No. The federal regulations that govern human subjects research do not allow for IRB approval of research that has already been conducted. If data were initially collected for purposes that the IRB determines to be non-research (e.g., program evaluation or a quality improvement project), IRB approval can be sought to analyze these data for research purposes. 

If participants are self-reporting health-related data for your research, HIPAA does not apply. HIPAA privacy and security rules only apply when information is being collected about a participant from a covered entity such as a healthcare provider. Click here to learn more about HIPAA guidelines.

New applications are submitted online via iMedRIS. Any member of the study team can create and edit a study application in iMedRIS as long as they are given the role of Study Contact in the application.

The following materials are required for initial review:

• Completed IRB Application
• Recruitment and Screening materials (if applicable)
• Informed Consent and/or Assent Document(s)
• Any data collection materials (e.g. surveys, questionnaires, interview protocols)
• External funding proposals (if applicable)

When you resubmit an application with requested changes, the status in iMedRIS does not change until after a review has been completed by one of our reviewers. So, even though you may have provided all of the requested information, your status will still read Pre-Review Changes Requested or Incomplete Application until a reviewer has looked at it and we have changed the review status. See the question below about tracking your submission for more information.

You can track the status of your submission in iMedRIS.

First, try searching the LDAP directory instead of the iMedRIS database. In the application section titled Setup Project Personnel there is a section at the top of the screen where you can choose to Search From either the iMedRIS database or the LDAP directory.  If you still cannot find the individual in the LDAP directory, try having them log into iMedRIS and log back out to initiate activation of their account. If you still cannot find the individual within 48 hours after they have activated their account, contact the HRPP office for help.

These individuals should be added in application section (1200) Site Information. 

Review timelines depend on the nature of the study and the characteristics of the participant population. Please note that your application will not be sent to a reviewer until after all required signoffs are completed. The status of signoffs can be tracked in iMedRIS. Once the submission has been assigned to a reviewer, you should expect to receive a submission response within 5 business days for exempt applications and within 10 business days for expedited applications. Research that involves greater than minimal risk to participants will be reviewed at a convened meeting of the Full Board. These meetings occur once a month, on the third Thursday of every month (with some exceptions for university closures and holidays). Submissions that are received and contain all required materials by the first business day of the month will be placed on the agenda for that month’s board meeting. Click here to learn more about the review process.

IRB records (i.e., all records of communications with the IRB and all approval documents) should be maintained for at least six (6) years after completion of the research. IRB records for research cancelled without participant enrollment should be retained for at least three (3) years after closure. For studies that involve a HIPPA Authorization or waiver of HIPPA Authorization, these documents should be maintained for six (6) years after the completion of the research.

Note that participant data does not have to be destroyed at the completion of the research. Participant data can be kept indefinitely if participants are informed of this in the consent and there is a plan to store the data securely.

 Once you are finished analyzing data or are no longer analyzing identifiable data you may close your study by submitting a Study Closure Form in iMedRIS. Once a study has been closed, investigators may not conduct any additional analysis of identified data without applying for IRB approval or exemption. Investigators must continue to protect the confidentiality of the data as described to the IRB and honor any other commitments that were agreed to as part of the approved research including, for example, future use of data or specimens, provision of research results to subjects, and provision of any outstanding payments or compensation.

The IRB will review study closure reports, typically by expedited review, and either approve the closure of the study or request additional information or confirmation of facts from the investigator. Click here to learn more about study closure.

If you are a student who is graduating from the university, you may not continue to work on any studies in which you have access to identifiable data after you graduate without first signing a Reliance Agreement or Individual Investigator Agreement. An amendment request must also be submitted to remove students who have graduated as University of Tennessee, Knoxville study personnel and add them as external researchers.

Federal regulations require that the following information be conveyed to each study participant:

• ​​a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
• a description of any reasonably foreseeable risks or discomforts to the subject;
• a description of any benefits to the subject or to others which may reasonably be expected from the research;
• a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
• a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
• for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
• an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
• a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements may also be required in some instances. See https://www.hhs.gov/ohrp/regulations-and-policy/guidance/checklists/index.html for additional information. 

If an adult subject is unable to consent to research due to medical incapacity, the subject’s legally authorized representative (a court appointed conservator or guardian) may consent on their behalf. If there is no legally authorized representative, and the adult subject cannot consent, the subject may not become a human subject in an experiment unless the federal requirements for waiver of consent have been met.

Adults who lack or who have impaired, fluctuating, or diminishing decision-making capacity are particularly vulnerable. Investigators and IRBs must carefully consider whether inclusion of such subjects in a research study is appropriate; and when it is, must consider how best to ensure that these subjects are adequately protected. In general, the IRB will only approve research involving subjects unable to provide consent or with impaired decision-making capacity when the aims of the research cannot reasonably be achieved without inclusion of the population, and there are appropriate provisions to: (1) evaluate capacity, (2) obtain consent (and assent if possible), and (3) otherwise protect subjects.

If a minor is unable to consent due to medical incapacity, a parent or legal guardian may provide consent for research. (Note: under normal circumstances, enrollment of minors as subjects requires consent by the parent or legal guardian as well as assent by the minor.)

Please visit the U.S. Department of Health and Human Services website for additional information.

An IRB may waive the requirement to obtain informed consent, provided the IRB finds and documents that the below criteria are satisfied. Likewise, an IRB may approve a consent procedure that omits some, or alters some or all, of the basic and additional elements of informed consent (an “alteration”), provided that the IRB finds and documents that the below criteria are satisfied.

• The research involves no more than minimal risk
• The waiver of informed consent will not adversely affect the rights and welfare of the subjects
• It is not practicable to conduct the research without the waiver or alteration
• Whenever appropriate, participants will be provided with additional pertinent information after their participation.
• Click here for forms and templates.

A waiver of documentation of consent means that the investigator is not required to obtain a signed consent form from participants. Instead they may have participants verbally consent or click an “I Agree” button at the beginning of an online survey. The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds any of the following:

• The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm from a breach of confidentiality (e.g., domestic violence research where the primary risk is discovery by the abuser). Each subject (or LAR) will be asked whether they want documentation linking them with the research, and their wishes must govern. This option does not apply to FDA-regulated research.
• 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. Procedures such as non-sensitive surveys, questionnaires and interviews generally do not require written consent when conducted by non-investigators (e.g., marketing surveys, telemarketing). This option does apply to FDA-regulated research.
• If the subjects or LARs are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. This option does not apply to research subject to the pre-2018 Common Rule or to FDA or DOJ regulations.
• Click here for forms and templates.

Investigators can recruit students from their own class with a few stipulations. Recruitment must be done in such a way that there is no hint of coercion or undue influence. Because of the power differential in the relationship between students and instructors, students may feel pressured to participate in research that they otherwise would not want to participate in. Students should be made aware that if they refuse to participate, their refusal will not influence their grades for the course or their relationship with their instructor. The IRB recommends that investigators should not be made aware of which students participated in the study until final grades are posted. Lastly, equivalent alternatives to research participation should be offered to students. Click here to learn more about student recruitment.

Under Tennessee State Law, lotteries or drawings where individuals are entered into a drawing for completing a research study are considered gambling, which the university is prohibited from participating in. Because of this, investigators must give everyone a chance to enter the drawing and not just those who complete the study. Most individuals handle this by adding a sentence to their consent form letting individuals know how to enter the drawing without completing the study. 

​​​​​​​If your study approval has lapsed, all study activities must cease until approval is reinstated. This includes recruiting participants, collecting informed consent, and collecting or analyzing data.

In rare instances stopping research procedures would put research participants at harm. For example, this might be the case if a participant is receiving medication as part of a clinical trial. If you believe this applies to your study and your study approval has lapsed, please contact the IRB for guidance. Click here to learn more about continuing review.

iMedRIS will send continuing review reminders 60, 30, and 25 days before your study expiration date. Please note that although you can submit your continuing review at any time, the regulations do not allow for review of the Continuing Review any sooner than 30 days before the study’s expiration date. For example, if your study expires on June 1 and you submit your Continuing Review on May 1, the IRB office cannot review your Continuing Review until at least July 1.

Ensure that you submit your Continuing Review form early enough so that the IRB has time to review it prior to the study expiration. If you submit your Continuing Review a few days or the night before your study expires, we will not have time to review it and grant a continuation before the study expired. The IRB recommends submitting your Continuing review 30 days before the study expiration date. 

 Once the application is approved, the study team cannot make any changes to the study procedures or the approved study documents without IRB approval. To make changes to a currently approved study, you should submit a Form 2 Change Request via iMedRIS. 

Reactivation of closed studies is handled on a case-by-case basis. If a study was recently closed and a justification can be provided for requesting the re-opening of the study, the IRB will review the request. In some instances, previously closed studies will not be able to be reactivated and a new study submission will be required. Please contact the HRPP office to discuss any requests for reactivation.

If you have conducted or are conducting human subjects research without IRB approval, you are in violation of federal regulations and subject to non-compliance and research misconduct reporting to university officials. The IRB does not grant retroactive approval for research that has already been conducted.

Investigators must report the following events or issues to the IRB as soon as possible but within 7 working days after the investigator first learns of the event using the Reportable New Information form in iMedRIS. Examples of reportable events include, but are not limited to:

• Actions taken without prior IRB review and approval to eliminate an apparent immediate hazard to a research subject(s);
• Sponsor or lead investigator/coordinating center-imposed suspension or termination of some or all research activities
• An unanticipated event related to the research that exposes subjects to potential risk but that does not involve direct harm to subjects;
• A breach of confidentiality or loss of research data (e.g., a laptop or thumb drive is lost or stolen);
• Incarceration of a research subject
• A subject complaint;
• An unanticipated event related to the research that results in actual harm or exposes individuals other than the research subjects (e.g., investigators, research assistants, students, the public, etc.) to potential risk
• New information that indicates increased risk, new risk(s), or decrease to potential benefit from what was previously understood.

Enrolling more subjects than approved by the IRB is noncompliance. Investigators should submit a Reportable New Information (Form 4) if this occurs. In order to avoid this potential issue, the IRB recommends that investigators overestimate the study enrollment number in their initial application or submit an Amendment to increase the enrollment number.

Unanticipated problems involving risks to subjects or others (UAPs) should be reported to the IRB as soon as possible but within 7 working after the investigator first learns of the event using the Reportable New Information form in iMedRIS. UAPs are any incident, experience, outcome, or new information that:

• Is unexpected; and
• Is at least possibly related to participation in the research; and
• Indicates that subjects or others are at a greater risk of harm (including physical, psychological, economic, legal, or social harm) than was previously known or recognized

If you are unsure whether the event represents a UAP that needs to be reported, go ahead and submit a report or contact the HRPP Director or IRB Chair for further information.

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