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Human Subjects

If you have questions please call Regulatory Services at 817-272-3723 or email us at regulatoryservices@uta.edu

Regulatory Requirements

If your research involves human subjects you must become familiar with the regulations governing the rights and safety of the research participants. 

These regulations include:

  • The researcher’s institutional rules
  • The requirements of the researcher’s Institutional Review Board (IRB)
  • Regulations in the Code of Federal Regulations, Title 45, Part 46:  Protection of Human Subjects and Food and Drug Administration Regulations, 21 CFR, Part 50, 56

Please consult your Regulatory Services Specialist in the Office of Research Administration; Regulatory Services

In addition, The University of Texas at Arlington has a Federalwide Assurance (FWA).  Any institution engaged in federally conducted or supported human subjects research must commit itself in writing to the protection of those subjects.  This written commitment is called an Assurance of Compliance.

For human subjects research conducted or supported by the Department of Health and Human Services (HHS), the Office for Human Research Protections (OHRP) must approve an institution's Assurance before the funds can be awarded and human subjects research can begin.

Definitions

  • Research according to OHRP means a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for the purposes of this policy, whether or not they are supported under a program which is considered research for other purposes. --- 45 CFR46.102(d)
  • Research according to FDA regulations is any experiment that involves any drug or biological product for human use, a medical device for human use, a food additive, an electronic product or any other article subject to regulation by the Food, Drug and Cosmetic Act.
  • Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. --- 45 CFR 46.102(f)(1),(2)
  • Identifiable private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonable expect will not be made public (for example, a medical record). --- 45 CFR 46.102(f)(2)
  • Participant is a living individual about whom a research investigator (whether a professional or a student) obtains data through intervention or interaction with the individual or from individually identifiable information.  45 CFR 46.102(f).
  • IRB is an Institutional Review Board, a committee appointed annually by the Vice President for Research.  The IRB is charged with reviewing research to ensure it complies with 45 CFR 46, 21 CFR 56, UT Arlington polices and procedures and applicable law.
  • IRB membership consists of qualified and diverse faculty and community, scientist and non scientist.  The membership provides review of specific research protocols across the range of disciplines on the UT Arlington campus.  The IRB at UT Arlington is chaired by Dr. Patricia Turpin of the Department of Nursing.
  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
  • Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Applicability

If you are a student conducting research because of a class assignment then you do not submit a research protocol.  A class assignment is defined as a systematic investigation students conduct as assignments designed to teach human research methods, where the results and data are not being disseminated outside of the classroom.

  • Class projects cannot involve the following participants:  institutionalized persons, persons unable to consent themselves, or children.
  • If you are a student conducting human subjects research you must have a faculty Advisor.
  • Your sponsor must approve your application prior to IRB submission.
  • Choose a faculty Advisor who works well with you.  Your Advisor will provide valuable recommendations about research designs aimed at reducing the risk to human subjects and is your primary contact for human subject concerns and questions.

International human subjects research must always be guided by ethical principles.  All of the Institution’s human subjects research activities, regardless of whether the research is subject to U.S. federal regulations, will be guided by one of the following statements of ethical principles:

  • The World Medical Association's Declaration of Helsinki (as adopted in 1996 or 2000);
  • The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; or
  • Other appropriate international ethical standards recognized by U.S. federal departments and agencies that have adopted the U.S. Federal Policy for the Protection of Human Subjects, known as the Common Rule. 
  • Please consult your faculty advisor, the IRB and the country where the research is conducted.  

Collaborative research may include:

  • equal partnership between two academic faculty members who are pursuing mutually interesting and beneficial research, or
  • researchers of differing stature, funding status, and types of organizations, or
  • post-doctoral fellows, research staff members, graduate students, and/or undergraduate students.

Members of a collaboration, including those within a research group, should communicate clearly and frankly with each other in such a way that all members can answer the questions: What am I expected to contribute to this joint research project? What do I expect to get out of this collaboration?

Collaborative research may also include partnerships with other institutions.  Typical partners include UT Southwestern, UT Dallas, Veterans Administration, Department of Defense, Air Force and many others. 

  • If you are conducting research in a collaborative partnership please advise your faculty advisor and the IRB. 
  • The research is subject to the same IRB approval process by one of the institutions. 
  • The UT Arlington IRB recognizes the collaborative institution (listed above) as the IRB of record and will acknowledge their approval process. 
  • The UT researcher must submit the collaborative research protocol, the approval letter and maintain all the rules and regulations required from the UT IRB. 

Application Process and Review Timeline

There are three types of research that the IRB reviews. 

  • Exempt research
  • Expedited research
  • Full Board research

Request for Exemption Review

What qualifies as exempt? Click to view exempt categories of research. Once the researcher has logged into the SMARTIRB submission page the exemption categories will be presented and the option to select the applicable categories will be available.  The researcher will make this initial determination of whether or not they believe their protocol will qualify for exempt, or non-exempt, review.  If the protocol procedures do not appear to satisfy the requirements for any of the exemption categories then “Non-exempt” review would be the option selected to continue the submission process.  Once the level of review has been selected the researcher will be directed to the Institutional Review Board (IRB) Protocol Submission page.  Along with completing the submission page, the researcher is responsible for uploading a completed application Form 1A along with all study related documents (e.g., data collection tools, recruitment materials, informed consent documents, etc.).  Section 5 of the submission page is labeled, “Form Attachments.” This is where all forms are available for downloading, and all study related documents are uploaded for review.  Once the protocol submission page has been completed and study-related documents have been uploaded, the researcher will select the option to “Save” the protocol then select the option to submit the protocol for review.  For student researchers the option will read “Submit to Faculty Advisor,” and for faculty/staff the option will read, “Submit to IRB Coordinator.” Students are unable to submit IRB protocols directly to the IRB Coordinators prior to their Faculty Advisor first reviewing the submission and selecting the option to continue the review process.  A Faculty Advisor has the option to return the protocol to the student for editing or select, “Submit to IRB Coordinator” as with their own protocol submissions. You will be prompted to provide your NetID and password as an electronic signature to move the protocol forward in the review process (researchers and faculty advisors respectively).  IRB Coordinators will review the submission and either return the protocol to the researcher for revision requests or continue the review process by submitting the protocol to the IRB Chair (or designee) for IRB approval review.  NOTE: The IRB Chair (or designee) will make the final determination for exemption status upon review as established under 45CFR46 of the federal regulations. Upon approval, an official approval letter will be signed by the IRB Chair (or designee) and provided via email communication from the IRB Coordinators as well as stamped copies of the informed consent documents (if applicable). 

Request for Expedited Review

What qualifies for expedited review? Click to view the list of approved expedited review categories. . Once the researcher has logged into the SMARTIRB submission page the exemption categories will be presented and the option to select the applicable categories will be available.  The researcher will make this initial determination of whether or not they believe their protocol will qualify for exempt, or non-exempt, review.  If the protocol procedures do not appear to satisfy the requirements for any of the exemption categories then “Non-exempt” review would be the option selected to continue the submission process.  Once the level of review has been selected the researcher will be directed to the Institutional Review Board (IRB) Protocol Submission page.  Along with completing the submission page, the researcher is responsible for uploading a completed application Form 1 along with all study related documents (e.g., data collection tools, recruitment materials, informed consent documents, etc.).  If the study procedures will not include, or alter, some or all of the elements of informed consent the researcher must complete and submit Form 3 to request a waiver of the requirements for obtaining a signed consent form from some or all participants.  Click here to determine if the study procedures would require/qualify for the waiver provisions [45 CFR 46.116(c)(1) and (2), §46.116(d)(1)-(4) and §46.117(c)(1)or(2)]. Section 5 of the submission page is labeled, “Form Attachments.” This is where all forms are available for downloading, and all study related documents are uploaded for review. Once the protocol submission page has been completed and study-related documents have been uploaded, the researcher will select the option to “Save” the protocol then select the option to submit the protocol for review.  For student researchers the option will read “Submit to Faculty Advisor,” and for faculty/staff the option will read, “Submit to IRB Coordinator.” Students are unable to submit IRB protocols directly to the IRB Coordinators prior to their Faculty Advisor first reviewing the submission and selecting the option to continue the review process.  A Faculty Advisor has the option to return the protocol to the student for editing or select, “Submit to IRB Coordinator” as with their own protocol submissions. You will be prompted to provide your NetID and password as an electronic signature to move the protocol forward in the review process (researchers and faculty advisors respectively).  IRB Coordinators will review the submission and either return the protocol to the researcher for revision requests or continue the review process by submitting the protocol to the IRB member reviewers (Primary, and Secondary, if applicable) for approval review.  Upon approval, an official approval letter will be signed by the IRB Chair (or designee) and provided via email communication from the IRB Coordinators as well as stamped copies of the informed consent documents (if applicable). 

Request for Full Board Review

If the level of risk embodied within the research are determined to be more than minimal risk, the protocol must be reviewed at the level of Full Board during the convened meeting of the IRB.  The meetings are scheduled for the second Tuesday of every month, pending business (subject to change). The submission process for Full Board review is identical to Expedited review procedures. All protocols that will be considered for Full Board review must be submitted to the IRB one week prior to the scheduled, convened meeting.  NOTE: IRB Coordinator review for preliminary revision requests must have already been completed and the revised protocol must be assigned for Full Board review by the IRB Coordinator by this deadline (one week prior to convened meeting).  Protocols received for Full Board consideration after the deadline requirements will automatically be assigned for the subsequent meeting.  The researcher is responsible for making the initial determination of “Non-exempt” to encompass Expedited or Full Board review.  The IRB Coordinators and/or IRB will make the level of review determination (Expedited or Full Board).  The IRB Coordinators will inform the researcher of Full Board determination and procedures involved.  Researchers (and Faculty Advisors, if applicable) are invited to the IRB meeting to address the IRB members’ concerns or questions (if any) to assist with the approval determination process.  The IRB will make determinations as follows: Approved as submitted, Approve with revisions, Return for revisions and resubmit for Full Board review at next convened IRB meeting, or Do not approve.  Regardless of the determination, the researcher will be informed by the IRB Coordinators of the determination along with the procedures required of the researcher at that time (if applicable) for approval. Upon approval, an official approval letter will be signed by the IRB Chair (or designee) and provided via email communication from the IRB Coordinators as well as stamped copies of the informed consent documents (if applicable).    

Informed Consent:  Informed consent represents the voluntary consent of a person to participate once s/he has been told about the study and understands the following required elements:

  • Confidentiality procedures
  • What to do in case of injury
  • Possible conflict of interest
  • Study procedures
  • Withdrawal statements
  • Expected benefits
  • Contact phone numbers
  • Study purpose
  • Possible risks involved
  • Study alternatives
  • New findings

Informed consent must be given “before” the subject participates in any study protocol.

Non-English speaking subjects must have informed consent information presented in a written language that they can understand [21 CFR 50.20-27 and FDA information Sheets]  IRB approved informed consent documents must be available in English and other languages as appropriate to the subject population(s).

Every subject must be given a copy of the consent form for their personal records.

The informed consent document is vital to your research.  Consult your faculty advisor or Human Subjects Research Specialist when designing your consent document. 

Waiver of Consent:  In studies with sensitive, stigmatizing, or illegal personal information, keeping the identity of participants confidential may be as or more important than keeping the data obtained about the participants confidential.  In such cases, any written record linking subjects to the study can create a threat to confidentiality. 

Current federal policy allows the IRB to waive the requirement for the researcher to obtain a signed consent form in cases where it will be the only record linking participants to the research, and where a breach of confidentiality presents the principal risk of harm that might result from research.

A waiver or alternation of the informed consent process can be granted by the IRB if all of the following conditions are met:

  • Research involves no more than minimal risk
  • Waiver will not adversely affect rights and welfare of subjects
  • Research could not practicably be carried out without waiver
  • Subjects will be provided with additional pertinent information after participation, when appropriate

Assigned consent form may be waived if

  • The only record linking the subject to the research is the informed consent and there is a risk of brench of cofidentionallity, or
  • Research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required.

Note: All subjects under the agae of 18 must be consented by a guardia/parent and must assent themselves.

Training

For research involving human subjects, you will need to complete UTA's Human Subjects Protection (HSP) training modules found here   http://www.uta.edu/ra/real/loginscreen.php?view=7

  1. Login at http://www.uta.edu/ra/real/loginscreen.php?view=7 using your UTA NetID and password
  2. Locate the training that says Human Subjects Protection (HSP). It can be under Registered Trainings or Available Trainings..
  3. Click on the Start or Resume button to begin the training.

You will be able to save your progress at any point during the training and resume it again later by following steps 1-3. Any questions should be directed to Robin Dickey in the Office of Research Administration; Regulatory Services at robind@uta.edu or 817-272-9329.

Student Responsibilities Following Research Approval

Request for Continuing (or Continuing with Modification) Review

The regulations at 45 CFR 46.109(e) require continuing (annual) review of human subjects research by an Institutional Review Board (IRB) at intervals appropriate to the degree of risk, but not less than once per year. The UTA policy is to provide approvals based on risks for periods not to exceed twelve months. The IRB Coordinators will contact the researcher (and faculty advisor, if applicable) via email announcing the due date for continuation review at least six weeks ahead of the continuing review due date. This email notification will include the link and instructions for submitting a Continuing Review or a Continuing Review with Modification request.  The researcher must complete the Continuing Review request submission page with adequate  information necessary for the IRB to conduct its substantive, annual review of the ongoing research. Unless the researcher has indicated on Section 3. “Current Research Study Status,” that Study enrollment is permanently closed, and all research related interventions or interactions with human subjects are completed, the researcher should upload a copy of the most recently approved informed consent document (without the previous approval stamp) to the Continuing Review Attachments section of the submission page (at the very bottom of the page). If a Modification request is being submitted at the time of continuing review, the Continuing Review submission page should indicate a status changed to "continuing / revised." When both a Continuing Review and Modification request are submitted simultaneously for review, both submission pages will be completed and the respective pages are selected at the top of the submission screen under the Protocol Number (ex. Review #2012-xxxx.1).  Please reference the process for completing the Request for Modification (only) Review  to ensure the Modification portion of the Continuing Review with Modification request is accurately submitted.

 Once the submission page has been completed and study-related documents have been uploaded, the researcher will select the option to “Save” the submission then select the option to submit the protocol for review.  For student researchers the option will read “Submit to Faculty Advisor,” and for faculty/staff the option will read, “Submit to IRB Coordinator.” Students are unable to submit IRB protocols directly to the IRB Coordinators prior to their Faculty Advisor first reviewing the submission and selecting the option to continue the review process.  A Faculty Advisor has the option to return the protocol to the student for editing or select, “Submit to IRB Coordinator” as with their own protocol submissions. You will be prompted to provide your NetID and password as an electronic signature to move the protocol forward in the review process (researchers and faculty advisors respectively).  IRB Coordinators will review the submission and either return the protocol to the researcher for revision requests or continue the review process by submitting the protocol to the IRB Chair (or designee) for IRB approval review.  Unless otherwise communicated, Full Board protocol continuing reviews will be reviewed during the convened IRB meeting. Upon approval, an official approval letter will be signed by the IRB Chair (or designee) and provided via email communication from the IRB Coordinators as well as stamped copies of the informed consent documents (if applicable). 

IMPORTANT NOTE: Failure to submit the Continuing Review (with or without Modification) by the requested and specified date to the IRB Coordinators may cause the research to exceed the approval period. IRB approval cannot exceed 365 calendar days. If the submission has not been submitted and reviewed by the IRB prior to the expiration date, the protocol will automatically expire.  Should expiration occur, all research related activities must cease. No further recruitment/accrual, data collection, or analysis may take place. Any data collected after the period of approval cannot be used in the research. Any research-related activities that continue after expiration are considered issues of non-compliance and will be subject to further deliberation. Researchers (Faculty Advisors, if applicable) will be notified via email from the Electronic Research Administration (ERA) helpdesk as well as a formal letter signed by the Chair (or designee) of the IRB of expired protocols.

Request for Modification (only) Review

Once research has been approved by the IRB, no changes, modifications or revisions can be made prior to IRB approval [§46.103(b)(4)(iii)] except where necessary to eliminate apparent immediate hazards to the subject. Requests that are considered minor in nature (e.g., title change, increase in number of participants, change in protocol personnel, etc.) can be reviewed by expedited review procedures (reviewed and approved by the IRB Chair or designee).  In some instances it might be determined that the modification requests to Full Board protocols will need to be reviewed during the convened IRB meeting rather than Expedited procedures.  In these circumstances the researchers will be notified by the IRB Coordinators.  Researchers submitting a Modification request will do so via the SMARTIRB system.  Modification requests are created by selecting the Original Protocol for which the modification pertains from the Approved Protocols List and selecting “Start Modification Review.”  The Modification request submission page provides text boxes and categories to select for the researcher to describe the requests and upload revised documents for consideration.  If changes are being made to the informed consent document, researchers will need to upload a copy of the modification consent document to be stamped with a fresh approval date reflecting the changes. Documents affected by the Modification request are uploaded in the Modification Review Attachments section at the bottom of the submission page. Once the submission page has been completed and study-related documents have been uploaded, the researcher will select the option to “Save” the protocol then select the option to submit the protocol for review.  For student researchers the option will read “Submit to Faculty Advisor,” and for faculty/staff the option will read, “Submit to IRB Coordinator.” Students are unable to submit IRB protocols directly to the IRB Coordinators prior to their Faculty Advisor first reviewing the submission and selecting the option to continue the review process.  A Faculty Advisor has the option to return the protocol to the student for editing or select, “Submit to IRB Coordinator” as with their own protocol submissions. You will be prompted to provide your NetID and password as an electronic signature to move the protocol forward in the review process (researchers and faculty advisors respectively).  IRB Coordinators will review the submission and either return the protocol to the researcher for revision requests or continue the review process by submitting the protocol to the IRB member reviewers (Primary, and Secondary, if applicable) for approval review.  Upon approval, an official approval letter will be signed by the IRB Chair (or designee) and provided via email communication from the IRB Coordinators as well as stamped copies of the informed consent documents (if applicable). 

Unanticipated Problem/Adverse Events:  When a participant or researcher in a research study experiences an unanticipated problem, the PI must report this incident to the IRB within 5 days.  A summary of the unanticipated problem must be submitted to the IRB using the IRB adverse events form (link).

OHRP and UT Arlington consider unanticipated problems, in general, to include any incident, experience, or outcome that meets all of the following criteria:

  • unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
  • related or possibly related to participation in the research (there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
  • suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

The IRB votes to determine whether the unanticipated problem represents a problem involving risks to participants or others.  The IRB votes to take one of the following actions:

  • accept the actions taken by the PI to report and resolve the incident
  • notifying current participants when information about the unanticipated problem might affect their willingness to continue to take part in the research
  • alter the continuing review schedule;
  • suspension of some or all research activities
  • approve the study for a shorter period of time
  • termination

Researcher Responsibilities for Study Design:  The researcher is responsible for ensuring that:

  • the study is properly designed and is scientifically sound
  • the investigator and research staff have necessary backgrounds to comply with human subjects and research regulations, such as,
    • regulations concerning IRB review
    • informed consent requirements
    • reporting requirements
    • maintenance of records
    • retention of records
    • supervision of research conduct
  • the study must be designed to ensure minimal risk to participants
  • Investigators must identify possible risks
  • Must evaluate alternatives to the experimental design that could minimize risk
  • Must report conflict of interest to the IRB