This checklist is intended to help researchers create and submit applications, as well as avoid common errors and other issues that slow down review and delay approval.

Required Training

  • Ensure all members of the study team – faculty as well as students – have completed the required Human Subjects training. This can be completed using one of the two sites listed below. A certificate of completion for each member of the study team should be provided to the Office of Research Compliance (ORC) with your protocol.

NIH training on Protecting Human Research Participants

CITI Training

Building your Protocol

  • Does your research study qualify for Minimum Review, or should it be processed for Expedited or Full Board Review?
    • Selecting the correct forms to complete is essential. If you are unsure, please contact the Assistant Director, Amanda Boone.
  • Ensure all personnel engaged in research activities are listed as study team members, including non-UTD personnel, if any.
  • Ensure UTD Key personnel engaged in research activities (PI, Co-PI, Faculty Sponsor) have completed an annual Conflict of Interest disclosure.
    • Student PIs or Co-PIs can complete the COI short form.
    • UTD faculty and staff should contact the COI Manager, Conor Wakeman, for information. If you are unsure whether any member of your research team is current on their COI disclosure, contact Conor Wakeman or Amanda Boone.
  • Complete all sections of the application paperwork:
    • If the study is funded (federal grant, internal award, industry contract, etc.) indicate so on the application as appropriate.
  • Provide a complete description of the study:
    • Include research questions or a hypothesis to clearly define a project as research;
    • Ensure the objective of the project is clear and provide all steps needed in accomplishing the objective;
    • Write all responses and supporting study documents (recruitment, consent, instruments, etc.) in plain English; do not include academic jargon, abbreviations, citations, etc. All language should be written at a 6th grade reading level;
    • Provide appropriate justification of the scientific significance of the investigation.
  • Include a clear description of all potential risks to subjects:
    • A majority of research submitted to the IRB has a risk of a breach of confidentiality;
    • Other common risks include discomfort with sensitive questions; revealing personal, sensitive, or identifiable information in response to open-ended questions; embarrassment;
    • Include all risks in the application and consent documents;
    • Describe appropriate provisions for minimizing these risks.
  • Clearly state that there are no direct benefits to subjects:
    • In minimal risk research, direct benefits to subjects are very rare as they cannot be proven or guaranteed;
    • Compensation is not a benefit of research.
  • Understand confidentiality versus anonymity:
    • Very few studies submitted to the IRB are truly anonymous;
    • Most projects offer to protect the confidentiality of subject data through the use of pseudonyms, data projections, etc.;
    • The anonymity of participants very rarely has any impact on how a project is reviewed or approved;
    • If any identifiers are collected at any point in the study (contact with a study team member, consent documents, tracking recruitment, offering compensation), participants are not considered anonymous;
    • Even three seemingly benign pieces of demographic information can easily identify an individual.
  • Address data storage, access, and protection:
    • Long term data storage (5+ years) should be on UTD servers or in locked campus offices;
    • Short term storage of minimal risk data may be stored on laptops or other portable devices with appropriate protection measures (encryption, etc.).
  • Address consent and provide complete consent documents appropriate for the proposed consent process and subjects:
    • Consent must be addressed for all studies, even if the request is to waive the informed consent process completely;
    • Use the appropriate Consent Form Template to draft consent documents, to help ensure all required elements of consent are included;
    • Carefully review draft documents for edits and readability, appropriate language/reading level, and appropriate for the proposed consent process (signed/written document, information sheet/screen, oral script, etc.);
    • Include assent documents if the study involves working with children or other vulnerable populations.

Submitting

  • Review the application and supporting documents to ensure completion:
    • Ensure all documents are finalized (no draft documents) and ready for review;
    • Clearly explain if any site permissions, finalized contracts (Memorandum of Understanding/Data Use Agreement), or translated documents are forthcoming before final approval;
    • Ensure the application is signed by Principal Investigator, Co-Principal Investigator/Faculty Sponsors.
  • Review the application and supporting documents to ensure consistency:
    • Ensure numbers (time commitment, number of subjects, age of subjects, compensation, etc.) are consistent across all sections of the application and all documents;
    • Ensure risks and benefits are consistent in the application and consent, etc.

Review Process

  • Promptly address and respond to IRB comments or questions:
    • All responses should be sent directly to the IRB Specialist/Manager administering the protocol application;
    • Do not make additional revisions, beyond those requested by the IRB.
    • Track or highlight all revisions to the protocol and provide this copy along with a clean copy to the IRB Specialist/Manager.
    • Contact the assigned IRB Specialist/Manager if you do not understand the IRB’s feedback.
  • PI should resubmit responses in a timely manner.

Approval

  • Begin your project, only after final IRB approval has been provided:
    • Only activities and documents included in your approved application can be conducted/used;
    • If participants are providing signed, written consent, use only documents with the IRB approval stamp;
    • Retain documents and data in accordance with the approved application and campus policies. This will be reviewed if your study is selected for an IRB Post monitoring check.
    • Create and submit Modification applications – which have two parts – to propose updates or modifications to the study as needed;
    • Create and submit Continuing Review applications well in advance of expiration dates, if research activities need to continue.