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.
- 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.
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.
- 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.
- 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.
- 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.
- 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.
- Institutional Review Board (IRB)
- Institutional Animal Care and Use Committee (IACUC)
- Institutional Biosafety and Chemical Safety Committee (IBCC)
- Conflict of Interest (COI)
- Lab Safety
- Export Control
- Responsible Conduct of Research (RCR)
- Contact with Federal Officials