Submission Information

  1. Application Form: Completed IRB application form which includes qualifications to conduct the research, including necessary support services and facilities.
  2. Research Protocol Proposal:
    • Title and summary of the research.
    • Purpose of the study, including expected benefits and how risks are balanced with benefits.
    • Study sponsor.
    • Inclusion/exclusion criteria, with scientific and ethical reasons for excluding certain subjects.
    • Justification for using special or vulnerable populations (e.g., children, prisoners).
    • Study design and appropriateness of methods.
    • Description of procedures to be performed.
    • Provisions for managing adverse reactions.
    • Consent procedures, including setting, subject autonomy concerns, language difficulties, and considerations for vulnerable populations.
    • Procedures for obtaining and documenting informed consent, including assent from minors, legally authorized representatives, witnesses, and translators.
    • Remuneration and compensation details.
    • Measures for protecting subjects' privacy.
    • Extra costs to subjects for participation.
    • Inclusion/exclusion of women, minorities, and children.
  1. CITI Training Certificates: Certificates of completion for personnel engaged in research.
  2. External Entity Documents: For studies involving an external entity, include a letter of support. If your work is non-exempt and involves an institution with an established IRB, please provide their external entities contact information as we may need to execute a reliance agreement.  For reference, see IRB Guidance on Reliance Agreements. 
  3. Student Research: Refer to IRB Guidance on Students as Research Participants.
  4. Minor Research: Simplified assent form for minors, in addition to the adult parental consent form.
  5. Recording Studies: Consent form includes a recording section which incorporates paragraphs 2-5 of the recording consent template.
  6. Translated Documents: Certificate of translation for any translated documents.
  7. International Research: The International Research Checklist(in addition to the proposal) and a Letter of Cultural Appropriateness from the local ethics entity. For reference, see the IRB Guidance on International Research. 
  8. Study Materials: Copies of recruitment materials, advertisements, surveys, interview scripts, questionnaires, or other materials provided to subjects.
  9. Funding Applications: Copies of relevant grant applications.
  10. Informed Consent Form: Proposed informed consent form, including translated documents or request for waiver of informed consent.
  11. Investigator’s Brochure, when one exists.
  12. Case Report Form, when one exists.
  1. Amendment and Report Form: Completed form detailing changes and/or new information related to the study.
  2. Explanation of Changes: Detailed explanation of the circumstances for the submission.
  3. New Study Instruments: Include updated or new study instruments, as applicable.
  4. Tracked Changes: Document revisions to previously approved IRB documents using tracked changes.
  5. Reports: Updated reports of unexpected adverse events and unanticipated problems involving risks to subjects. Including, if available, data safety monitoring reports. Progress/interim reports that include reports of protocol breaches of confidentiality, violations and/or deviations, and any other instances of noncompliance.

In order to conduct research, all key research personnel must complete a training course online. Studies will not be approved if required training has not been completed. All active staff must complete the necessary training via CITI program  (as applicable): 

  1. Responsible Conduct for Research. [required for all]
  2. Human Subject Research Investigators. [required for studies involving human subjects]
  3. Data or Specimens Only Research. [required for studies only involving data or specimens]
  4. Good Clinical Practice. [required for clinical studies]

On the CITIProgram website, log in via SSO to begin training. If you do not have a pre-existing account, create a new account using the UMassD email which will automatically add UMassD as an affiliation. If there is a pre-existing CITI account, then UMassD must be added as an affiliation. Once logged in, go to “Add Affiliation” then search for “University of Massachusetts Dartmouth”. Once selected, the user is prompted to enter their UMassD email. The IRB is unable to access CITI accounts affiliated to any other institution. Once affiliated, the user must go to “Add a Course” to select course assignments as identified before from the UMassD CITI subscription. Alternatively, the IRB can accept comparable CITI certificates of completion which have not yet expired but are completed under another affiliation.

Different types of studies have different timetables for review. Exempt studies, posing minimal risk to human subjects, take approximately 2-3 weeks to approve from the date received by the IRB. Expedited studies take approximately 2-4 weeks to approve from the date received by IRB. Depending on the time of year, it could take longer than this time frame for IRB approval due to an increase in research studies needing IRB approval. It is important to remember studies requiring full board review require a convened full board meeting, which may require additional time. Full board studies are generally reviewed monthly, during scheduled full board IRB meetings. A study must be submitted on or before the agenda deadline to be reviewed by the board at that month's meeting. Notification of determinations reached at the full board meetings are emailed to PIs within three business days after the meeting date.