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.

3. CITI Training Certificates: Certificates of completion for personnel engaged in research.
4. 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. 
5. Student Research: Refer to IRB Guidance on Students as Research Participants.
6. Minor Research: Simplified assent form for minors, in addition to the adult parental consent form.
7. Recording Studies: Consent form includes a recording section which incorporates paragraphs 2-5 of the recording consent template.
8. Translated Documents: Certificate of translation for any translated documents.
9. 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. 
10. Study Materials: Copies of recruitment materials, advertisements, surveys, interview scripts, questionnaires, or other materials provided to subjects.
11. Funding Applications: Copies of relevant grant applications.
12. Informed Consent Form: Proposed informed consent form, including translated documents or request for waiver of informed consent.
13. Investigator’s Brochure, when one exists.
14. 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.

The IRB ensures the following specific criteria are met for approving research involving human subjects:

1. Minimization of Risks: Risks to subjects are minimized:
   1. By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
   2. Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risk-Benefit Ratio: Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
3. Equitable Selection of Subjects: The selection of subjects is equitable. In making this assessment, the IRB should consider the research's purposes and the setting in which it will be conducted. The IRB should be particularly cognizant of the special problems of research that involve a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
4. Informed Consent: Each subject or their legally authorized representative must provide informed consent as required by 45 CFR 46.116. Consent should be appropriately documented or waived per 45 CFR 46.117.
5. Deception or Withholding of Information: If deception or withholding of information is necessary for adequate testing of the hypotheses and there is no practical alternative:
   1. Sufficient justification must be provided that the potential benefits to the subject or the importance of the knowledge to be gained outweigh any potential risks that may be present as a result of such deception.
   2. Assurances of acceptable debriefing must be provided, if appropriate. The PI must give each subject an explanation to questions ensuing from participation in the research project following its conclusion. It is strongly recommended that this occur immediately following participation for each subject, but if, in the judgment of the IRB, such information could adversely affect subsequent data collection in the same study, the full explanation may be delayed for a reasonable period. In cases where deception is unavoidable and may result in emotional stress, full debriefing is mandatory immediately following completed participation.
6. Adequacy of Facilities and Resources: The adequacy of facilities and other resources necessary for the completion of the study and the protection of subjects’ rights must be assessed.
7. Data Monitoring: Adequate provisions must ensure data monitoring to protect subject safety.
8. Privacy and Confidentiality: Measures to protect subject privacy and maintain data confidentiality must be in place.
9. Protection of Vulnerable Subjects: When some or all subjects are likely vulnerable to coercion or undue influence (e.g., children, prisoners, individuals with impaired decision-making capacity, economically or educationally disadvantaged persons), additional safeguards are integrated into the study to protect their rights and welfare.
10. Protocol Completeness: The protocol explicitly outlines the design and procedures from inception to completion.

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.