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Institutional Review Board

The primary mission of the UMass Dartmouth Institutional Review Board (IRB) is to provide a comprehensive and systematic review process designed to protect the rights, dignity, and welfare of individuals who are the subjects of research conducted by university faculty, staff, or students. The UMass Dartmouth IRB is registered with the US Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) (IRB00000820) and UMass Dartmouth holds a Federalwide Assurance (FWA) which documents the University’s commitment to comply with federal regulations for the protection of human subjects in research (FWA00000180).

UMass Dartmouth IRB subscribes to the ethical standards delineated in the Belmont Report and the Declaration of Helsinki, all applicable federal, state, and local regulations related to the conduct of human subject research, and University policies and procedures. The University also understands the necessity to take into consideration various cultural contexts and to comply with local laws and customs when conducting transnational research.

To achieve this mission, the IRB and Human Research Protection Program (HRPP) strive to:

  1. Ensure Ethical Conduct and Safeguard Participants: Promote and uphold the ethical principles of respect for persons, beneficence, and justice as outlined in the Belmont Report, and protect the rights, safety, and well-being of research participants by thoroughly reviewing and monitoring research protocols.
  2. Foster Compliance and Promote Quality Research: Ensure all research involving human subjects complies with relevant laws, regulations, and institutional policies, and facilitate the conduct of high-quality, ethically sound research that advances knowledge and benefits society.
  3. Educate, Support, and Engage Researchers: Provide education, training, and guidance to researchers on ethical standards and regulatory requirements for human subjects research, and foster open communication and collaboration with the research community, ensuring transparency in IRB processes and decisions.
  4. Commit to Continuous Improvement: Regularly assess and enhance IRB practices and procedures to ensure they meet evolving ethical and regulatory standards.

The IRB is dedicated to maintaining a culture of respect, integrity, and accountability, ensuring that all research participants are treated with dignity and respect, and that their rights and welfare are a central focus of the research enterprise at UMass Dartmouth.

Human subjects research is defined as activities which meet the criteria articulated in applicable U.S. DHHS regulations as both “research” and as involving “human subjects.”

Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 

Systematic investigation: an activity that involves a prospective study plan that incorporates data collection and analysis, either quantitative or qualitative, to answer a study question. Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population or situation).

Generalizable knowledge: the purpose or intent of the project is to test or to develop scientific theories or hypotheses, or to draw conclusions intended to be applicable to, or shared beyond, the populations or situations being studied (i.e., knowledge contributes to an already established body of knowledge via presentation of data at meetings, conference, seminars, etc.).

Human subject: a living individual about whom an investigator (whether professional or student) conducting research obtains:  
(i) Obtains data (information or biospecimens) through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Answers to questions about our office, the IRB submission review process, consent requirements, recruitment, and other information relating to human subjects research is available in our Standard Operating Procedures. 

If you have IRB specific questions or to submit IRB applications please email irb.research@umassd.edu.

Participants with questions, concerns, or complaints about research should contact Stephanie Pena, Director of Institutional Compliance & Ethics, via email at spena4@umassd.edu.