Research on human subjects allows researchers to acquire knowledge that is vital to the development of interventions and treatments that may ultimately benefit humans. Some research results in direct benefits to individual participants. More frequently, human subjects research results in societal benefits through the knowledge gained.
Human Subjects FAQ
There are many different types of research studies conducted at UMass Amherst. Some focus on investigating attitudes or beliefs and others focus on developing interventions or treatments that will ultimately benefit society. Methods of data collection include surveys, interviews, focus groups, behavioral observations, and analysis of data that was previously collected for non-research purposes. Some research studies consist of behavioral tasks that involve problem-solving, performing exercise, or responding to visual or auditory stimuli. Researchers at UMass also conduct biomedical research that may include analysis of biospecimens or use of imaging techniques such as MRI.
The Institutional Review Board (IRB) is a federally required committee that reviews human subjects research to ensure that it is both ethical and conducted in compliance with federal regulations, state regulations, and institutional policies and procedures. The IRB must approve human subjects research prior to its initiation and oversees the progress of approved research via annual renewals and check-ins.
Before a researcher can begin work with human subjects, the researcher must submit a protocol outlining the intended procedures. Protocols submitted to the IRB receive a robust review focusing on the rights and welfare of those individuals who voluntarily agree to take part as research participants. The protocol must include necessary materials for the IRB to conduct the review including:
- a detailed description of the project procedures, copies of items participants will be asked to complete (e.g., surveys, questionnaires, description of actions they will be asked to take, etc.);
- a description of how participants will be recruited;
- a description of how participants will provide consent to participate; and,
- a description of how the subjects' privacy and confidentiality will be safeguarded, etc.
The IRB or representatives examine these materials to determine if the research participants are adequately protected. The IRB's consideration is based primarily on weighing the risks and benefits of the research. Risks may be physical, psychological, social, or economic. Benefits include both those to the individual research participant and to society as a whole. As part of that review, the IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.
For more information on the review process, view Getting Started – IRB Process Overview.
The Institutional Review Board (IRB) oversees recruitment of research participants to ensure that participation is voluntary and recruitment methods are appropriate for the proposed study, with minimal risk of individuals being coerced or unduly influenced to participate. A variety of methods are used for recruiting, including posting physical flyers, advertising studies in newspapers and/or on social media, radio announcements, email invitations sent to groups or organizations, and verbal announcements at meetings or in classes.
The benefits of participation in research vary depending on the study. Some research studies offer direct benefits such as providing participants with a health assessment or access to interventions or treatments, or small monetary compensation. Other research studies provide no direct benefit to participants. Nevertheless, participants may find it rewarding to contribute to research that will generate useful knowledge and potentially lead to benefits for others in the future.
Anyone with concerns about the treatment of human subjects in research at UMass Amherst should reach out to the Human Research Protection Office (HRPO) via phone (413-545-3428) or email (humansubjects@ora.umass.edu). All concerns are taken seriously. Once reports are received, they will be reviewed and an investigation into the matter will be initiated immediately. HRPO will attempt to remain in contact with the individual submitting the report and inform them of the outcome of the investigation.