General Human Subjects/IRB
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. See Activities Involving Human Subjects Research for more information.
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 (@email). 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.
Determination Process in Kuali
- If your project is determined to be Human Subjects Research, the Kuali system will send you an email notifying you that you have received review comments. Your review comments in the protocol will indicate that the project has been determined to be human subjects research and will provide instructions on how to proceed.
- If your project is determined to be “Not Human Subjects Research (NHSR)” or a determination of “Not Engaged in Human Subjects Research” is made, you will receive a notification from the Kuali system indicating that a Determination has been made. The notification will include instructions for accessing your official determination memo.
No. If you wish to make changes to an existing NHSR determination, please reach out to @email and provide the Kuali number in addition to a brief description of the proposed changes. HRPO staff will advise you regarding whether another determination form should be submitted in Kuali.
No. Responses you provided during the determination process will remain in the protocol form and will not need to be re-entered.
CITI Training
The Collaborative IRB Training Initiative (CITI) is an educational program for the protection of human subjects in research. CITI was developed by experts in the IRB community and is focused on different aspects of bioethics and human subject research. There is a core course in biomedical research and one in social/behavioral research. Each module includes educational materials that can either be read on the screen or printed out. A brief quiz follows each module.
A person listed as study personnel in the IRB application is required to take the training. Any individual who is interacting and/or intervening with human subjects or handles personally identifiable data of a human subject is considered study personnel. Study personnel who are involved in the informed consent process should also be included on the IRB study personnel list.
The university pays an annual fee for all UMass Amherst users. Individual users are not assessed a fee for the CITI training.
The training site can be found at the CITI website. For more information on UMass requirements, please see: Human Subjects/IRB Training.
Researchers should select the track that corresponds to the type of research typically conducted. Generally, the Biomedical Research Module would be required for medical, physiological or pharmacological studies. This includes, but is not limited to, research with drugs, devices or other interventions. The Social and Behavioral Research Module related to studies on sociological, psychological, anthropological or educational phenomena including observational and survey research and work with population and/or epidemiological studies.
All human subjects researchers at UMass are required to complete a CITI Training refresher every 5 years. If researchers completed the basic course more than 5 years ago, a refresher course will be required in order to be considered in good standing.
The time required to complete each of the basic modules varies between 10 to 30 minutes. The total time is estimated to be 2-3 hours. The course does not have to be completed in one sitting and you can return to the course at any time. Units are designed to be taken sequentially.
The refresher course is comprised of various short modules which take about 5-10 minutes to complete. The refresher course in its entirety takes approximately 45 minutes to complete.
You do not need to complete the course in just one session. You are encouraged to use several "log-on" sessions, but you should take the quizzes immediately after completing each module.
If you log off the site and return at a later time, you will re-enter at the "Learner's Menu" page. Choose the Basic or Refresher Course and you will be taken to the Grade Book to begin at the next required module. The course software will keep track of your progress. When you finish the quiz for a module, the software will give you a link to your next module or the opportunity to view the Grade Book.
A passing score of 80% is required. If you are not satisfied with your score, you can retake the quiz to improve.
You are not required to submit your certification to the IRB. HRPO has access to the CITI course completion report and will review your training certification upon your submission to the IRB.
All human subjects researchers at UMass are required to complete the CITI course. Certificates of training from other institutions are not accepted. To receive credit for modules previously taken from other institutions, you would need to affiliate your training with UMass. Because each institution determines which modules are available in their courses not all modules will transfer. For instructions on how to affiliate your training, please go to: Human Subjects/IRB Training.
All human subjects researchers at UMass are required to complete a CITI Training refresher every 5 years. The refresher takes approximately 45 minutes to complete. If CITI training is expired (over 5 years), IRB submissions such as new studies, revisions, or renewals will not be processed until the CITI refresher has been completed. Note: Those who were grandfathered in with the NIH or VA training must now complete the CITI training.
Contact the Human Research Protection Office (HRPO):
- Phone: (413) 545-3428
- Email: @email