Human Subjects FAQ

The UMass Amherst IRB currently consists of a community member, some non-scientific members, two physicians and eight faculty members from a range of academic departments.

The IRB meets monthly. Protocols requiring review by the full IRB should be submitted 10 days in advance of the full board meeting.  Meeting times and places are posted on the Compliance web site.

Studies undertaken by students must be sponsored by a faculty advisor. Postdoctoral scholars may submit independently if they have written approval from the Department and Dean. Otherwise they should submit listing the faculty mentor as Co-Investigator.

Not usually. Course-related research projects usually are limited in scope, do not lead to generalizable knowledge and are not undertaken with that goal in mind. These projects are considered classroom exercises and are not subject to review by the IRB.

An informed consent document is a document that records a subject's voluntary participation in a research study and which provides the subject with a description of the study, the risks and benefits of the study to the subject and society, and contact information.

Usually subjects are asked to provide written consent to participate in the study by signing the informed consent document, but there are times when written consent is not needed (e.g., if the data collected are to be anonymous). In those cases, a subject can be “consented” through consent discussion and be provided with an information sheet which provides a description of the study and contact information. If verbal consent is to be obtained the researcher should provide a script for the IRB to review.

All modification/changes in a project previously approved by the IRB must be received and approved by the IRB before they are initiated except where necessary to eliminate apparent immediate hazard to the subject.

Requests for approval of modifications/changes may be submitted at any time by an investigator. Additional guidelines may be found at Revisions to a Protocol.

Investigators and laboratory or department heads are responsible for reporting promptly to the IRB any serious or continuing noncompliance with university policies or federal regulations.

In addition, every approval of a research project is granted with the stipulation that any unanticipated problems and risks, changes in the research plan, and any injury to subjects be reported to the Committee. Please follow the instructions included in Adverse Events Reporting.

If your protocol was reviewed and found to be exempt you will only need to update your protocol once every 3 years or if you wish to change the scope of work.

For all other protocols IRB approval is for a maximum period of 1 year. At the end of this period you need to return an annual update form to the IRB requesting a renewal. If you have made significant changes to your research you will need to submit a new protocol.

At any time, if you make changes to your procedures and/or your informed consent document you must inform the Review Board. Sensitive research may need review by the IRB at more frequent intervals. The interval will be determined at the time the protocol is first reviewed.

Normally yes. Every effort is made to remind you when your annual update is due by sending you a Continuing/Final Report Form when your protocol is approaching the end of its approval period. However, it is ultimately your responsibility to keep track of the deadlines and keep your approvals current.

For e-Protocol continuations, please see instructions at Renewal/Continuation of an Approved Protocol for e-Protocol Submissions.

The Human Research Protection Office (HRPO) has converted to the online human subject approval system called e-Protocol.

In order to access e-Protocol, you will need to contact the HRPO and provide the following information: Name, Department, Title (e.g., graduate student, postdoc, associate professor), e-mail and NETID.  Please note: the CITI human subjects on-line training must be complete before a login can be provided for e-Protocol.

Once your submission is complete it goes to the IRB chair who reviews your protocol and decides the appropriate level of review from three options:

  1. Protocol is exempt from further IRB oversight
  2. Protocol will receive expedited review
  3. Protocol requires review by the full IRB

Depending on the level of review required he/she will assign reviewer(s) from among the IRB members.

HIPAA is shorthand for the Health Insurance Portability and Accountability Act which contains privacy regulations affecting researchers collecting data from a covered entity, such as Baystate Medical Center. (UMass is a hybrid entity). These regulations provide significant new privacy protections for the health information of patients and research subjects including the following:

  • Gives patients more control over their health information.
  • Sets boundaries on the use and release of health records.
  • Establishes appropriate safeguards that health care providers and others must achieve to protect the privacy of health information.
  • Holds violators accountable, with civil and criminal penalties that can be imposed if they violate patients' privacy rights.
  • Strikes a balance when public responsibility requires disclosure of some forms of data - for example, to protect public health. For patients - it means being able to make informed choices when seeking care and reimbursement for care based on how personal health information may be used.
  • Enables patients to find out how their information may be used and what disclosures of their information have been made.
  • Generally limits release of information to the minimum reasonably needed for the purpose of the disclosure.
  • Gives patients the right to examine and obtain a copy of their own health records and request corrections.

HIPAA Frequently Asked Questions

If you have any further questions, please contact HRPO at 545-3428.

UMass researchers working with collaborators at Baystate may now be eligible to seek IRB review at Baystate only, thereby avoiding the requirement for both UMass and Baystate IRB review. Please see IRB Guidance for more information.

Investigators should contact the Human Research Protection Office (HRPO) whenever collaborative research is planned. Separate IRB applications may be necessary, or an IRB collaboration agreement may be reached with the other institution depending on the nature of the study.

An assurance is a contract that the university enters into with the federal government to allow federally-sponsored human research to take place at that institution. The Federal Wide Assurance (FWA) number for UMass is FWA00003909.

Under certain conditions the IRB can waive the requirement that the subject sign an informed consent document. These conditions include the following :

  1. Where the informed consent document is the only record linking the subject and the research, and the principal risk would be potential harm resulting from breach of confidentiality, subjects may be asked whether or not they want documentation linking them to the research and their wishes should be respected.
  2. Where the research presents no more than minimal risk to the subjects and involves no procedures for which written consent is normally required outside the research context.
  3. For projects of minimal risk involving the use of questionnaires, the elements of informed consent may be included in an introductory letter attached to the instrument which should also include a statement to the effect that return of the questionnaire will constitute consent to participate.

Anonymous data are recorded so that the information can never be linked to the subject who supplied it.

Confidential data are recorded so that the information is not immediately identified with the subject who supplied it, but such a link is possible. Confidential data are usually coded–that is, the subject is assigned a unique identifier that will be used to identify the data. The code identifies the data and the subject's identity is kept separate from the code and data. Coded data are not anonymous.

Yes, the training is required of all investigators, including faculty, staff and students, who are interacting and/or intervening with human subjects or handle the personally identifiable data of a human subject.

No. There is no provision allowing you to be granted a pre-approval status to start your project. Your protocol must be submitted, reviewed and approved in writing before you can start your project so plan ahead.

Yes, researchers can be subjects in their own studies. However, UMASS Amherst policy considers investigator self-experimentation as research with human participants, and generally requires the same review and approval as research that recruits other people as subjects.

Though investigator self-experimentation may not raise the conventional ethical concerns outlined in the Belmont Report, all human research projects should undergo ethical review to assure the safety of people involved and the integrity of the research at the university. While researchers may be aware of the risks of self-experimentation, they may also be more willing to accept risks that are ill-advised. Application for review with the IRB office allows a neutral third party to raise concerns and/or propose measures to promote the welfare of researchers.

The IRB is looking for content in your protocol that will allow it to determine the following:

  • That the participation of all the subjects is voluntary.
  • That the rights and welfare of all the subjects will be adequately protected.    
  • That the consent process will be conducted in accordance with federal regulations and UMass human subjects policies.
  • That the potential harms (risks) to the subjects are outweighed by the study's potential benefits to science and society.

This determination can only be made if the protocol contains a robust description of the study procedures. Note that the IRB can review only the information submitted in the protocol. Therefore an inadequately prepared protocol will be returned to the investigator for revision/clarification.

Protocols requiring full IRB review must be submitted 10 working days in advance of the meeting dates. All other protocols may be submitted at any time.

Contact the Human Research Protection Office (HRPO) at 545-3428 for assistance in determining the type of review.

You can contact the Human Protections Administrator's office at 545-3428.  They will help you decide whether your project 1) fits the definition of research, and 2) fits the definition of ‘human subjects' research. If it fits both definitions it will need oversight by the IRB.

Additional information can be found at Activities Involving Human Subjects Research or in the OHRP decision charts.

Yes. Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the 6 federally designated exempt review categories. Studies that may qualify for “Exempt” must still be submitted to the IRB for review.

Yes, if human subjects are involved. Student researchers must have a faculty sponsor for each research project. Please refer to the Information for Students and their Advisors.

Yes. Federal regulations define human subjects research to broadly cover interactions as well as interventions with human subjects for research purposes. Surveys, interviews, and questionnaires are all covered by the federal regulations. IRB approval must be obtained before starting the research project. Most of this research, however, qualifies as "exempt".