IRB Guidelines - Research Responsibility

To assure the protection of human subjects and to comply with Federal law, the University of Massachusetts Amherst requires researchers to obtain approval for proposed human subjects research prior to recruiting subjects or collecting data from subjects. This applies to preliminary and pilot studies which are developing or testing instruments and procedures, as well as the full study.

Researchers shall explain to subjects, prior to their decision about whether or not to participate, the objectives of the research, the procedures to be followed and the potential risks and benefits.

Once a study is approved, researchers responsibilities include the following:

  • Modifications – Changes in any aspect of the study (for example, project design, procedures, consent forms, advertising materials, additional key personnel or subject population) are submitted to the IRB for approval before instituting the changes.
  • Consent Forms – All subjects are given a copy of the signed consent form. Investigators are required to retain signed consent documents for six (6) years after close of the grant or three (3) years if unfunded.
  • Training – Human subject training certificates, including those for any newly added personnel, are provided for all key personnel.
  • Adverse Events – All adverse events occurring in the course of the protocol are reported to the IRB as soon as possible, but not later than ten (10) working days.
  • Continuing Review – IRB Protocol Report Forms are submitted annually at least two weeks prior to expiration, six weeks for protocols that required full review.
  • Completion Report – The IRB is notified when your study is complete. To do this, complete the IRB Protocol Report Form and select “Final Report.”

OHRP Investigator Responsibility Frequently Asked Questions