Submitting and Reporting to the IRB
1. Does Your Study need IRB Review?
2. New Protocol (including Informed Consent templates)
3. Amendments/Modifications to a Protocol
4. Renewal/Continuing Review
5. Unanticipated/Adverse Events
6. Reporting Deviations/Violations
7. Final Report/Review
8. Forms for Human Subjects Research
Faculty, staff and students at the University of Massachusetts Amherst proposing research that involves intervention or interaction with individuals, or involves obtaining information about individuals, must seek human subjects approval.
The first question a researcher should consider with respect to IRB review is whether the research project fits the definition of human subjects research. Federal Regulations define research as “a systemic investigation, including development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45CFR46.102(d)). Please see guidance listed below for additional information:
- Is Your Project Human Subjects Research? A Guide for Investigators. (from University of Southern California
- Activities Using Human Subjects Research
- Information for Students and their Advisors
- Students please note that application materials submitted to the IRB must be submitted by your faculty sponsor or staff sponsor who will act as the Principal Investigator (PI). PI's will be responsible for the oversight of the project and will be required, along with all key personnel, to complete the on-line training.
All funded research is approved through the Institutional Review Board (IRB). Research projects that are not funded may seek approval through the local review board. Please refer to the listing of Local Review Boards to determine if there is one within your discipline. Those disciplines without a local review board may submit their protocol materials to the IRB.
Researchers collaborating with Baystate Medical Center should review Baystate Collaborative Research Guidance for information on streamlining the review process.
Once you have determined that your study requires IRB approval, you must submit a protocol to the IRB for review. If you have questions about the level of review that would be appropriate for your study, please contact the Human Research Protection Office (HRPO) at email@example.com, or at 545-3428.
Before you can begin to develop your protocol, the following steps must be completed:
1. Take the appropriate CITI training module and secure a completion certificate. (Note: If you are a student, your faculty sponsor will also need CITI training certification.)
2. Refer to the guidance for establishing a login and for configuring your computer for the electronic protocol system, e-Protocol. (Note: If you are a student, your faculty sponsor will also need to have an e-Protocol login and configure their computer.)
3. Before starting your protocol submission, refer to the guidance for entering information in e-Protocol.
If you have already completed steps 1-3, you can go directly to e-Protocol.
Consent Forms may be required in e-Protocol. See below for consent form templates:
Further guidance on protocol submissions, such as specimen use, audio recordings, focus group, etc. can be found at http://www.umass.edu/research/irb-guidelines/irb-guidelines .
- Informed Consent and Assent Guidance (Elements required by federal regulations)
- Informed Consent Templates and Instructions
- Assent Form Template
All modification/changes in a project previously approved by the UMass Amherst Human Subjects Institutional Review Board (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.
See Amendments/Modifications for submission requirements.
Researchers are responsible for providing continuing review information to the IRB. This is a monitoring mechanism that assures that continuing safeguards are in place to protect the rights and welfare of study participants. Continuing review of research is required at intervals appropriate to the degree of risk, but not less often than once per year (45 CFR 46.109(e)).
See Continuing Review for submission requirements.
Federal regulations [45CFR46.103(b)(5) and 21CFR56.108(b)(1)] require the IRB to ensure that investigators promptly report "any unanticipated problems in involving risk to subjects or others."
- Unanticipated Event - To determine the type of event and the reporting requirements, see Reporting Unanticipated Problems.
- Adverse Event - To determine the type of event and reporting requirements, see Adverse Event and Adverse Event Reporting.
The IRB requires reporting of all protocol deviations and/or protocol violations within five (5) business days as per IRB Policy.
1. Deviations generally do not have a major impact on subject welfare or data integrity. Examples of a protocol deviation may include:
- Scheduling a required procedure outside of the time frame specified in the protocol
- Failure of subject to return study medication
- Implementation of unapproved recruitment procedure
2. Violations affect a subjects rights, safety or well-being or integrity of the data being collected. It may also affect the primary safety or efficacy endpoints of the study. Examples are:
- Enrolling subjects who did not meet entry criteria without prior permission
- Failing to obtain informed consent prior to any study-related procedures
Failure to treat subjects according to protocol procedures that specifically relate to primary safety or efficacy endpoints.
Reporting Protocol Deviation/Violation Report Forms
Final reports must be submitted upon completion of the study. Studies would be considered eligible for closure once the following is complete:
- enrollment of subjects is closed, and subjects have completed all research-related interventions, and
- data collection is complete, and
- data are de-identified, for example data are being maintained in such a way that identifiers are separated from the coding system, or data is in a secure location, and
- there is no additional research beyond the original intent planned for these data.
See Final Review for submission requirements.