Standard Operating Procedures - Appendix A

Institutional Review Board (IRB)
Standard Operating Procedures (SOP)
University of MassachusettsAmherst

HANDLING ALLEGATIONS OF NON COMPLIANCE

I. Introduction

Under institutional authority and federal regulations [Title 45 CFR 46.103(b)(5), Title 45 CFR 46.113, Title 21 CFR 56.113], Institutional Review Boards (IRBs) are responsible to oversee the safety of research participants and may suspend or terminate human research that: (1) is not being conducted in accordance with the federal and institutional requirements, or (2) has been associated with unexpected serious harm to participants. The IRB is supported in this process by the Human Research Protection Office (HRPO).

II. Applicability

The following apply to all research activities of faculty, staff, students and others who are involved in human research as defined by the UMASS University Policy “Assurance of Compliance with OHRP Regulations for Protection of Human Research Subjects.”

III. Definitions

A. Noncompliance is defined as research not conducted in accordance with institutional policy or federal regulatory requirements for human participant protection.

Nonserious and Noncontinuing noncompliance involves isolated incidents, e.g. an unintentional mistake, an oversight, or a misunderstanding. The issue is not serious or continuing in nature.
Serious and/or Continuing noncompliance involves practices that appear to: (1) cause injury (physical, psychological, emotional, etc.) or any other unanticipated problems involving risks to participants and/or others, or (2) constitute serious or continuing noncompliance with IRB determinations or federal regulations.

B. Protocol Deviations and Variances from the Protocol do not fall within these definitions until they are considered "serious and/or continuing."

IV. Process to Address Allegations of Noncompliance

Information regarding noncompliance in studies that enroll human participants may come to the attention of the IRB through several pathways:

New applications
Continuing reviews
Internal audits
FDA audit reports
Adverse event/safety reports
Reports from collaborators, employees, participants, family members, community members
Any other sources.

Each complaint or concern is taken seriously and reviewed in a consistent, prompt, and professional manner. Additionally, care is taken to maintain confidentiality. All communications and documentations are to be factual and objective.

A. Preliminary Determination of Suspension or Non-suspension

The Human Protection Administrator (HPA) in collaboration with the Chair of the IRB determines if immediate suspension of study procedures and/or study enrollment is required for the project in question, as well as for other projects under the same investigator. This initial decision is based on preliminary review of available information, communication with the principal investigator(s) involved in alleged noncompliance activities, and the seriousness of the allegations.

The principal investigator(s) in the allegations and associated research staff personnel, appropriate Department Head(s), and Institutional Official (IO) are notified in writing about any suspension.
Federal regulatory agencies are notified, if applicable.

Further fact-finding and timely review by a convened IRB determines the length of any suspension.

B. Inquiry

The HPA undertakes an inquiry of the allegations within 10 week days of the recognized concern. The purpose of the inquiry is fact-finding, and may involve examination of study records and discussion with the research team, other personnel, research participants, witnesses, the complainant (if not anonymous), and others as appropriate.
The HPA documents and compiles the information and in collaboration with the IRB Chair; determines whether the noncompliance is (1) nonserious and noncontinuing or (2) a serious or continuing situation that warrants investigation by the IRB.

C. Resolution of Inquiry

1. Nonserious and Noncontinuing Noncompliance
If the noncompliance activity is determined to be nonserious and noncontinuing:

The issue is resolved between any combination of the HPA, IRB Chair, principal investigator(s) involved in noncompliance activities and Department Head(s).
The HPA documents the outcome of all communications in writing. This report includes any sanctions or corrective actions required on the part of the investigator and the timelines for resolution.

A copy of this report is sent to the principal investigator(s) involved in noncompliance activities, associated research staff personnel, and others deemed appropriate.

A written response from the principal investigator acknowledging the report and describing corrective actions is required within 10 week days from the date of the corrective report.
The complainant will be provided information as deemed appropriate by the HPA.
All communication is documented in a restricted IRB noncompliance and confidential section within the specific IRB research study folder.
Depending on IRB request, the IRB will be kept apprised of nonserious and noncontinuing noncompliance actions, as they arise including the corrective report and written response from the principal investigator.

2. Serious and/or Continuing Noncompliance
If the noncompliance activity is determined to be a serious or continuing situation that warrants investigation by the IRB:

The HPA, in conjunction with the IRB Chair, reconsiders the possible need for suspension of study procedures and/or study enrollment for the project in question, as well as for other projects under the same investigator, pending a timely review by a convened Institutional Review Board.
The principal investigator(s) involved in alleged noncompliance activities is/are notified and provided with an opportunity to discuss allegations.
If research activity suspension is warranted:
- The principal investigator(s) involved in noncompliance activities and associated research staff personnel, Department Head(s), and Institutional Official are notified in writing about any suspension.
- Federal regulatory agencies are notified, if applicable.
- In cases of externally funded programs, notice is sent to the sponsor and to the Office of Grant and Contract Administration.
A written report summarizing the inquiry findings is sent to the principal investigator(s) involved in noncompliance activities and associated research staff personnel.
The principal investigator(s) involved in noncompliance activities is/are required to respond to the inquiry findings within 10 week days from the date of the written report, unless an extension is requested in writing and granted by the HPA. The principal investigator and the complainant (if not anonymous), will be invited to attend the next convened IRB meeting to address the allegations.
Convened IRB Review.
- The issue is presented to the next appropriate convened IRB. For urgent issues, the HPA may convene an emergency meeting of the IRB.
- The IRB reviews the outcome of all documented communications and discussions concerning the noncompliance, determines if further information is required, and meets with the principal investigator involved in noncompliant activities, the complainant (if not anonymous), and others as needed. Once the IRB has completed its investigation, a vote is taken as to whether noncompliance has occurred. If noncompliance is found, the IRB votes on the appropriate course of action.
  - The IRB has the authority to suspend or terminate IRB approval of protocols that are found to be noncompliant with institutional policies and procedures, state laws, and/or federal laws or regulations.
  - Other sanctions imposed by the IRB may include, but are not limited to, compliance audits, letters of reprimand, additional training, and restrictions on serving as an investigator on protocols that enroll human participants.
Dissemination of Findings
All communication is documented in a restricted IRB noncompliance and confidential section within the IRB research study folder.
- The HRPO, on behalf of the IRB, sends written notification of the IRB’s determinations and required actions to the principal investigator(s) involved in the allegations and associated research staff personnel, Department Head(s), and Institutional Officials.
- In cases of externally funded programs, notice is sent to the sponsor and to the Office of Grant and Contract Administration when any action includes suspension or termination.
- Federal regulatory agencies are notified, if applicable.
- Others are notified as appropriate (e.g., the complainant, study participants, other research sites, etc.

V. Research Misconduct

In cases that involve allegations of research misconduct, the HPA notifies the Institutional Official for further action. This does not preclude the IRB Chair(s) or any member of the IRB from independently contacting the Institutional Official about any allegation of research misconduct. Inquiries or investigations into research misconduct do not preclude IRB reviews and actions.




Research Home Compliance Home Animal Use Biological Safety Feedback Forms Human Subjects Research Policies Responsible Conduct Staff		Standard Operating Procedures - Appendix A Institutional Review Board (IRB) Standard Operating Procedures (SOP) University of MassachusettsAmherst *HANDLING ALLEGATIONS OF NON COMPLIANCE* I. Introduction Under institutional authority and federal regulations [Title 45 CFR 46.103(b)(5), Title 45 CFR 46.113, Title 21 CFR 56.113], Institutional Review Boards (IRBs) are responsible to oversee the safety of research participants and may suspend or terminate human research that: (1) is not being conducted in accordance with the federal and institutional requirements, or (2) has been associated with unexpected serious harm to participants. The IRB is supported in this process by the Human Research Protection Office (HRPO). II. Applicability The following apply to all research activities of faculty, staff, students and others who are involved in human research as defined by the UMASS University Policy “Assurance of Compliance with OHRP Regulations for Protection of Human Research Subjects.” III. Definitions A. Noncompliance is defined as research not conducted in accordance with institutional policy or federal regulatory requirements for human participant protection. Nonserious and Noncontinuing noncompliance involves isolated incidents, e.g. an unintentional mistake, an oversight, or a misunderstanding. The issue is not serious or continuing in nature. Serious and/or Continuing noncompliance involves practices that appear to: (1) cause injury (physical, psychological, emotional, etc.) or any other unanticipated problems involving risks to participants and/or others, or (2) constitute serious or continuing noncompliance with IRB determinations or federal regulations. B. Protocol Deviations and Variances from the Protocol do not fall within these definitions until they are considered "serious and/or continuing." IV. Process to Address Allegations of Noncompliance Information regarding noncompliance in studies that enroll human participants may come to the attention of the IRB through several pathways: New applications Continuing reviews Internal audits FDA audit reports Adverse event/safety reports Reports from collaborators, employees, participants, family members, community members Any other sources. Each complaint or concern is taken seriously and reviewed in a consistent, prompt, and professional manner. Additionally, care is taken to maintain confidentiality. All communications and documentations are to be factual and objective. A. Preliminary Determination of Suspension or Non-suspension The Human Protection Administrator (HPA) in collaboration with the Chair of the IRB determines if immediate suspension of study procedures and/or study enrollment is required for the project in question, as well as for other projects under the same investigator. This initial decision is based on preliminary review of available information, communication with the principal investigator(s) involved in alleged noncompliance activities, and the seriousness of the allegations. The principal investigator(s) in the allegations and associated research staff personnel, appropriate Department Head(s), and Institutional Official (IO) are notified in writing about any suspension. Federal regulatory agencies are notified, if applicable. Further fact-finding and timely review by a convened IRB determines the length of any suspension. B. Inquiry The HPA undertakes an inquiry of the allegations within 10 week days of the recognized concern. The purpose of the inquiry is fact-finding, and may involve examination of study records and discussion with the research team, other personnel, research participants, witnesses, the complainant (if not anonymous), and others as appropriate. The HPA documents and compiles the information and in collaboration with the IRB Chair; determines whether the noncompliance is (1) nonserious and noncontinuing or (2) a serious or continuing situation that warrants investigation by the IRB. C. Resolution of Inquiry *1. Nonserious and Noncontinuing Noncompliance* If the noncompliance activity is determined to be nonserious and noncontinuing: The issue is resolved between any combination of the HPA, IRB Chair, principal investigator(s) involved in noncompliance activities and Department Head(s). The HPA documents the outcome of all communications in writing. This report includes any sanctions or corrective actions required on the part of the investigator and the timelines for resolution. A copy of this report is sent to the principal investigator(s) involved in noncompliance activities, associated research staff personnel, and others deemed appropriate. A written response from the principal investigator acknowledging the report and describing corrective actions is required within 10 week days from the date of the corrective report. The complainant will be provided information as deemed appropriate by the HPA. All communication is documented in a restricted IRB noncompliance and confidential section within the specific IRB research study folder. Depending on IRB request, the IRB will be kept apprised of nonserious and noncontinuing noncompliance actions, as they arise including the corrective report and written response from the principal investigator. 2. Serious and/or Continuing Noncompliance If the noncompliance activity is determined to be a serious or continuing situation that warrants investigation by the IRB: The HPA, in conjunction with the IRB Chair, reconsiders the possible need for suspension of study procedures and/or study enrollment for the project in question, as well as for other projects under the same investigator, pending a timely review by a convened Institutional Review Board. The principal investigator(s) involved in alleged noncompliance activities is/are notified and provided with an opportunity to discuss allegations. If research activity suspension is warranted: The principal investigator(s) involved in noncompliance activities and associated research staff personnel, Department Head(s), and Institutional Official are notified in writing about any suspension. Federal regulatory agencies are notified, if applicable. In cases of externally funded programs, notice is sent to the sponsor and to the Office of Grant and Contract Administration. A written report summarizing the inquiry findings is sent to the principal investigator(s) involved in noncompliance activities and associated research staff personnel. The principal investigator(s) involved in noncompliance activities is/are required to respond to the inquiry findings within 10 week days from the date of the written report, unless an extension is requested in writing and granted by the HPA. The principal investigator and the complainant (if not anonymous), will be invited to attend the next convened IRB meeting to address the allegations. Convened IRB Review. The issue is presented to the next appropriate convened IRB. For urgent issues, the HPA may convene an emergency meeting of the IRB. The IRB reviews the outcome of all documented communications and discussions concerning the noncompliance, determines if further information is required, and meets with the principal investigator involved in noncompliant activities, the complainant (if not anonymous), and others as needed. Once the IRB has completed its investigation, a vote is taken as to whether noncompliance has occurred. If noncompliance is found, the IRB votes on the appropriate course of action. The IRB has the authority to suspend or terminate IRB approval of protocols that are found to be noncompliant with institutional policies and procedures, state laws, and/or federal laws or regulations. Other sanctions imposed by the IRB may include, but are not limited to, compliance audits, letters of reprimand, additional training, and restrictions on serving as an investigator on protocols that enroll human participants. Dissemination of Findings All communication is documented in a restricted IRB noncompliance and confidential section within the IRB research study folder. The HRPO, on behalf of the IRB, sends written notification of the IRB’s determinations and required actions to the principal investigator(s) involved in the allegations and associated research staff personnel, Department Head(s), and Institutional Officials. In cases of externally funded programs, notice is sent to the sponsor and to the Office of Grant and Contract Administration when any action includes suspension or termination. Federal regulatory agencies are notified, if applicable. Others are notified as appropriate (e.g., the complainant, study participants, other research sites, etc. V. Research Misconduct In cases that involve allegations of research misconduct, the HPA notifies the Institutional Official for further action. This does not preclude the IRB Chair(s) or any member of the IRB from independently contacting the Institutional Official about any allegation of research misconduct. Inquiries or investigations into research misconduct do not preclude IRB reviews and actions.


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