Standard Operating Procedures - Chapter 9

FUNCTIONS OF THE IRB

9.1	Conducting Initial and Continuing Reviews
9.2	Reporting Findings and Actions to the Investigator and Institution
9.3	Determining which Studies Require Review more Often than Annually
9.4	Determining which Studies Need Verification from Other Sources
9.5	Determining that no Material Changes have Occurred since Previous IRB Review and Approval
9.6	Insuring that Changes in Approved Research are not Initiated without IRB Review and Approval
9.7	Insuring Prompt Reporting of Unanticipated Problems involving Risks to Participants or Others
9.8	Suspension or Termination of IRB Approved Research
9.9	Reporting to Federal Oversight Agencies

9.1 Conducting Initial and Continuing Reviews

The IRB will conduct initial and continuing reviews of funded human participant research to ensure that all such research is conducted in accordance with the Assurances on file with the DHHS involving human participants. After initial screening of applications by the HRPO for completeness, IRB review of applications is conducted to:

Determine that the use of human participants has research relevance and to consider ethical issues with regard to the study’s design and conduct;
Determine that the proposed research design is scientifically sound and does not unnecessarily expose participants to risks;
Identify the risks associated with the research, as distinguished from the risks of procedures the participants would receive even if not participating in research;
Identify the risk level;
Determine that the risks are minimized and safety is maximized to the extent possible;
Identify the probable benefits to be gained from the research;
Determine that the risks are reasonable in relation to the benefits to participants, if any, and the importance of the knowledge to be gained;
Assure that the participant selection is equitable;
Assure that potential participants are provided with an accurate and fair description of the research, including the procedures, the risks or discomforts and the anticipated benefits and information necessary for informed consent;
Determine intervals of periodic review;
Determine that adequate provisions are in place for monitoring the data collected, where appropriate;
Determine the adequacy of the provisions to protect the privacy of participants and to maintain the confidentiality of the data;
Where the participants are likely to be members of a vulnerable population, determine that appropriate additional safeguards are in place to protect the rights and welfare of these participants.

9.2 Reporting Findings and Actions to the Investigator and Institution

IRB findings and actions are reported in writing to the investigator submitting the application. The institutional official is notified if a previously approved research study has been suspended or terminated for causes other than failure to complete routine documentation as required under HRPO procedures.

9.3 Determining which Studies Require Review more often than Annually

Each study is required to undergo continuing review at a minimum of once every 365 days. At the time of initial approval, or any time thereafter, the IRB may require that a study undergo continuing review at more frequent intervals.

9.4 Determining which Studies need Verification from other Sources

Ordinarily, the IRB places trust in the PI of an approved research study to carry out the research as planned and presented to the IRB. However, certain situations may be encountered that would cause the IRB to require verification of information related to the conduct of the study from sources other than the investigators. Examples of such situations would include allegations of misconduct by an investigator, complaints from a participant or a third party “whistle-blower,” or a random compliance audit by IRB staff.

9.5 Determining that no Material Changes have occurred since Previous IRB Review and Approval

As part of the continuing review reporting process, the PI must specify what changes, if any, have occurred since the previous IRB review. The IRB staff may perform a compliance audit of any study’s records to ascertain the degree of compliance.

9.6 Insuring that Changes in Approved Research are not initiated without IRB Review and Approval

As outlined in approval letters, investigators agree to notify the HRPO of any additions or changes in study procedures that would alter participant risk. All investigators are required to submit any changes to the research study to the IRB for review and approval before implementation, except where necessary to eliminate apparent immediate hazards to the participants. Changes include, but are not limited to, the following: (1) procedures involving human participants; (2) informed consent form or informed consent procedures; and (3) identity of the investigators and/or personnel involved in the study. In the case of changes implemented to eliminate immediate hazards to the participant, the IRB must be notified no later than the next workday. To insure compliance, IRB staff may conduct random compliance audits.

9.7 Insuring Prompt Reporting of Unanticipated Problems involving Risks to Participants or Others

Adverse Event Guidelines document IRB actions to be taken. All investigators are required to report to the HRPO, in a timely manner, information regarding: (1) injury to a human participant; (2) unanticipated problems; (3) new information; and/or (4) evidence of research misconduct involving risks to research participants or others.

9.8 Suspension or Termination of IRB Approved Research

The IRB has the authority to suspend or terminate approval of human participant research that: (1) is not being conducted in accordance with the IRB’s requirements and federal regulations; (2) is not being conducted in accordance with applicable rules and regulations or the IRB’s requirements; (3) has been associated with unexpected serious harm to participants; (4) creates a potential threat to the safety and welfare of research participants, the research community and/or others. Any suspension or termination of approval includes a statement of the reasons for the IRB’s action and is reported promptly to the principal investigator, other investigators involved in the research, department chairs/heads, the institutional official, the OHRP if applicable, and funding sources, when applicable. Additionally, if applicable, current participants will be notified, and their rights and welfare will be taken into consideration. If participant follow-up, for safety reasons, is permitted or required by the IRB, participants will be informed that any adverse events should be reported to the IRB and the sponsor, where applicable.

9.9 Reporting to Federal Oversight Agencies

OHRP (in accordance with the terms of the UMASS FWA) and the FDA (for studies subject to 21 CFR Parts 50 and 56) are notified in a timely manner of: (1) serious or continuing noncompliance; (2) unanticipated problems involving risks to participants or others; or (3) suspension or termination of IRB approval for a study (except in the case where the study has been terminated due to lack of timely submission of forms such as continuing review forms).