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INSTITUTIONAL REVIEW BOARD for the PROTECTION OF HUMAN SUBJECTS

University of Massachusetts Dartmouth

Office of Research Administration

              ABOUT THE IRB

Role of the Institutional Review Board for the Protection of Human Subjects (IRB)

The IRB is responsible for protecting the rights and welfare of human subjects in research conducted by all members of the campus community.  Research is defined as an activity that is a systematic investigation designed to develop or contribute to general knowledge.  The IRB ensures the safe and ethical treatment of all human subjects and is guided by the ethical principles regarding all research involving humans as subjects set forth in the Belmont Report and by federal requirements. Federal requirements for the protection of human subjects can be found in the Code of Federal Regulations in Title 45, Part 46; the Belmont Report has been captured in\  the code.  The University of Massachusetts Dartmouth will meet the requirements set forth in Title 45, Part 46 of the Code of Federal Regulation (45 CFR 46) for all  research without regard to source of funding, including internally funded research and  research conducted by students.  The IRB must review and approve all work to be done with human subjects prior to the work commencing.  Work completed without approval cannot be published.  Ongoing work must be reviewed by the IRB on at least an annual basis.  Any changes in protocol including renewals must also be approved by the IRB prior to implementation.  The regulations also deal with specific sensitive populations and  acceptable exemptions.  Exemptions must also be approved by the IRB.  The ORA should be contacted at any time an investigator is not sure the research involves human subjects as defined by the code, or is considering a change in protocol.

                              Members of the IRB

 The IRB is made up of eight faculty members and one community member.  Five members are appointed by the Chancellor and four by the Faculty Senate.  Members serve a three year term. The Office of Research Administration (ORA) serves as the Administrative unit of  the IRB and is the point of contact for IRB related issues.  Services provided by the ORA to the IRB include:

 Assist with interpreting guidelines, determining if IRB approval is required, and with applications

 Initial review and identification of any problems, suggest corrections to the researcher

Identification of protocols eligible for expedited review

Forwards protocols to full board for review and action

Communicate IRB decisions to investigators

Maintain records

                              Training Requirements

All individuals involved in the conduct of research involving human subjects must receive training.  UMassD is implementing the CITI training program.  The CITI program is a web base training course that must be taken prior to review of a new submission or annual review of an ongoing submission.  Certifications are valid for three years.

                  PROCESS

                              Application    

Prior to commencing work the investigator submits a protocol to the IRB

 Administrator in the Office of Research Administration.  The complete application must include:

 Brief description of the project, title and sponsor if applicable

 Statement of the Problem to be investigated

Descriptions of the methods, procedures and subjects involved

Review of literature describing extent to which any portion of the project isexperimental in nature and comments on any experimental treatment that may be involved

Descriptions of potential risks

Descriptions of potential benefits

 Description of steps taken to ensure rights and welfare of subjects

Copy of the consent form that will be used

Copies of all interview questions

The applications are due to ORA two weeks prior to the scheduled monthly meeting of the IRB.

                              Review

The IRB Administrator reviews the application for completeness and will work with the investigator in preparing a complete application.

Once the application is complete a review is made initially by the IRB Administrator and then by the IRB chairs to determine if a protocol is exempt from the regulations.

 If the requirements are met the protocol is then approved as exempt.

A review is also made by the IRB Administrator to determine if the approval can be expedited under the regulations.  Protocols deemed eligible for expedited review are forwarded to IRB members for review.  Only research activities meeting the specified criteria are eligible for expedited review.  Review cannot be expedited solely on the basis of time and need.  (See 3b below for additional discussion on expedited review.)

 Completed applications are submitted to the IRB members prior to the monthly meeting.

 The applications are reviewed by the board and discussed at the meeting; a quorum must be present to have an official meeting.

 The investigators are notified if approval has been granted.

 If approval cannot be granted at the meeting, the board contacts the investigator for clarification and/or changes to the application and the research.  Ongoing review and approval of these applications are conducted outside of the monthly meeting if needed.

                  IMPORTANT CONSIDERATIONS

 Approvals are project specific.  They cannot be transferred from one project to another.  A consent form must be reapproved if it will be used on another project or if the project is revised.

Certain populations are considered vulnerable subjects.  The regulations address these populations with specific requirements that must be met during the research.  These populations include pregnant women, children, prisoners and individuals institutionalized as mentally disabled.

 Only the IRP has the authority to authorize expedited reviews or to determine whether a specific research project is exempt.

                  RISK ASSESSMENT

  The federal regulations allow the IRB to categorize research into three levels according to the level of risk involved and to complete reviews at different levels according to that risk.

                              Full Review

 Research that exposes subjects to risks that are greater than the kind of risks normally experienced in daily life must be reviewed by the full IRB at a properly convened  meeting.  The IRB will review the protocol and consent documents to ensure they are in compliance with federal regulations.  They will also assess the risks and the anticipated benefits of the study to ensure the health and welfare of the subjects.

                              Expedited Approval

 Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson  from among members of the IRB rather then the full board.

 In order for research to be expedited the research must fall into one of seven categories outlined in 45CFR46.110.  It must present no more than a minimal risk tothe subjects and it must not fall under the category of classified research.  Public identification of the subjects must not put them at risk or the risk must be minimized.

  The IRB must review all of the above criteria and ensure that all conditions have been met before determining review can be expedited.  The reasons for the expeditedapproval must be documented by the IRB.

The categories eligible for expedited review include:

Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).

Collection of data from voice, video, digital, or image recordings made for research purposes

Research on individual or group characteristics or behavior (including, but not limited to: research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

                              Exempt Research (45CFR46.101)

Funded research involving the use of perceptual/cognitive material, standard tests (educational, cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observations of public behavior are exempt from theseassurances unless:

  a.  information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and

 b.  any disclosure of the human subjects responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing or employability.

The University of Massachusetts Dartmouth has implemented the CITI 
Course in the protection of Human Subjects.
http://www.citiprogram.org/