Policies and Procedures

GENERAL POLICIES AND RESPONSIBILITIES
1. University Commitments
  UMass Global is committed to safeguarding the rights and welfare of all people who participate in research conducted by UMass Global faculty. It is also committed to insuring humane care and use of animals in teaching and research. UMass Global supports responsible experimentation which promises to increase knowledge and understanding, and encourages the highest ethical standards among UMass Global researchers.
  
  In addition to assuring compliance with Department of Health and Human Services (DHHS) regulations 45 CFR 46, as specified in the Office for Protection from Research Risks (OPRR) 1983 report on Protection of Human Subjects, UMass Global accepts responsibility for complying with Food and Drug Administration (FDA) regulations (21 CFR 56) and all other applicable state and local laws as they may relate to research covered by the DHHS policy. Categories of research exempted from this policy are those specifically listed in 45 CFR 46.101 (2) (B) 1 through 5 (see UMASS GLOBAL INSTITUTIONAL ASSURANCE Section II.f.).
  
  UMass Global also abides by the provisions of the DHHS Guide to the Care and Use of Laboratory Animals and Principles for Use of Animals; the Animal Welfare Act PL 85-544; and the Standards for Accreditation by the American Association for the Accreditation of Laboratory Animal Care (AAALAC).
2. General Aim of the IRB
  The central aim of the IRB is to protect the rights of human participants in research studies, including their rights to give informed consent and to have their safety protected from undue risk.
3. General charge to the IRB
  The IRB has the responsibility and authority to review and approve all research projects by UMass Global faculty and students involving human or animal participants. It will approve only experiments that conform to the professional standards as understood within the relevant discipline.
RESPONSIBILITIES AND AUTHORITY OF THE IRB
1. Review all new and ongoing projects involving human participants at convened IRB meetings with the majority of the Board's membership constituting a quorum; a IRB member whose concerns are primarily in non-scientific areas must be included in the quorum. Voting on projects is limited to duly appointed Board members. Excluded from this process are those submissions which are participant to expedited review.
2. Review projects on an annual basis or more frequently as deemed appropriate.
3. Require written notification by investigators when changes in a research activity are proposed.
4. Require prompt reporting by investigators when unanticipated problems involving risks to participants occur.
5. Suspend or terminate approval of research that has been associated with unexpected serious harm to participants or that is not being conducted in accordance with the IRB's decisions.
6. Report to the Vice Chancellor of Academic Affairs of UMass Global any suspension or termination of approved research.
7. Require that the informed consent procedure is in accordance with policy.
8. Notify investigators of the results of IRB review.
9. Observe or have a third party observe the consent process and the research, when appropriate.
10. Advise and consult with investigators regarding specific problems associated with protocols involving human participants.
11. Distribute campus guidelines to aid principal investigators in the preparation of their application for approval of research involving human and animal participants.
12. Maintain complete records.
13. Interpret government and UMass Global policies pertaining to the protection of human and animal research participants.
14. Develop and publish campus policies and procedures governing review of research involving human or animal participants.
15. Provide consultation through its Chair to any participant or principal investigator.
16. Establish procedures for monitoring implementation of IRB action.
17. Maintain communication with Federal, State, and local agencies and institutions to insure that IRB procedures are current and consistent.
18. If the research activity is funded in whole or in part by a DHHS grant, contract, or fellowship, report to the Secretary of DHHS on serious or continuing noncompliance by investigators with the requirements and determinations of the IRB; suspension or termination of approved research that is not being conducted in accordance with the IRB's requirements; or any unexpected serious harm to participants associated with a research project.
19. Coordinate review of research carried out at non-university sites.
20. Through its Chair, report any changes in IRB membership to the Vice Chancellor of Academic Affairs of UMass Global.
COMPOSITION OF THE IRB
All review of human participant involvement in research activities covered by this policy shall be carried out by the IRB following the procedures set forth in this policy. IRB members are appointed by the Chancellor of UMass Global and reviewed by the Faculty Executive Committee.

The IRB is sufficiently qualified through the experience, expertise, and diversity of its members, including sensitivity to community attitudes, to command respect for its advice and counsel in safeguarding the rights and welfare of research participants.

The IRB is composed of at least five members from UMass Global, representing diverse backgrounds and possessing the professional competence necessary to review the specific research activities assigned to it. The IRB shall not consist entirely of men or women or entirely of persons in one profession. IRB includes at least one member with no formal affiliation with UMass Global. At any time, consultants may be sought, but these persons may not participate by vote in IRB actions.
RESPONSIBILITY AND AUTHORITY OF UMASS GLOBAL
1. Legal assistance. UMass Global Legal Office is available to the IRB and investigators for legal consultation and assistance.
2. Liabilities. UMass Global is legally responsible for the acts and omissions of its investigators while acting in the course and scope of their UMass Global duties. In the event of a suit against investigators or members of an IRB based on their actions in connection with a research activity involving human participants, UMass Global would be obligated to assume their defense if the research project was approved by an IRB in accordance with this policy. If a principal investigator has, or should have, knowledge of the applicable UMass Global policy requiring that every research activity placing human participants at risk be reviewed by an IRB and fails to obtain such approval prior to involvement of human participants, the investigator would be acting outside the scope of his/her duties and UMass Global would not be obligated to defend or indemnify the investigator if legal actions were initiated by a participant.

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Policies and Procedures