Institutional Review Board

MANDATE

The Institutional Review Board (IRB) of Southern Adventist University (Southern) operates as a subcommittee of the Southern Academic Research Committee (ARC) under the US Department of Health and Human Services regulations for the Protection of Human Research Subjects:  Title 45 of the Code of Federal Regulations, Part 46 (45 CFR 46).  The IRB also is guided by the ethical principles regarding all research involving humans as subjects as set forth in the April 18, 1979, report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, entitled: "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," commonly referred to as The Belmont Report. For more information on these documents and the historical evolution of these principles, please consult the IRB Policy Manual.

MISSION

The mission of the Institutional Review Board (IRB) is to ensure that vital, university research can be conducted in full compliance with both the letter and the spirit of regulations designed to protect the rights and welfare of human subjects.  Both ARC and IRB are charged to monitor research to ensure all human subjects involved with research are protected from undue risk and from deprivation of personal rights and dignity.  This protection is assured by consideration of three principles that are the basis of ethical research:

 

  1. That voluntary participation by the subjects, indicated by free and informed consent, is assured by the investigators;
  2. That an appropriate balance exists between potential benefits of the research to the subject or to society and the risks assumed by the subject; and
  3. That there are fair procedures and outcomes in the selection of research subjects.

 

Jurisdiction

All faculty and staff (both full-time and part-time) using human subjects or identifiable, private information about human subjects to conduct research within the course and scope of their duties are required to have prior approval from the IRB. Projects must be approved regardless of whether or not the research is funded and regardless of the source of funds.  Southern Researchers must apply to the IRB when conducting research other than for institutional reports. They must fill out the appropriate forms when using human subjects and vertebrates, or identifiable, private information about human subjects to conduct research within the course and scope of their duties, are required to have prior approval from the IRB before research is initiated.  Please see this manual for complete details as to which forms are required. 

All projects must be approved. This policy also applies to students whose research is conducted under the advisement of a faculty member.  All research proposals must be reviewed by the IRB and no individual other than the IRB Chair may exempt a proposal from further review. 

Research is defined as:  “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this policy, whether they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstration and service programs may include research activities” (Code of Federal Regulations, 45 CFR 46.102d).

A Human Subject means:  “A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” (Code of Federal Regulations, 45 CFR 46.102f)

 

Functions

  1. To recommend to the Academic Research Committee (ARC) policies and procedures for the conduct of academic research involving human subjects, animals and plants campus-wide.
  2. To review all academic research proposals to determine whether they are Exempt, Expedited or require Full Review approval from IRB:
  • Exempt studies are those with no risk to subjects.
  • Expedited studies are those with minimal risk to subjects.
  • Full Review studies are those which involve more than minimal risk to the subjects and require review by the full IRB committee membership.
  1. To consider whether:
  • Risks to subjects are minimized
  • Selection of subjects is equitable
  • Informed consent is sought from each subject
  • Risks are reasonable in relation to anticipated benefits
  • Informed consent is appropriately documented

4. Review for approval, all non-exempt academic research proposals involving human subjects, animals and plants.

5. To ensure compliance with legal, regulatory, and ethical mandates and provisions relating to research involving human subjects, animals and plants.

  1. To coordinate with the ARC, with Academic Administration and with the Dean of Graduate Studies in maintaining records of on-going academic research.
  1. To coordinate with the ARC, with Academic Administration and with the Dean of Graduate Studies in maintaining records of ethics training of faculty and students.

 

Responsibilities

  1. Complies with approved policies and procedures that ensure the integrity of campus-wide exempt, non-exempt, and full review academic research.
  1. Provides certified research compliance training for faculty and students involved in academic research involving human subjects, animals or plants, and other as described.
  1. Makes available to faculty and students the necessary IRB applications needed for IRB approval.
  1. Provides assistance needed by faculty and students in completing the necessary IRB applications.  An explanation of application forms is available in the IRB Policy Manual. 
  1. Reviews to approve, exempt, request modifications to secure approval, or disapprove all research activity proposals covered by this policy.
  1. Conducts review of on-going research at intervals appropriate to the degree of risk, but not less than once per year.  
  1. Reviews proposed changes in research activities as requested on Form B to ensure that changes in approved research continues to comply with IRB protocols during the period for which IRB approval has been given.
  1. Requires that information given to subjects as part of informed consent is in accordance with policy.
  1. Requires or waives documentation of informed consent.
  1. Notifies, in writing, investigators and the institution of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval for the research activity. If the IRB disapproves a research application, it shall include in its written notification a statement of the reasons for its decision, and give the investigator an opportunity to respond in person or in writing.
  1. Monitors and provides additional safeguards when vulnerable subjects (minors, mentally incompetent, prisoners, economically disadvantaged, pregnant females) are involved in the research in order to protect against coercion or undue influence.
  1. Conducts its review of potentially sensitive research (except when an approved exempt or expedited review procedure is used) at convened meetings where a majority of the members of the IRB are present.
  1. Approves potentially sensitive research only with the concurrence of a majority of those members in attendance or with an e-vote.
  1. Reports to Academic Administration and Dean of Graduate Studies any continuing or serious matters of non-compliance by investigators with the requirements and determination by the IRB.
  1. Suspends or terminates approval of research that is not in compliance with the IRB’s determinations or has been associated with unexpected serious harm to subjects.
  1. Archives records of all IRB actions related to research conducted at the institution.

 

Records

  1. Retains copies of all research proposals reviewed, scientific evaluations, if any, that accompany proposals, approved sample consent documents, approved advertising or other solicitations for subjects, progress reports and injuries to subjects. The IRB through the ARC SharePoint.
  1. Maintains minutes of all IRB meetings which shall be in sufficient detail to show meeting attendance, actions taken by the IRB, the vote on these actions, including the number of members voting for, against, and abstaining, the basis for requiring changes in or disapproving research, and a written summary of the discussion of controversial issues and their resolution.
  1. Maintains records of completion of the Collaborative Institutional Training Initiative (CITI) modules which have been identified by ARC for faculty and student completion.  These CITI modules are accessed through the IRB eClass site.  Modules have been identified as most appropriate and necessary for completion prior to conducting research in the areas of: Science/Math, Life Sciences and Liberal Arts.   
  1. Maintains records of continuing review activities.
  1. Retains copies of all correspondence between the IRB and investigators.
  1. Maintains listings of all IRB members identified by name, earned degrees and their professional representative capacity.
  1. Maintains a manual and website outlining IRB procedures and provides all IRB applications and forms.

 

Quality Assurance/Review

  1. Complies with approved policies and procedures that ensure the integrity of campus-wide exempt and non-exempt academic research.
  1. Provides certified research compliance training for faculty and students involved in academic research. 
  1. Makes available to faculty and students the necessary IRB applications needed for submittal for IRB approval.
  1. Provide assistance needed by faculty and students in completing the necessary IRB applications.
  1. Reviews to approve, exempt, require modifications (to secure approval), or disapprove all research activities proposals covered by this policy.
  1. Conducts review of on-going research at intervals appropriate to the degree of risk, but not less than once per year.
  1. Reviews proposed changes in research activities to insure that changes in approved research, during the period for which IRB approval has been given continues to comply with IRB protocols.
  1. Requires that information given to subjects as part of informed consent is in accordance with policy.
  1. Requires or waives documentation of informed consent.
  1. Notifies, in writing, investigators and the institution of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision, and give the investigator an opportunity to respond in person or in writing.
  1. Monitors additional safeguards when vulnerable subjects (minors, mentally incompetent, prisoners, economically disadvantaged, pregnant females) are involved in the research in order to protect against coercion or undue influence.
  1. Conducts its review of potentially sensitive research (except when an approved exempt or expedited review procedure is used) at convened meetings where a majority of the members of the IRB are present.
  1. Approves potentially sensitive research only with the concurrence of a majority of those members in attendance or with an e-vote.
  1. Reports to the Graduate Dean and Academic VP any continuing or serious matters of non-compliance by investigators with the requirements and determination by the IRB.
  1. Suspends or terminates approval of research that is not in compliance with the IRB’s determinations or has been associated with unexpected serious harm to subjects.
  1. Maintains up to date records of all research conducted at SAU.

 

Recording and Reporting

The Institutional Review Board Chair and Graduate Assistant maintains:

  1. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany proposals, approved sample consent documents, approved advertising or other solicitations for subjects, progress reports and injuries to subjects.
  2. Minutes of all ARC/IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controversial issues and their resolution.
  3. Records of IRB training programs including faculty and student completion of CITI training.
  4. Records of continuing review activities.
  5. Copies of all correspondence between the IRB and investigators.
  6. A list of all IRB members identified by name; earned degrees and their professional representative capacity.
  7. A manual and website outlining IRB procedures; and providing all IRB applications and forms.  https://teams.southern.edu/teams/irb .

 

IRB Approval Involving Externally Funded Applications

Investigators are encouraged to submit IRB applications for approval prior to securing funding; however, if there is insufficient time to do so, proposals may be submitted with the assurance that IRB approval will be sought and received prior to pursing any research related activities.  In these cases, the researcher must articulate the specific portion of the grant that will require IRB approval in the funding application and provide an anticipated start date for these activities. For example, a researcher might apply for a grant with a funding cycle that begins in January; however, there are no activities that require human subjects’ approval until June.  From January to June the investigators might be engaged in planning activities, drafting questionnaires, or offering direct services.  In these types of cases, the investigator would use the following type of language in the grant application:

Any necessary IRB approvals will be secured prior to engaging in any research involving human subjects.  If funded, the project will require IRB approval for the specific purpose of approval of questionnaires that will be used to evaluate the efficacy of the grant activities. It is anticipated that IRB approval would be secured no later than June 1, 20XX, of the university fiscal year and yearly a FORM B will be completed indicating the progress of the funded research grant. See FORM B details on pages 29-30.

 

IRB Documents

IRB Policy Manual

IRB Process and Application Checklist

FORM A

FORM B

FORM C

FORM D
Adverse Incident Report Form
CITI Training Directions