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Institution Review Board Policy Manual

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Limestone College

Limestone CollegeInstitutional Review Board

Policy Manual

Human Research Policy and ProceduresBonnie M. Wright, Ph.D.

Assoc. Vice President for Planning & Assessment

Version 1bJuly 25, 2011Table of Contents

Section Page I. History of the IRB 3II. Research Ethics in Practice 3 Common Guidelines

Research NOT Needing IRB Approval

III Structure of the LC IRB 4 Mission

Membership Procedures Decisions

Penalties IV. Resources and further reading 7 VI Appendix 8 IRB Certificate 9 Application 10 Protocol Completion Certificate 12 Current Members 13 Sample Consent Form 14 IRB Flow Chart 15 VII. IndexThe History of the IRB

The National Research Act of 1974 established the IRB system for monitoring and approving research. The IRB regulations now come from the U.S. Department of Health and Human Services (45 CFR 46). Researchers requesting grant money are required to certify that their protocol has received IRB approval. The full text of the guidebook may be found at http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htmAmdur and Bankert (2007) give several examples of research from the 1930s through 1973 which is now recognized as unethical for several reasons. The Belmont Report (1978) describes the main ethical principles of research (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm).

The three basic principles of the Belmont Report include respect for persons, beneficence, and justice. The principle of respect for persons is the mandate that research participants must be able to give their informed consent to participation.

Participation is voluntary, and they must have the freedom to withdraw their consent without penalty. The principle of beneficence means that research participants must be kept free from harm. The principle of justice is about treating research participants equally. Research Ethics in PracticeCommon GuidelinesThe practical application of the Belmont Report yields these common guidelines:

The research participant must be able to give informed consent, and has the right to withdraw consent during the course of the research (i.e., I quit). The research participant must be kept free from harm.

The research participant has the right to confidentiality. His or her participation must be kept anonymous, so that names may not be associated with data.

At the conclusion of the study, the research participant has the right to debriefing, as

well as the right to ask questions about the study and his or her participation in that

study.

Research NOT needing IRB approvalResearch for classroom use only, including anonymous tests, surveys and program evaluation, does NOT require IRB approval. (Any professor may request IRB approval for class research if he or she so desires to do so.)Structure of the Limestone College IRBMissionThe IRB serves to support the research of Limestone College faculty and students. The policy is meant to serve the current needs of faculty and students. It may be modified as their needs change and programs expand.The IRB may approve, request revisions or deny research conducted on the Limestone College campus, Extended Campus sites, or through the Limestone College Internet programs (via e-mail, Blackboard, or WebCT).

If the IRB does not approve a particular research protocol, then no one else may approve that research. The research protocol may, however, be resubmitted to the IRB with modifications for reconsideration.MembershipThe membership of the IRB shall consist of

Associate Vice President for Planning and Assessment (Chair; Authorized Institutional Officer)Director of the Honors Program

Associate Vice President for Academic Affairs

Chair, Department of PsychologyAssoc. Dean/Director of the Social Work Program

Chair, Department of Criminal Justice, Political Science, and SociologyOne member from outside of Limestone College,

invited to serve for a one-year term (renewable) by the IRB (by 3/2010)

Two at-large Faculty members (appointed by the Vice President for Academic Affairs)

Any Departments where research is conducted may have representation on the IRB. At least one member must be an Extended Campus faculty member. Members of other departments may join as their research needs require.Department Chairs may send a request for IRB representation to the Vice President for Academic Affairs.Records of IRB applications, minutes, IRB Certificates, Protocol Completion certificates, and abstracts will be filed in the office of the Associate Vice President for Planning and Assessment who will serve as the Authorized Institutional Officer (AIO).Members need to be familiar with the U.S. Department of Health and Human Services Office for Human Research Protections IRB Guidebook (2001) (http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm).

ProceduresResearch at Limestone College is typically conducted in conjunction with a class research project. Student researchers must be advised of research ethics by their faculty sponsor. They should also review the Protecting Human Subjects (DHHS) video available in the Limestone College Library as well as the Institutional Review Board tutorial located at http://www.limestone.edu/lilbrary-tutorials. The student or faculty member completes the IRB application form (see appendix). Students must have a faculty sponsor. The faculty member gives the form to an IRB member, usually a representative from his or her department. If the research is considered to be exempt, then the IRB certificate is signed by two IRB members and the application filed in the office of the Associate Vice President for Planning and Assessment. If the application is considered to be expedited, then the application is given to the IRB chair and submitted to the IRB for review by e-mail vote or full IRB review. If the application requires full IRB review, then it is given to the IRB chair, copies are made, and the IRB is called to meet within 10 days (see Appendix: IRB Flow Chart). Members of the IRB will respond to requests for feedback regarding research protocol by e-mail. In the event that a research protocol requires full IRB review, the IRB must meet within 10 days to fulfill that need. Materials will be submitted to members by e-mail or through campus mail.

Research from off-campus, research by faculty members of staff including research for masters degrees or doctorates must be handled using a full IRB review. Some research, then, will require IRB approval from both Limestone College and the institution where a faculty member of staff member is attending graduate school. [The Limestone College IRB will not consider graduate research from another institution which has not had prior approval from that institution (5-9-2011 policy update).]Any research other than institutional assessment through the e-mail system or Blackboard/Web CT must go through the IRB.

DecisionsIRB applications fall into three categories, exempt, expedited, and full IRB review.

Exempt research is commonly used in classroom experiments. A survey is passed out, students respond, and the papers are collected. As long as the topic is non-controversial and the participation is anonymous, then the research is considered exempt. This research may be approved by two IRB committee members. An IRB certificate must be obtained in order to conduct the research. (At least one signature must be from outside of the applicants department.)Research may be classified as expedited research if there are questions about anonymity or the nature of the dependent variable. Research involving a pre and posttest design or research of a sensitive nature (e.g., a survey on sexuality or addiction) would require expedited review. Insuring confidentiality is critical here. This kind of research requires dissemination of the application materials and a vote of the IRB by e-mail or in person. The IRB may require changes in the research protocol if they are considered necessary. Again, the IRB certificate must be obtained in order to conduct the research.A full IRB review is required if the researchers are from outside of Limestone College, if research uses the Blackboard/Web CT or e-mail system, if the research involves a vulnerable population (e.g., children or prisoners), if there is deception involved, or if it is not possible to obtain informed consent. IRB members may not vote on their own research protocols or on research protocols from students in their own class. When the decision is made, the IRB certificate (see appendix) is completed and signed. A copy is sent to the researcher, the sponsoring faculty member, and the Associate Vice President for Planning and Assessment. The IRB certificate has a place to check the IRB decision and a place to indicate an expiration date for the IRB permission. The expiration date is usually the last day of classes of the semester, unless reason is found to grant a