Limestone CollegeInstitutional Review Board

Policy Manual

Human Research Policy and Procedures

Bonnie M. Wright, Ph.D.Assoc. Vice President for Planning & Assessment

Version 1bJuly 25, 2011

Table of Contents

Section Page

I. History of the IRB 3

II. 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. Index

2

The 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.htm

Amdur and Bankert (2007) give several examples of research from the 1930’s 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 Practice

Common Guidelines

The 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 approval

Research 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.)

3

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.

Membership

The 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 AffairsChair, Department of PsychologyAssoc. Dean/Director of the Social Work ProgramChair, 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 ).

4

Procedures

Research 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 master’s 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.

Decisions

IRB 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 applicant’s 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

5

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 an extension. At the end of the semester the researchers fill out an IRB Protocol Completion form (see appendix) to indicate that the research has been completed. An abstract of the research is to be attached.

The application, IRB certificate, and IRB Protocol Completion form are all kept on file in the office of the Associate Vice President for Planning and Assessment (AIO) for at least 3 years, according to Federal standards.

Penalties

Use of the IRB to approve research must be monitored by the IRB, faculty, and administration of Limestone College. Any concerns may be addressed to any IRB member.

If a student conducts research without IRB approval- The IRB may recommend failure of the research project or failure of the class.

The IRB may recommend banning the student from future research on the Limestone campus.

For a serious infraction, the IRB may recommend expulsion to the Associate Vice President for Academic Affairs.

In the event that the IRB supports penalizing a student, a letter will be sent from Associate Vice President for Academic Affairs to the student, his or her advisor, the student’s professor (if the research was in conjunction with a class) and to the Executive Vice President. The letter will describe the suggested penalty.

If a Limestone College faculty or staff member conducts research without IRB approval

6

The IRB may recommend placing a letter in that person’s file from the Associate Vice President for Academic Affairs. A copy goes to the faculty or staff member and to the Executive Vice President

The IRB may bar that faculty or staff member from conducting future research at Limestone College.

Resources and Further Reading

Amdur, R.J. & Bankert, E.A. (2007). Institutional review board member handbook (2 nd ed). Boston: Jones & Bartlett Publishers.

Bankert, E.A. & Amdur, R.J. (2006). Institutional review board: Management and

Function (2 nd ed). Boston: Jones & Bartlett Publishers.

Penslar, R.L. & Porter, J.P. (2001). Office for Human Research Participants: IRB

guidebook. http://www.hhs.gov/ohrp/irb/irb_guidebook.htm

Sparks, J. (2002). Timeline of laws related to the protection of human subjects.

http://history.nih.gov/01Docs/historical/2020b.htm

Sparks, J. (2002). Timeline of laws related to the protection of animal subjects.

http://history.nih.gov/01Docs/historical/2020d.htm

Wright, B. (2010). Institutional review board tutorial.

http://www.limestone.edu/library-tutorials.

There is a copy of Amdur & Bankert’s first edition text on reserve at the front desk of the library for your convenience. The library also has a copy of Protecting Human Subjects (2001), which is the video from the Office of Human Research Protection. The video contains segments of “Evolving Concern”, “Balancing Society’s Mandates”, and “The Belmont Report”.

7

VI. Appendix

IRB certificate

Application for conducting research at Limestone College

IRB Protocol Completion Certificate

Membership of the IRB, 2009-2010

Sample Informed Consent Form

IRB Flow Chart

8

The Institutional Review Boardof

Limestone College

This is to certify that research project ________________________________________

being conducted by _______________________________________________________

has received approval by the Limestone College IRB.

Date__________________

Signed__________________________________________

__________________________________________ Chair and 1 representative outside of the department required.

Expiration date__________

Approval type:

Exempt__________ Expedited___________ Full IRB Review _________

9

Limestone CollegeInstitutional Review Board

Application to Conduct Research with Human Research Participants

Researchers: _____________________________________________________________

Address_________________________________________________________________

Phone___________________________________________________________________

Department ______________________________________________________________

Class/Professor___________________________________________________________

Title of research project____________________________________________________

What is the research hypothesis? _____________________________________________

How many research participants will be used? How will they be obtained? Will incentives be used?

What is your research methodology? Attach any tests/references to this form.

10

Describe the research procedure. Attach a copy of the consent form and debriefing statement. How will you protect their rights to NOT participate? How will you protect their right to confidentiality?

Are there any risks at all to the research participants? Describe how they will be protected.Is any deception involved?

Will the results of the research be reported? Describe how, when, and where this should be accomplished.

If there are changes to this research protocol, please contact the IRB with an update. If the research results are published, please forward the abstract to the IRB.

When do you expect to complete the data collection? _____________________________

Are there any outside sponsors /grants for your research? If so, explain.

11

IRB Protocol Completion Certificate

Date_________________________

To: IRB Chair

From (researchers) ___________________________________________

Class ________________________________________________________

This is to certify that the following research protocol has been completed:

Signatures of investigators

12

(Please attach an abstract of the results.)

Current Members of the Limestone CollegeInstitutional Review Board

2009-2010Members: Phone #

Bonnie Wright, Ph.D. X 8318Associate Vice President for Planning and Assessment(Chair; Authorized Institutional Officer) Professor of Psychology

Mark Reger, Ph.D. X 8317Associate Vice President for Academic AffairsProfessor of English

Randall Wolfe, Ph.D. X 4524Chair, Department of PsychologyAssociate Professor of Psychology

Thomas Thomson, Ph.D. X 4500Director, Honors ProgramProfessor of History

Jackie Puckett, M.S.W. X 4585Assoc. Dean/Director of the Social Work ProgramAssociate Professor of Social Work

Henry Hiott, M.S.W. 843 549 0450Assistant Director of the Social Work ProgramAssistant Professor of Social Work (Low Country)

Betsy Witt, Ph.D. X 4619Chair, Department of Criminal Justice, Political Science, And SociologyProfessor, Criminal Justice

13

Outside Member (first to be elected 3/2010)

Sample Consent Form

Date______________ Researcher________________

I, ________________________________________________ (name) give

My consent to participate in the study titled ________________________

_____________________________________________________________.

I understand that I will be asked to_______________________________

_____________________________________________________________.

I understand that any risks to my participation involve

________________________________________________________________________.

I understand that my participation is voluntary. My results will be kept

anonymous and confidential. I may at any time withdraw my consent

and discontinue participation without any penalty.

I understand that I will be debriefed at the conclusion of the study, and

that I will have the opportunity to ask questions.

Research participant

Witness

14

(Note: Research involving children requires parental consent in addition to the minor’s consent. Research involving public school also requires the principal and classroom teacher’s cinsent.)

IRB Flow Chart:From Application to IRB Approval

Application submitted to IRB for approval to conduct

research.IRB representative

seeks approval .

Exempt:Two IRB reps. Sign

IRB approval certificate; file copy

with AIO.

Expedited:IRB rep. sends

application to IRB chair. IRB reviews by e-mail..Changes

may be needed before IRB approval

certificate is filed..

Full IRB review:IRB rep. sends

application to IRB chair. IRB reviews by e-mail..Changes

may be needed before IRB approval

certificate is filed..

Denied:IRB may require changes in the

research protocol. They may also deny approval to conduct

research.

15

VII. Index

Abstracts …………………………… 4, 11Application ……………………………...4, 5, 6, 10Authorized Institutional Officer……….4, 6Belmont Report ……………………….. 3Chair of IRB……………………………...4, 5, 9Children, research on minors ………….16Confidentiality…………………………. 3, 5, 10, 14Consent form ………………………… 10, 14Debriefing ……………………………… 3, 10, 14Deception ……………………………….. 5, 11Dependent variable ……………………. 5Exempt research ………………………. 5, 9, 15Expedited research ……………………. 5, 9, 15Full IRB review ………………………… 5, 9, 15Informed consent ………………………. 3, 5IRB certificate …………………………...4, 5, 6, 9, 15IRB Guidebook ………………………... 3, 4, 7, 13IRB Chair …………………………….… 4, 13Membership of the IRB ……………….. 4Minutes …………………………………. 4National Research Act of 1974 ………... 3Off-campus research …………………… 5Outside LC IRB membership………….. 4, 13Penalties ………………………………… 6Protocol completion certificate…………. 4, 5, 6, 12, andResearch protocol ……………………….. 4, 5

16