Faculty Handbook 2013-2014

IX.  Institutional Review Board Policies and Procedures  (Institutional Review Board)

INTRODUCTION
SPECIAL APPROVALS
Other Institutions
Research Conducted at a VA Medical Center
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GENERAL INFORMATION
Inclusion of Women and Minorities in Research
Duration of IRB Approval
Amendments or Changes to Protocol and Consent Forms
Adverse Effects or Unanticipated Problems
THE INFORMED CONSENT PROCESS
IRB Approval Stamp
Format of Consent Forms
Research Involving Children as Subjects
IRB EXEMPTION
Procedure for Requesting an IRB Exemption
EXPEDITED REVIEW
Procedures and General Information for Expedited Review
IRB FULL REVIEW
Instructions for IRB Submission
Renewal Instructions
Final Report Instructions
APPENDIX A – Sample Consent Form
APPENDIX B – Sample Signature Page of Consent Form for Research Involving Children
APPENDIX C – IRB Exemption Application
APPENDIX D – IRB Expedited Review Application
APPENDIX E – Human Subjects Protocol for Expedited Review 
APPENDIX F – Human Subjects Protocol for Full Review
APPENDIX G – Investigator's Progress Report 

INTRODUCTION

The Institutional Review Board for Human Use (IRB) is a committee that reviews all research involving human subjects conducted at Georgia Southwestern State University (GSW). The aim of IRB review is to assure that research is conducted in an ethical manner. This includes ensuring that risks to subjects are minimized, selection of subjects is equitable, and subjects are informed fully of what their participation will involve.

The IRB staff reviews all applications for extramural support as part of the review by the Office of Institutional Research. The staff verifies whether or not the application involves human subjects. For studies involving human subjects, the staff confirms that the study has IRB approval or, if it requires review, provides the appropriate forms for submission with the application.

It is GSW policy that no research involving human subjects may be undertaken until approval has been granted by the IRB. For these purposes, human subjects are defined as not only living persons, but also human tissue, blood samples, pathology or diagnostic specimens, and medical records. Research is defined as a systematic investigation designed to develop or contribute to generalized knowledge. These guidelines also apply to student projects done for classes or independent study. However, in-class demonstrations done for the purpose of illustrating a specific educational concept (e.g., research design, sampling bias, memory) do not.

An application for review of a research project involving human subjects is processed by the IRB in one of three ways:

  1. Exempted Review Application
  2. Expedited Review Application
  3. Full Review Application

All IRB materials and correspondence should be submitted to the IRB Chairperson.  Investigators who require contact information for the IRB Chairperson should request that information from the Office of Academic Affairs, Room 205, Administration Building, (229) 928-1361.

SPECIAL APPROVALS

Other Institutions

If subjects from another institution (hospital, school, business, etc.) comprise all or part of the population for this study, or if any part of the research will occur on the grounds of another institution, it is necessary to provide written documentation that the other institution approves of the research to be conducted.  If the other institution has its own IRB or research review panel, then that IRB or panel must approve the study, and a copy of its approval must be attached to the GSW IRB application.  If the other institution does not have its own IRB or review panel, then written approval should be obtained from an authorized official of that institution and submitted along with the GSW IRB application.  If it is not possible to obtain the other institution’s written approval prior to submission of materials to the GSW IRB, then a statement of preliminary contacts with the appropriate officials should be attached to materials submitted for GSW IRB review.  Approval from the other institution does not guarantee GSW IRB approval.  Furthermore, a project that receives GSW IRB approval but does not receive approval from the other institution cannot be conducted at that institution; GSW IRB approval does not “override” the approval of the other institution.

Research Conducted at a Veterans Administration Medical Center

All research conducted at a Veterans Administration Medical Center (VAMC) involving human subjects is reviewed not only by the IRB, but also by the VAMC's Research and Development Committee. Research protocols may be reviewed concurrently by both the GSW IRB and the VAMC’s Research and Development Committee.  Both the GSW IRB and the VAMC must approve the project before it can be conducted, and these approvals are considered and granted independently.

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Advertisements that incorporate the GSW name or logo must be approved by the Office of University Relations as well as the IRB. Investigators should contact University Relations at 931‑2028. Advertisements should be limited to the following information:

  1. The name and address of the investigator;

  2. The purpose of the research and a summary of the eligibility criteria;

  3. A description of the benefits;

  4. The location of the research; and

  5. The person to contact for further information.

GENERAL INFORMATION

Inclusion of Women and Minorities in Research

Women and minorities are often underrepresented in research.  Their inclusion is important to ensure that they receive an appropriate share of the benefits of research. Moreover, their inclusion facilitates the generalization of research results.  Therefore, investigators must include the widest possible range of population groups in their subject pool. If the phenomenon to be studied may affect one gender or minority group differently, investigators should cite research evidence or lack thereof and describe how the proposed research addresses that evidence. Investigators should be prepared to describe the extent to which both genders and persons of various ethnic and racial backgrounds are or have been involved in similar research. Please note in the protocol if potential participants will be recruited without regard to gender and/or race.

Duration of IRB Approval

IRB approval is given for one year, unless otherwise specified, commencing with the approval date. Research activities may not continue past the one-year anniversary of the IRB approval date. For certain projects with unusual risks, the IRB may specify a period of approval shorter than one year. In all cases, the investigator will receive a letter indicating the approval date or listing any required modifications upon which approval is contingent. In addition to the approval form, the investigator will receive one copy of the consent form stamped with the IRB approval date. Copies of this stamped consent form must be used for study participants. If modifications to the protocol are required by the IRB, approval is contingent upon the IRB receiving written notice from the investigator specifying that the changes have been made. IRB approval will not be issued until the required changes have been reviewed and approved, and the period of approval will commence with the date on which the changes were approved.

Renewal notices are issued by the IRB Chairperson prior to the protocol approval expiration date. However, the investigator is responsible for monitoring approval and expiration dates and ensuring that necessary renewal forms are submitted on time.

Amendments or Changes to the Protocol and/or the Consent Form

The investigator must report to the IRB any modifications in the consent form, study methodology, and/or protocol. This report should take the form of a memo submitted to the IRB Chairperson describing the proposed changes and their effects on the current protocol.  These changes must be reported before they are implemented.  If the consent form is being changed for any reason, a copy of the revised consent form should be submitted with all changes highlighted.  IRB approval may be rescinded if the modifications to the protocol or consent form are considered to render the study unethical.

Adverse Effects or Unanticipated Problems

The investigator must report promptly to the IRB any research-related injuries to human subjects or any unanticipated risks to subjects or others at participating sites. Any research project that results in unexpected serious physical, psychological, or emotional harm to the subjects must be terminated immediately. If the research involves an investigational new drug or device, the investigator must also report such incidents to the sponsoring agency and/or the FDA.

THE INFORMED CONSENT PROCESS

Informed consent is one of the primary ethical considerations underlying research with human subjects.  Informed consent is not just a piece of paper that must be signed, but rather an ongoing educational process that takes place between the investigator and prospective subject.  In most cases, federal regulations require that informed consent be documented.  It should be reiterated, however, that the consent document does not substitute for discussion.  A potential subject’s assent (verbal or nonverbal agreement to participate in a study) is insufficient; the informed consent form should be signed for all subjects.

Appendix A contains a prototype of the standardized consent form and a sample consent form that adheres to the guidelines stated on the prototype and on pages 4-7.  Below are instructions for preparing the consent form.  Please follow all instructions carefully.

  1. Use the standardized consent form (Appendix A). Items with asterisks may be deleted if they are not applicable.
  2. The language in the form should be aimed at a sixth-grade reading level. Do not use technical jargon.
  3. If the research involves the participation of minors (under 14 years of age), please read the section “Description of Requirements for Research Involving Children.”
  4. If the research involves pregnant women, both the mother and father must give consent after having been fully informed regarding the potential impact of the research on the fetus. (NOTE: Federal regulations do specify certain conditions under which the father’s consent is not necessary. For a list of those conditions, see the following section on “Signatures.”)
  5. If the research could possibly put at risk an unborn child or a man or woman’s ability to procreate, the following statement(s) (revised to meet the needs of your particular study) should be included in the consent form:
    • “If I am pregnant, I cannot participate in this study. If I am a woman of child-bearing potential, it will be necessary to have a urine test to see if I am pregnant before I start this study. If I am a sexually active male or female, I agree to take precautions to avoid the possibility of impregnation because it is not known how this drug (treatment, device, etc.) will affect an unborn child. If I become pregnant during the course of the study, I agree to notify the principal investigator of this fact as soon as possible.”
  6. If VA patients who have been deemed incompetent are to be enrolled in the study, additional requirements may be necessary for the consent form and additional procedures implemented to ensure the patient’s rights are protected. These additional requirements can be obtained through the Research Office at the VAMC.
  7. If the researcher believes that bodily fluids, tissues, or other substances of a research subject could be part of or lead to the development of a commercially valuable product, the consent form should contain the following statement:
    • “By my consent to participate in this research study, I give up any property rights I may have in my bodily fluids, tissues, or substances.”

IRB Approval Stamp

Consent forms receiving initial approval (i.e., new applications) will be validated with an approval stamp that includes dates for which the approval is effective.  Only consent forms with a valid IRB approval stamp should be used to enroll subjects. 

Format of Consent Forms

Consent forms should follow the standard format depicted in Appendix A.  The basic elements of a consent form are listed below.

  1. Explanation of Procedures: The consent form must be written in non-technical language and should contain an explanation of the study’s purpose and a description of the procedures to be followed. If experimental and control groups are to be used, then the chances and consequences of being enrolled in each group must be explained.
  2. Risks or Discomforts: Any reasonably foreseen risks or discomforts resulting from participation should be described. The consent form should also specify what types of treatment, if any, will be provided to subjects who receive a research-related injury and state who is responsible for providing and paying for that treatment. It should be explicitly stated that GSW has made no provisions for monetary compensation in the event of research-related injury, and that in the event of such injury, medical treatment is not provided free of charge. If a sponsoring agency has agreed to provide compensation or treatment to injured research subjects, documentation of this agreement should be submitted to the IRB along with the application.
  3. Benefits: Any direct benefits to the subject, as well as general benefits that are anticipated (e.g., furthering of knowledge, help to others in similar situations in the future), should be identified.
  4. Confidentiality: Methods for establishing and maintaining confidentiality should be described. If any other agency (e.g., federal government, corporate sponsor) will have access to the subjects’ records, this should be indicated.
  5. Withdrawal: The consent form should state any anticipated circumstances under which the subject’s participation may be terminated by the investigator without the subject’s consent (e.g., noncompliance with instructions). Additionally, the consequences of a subject’s decision to withdraw from the research, and procedures for orderly termination of participation by the subject, should also be stated.
  6. Costs and Payments to Subject for Participation: The consent form should specify any costs the subject will have to bear as a result of participation. Examples of possible costs include charges for medications, medical tests, or devices. However, medications the subject is currently taking, devices the subject already owns, or medical tests the subject has already received do not apply. The consent form should also specify the amount and nature of payment or other compensation given to the subject for research participation, as well as the conditions under which payment will not be given.
  7. New Findings: The consent form should contain a statement noting that significant new findings developed or obtained during the course of the research will be provided to the subject if these findings could reasonably be expected to affect a subject’s willingness to continue participation in the study.
  8. Questions: The consent form should contain an offer to answer any of the subject’s research-related questions and should include a specific name and telephone number of the person to whom research-related inquiries may be directed. The name and number of the person or persons to contact if the subject needs more information regarding compensation or his or her rights, or in the event of a research-related injury, should also be provided.
  9. Legal Rights: The consent form should state that the subject is not waiving any legal rights by signing the form.
  10. Initials: If the consent form has more than one page, then a line for the subject’s initials should be included at the bottom of each individual page, except for the page which contains the signature lines.
  11. Signatures: Each consent form should provide a place for the signature of the subject or that subject’s legally authorized representative, a witness (not the investigator), and the investigator. The dates of receipt of these signatures should also be indicated.
    1.  
      1. The purpose of the research activity is to meet the health needs of the mother
      2. The father’s identity or whereabouts cannot be reasonably ascertained
      3. The father is not reasonably available due to military duty, incarceration, etc.
      4. The pregnancy resulted from rape
      5. The mother has reason to believe that her safety or the safety of her unborn child would be in danger if the father were contacted
    • For research involving children, the consent form should also provide a place for the “Assent of Child” and/or “Waiver of Assent” (see Appendix B).
    • For research involving people whose legal competence is questionable or who have been judged incompetent in a court of law, a signature from a guardian or other authorized representative may be substituted for the subject’s. However, the subject’s assent is still required unless it can be reasonably waived.
    • For research involving pregnant women, the consent form should include a signature line for both mother and father if they have been fully informed regarding possible impact on the fetus. The father’s informed consent need not be obtained if one of more of the following situations applies:

For clarification or additional information, contact the IRB Chairperson.

Research Involving Children as the Subjects

For research involving children, the following conditions must be met:

Assent of Child

Assent means the potential subject’s affirmative agreement to participate in the research.  Mere failure to object should not, in the absence of affirmative agreement, be construed as assent.  The following list indicates how assent of children should be handled for children of different ages.



  1. For children under 7 years of age, the child is assumed to be incapable of giving assent, and parental consent is all that is required for participation.
  2. For children 7-13 years of age, the assent of the child or documentation of the reason for waiver of the assent is required. Assent of the child may be waived if the capability of the child to give assent is judged limited by age, maturity, or psychological state. An example signature page of a consent form for research involving children is in the Appendix.
  3. Adolescents 14 years of age and over are considered able to sign a consent form as an adult.

Parental Consent



  1. If the proposed research involves no more than minimal risk, or is of possible direct benefit to the child, the consent of only one parent is required.
  2. If the research involves greater than minimal risk without direct individual benefit, permission must be obtained from both parents unless there is only one reasonable available parent. Guardian consent should be substituted for parental under appropriate legal constraints.
  3. The Investigator may request a waiver of parental or guardian consent if the research design does not require such consent to protect the subjects (for example, neglected or abused children), provided an appropriate protection mechanism is substituted.
  4. Special provisions must be made for children who are wards of the state or any other agency, institution, or entity to be included in research involving greater than minimal risk without direct individual benefit.

IRB EXEMPTION

PROCEDURE FOR REQUESTING AN IRB Exemption

It is possible to obtain exemption from IRB review for certain types of noninvasive projects, such as those involving educational tests, analyses of existing data sets, and studies of taste and food quality (see Appendix C for a complete list of exemption categories and the Exemption Application). However, exemption must be formally granted and not merely assumed by the investigator. To apply for exemption from IRB review, the investigator must complete one copy of the Exemption Application (Appendix C) and return it to the IRB Chairperson. If a consent form, questionnaire, or other materials (e.g., lists of words for a memory study, sample advertisements for marketing research) are to be used, one copy should be submitted along with the application.

Consent forms may not be necessary if the study falls into categories 2, 3, and/or 4 on the Exemption Application.  However, investigators are encouraged to design consent forms for all studies, even those for which an exemption will be requested.

If the investigator will be using pathological or diagnostic specimens, a release form is required from the agency responsible for providing the specimens.  The specimen release forms should be attached to the IRB exemption application form.

There are no deadlines for submission of Exempted Review applications; however, investigators should allow at least one month for the application to be processed and approved.  If there are any questions regarding the exemption application, please contact the IRB Chairperson.  The completed application form should be submitted to the IRB Chairperson.

Exempted Review for Research Involving Children

Exempted review category 2 (survey or interview procedures) on the Exemption Application form cannot be applied to research proposals involving children (persons under 14 years of age) as subjects.  In addition, category 3 is applicable to research involving children only where the investigator does not participate in the activities being observed. 

EXPEDITED REVIEW

Procedures and General Information for Expedited Review

Expedited review is intended for research activities which involve no more than minimal risk to the human subjects and which can be placed in one or more of the ten categories listed on the application form (see Appendix D).

To apply for expedited review, the investigator must submit the following materials to the IRB Chairperson:

  1. The Expedited Review application (Appendix D) with a check by the category or categories which he/she is claiming for Expedited Review
  2. A copy of the Expedited Review Human Subjects Protocol (Appendix E)
  3. A copy of the consent form (Appendix A, and B if necessary)

If a questionnaire or other material (e.g., lists of words for a memory study, sample advertisements for marketing research) is to be used, the investigator should submit a copy with this application.

If the investigator will be using pathological or diagnostic specimens, a release form is required from the agency responsible for providing the specimens.  The specimen release should be attached to the application form.

All materials should be submitted to the IRB Chairperson.  Questions should also be directed to the IRB Chairperson.  There are no deadlines for submission of Expedited Review applications; however, investigators should allow at least one month for the application to be processed.

Expedited Review for Research Involving Children

Expedited review is not allowed for research where children (persons under 14 years of age) are the subjects.  In addition, for categories 3 and 4 on the Expedited Review application (Appendix D), expedited review is not allowed unless the subjects are over 18 years of age.

IRB FULL REVIEW

Projects that involve investigational drugs or devices, or extensive and/or invasive data collection, require full IRB review.  Full Review may also be required for projects involving children, adults with cognitive impairment, or people of any age who are deemed to be “vulnerable populations” due to inability to freely give informed consent.

Instructions for IRB Submission

The instructions and forms necessary for IRB Full Review can be found on the following pages. The attached forms may be reproduced as necessary.

The IRB meets on the second Wednesday of each month. All materials should be submitted to the IRB Chairperson at least two weeks prior to the meeting.  Should holidays appear to conflict with meetings or deadlines, please contact the IRB Chairperson for clarification. Investigators are welcome to attend IRB meetings, but are not required to do so. If an investigator plans to attend the meeting, he/she should notify the IRB Chairperson. The following list briefly describes the procedures to be undertaken by the investigator prior to submission to the IRB.

  1. Complete the Human Subjects Protocol (Appendix F).
  2. Obtain any special approvals that may be required.
  3. Develop a consent form in compliance with IRB standards.
  4. Submit the following materials to the IRB Chairperson prior to the deadline:
    1. 1. The original Human Subjects Protocol (Appendix F) signed by the investigator;
    2. The consent form (Appendix A, and B if necessary);
    3. Any questionnaire to be used;
    4. Any recruitment materials, including advertisements;
    5. If the research is funded by any agency, the sponsor's protocol, the grant/funding application, and/or scientific evaluations, if any, that accompany the protocol;
    6. Any special approvals.

THE HUMAN SUBJECTS PROTOCOL



The human subjects protocol as shown in Appendix F enables the investigator to furnish considerable background information with a minimum of effort. Since a single protocol is used for all types of research requiring full review, some questions may not be applicable to the proposed study. Where questions do not apply, enter "NA" in the space provided.

The IRB prefers that the forms provided in this guidebook be used for submitting protocols for review. However, many investigators find it convenient to print the text of the IRB forms on a word processor. This is acceptable, but the IRB insists that responses to the questions be clearly distinguished from the questions themselves (by a different font, type size, etc.). Also, the pages should be in the same format as those provided in this guidebook.

The investigator must complete the entire protocol, including the outlined sections shown as items 11-14. Use additional pages as necessary to discuss each topic fully. Grant applications and/or sponsor's protocols will not be accepted in lieu of answering the questions outlined in the instructions. Since many members of the IRB are by law nonprofessional, and even the professional members have technical expertise in limited areas, the use of understandable, nontechnical language is essential.

Renewal Instructions

For multi year projects, annual IRB approval is required. Studies in which no new subjects are being entered, but one or more persons are being followed, still require renewal of the IRB approval. For renewal of IRB approval, the principal investigator must submit to the IRB the following materials:

  1. The original and 9 copies of the Investigator's Progress Report (Appendix G);

  2. Ten copies of the most recently approved consent form, minus the previous IRB approval stamp;

  3. Ten copies of the complete protocol including any modifications previously approved; and

  4. Ten copies of any progress reports sent to the sponsoring/funding agency.

The renewal materials should be collated into ten separate sets, with each set having one Progress Report and one consent form. Each set should be securely fastened, preferably with a standard staple. The copies of the protocol and/or agency progress reports should be included in the packets.

Renewal Instructions for Protocols Closed to Patient Accrual



For renewal of protocols where subjects are still participating in the study and/or receiving treatment, but no new subjects will be enrolled, the investigator should submit the original and ten copies of the Progress Report and ten copies of the complete protocol, including any modifications previously approved. Question #9 of the Progress Report should note that the protocol is open for follow‑up purposes only.

For renewal of protocols where all subjects have completed the study but long-term survival follow‑up is being continued, the investigator should submit the original and 10 copies of the Progress Report, noting on Question #9 of the Progress Report that the protocol is open for long‑term survival follow‑up purposes only.

Final Report Instructions

If the project is completed, submit ten copies of a Final Progress Report. Use the form for the Investigator's Progress Report (Appendix G) and add the word "FINAL" to the top of the form.  The Final Progress Report should include the following:

  1. State the final number of subjects entered into the study at GSW.

  2. State any side effects or problems that occurred since the last report to the IRB.

  3. Describe the positive and negative results of the study.

APPENDIX A – Sample Consent Form

APPENDIX B – Sample Signature Page of Consent Form for Research Involving Children

APPENDIX C – IRB Exemption Application

APPENDIX D – IRB Expedited Review Application

APPENDIX E – Human Subjects Protocol for Expedited Review 

APPENDIX F – Human Subjects Protocol for Full Review

APPENDIX G – Investigator's Progress Report