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Institutional Review Board (IRB) Georgia Highlands College SECTION 1 OVERVIEW The purpose of this document is to provide the faculty, staff, and students of Georgia Highlands College (GHC) with insight into the college’s Institutional Review Board (IRB). Following this introductory section, this document addresses the following topics in each of the noted sections:

SECTION 2: Composition of the IRB, how members are appointed, SECTION 3: Sample requisite forms (e.g., application/proposal, informed consent, assent of a minor…), SECTION 4: The various IRB review categories (i.e., administrative review, expedited review, full review), as well as the difference between proposals that need IRB review and those that do not because they are part of typical class coursework,

SECTION 5: IRB review time considerations (i.e., when documents are due to the committee and committee turnaround time),

SECTION 6: IRB approval criteria and disapproval criteria, SECTION 7: Responsibilities of investigators,

SECTION 8: Research proposal format style (an example is provided), SECTION 9: How the IRB handles its records and any violations of the college’s human subjects compliance policy, and SECTION 10: Course-Directed Human Subjects Activity (CDHSA). The GHC IRB allows the college a mechanism whereby research activities involving human participants directed by GHC faculty, staff, and/or students will be in full compliance with the regulations and guidelines defined by the Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP). The contents of this document also apply to visitors and users of the college campus or off-campus facilities, and/or use of non-public records to identify, contact, or recruit potential human participants. All research activity that involves GHC and human subjects must comply with IRB guidelines. Regardless of whether an activity is externally funded or not, involves minimal risk or greater than minimal risk, or is conducted by students or faculty, it falls within the purview of the IRB. Georgia Highlands College will assure compliance with the OHRP, a subdivision of the DHHS. An assurance document provides written assurance that all research conducted at the college that involves human participants will be in compliance with the Code of Federal Regulations (CFR) Title 45, Part 46. These regulations cover research from grants funded by the National Institutes of Health (NIH) that have been adopted by GHC to cover all research activities involving human subjects, regardless of their funding sources or lack of funding.

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Data generated as part of GHC coursework is considered an element of teaching and not research per se. Thus, ordinary course collection of laboratory data; information collected from tests, journal entries, class surveys, measurements obtained in health classes, and other similar data, do not have to go through the IRB process as they are viewed as part of the teaching process and are not considered research involving human participants.

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SECTION 2 COMPOSITION OF IRB AND PROCEDURES PERTAINING THERETO The GHC IRB will have at least five (5) members, but no more than nine (9). The GHC IRB is comprised of:

A. Men and women, but not chosen specifically for their gender. B. Members who are NOT all from the same discipline, college division, or profession. C. Ideally, members from at least three (3) different GHC Academic Divisions. D. At least one member who is a scientist, which is defined as a member from the fields of

biology, medicine, chemistry, or psychology. E. At least one “community member” who is not affiliated with GHC in any other official

capacity. For example, this person could be a retiree of GHC.

Members of the GHC IRB will serve three (3) year terms. In its initial year, IRB members will serve terms for the following duration: Two will serve three (3) year terms, two will serve two (2) year terms, and any remaining member(s) will serve a single year term. This step is taken in order to facilitate future IRB composition that provides heterogeneous levels of experience and service among IRB members. The IRB shall be chaired by an individual who has at least one (1) year of experience serving on the GHC IRB, with the exception of the initial year of the GHC IRB. The Chair shall be selected by a vote of the IRB members at their first meeting each academic year.

Appointments to the IRB will be at the discretion of the Vice President for Academic Affairs, who will present IRB appointments to the faculty at a meeting of the full faculty for their affirmation. Members should have the requisite experience, expertise, and diversity to make informed decisions on whether proposed research is ethical, whether informed consent is sufficient, and whether appropriate safeguards have been put in place. Members need to be familiar with potential groups that are participants of studies. For example, if a study includes prisoners as participants, then one IRB member should be a person who is capable of advocating on their behalf. A quorum for votes on proposals undergoing Full Board Review is defined as more than ½ of the current board members, one of whom must be a non-scientist. IRB members may not vote on their own projects. IRB members may ask consultants to attend meetings to represent/meet requirements for expertise/diversity regarding projects in need of such expertise that the IRB itself does not possess, but those consultants may not vote.

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SECTION 3 SAMPLE FORMS Sample forms for (a) research proposals and (b) consent/assent are provided beginning on the next page. Additionally, there is a form that is required to be submitted if the research proposal involve Protected Health Information (PHI).

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GEORGIA HIGHLANDS COLLEGE Application No.:

Human Subjects Application to the INSTITUTIONAL REVIEW BOARD for RESEARCH INVOLVING HUMAN SUBJECTS

The Federal Government and college policy require that the use of human subjects in research be monitored by the Institutional Review Board (IRB). The following information must be provided when humans are used in research studies, whether internally funded, extramurally funded or unfunded. Research in which humans are used may not be performed in the absence of IRB approval. PLEASE COMPLETE AND SUBMIT PAGES 1 AND 2 PLUS YOUR ANSWERS TO THE QUESTIONS (on page 3) IN TYPEWRITTEN FORM TO THE GHC INSTITUTIONAL REVIEW BOARD.

Researcher: Date: Project Title: Project Period (starting/ending dates): Position in college (faculty, etc.): ( If student, please indicate GHC Faculty Advisor): Department: Telephone: E-Mail Address: (where you can be reached in case of a problem with your application) Mailing Address (where your approval will be mailed): Project is (please check one): _____ teaching _____ other Project is: _________unfunded _________ funded (if funded, please complete the following):

Funding Agency (actual/potential): 1. ____________________________ 2.____________________________ Contract/Grant No. (if applicable): __________________________________________

FOR EVALUATION OF YOUR PROJECT, PLEASE CHECK THE FOLLOWING WHICH APPLY:

Mentally or Physically Challenged Subjects Subjects studied at GHC Children or Minor Subjects (under 18 years old) Subjects studied at non-GHC location(s) Prisoners, Parolees or Incarcerated Subjects Students as Subjects Filming, Video or Audio Recording of Subjects Employees as Subjects Questionnaires or Survey(s) to be administered Pregnant Subjects Review of Data Banks, Archives or Medical Records Fetal, placental or surgical pathology tissue(s) Subjects’ major language is not English Involves Blood Samples (fingerpricks/venipuncture, etc.) Involves Deception (if yes, fully describe at Question No. 7) Subjects to be paid Exclusion of Women or Children Subjects (must explain why they are being excluded)

This document is available in alternative format upon request by calling (706) 204-2368.

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Survey Techniques: Check applicable category if the only involvement of human subjects will be in one or more of the following categories: __________ Research on normal educational practices in commonly accepted educational settings __________ Research involving educational tests (cognitive, diagnostic, aptitude, achievement) __________ Research involving survey or interview procedures (if checked, please see below) __________ Research involving the collection or study of existing data, documents, records, specimens

If research involves use of survey or interview procedures to be performed, indicate:

1. Responses will be recorded in such a manner that human subjects cannot be identified, by persons other than the researcher, either directly or through identifiers linked to the subjects.

___yes ___ no

2. Would subject’s responses, if they became known outside the research, reasonably place

the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or employability.

___yes ___no

3. The research deals with sensitive aspects of the subject’s own behavior, such as illegal

conduct, drug use, sexual behavior, or use of alcohol. ___yes ___no

Does Research Involve Greater Than Minimal Risk to Human Subjects? ________ Yes ________ No (If yes, explain in full at Question No. 2)

“Minimal Risk” means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

I HAVE READ THE GEORGIA HIGHLANDS COLLEGE LETTER OF ASSURANCE FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH AND AGREE TO ABIDE BY IT. I ALSO AGREE TO REPORT ANY SIGNIFICANT AND RELEVANT CHANGES IN PROCEDURES AND INSTRUMENTS AS THEY RELATE TO SUBJECTS TO THE CHAIR, HUMAN SUBJECTS COMMITTEE, OFFICE OF RESEARCH.

RESEARCHER (signature) (Date) GHC FACULTY ADVISOR (signature) (Date) (Application will not be processed without Advisor’s signature)

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QUESTIONS FOR RESEARCH INVOLVING HUMAN SUBJECTS

Use additional sheets (if necessary) for answering the following questions

PLEASE SUBMIT YOUR ANSWERS IN TYPEWRITTEN FORM 1. GIVE A COMPLETE DESCRIPTION OF YOUR RESEARCH PROCEDURES AS

THEY RELATE TO THE USE OF HUMAN SUBJECTS.

Participants

Instrumentation

Procedure

2. HAVE THE RISKS INVOLVED BEEN MINIMIZED AND ARE THEY

REASONABLE IN RELATION TO ANTICIPATED BENEFITS OF THE RESEARCH, IF ANY, TO THE SUBJECTS AND THE IMPORTANCE OF THE KNOWLEDGE THAT MAY REASONABLY BE EXPECTED TO RESULT?

Yes/No (circle one)

WHAT PROVISIONS HAVE BEEN MADE TO INSURE THAT APPROPRIATE

FACILITIES AND PROFESSIONAL ATTENTION NECESSARY FOR THE HEALTH AND SAFETY OF THE SUBJECTS ARE AVAILABLE AND WILL BE UTILIZED?

3. DESCRIBE PROCEDURES TO BE USED TO OBTAIN INFORMED CONSENT. (See attached sample and tips on Informed Consent attached to this application.) Attach a copy of the informed consent you will use when submitting this application. ALSO, PLEASE ANSWER THE FOLLOWING:

(A) WHO WILL BE OBTAINING INFORMED CONSENT?

(B) WHEN WILL THE SUBJECTS BE ASKED TO PARTICIPATE AND SIGN THE CONSENT FORM?

(C) IN USING CHILDREN, HOW WILL THEIR ASSENT BE OBTAINED?

4. DESCRIBE HOW POTENTIAL SUBJECTS FOR THE RESEARCH PROJECT WILL BE

RECRUITED.

5. WILL CONFIDENTIALITY OF ALL SUBJECTS BE MAINTAINED? HOW WILL THIS BE ACCOMPLISHED? PLEASE ALSO SPECIFY WHAT WILL BE DONE WITH ALL AUDIO AND/OR VISUAL RECORDINGS, IF APPLICABLE, PICTURES

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AND PERSONAL DOCUMENTATION OF SUBJECTS BOTH DURING AND AFTER COMPLETION OF THE RESEARCH.

6. IS THE RESEARCH AREA CONTROVERSIAL AND IS THERE A POSSIBILITY YOUR PROJECT WILL GENERATE PUBLIC CONCERN? if SO, PLEASE EXPLAIN.

7. DESCRIBE THE PROCEDURE TO BE USED FOR SUBJECT DEBRIEFING AT THE END OF THE PROJECT. IF YOU DO NOT INTEND TO PROVIDE DEBRIEFING, PLEASE EXPLAIN.

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INFORMED CONSENT FORM

(SAMPLE A)

I freely and voluntarily and without element of force or coercion, consent to be a participant in the research project entitled “Mammography and Other Health Care Practices.” This research is being conducted by Jane Doe, RN, Ph.D., who is a Professor of Nursing at Georgia Highlands College. I understand the purpose of her research project is to better understand women’s health practices. In addition to general health care practices it is exploring women’s attitudes and practices related to early detection of breast cancer. I understand that if I participate in the project I will be asked questions about my feelings about breast cancer and mammograms as well as general information about myself and my health habits. I understand I will be asked to fill out paper and pencil questionnaires. I may also be asked to participate in an interview with a graduate nursing research assistant. The total time commitment would be about 45 minutes. If I participate in the interview, I will receive $10.00 compensation for my time. I will also receive printed information about breast cancer. My questions will be answered by the nursing research assistant or she will refer me to a knowledgeable source. I understand my participation is totally voluntary and I may stop participation at anytime. If I decide to stop participation, I will still be entitled to the $10.00 compensation given to me. All my answers to the questions will be kept confidential and identified by a subject code number. My name will not appear on any of the results. No individual responses will be reported. Only group findings will be reported. I understand there is a possibility of a minimal level of risk involved if I agree to participate in this study. I might experience anxiety when thinking about breast cancer, mammography or my personal health habits. The nursing research assistant will be available to talk with me about any emotional discomfort I may experience while participating. I am also able to stop my participation at any time I wish. I understand there are benefits for participating in this research project. First, my own awareness about my health may be increased. Also, I will be providing health care professionals with valuable insight into women’s feelings and behaviors regarding mammography, breast cancer, and women’s general health practices. This knowledge can assist them in providing health services that help women stay as healthy as possible. I understand that this consent may be withdrawn at any time without prejudice, penalty or loss of benefits to which I am otherwise entitled. I have been given the right to ask and have answered any inquiry concerning the study. Questions, if any, have been answered to my satisfaction. I understand that I may contact Dr. Jane Doe, Georgia Highlands College, School of Nursing, (xxx) xxx-xxxx, for answers to questions about this research or my rights. Group results will be sent to me upon my request. I have read and understand this consent form. ______________________________________________ __________________________ (Participant) (Date) ______________________________________________ (Witness)

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INFORMED CONSENT FORM (SAMPLE B)

Letter of Consent for Adults

Date:

Dear _________________,

I am a professor [a graduate student under the direction of Professor ________] in the Department/Division/College of __________________ Georgia Highlands College. I am conducting a research study to _____(state purpose of study) ________________.

Your participation will involve ______________________. (Explain the procedures and include the expected duration of the subject's participation). Your participation in this study is voluntary. If you choose not to participate or to withdraw from the study at any time, there will be no penalty, (e.g., it will not affect your grade, treatment/care, clearly identify any applicable information). The results of the research study may be published, but your name will not be used.

There are foreseeable risks or discomforts to me if I agree to participate in the study. The possible risks are ________. Possible discomforts include _____________. [Any foreseeable risks or discomforts are to be explained/described] OR There are no foreseeable risks or discomforts if I agree to participate in this study.

Although there may be no direct benefit to you, the possible benefit of your participation is _______________________________________________.

If you have any questions concerning this research study, please call me [or Dr. _____________ at (xxx) xxx-xxxx and/or [e-mail address, if available].

Sincerely,

(researcher's name)

* * * * * * *

I give my consent to participate in the above study. (Release statement for videotaping or relinquishing confidentiality must be inserted here, if applicable).

_______________________________ (signature) _______________________ (date)

If you have any questions about your rights as a subject/participant in this research, or if you feel you have been placed at risk, you can contact the Chair of the Human Subjects Committee, Institutional Review Board, at (xxx) xxx-xxxx.

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CONSENT FOR PROJECTS INVOLVING MINORS

In addition to a Parental Consent Form, an Assent Form is required when participants will be under 18 years of age. Below are the suggested forms of obtaining child/youth assent. Child Assent (for 7-12 year olds): This can be in the form of a “script” which will be read and will inform children in terms they can understand about the researcher’s project and what they will be asked to do. The children must also be told that although their parents have given permission for them to participate, they have a right to choose whether or not to do so. And, if they decide not to participate, they will not be punished or penalized. They must also be informed of any risks and benefits of the project. Youth Assent (for 13-18 year olds): This can be in the form of a written consent which will follow the same format as the parental consent guidelines, as above-described, and inform youths in terms that they can understand about the researcher’s project. This form will require the youth’s signature. Note: Below is an example of the preferred Parental Consent signature lines used for obtaining consent. _________________________________ ____________________________________ Child’s Name Parent’s Name ______________________ ___________________________________ Date Parent’s Signature

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CHILD ASSENT (7-12 yrs old) (SAMPLE SCRIPT)

Hello, __________________________, my name is Amanda. How are you doing today? I would like your help in a study that I am conducting. You will be asked to answer some questions about some pictures, and then you will get to draw a picture of yourself and tell me all about it. I’m going to be asking some of the other boys and girls in your class to help me answer the same questions and draw the same pictures too. Now, some of these questions are for older kids and you may not know the answer. That’s okay. You just try your best. And, if you feel funny and don’t want to answer any other questions, you just let me know and we can stop at anytime. You won’t get in any trouble, and no one will be mad at you. Okay? So will you help me by answering some questions? If Yes - Great, let’s get started. I’m going to be writing down what you say because it is very important: And do you see that little black box on the table? That is a tape recorder. It will record our voices while we are talking, and that will help me remember what you say. I’m going to leave it right over here so we don’t touch it and keep it safe. Now, we have to use our big voices so the recorder can hear us. Can I hear your big voice? Good job. Okay, we are all set. Are you ready to begin? If No - If the child says “no”, the researcher must ask a set of innocuous questions to rule out the “no” response set, (i.e.) “Do you have a dog?”; “Do you like pizza?”. If the “No” response set is ruled out, and the child still says “no” when asked to participate a second time, the child will be free to leave, thanked by the researcher, and dismissed from the study.

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Georgia Highlands College Health Insurance Portability and Accountability Act (HIPAA)

Authorization to Use or Disclose Protected Health Information (PHI) for Research Purposes

{Study Title}

HIPAA is a federal law that requires the protection of information that can identify you. Protected Health Information includes information that pertains to your past, present or future physical and mental health conditions, or the provision of health care. You are being asked to sign this Authorization because you are in the research study listed above. The researchers agree to protect your protected health information by using and disclosing it only as permitted by you in the Authorization and as directed by state and federal law. A. What is the purpose of the use and/or disclosure of your protected health information? Discuss why the disclosures are being made. Text from the Purpose section of the Informed

Consent may be inserted if it answers this question.

B. What protected health information will be used or disclosed?

You may be asked for health-related information relevant to the study.

C. Who will disclose your protected health information? The researchers and staff of Georgia Highlands College who are involved in this research study will disclose your medical/health information for this study.

D. Who will receive your protected health information? Your protected health information may be used or shared with others outside of GHC for purposes directly related to the conduct of the research. Once this information leaves GHC, we cannot guarantee that it will be protected by this authorization.

(This is a list of potential recipients – add/delete groups as applicable) Your protected health information may be shared with the following:

• Sponsor of the research study, or its agents such as data repositories or contract research organization;

• Other institutions/ investigators outside of GHC participating in the research study;

IT IS THE RESPONSIBILITY OF THE RESEARCH TEAM TO GIVE THE SUBJECT A

COPY OF THE PRIVACY NOTICE, EVEN IF THEY HAVE ALREADY RECEIVED ONE. THIS MUST BE DONE BEFORE THE SUBJECT PARTICIPATES IN THE

STUDY.

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• Federal and state agencies and GHC committees that have authority over the research, such as:

o The Institutional Review Board (IRB) that oversees human research at the GHC o Committees with oversight or quality improvement responsibilities o Office of Human Research Protections (OHRP) o Food and Drug Administration (FDA)(If drug/device study) o National Institutes of Health (NIH) o Department of Health and Human Services (DHHS) o Department of Social Services (DSS) o Other governmental offices as required by law

• If study enrolls subjects < 18 years of age, add: Parents of research subjects ages 16 up to 18 years of age. Parents of minors < 16 may receive information without authorization from the child.

E. Do you have to sign this authorization? You do not have to sign this authorization. If you choose not to sign the authorization, it will not affect your treatment, payment or enrollment in any health plan or affect your eligibility for benefits. You will not be allowed to participate in the research study. F. If you sign the authorization, can you change your mind? You have the right to withdraw your authorization to allow GHC to use or share your protected health information collected for this research study. Protected health information that has already been used or disclosed cannot be withdrawn. Your protected health information may still be used and disclosed if you have an adverse event. Once authorization is withdrawn and you are no longer participating in the study, no more protected health information will be collected. If you want to withdraw your permission, you must do so in writing to the investigator. The investigator’s address is:

{Insert name and address here}

If you withdraw your authorization, you will not be allowed to participate in the research study. G. Include one of the following options: {Option 1} You have a right to see and copy the information described on this authorization form. OR {Option 2} You will not be allowed to see or copy the information described on this form as long as the research is in progress. When the study is over, you will have the right to see and copy the information described on this authorization form. H. Authorization:

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You authorize (add PI name) and his/her staff to use and disclose your protected health information for the purposes described above. I. Privacy Notice: You have been given a copy of the Privacy Notice that describes the practices of GHC regarding your protected health information. Please initial here: _______________

If you have any questions or concerns about your privacy rights, you should contact GHC at 706-802-5000.

You will be given a signed copy of this form. There is no expiration date for this authorization.

Signature of Research Subject ages 16 & above1 Date __________________________________________________________________ Research Subject’s Personal Representative2 Date (if applicable) ___________________________________________________________ Printed Name of Research Subject or Research Subject’s Personal Representative (if applicable)

Representative’s Relationship to Research Subject

1 If research subjects are ages 16 up to 18 years of age, signatures of both the research subject and the personal representative are required. 2 Personal Representative: A person authorized under state or other law to act on behalf of the individual in making health-related decisions. Examples: Court-appointed guardian with medical authority, a health care agent under a health care proxy, and a parent acting on behalf of an unemancipated minor.

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SECTION 4 REVIEW CATEGORIES

All research projects, including those that the investigator believes fall into the exempt category, must be submitted to the IRB for confirmation. The criteria used to determine specific review category (i.e., exempt, expedited, or full committee review) are described below.

See SECTION 10 for clarification addressing activities that are to be considered aspects of normal coursework and THEREFORE DO NOT REQUIRE IRB REVIEW (e.g., anonymous public opinion polls that otherwise comply with Part I and Part II of the “Exempt from Full Review” criteria listed below). Exempt from Full Review Part I (all items must apply)

A. The research does not involve as a participant prisoners, fetuses, pregnant women, seriously ill individuals, or mentally or cognitively compromised adults.

B. The research does not involve the collection or recording of behavior that, if known outside the research, could reasonably place the participant at risk of criminal or civil liability, be stigmatizing, or be damaging to the participant's financial standing, employability, insurability, or reputation.

C. The research does not involve the collection of information regarding sensitive aspects of a participant’s behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).

D. The research does not involve any participant under the age of 18 (except as noted in Part II, items A, C, D, and/or E). Part II, item B studies that include minors should be submitted for expedited review.

E. The research does not involve deception. F. The procedures of this research are free of foreseeable risk to the participant. G. The research does not require a waiver from informed consent procedures.

Part II (at least one must apply)

A. Research conducted in established or commonly accepted educational settings and involving normal educational practices (e.g., research on regular and special education instructional strategies, research on instructional techniques, curricula, or classroom management methods).

B. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, where information is recorded anonymously (i.e., so that the human participant cannot be identified, directly or indirectly through identifiers linked to the participant). All survey/ interview/observational research in which elected or appointed public officials or candidates for public office serve as participants is exempt, whether or not data collection is anonymous.

C. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These sources must be either publicly available or the information must be recorded anonymously (i.e., in such a manner that participants cannot be identified, directly or through identifiers linked to the participant).

D. Research (including demonstration projects) conducted by or participant to the approval of federal department or agency heads and designed to study, evaluate, or otherwise

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examine (a) public benefit or service programs (e.g., social security, welfare, etc.); (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.

E. Research involving taste or food quality evaluations or consumer acceptance studies, where the tested products are wholesome foods without additives, or foods that contain additives at or below levels found to be safe by the FDA or approved by the EPA of the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Expedited Review Part I (all items must apply)

A. The research does not involve as a participant prisoners, fetuses, pregnant women, seriously ill individuals, or mentally or cognitively compromised adults.

B. The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the participant at risk of criminal or civil liability, be stigmatizing, or be damaging to the participant's financial standing, employability, insurability, or reputation.

C. The research does not involve the collection of information regarding sensitive aspects of the participant’s behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).

D. The procedures of this research present no more than minimal risk to the participant. ("Minimal risk" means that the participant will encounter no greater harm or discomfort than encountered in daily life or during the performance of routine physical or psychological examinations or tests.)

Part II (at least one item should apply) A. Research involving existing identifiable data, documents, records, or biological

specimens (including pathological or diagnostic specimens), where these materials, in their entirety, have been collected or will be collected solely for non-research purposes. These sources are not publicly available and, although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio or video tapes, names will be recorded, even if they are not directly associated with the data).

B. Collection of data through use of the following procedures: (a) non-invasive procedures routinely employed in clinical practice excluding procedures involving x-rays or microwaves; (b) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant's privacy; (c) weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, echography, sonography, ultrasound, magnetic resonance imaging (MRI), diagnostic infrared imaging, doppler blood flow, and echocardiography; or (d) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

C. Collection of data from voice, video, digital, or image recordings made for research purposes where identification of the participant and/or their response would not

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reasonably place them at risk of criminal or civil liability or be damaging to the participant’s financial standing, employability, or reputation.

D. Research on individual or group characteristics or behaviors (including, but not limited to research involving perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior, or research employing surveys, interviews, oral history, focus groups, program evaluation, human factors evaluation, or quality assurance methodologies).

E. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior. Although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or videotapes, names will be recorded, even if they are not directly associated with the data).

F. Research that involves deception. Deception must be scientifically justified and de-briefing procedures must be outlined in detail.

G. Prospective collection for research purposes of biological specimens such as: 1. collection of blood samples by finger stick or venipuncture. 2. hair and nail clippings in a nondisfiguring manner. 3. deciduous teeth at time of exfoliation or if routine patient care indicates a need for

extraction. 4. permanent teeth if routine patient care indicates a need for extraction. 5. excreta and external secretions (including sweat). 6. uncannulated saliva collected either in an unstimulated or stimulated fashion. 7. muscosal and skin cells collected by buccal scraping or swab, skin swab, or mouth

washings. 8. research on drugs or devices for which an investigational new drug exemption or an

investigational device exemption is not required. H. Research previously approved by the convened IRB as follows: (a) where (i) the research

is permanently closed to the enrollment of new participants; (ii) all participants have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of participants; or (b) where the research remains active only for the purposes of data analysis; or (c) where the IRB has determined that the research involves no greater than minimal risk and no additional risks have been identified; or (d) where no participants have been enrolled and no additional risks have been identified.

Full Committee Review If ANY OF these apply:

A. The research involves as a participant prisoners, fetuses, pregnant women, seriously ill individuals, or mentally or cognitively compromised adults.

B. The research involves the collection or recording of behavior that, if known outside the research, could reasonably place the participant at risk of criminal or civil liability, be stigmatizing, or be damaging to the participant’s financial standing, employability, insurability, or reputation.

C. The research involves the collection of information regarding sensitive aspects of the participant’s behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).

D. The procedures of the research involve more than minimal risk to the participant (where "more than minimal risk" means that the participant will encounter greater harm or

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discomfort than encountered in daily life or during the performance of routine physical or psychological examinations or tests).

E. Any research that does not fall into any of the categories explicitly identified as qualifying for exempt or expedited status.

Activities considered aspects of normal coursework that do not require IRB review

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SECTION 5 REVIEW TIME CONSIDERATIONS AND DEADLINES

Upon receipt, an IRB application is checked for completeness, reviewed for ethical methodology, and placed into a category of review. If anything is incomplete or unclear, the applicant will hear back from the IRB within 10 working days of the submission date. The timeline for review of complete applications is as follows. See SECTION 4 for a full description of IRB review categories.

A. Exempt Review –Review is completed within 10 working days, if the IRB deems the

proposal complete and not in need of revisions.

B. Expedited Review –Projects qualifying for expedited review are sent out to IRB members on a regular basis. Review is generally completed within four weeks of the receipt date.

C. Full Board Review –Applications for research that require this level of review should be submitted to the IRB at least 1 month prior to a scheduled IRB meeting, unless other arrangements have been made with the IRB. The IRB should be consulted for specific meeting schedules and application submission deadlines to help ensure suitable review.

CONTINUING REVIEW OF IRB-APPROVED ACTIVITIES A. The IRB has the authority to observe, or have a third party observe, the consent process,

and any activity associated with any application approved by the IRB.

B. Research that has been previously approved by the IRB is required to be reviewed according to the original approval criteria stipulated by the IRB. Continuing Renewal Procedures are as follows:

1. First Notice to Renew: Principal Investigators (PI) are supplied with a form to be

utilized for renewing, changing, or closing applications. Approximately two weeks prior to the end of the research’s approval period, the PI will be sent a reminder outlining the materials that must be submitted in order to renew a project. .

2. Required renewal materials include the following, and these materials must be

submitted to the IRB for appropriate action:

a. Renewal application, including all requisite signatures. b. Participant consent and assent form(s) as needed. c. Additional information as requested.

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3. Unless information received during the prior approval period, or at the time of renewal, suggests that a project’s review category (administrative, expedited, full committee) must be changed, the renewal materials will be reviewed in the same manner in which original approval was obtained. Review time considerations are as outlined in the beginning of this Section.

4. Failure to respond to a Renewal Notice.

Approved applications are closed by the IRB if the renewal materials are not received by the end of the month in which their approval expires. Once the investigator receives a notice that the IRB has closed the PI’s study, all activities involving human participants that were covered under the originally approved application must cease. All relevant Federal Agencies will be notified of IRB closures. The IRB must be contacted if and when the PI wishes to reactivate the application.

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SECTION 6 APPROVAL CRITERIA AND DISAPPROVAL CRITERIA

IRB APPROVAL In order for an application for human subject’s research to be approved, the IRB must determine that all of the following requirements (i.e., A, B, C, D, and E) are satisfied:

A. Risks to participants are minimal. This is determined by:

1. Using procedures that are consistent with sound research design and do not

unnecessarily expose participants to risk.

2. By using procedures already being performed on the participants for other purposes, whenever this opportunity exists.

There is a wide range of medical, social, and behavioral research that may pose no immediate physical risk to the participant, but that may involve varying degrees of emotional stress, deceit, or invasion of privacy, etc. Minimal risk is defined in SECTION 4, under Expedited Review, Part I, Item D. It is the PI’s responsibility to minimize the risks associated with any research and to explain to the research participants any individual benefits that they may expect, or more generally any benefits to society. Evaluation of the risk/benefit ratio is a primary consideration in the IRB review of research protocols.

B. Risks to participants must be reasonable in relation to any potential benefits to those participants and to the importance of the knowledge that may reasonably be expected to result from the research project. In this regard, evaluation shall include only those risks and benefits that may result from the research itself, and not to risks and benefits participants would receive even if not participating in the research.

C. Selection of participants must be equitable, and take into account the purposes of the

research, the setting in which it will be conducted, and the population from which participants will be recruited.

1. Participants should not be selected for potentially beneficial research on the basis

of favoritism, nor should research be directed at participants for non-scientific reasons. Certain groups, such as the economically disadvantaged, the cognitively impaired, and incarcerated individuals, may have diminished capacity for free consent and should be protected from the danger of being involved in research for convenience or because they can be manipulated easily.

2. No coercion, explicit or implicit, should be used to obtain or maintain

cooperation. When the investigator has a specific relationship (e.g., teacher-student, professional-client, employer-employee) with a potential participant,

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special care must be taken to ensure that the participant’s consent is truly voluntary and that the participant feels free to decline to participate.

3. If access to research participants is gained through cooperating institutions not

under the control of GHC, that institution(s) must be identified on the IRB form and evidence provided that the authorized official of that institution IRB approved the research application.

D. Appropriate steps must be taken to obtain and document the informed consent of the

participant, or the participant’s legally authorized representative, prior to participating in the research. See SECTION 3 for examples of these documents.

E. When needed, adequate provisions must be made for monitoring data collection to insure

safety of participants and to protect their privacy by maintaining anonymity or confidentiality of the data.

1. In all research involving human participants, confidentiality of identifiable

information is presumed and therefore must be maintained unless the investigator obtains the explicit permission of the participant to do otherwise. Ordinarily, all questionnaires, inventories, interview schedules, and other data-gathering instruments and procedures must be carefully designed to limit personal information to only that which is essential for conduct of the research. Data that could reveal a participant’s identity should be stored in files that are accessible only to the project investigator and authorized staff.

2. Participants’ personal information should be coded to remove all personal

identifying information. The identity of participants must not be released except with their written permission. Use of existing data that was originally obtained for different purposes and that involves identifiable participant information, requires reexamination of associated risks. There must be a determination of whether the new use is within the scope of the original consent or whether it is necessary or feasible to obtain additional consent.

3. When research protocols use audio and video taping of research participants,

participants are to be told during informed consent, that taping will occur. Explicit consent must be obtained for any public use of the tapes such as use in the classroom or as part of a public presentation of the research results, since this constitutes a waiver of confidentiality.

4. Under federal law, researchers can obtain “advance grant of confidentiality.” This

provides some protection against subpoenas of research data (Public Health Service Act 301(d)). Protection is available whether or not the project has HSA federal funding.

Where participants are potentially vulnerable to coercion or undue influence, appropriate additional safeguards must be included in the study to protect the rights and welfare of these

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participants. Such participants include, but are not limited to, persons with acute or severe physical or mental illness, and persons who are economically or educationally disadvantaged. IRB DISAPPROVAL Disapproval of a research proposal that includes human subjects is determined at meetings including a quorum of the IRB. The PI will be notified in writing if the IRB does not approve his or her research application. The PI has the right to appeal the decision in writing or in person at an IRB meeting. If the investigator is not satisfied with the decision reached by the IRB, the investigator may request a re-review by the IRB whenever significant changes are made to the application or significant new information becomes available.

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SECTION 7 RESPONSIBILITIES OF INVESTIGATORS

Those who plan to engage in research must submit all relevant documentation of the planned research to the IRB. Relevant documentation can include, but is not necessarily limited to, the research proposal and consent/assent forms. General responsibilities that investigators must adhere to are listed here. Additionally, sample forms are provided in SECTION 3.

A. Projects approved by the IRB are required to follow the guidelines listed below. 1. Researchers may only engage in the specific activities approved by the IRB. 2. Any changes to the approved research study must be submitted to the IRB for

approval prior to implementation. However, an exception will be made in the instance that changes are made to eliminate any potential risks that may cause harm to the participants.

3. Any changes or unanticipated problems involving the wellbeing of participants must be reported to the IRB as required by federal regulations. This includes any event that may cause physical, psychological, social, economic, or other harm to a participant. These events must be reported to the IRB within 72 hours of the investigation team becoming aware of the event. However, if an event is considered to be a serious adverse event (see below) the IRB must be notified within 24 hours. a. Serious adverse events are defined as death (regardless of cause), life-threatening

event, a substantial or permanent disability, admission to hospital, or report of overdose. Sponsors of the research project must also be notified of any such events. If a sponsor reports a serious adverse event to a member of the research team the IRB should be notified within 72 hours. The report will be reviewed to determine if the current protocol should be revised.

b. The IRB will review all reports of unexpected and serious adverse events and make decisions regarding modification to procedures, forms, etc. Furthermore, if necessary the IRB will prohibit the continuation of the project.

c. All reports must include the title of project, IRB identification number, Principal Investigator’s name, and name of the individual submitting the report.

4. If it is anticipated that data collection will not be completed by the project’s expiration date, a request of extension must be completed and submitted to the IRB prior to the expiration date (see SECTION 5).

B. If the above requirements are not met or the researcher has put any human participants at risk, the IRB has the authority to suspend, terminate, or restrict that study.

C. Researchers completing research involving human participants must obtain consent from all participants. 1. The only exceptions to this requirement are:

a. Research that only utilizes anonymous observation of human participants. b. Research that exclusively uses of anonymous databases. c. Research involving normal educational practices, conducted in established

educational settings.

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d. The IRB waives the requirement of a signed consent form. This may be the case if the IRB finds:

i. A signed consent form would be the only piece of information in the study linking the participant to the study. In this case consent may cause a potential breach in confidentiality and therefore may cause harm to the participant. Therefore, the IRB may allow each participant to determine if they would or would not like to sign the consent form which would link them with the study, or

ii. The study presents no more than minimal risk of harm to the participants and there are no procedures requiring consent. If the IRB approves a waiver of consent, the researcher may be required to provide a written statement about the research study to the participant.

2. If the participant is a minor (defined as an individual under 18 years of age), the minor must provide assent to participate, unless the conditions noted below exist. Additionally, his or her parental or guardian must provide consent prior to the minor participating in the study. Assent refers to an agreement of a minor or incompetent adult to participate in research. The document for assent should state in simple terms, the purpose, the expectations, and any risks and/or benefits of participation that the participant may experience due to his or her involvement in the research study. The document should also indicate the child has the right to discontinue his or her participation without any penalty. Moreover, information must be provided to the child identifying to whom he or she can talk to about the study (researcher and/or parents) if they have concerns or questions. An assent form must be completed by the minor unless: a. He or she is incapable of providing assent due to age or condition, or b. The nature of the study does not allow the benefits of the study to be released

knowingly to the participant and the intervention is only available in the research context.

If either a. or b. exist then parental/guardian consent is sufficient. 3. Researchers must keep consent forms on file for at least three years after the

completion of the research. IRB approval must be obtained before distributing any consent and assent forms to potential participants.

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SECTION 8 PROPOSAL FORMAT STYLE

A well thought out research proposal must include a number of items if it is to earn IRB approval. These include informed consent and assent (if applicable), which are outlined in this section. INFORMED CONSENT: GENERAL REQUIREMENTS

A. Research Requiring Informed Consent

No investigator (except as noted below) may involve humans as participants in research unless the investigator has obtained the informed consent of the participant or the participant’s legally authorized representative. The only exceptions to this requirement are (a) research in which the only involvement of human participants is that of anonymous observation, as discussed in SECTION 4, (b) research involves the use of anonymous data bases, or in some cases (c) research that is conducted in established educational settings, involving normal educational practices.

B. Circumstances Under Which Consent Must be Sought

Consent must be sought under circumstances where the participant or guardian is provided enough time to consider whether or not to be in the study, and where the possibility of coercion or undue influence is minimized. Information provided to the participant or representative must be written in simple language and all aspects of the research (e.g., purpose, risks, and benefits) are clearly stated.

C. Documentation of Informed Consent

Documentation of informed consent is required in all cases, unless the IRB HSA approved a waiver of consent.

D. Waiver of Signed Consent

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all participants if it finds that:

1. The only record linking the participant to the research would be the consent

document, and the principal risk would be potential harm resulting from a breach of confidentiality. The IRB may determine that each participant be asked whether s/he wants documentation linking the participants with the research, and the participant’s wishes will govern; OR

2. The research presents no more than minimal risk of harm to participants and

involves no procedures for which written consent is normally required outside of the research context. In cases where the requirement of documentation is waived,

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the IRB may require that the investigator provide the participant with a written statement regarding the research.

E. Required Format For Consent Form: Adult Participants (18 Years Old And Older) And

Parental Consent For Minors 1. This Format Guide for Consent Form contains the minimum elements that are

required. 2. However, different formats may be used if they contain the same information and

are approved by the IRB. 3. If you are mailing a questionnaire/survey to participants, a cover letter may be

used rather than a consent form. Cover letters must include at least the elements required in a consent form.

4. It may be necessary to use separate consent forms for various aspects of a study, such as different participant groups or individual phases of a multi-phase study.

5. Prepare your consent form/cover letter in a way that will be easily understood by participants or their guardians. Write consent forms in “lay language,” (i.e., in a language that will be understood by the person asked to give consent). In most cases, the use of scientific jargon is not appropriate. The consent form should be written at an eighth grade reading level unless the population to be included is particularly well educated.

6. Remember that obtaining consent is a process, not just a form. Researchers should plan to explain the research, answer questions, and conduct a debriefing if appropriate.

NOTE TO RESEARCHERS: The researcher must retain consent forms for a period of at least three years after completion of the research. Consent forms are not to be distributed, nor is research to begin until approval is received from the IRB.

F. Assent (and Documentation of Assent) Requirement

The IRB requires that provisions be made for soliciting the assent of children, who, in the judgment of the IRB, are capable of providing assent. Aside from age, usually 7-17 years old, the potential participant’s maturity and psychological/physical state must be taken into account in determining the ability of obtaining assent. The IRB may require submission of an assent document that states, in very simple terms, the purpose of the study, what is expected of the minor, the risks, the benefits, the voluntary nature of participation, the right to leave the study at any time, and to whom the minor can speak (parent and/or investigator) if he or she has questions about the study. Assent refers to agreement by a minor or incompetent adult to participate in research. Assent must be accompanied by consent from the parent or guardian. Assent must be sought from the child unless:

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1. The child is incapable of providing assent (due to age or condition), or

2. The intervention provides the prospect of direct benefit to the child and the intervention is available only in the research context. In these two situations, consent from the parent(s) is sufficient.

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Format Guide for Consent Form Opening Paragraph: I agree (OR, I agree to allow my child _________________________________) to take part in a research study titled (title of research in quotes), which is being conducted by (investigator’s name, division at GHC, and phone number where researcher can be contacted) under the direction of (GHC faculty advisor, division and phone number). I acknowledge that I do not have to take part in this study (OR, I do not have to allow my child to take part in this study), and I (OR, I and my child) can withdraw from this study at any time without giving any reason, and without penalty. Additionally, I can ask to have information related to me (OR, to my child) returned to me, removed from the research records, or destroyed. NOTES: INFORMATION RELATIVE TO YOUR STUDY SHOULD BE INSERTED AS INDICATED IN THE PARENTHESES of the opening paragraph. You should remove the parentheses from the consent form you draft. Additional Required Consent Form Items: Item #1: REASON/PURPOSE The reason for the study is…OR, the purpose of the study is…

• Provide a short description of the background and purpose of the study. Make sure that this description/explanation can be easily understood by potential participants/participants.

Item #2: BENEFITS The benefits that I may expect for participating in this research are: OR I will not benefit directly from this research. However, my participation in this research may lead to information that could…

• Describe any direct benefits to the participant or indirect benefits to others that may be derived from participation in the study. You may include compensation/reimbursement (e.g., money, participant pool credits) as a benefit. Indicate how the incentive will be prorated, in case the participant withdraws from the study prior to completing his/her participation in it.

• If there are no direct benefits associated with a participant’s participation, the consent form should include such a statement.

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Item #3: PROCEDURES The procedures are as follows: OR If I volunteer to take part in this study, I will be asked to do the following things:

• Describe what will happen to the participant, including the time, place, and duration

(e.g., “Your part in this study will last for two weeks,” “Each visit will last thirty minutes”).

• Describe the procedures chronologically using simple language, short sentences and short paragraphs. The use of subheadings helps to organize this section and increases readability.

• Appropriate alternative procedures, if any, that might be advantageous to the participant, must be disclosed.

Item #4: RISKS

• Describe the reasonably foreseeable risk (e.g., physical, psychological, social, or legal) that may be expected from each of the procedures that a participant will be undergoing for research purposes.

• Each risk should be accompanied with an indication of the probability of occurrence (e.g., ‘rare,’ ‘common’).

• Also list the steps to be taken if harm should come to the participant, including any availability of medical or psychological treatment or referrals if needed.

• An explanation of whom to contact in the event of a research-related injury to the participants must be provided, if appropriate.

• If no risks are foreseen, the consent form must include: “No risks are expected” OR another similar statement.

• Describe any anticipated circumstances under which the participant’s participation may be terminated by the investigator without regard to the participant’s consent.

Item #5: DECEPTION (Use only if applicable)

• If deception is necessary, state: “in order to improve the design of the current study , some information about my (or my child’s) participation will be withheld until after the study”.

Item #6: CONFIDENTIAL, ANONYMOUS, OR PUBLIC

• Procedures regarding anonymity OR confidentiality should be described as appropriate.

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• If you or anyone else can trace the identity of the participant through the data, participation is NOT anonymous. Participation CANNOT be both anonymous and confidential.

• If information will be released to any other party for any reason, state the person/agency to which the information will be furnished, the nature of the information, and the purpose of the disclosure.

• If activities are to be audio- or videotaped, describe the participant’s right to review/edit the tapes, who will have access, whether or not these tapes will be used for education purpose, and when these tapes will be erased.

• Describe the extent, if any, to which confidentiality of records that identify the participant will be maintained.

• Consent forms for research that involves data collection that takes place over the internet must contain the following statement: “There is a limit to the confidentiality that can be guaranteed due to the technology itself.”

• Examples of such wording: ° The only people who will know that you are a research participant are members of

the research team. No information about you, or provided by you during the research, will be shared with others without your written permission, except if necessary to protect your rights or welfare (e.g., if you are injured and need emergency care); or if required by law.

° Any information that is obtained in connection with this study and that can be identified with you will remain confidential and will be disclosed only with your permission, or as required by law.

° All information concerning you will be kept private. If information about you is published, it will be written in a way that you cannot be recognized. However, in rare cases it is possible that research records will be requested by court order.

• You may also use the following statements as appropriate: “My identity and the results of this participation will be made public.” OR

“The results of this participation will be anonymous.” “Any information collected about me will be kept confidential.”

NOTE: Confidentiality cannot be retained in circumstances involving suicide, homicide, or child/elder abuse, which must be reported as required by law. Item #7: FUTHER QUESTIONS “The researcher will answer any further questions about the research, now or during the course of the project, and can be reached by telephone at: ###-###-####.”

• Include the above statement with the correct phone number. Item #8: FINAL AGREEMENT & CONSENT FORM COPY My signature below indicates that the researchers have answered all of my questions to my satisfaction and that I consent to participate in this study. I have been given a copy of this form.

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OR, I understand the procedures described above. My questions have been answered to my satisfaction, and I agree to participate in this study. I have been given a copy of this form.

• You must include one of these statements above the signature lines. Item #9: CONSENT FORM SIGNATURE LINES Signature of Researcher Date Signature of Participant Date OR, Signature of Parent or Guardian Date Item #10: IRB OVERSIGHT PARAGRAPH For questions or problems about your rights please call or write: (Name of Chair of IRB), Institutional Review Board, Georgia Highlands College, TBD, Rome, GA, 30161; (Telephone number of Chair), (E-mail Address of Chair). Note: This oversight paragraph MUST be included verbatim at the bottom of each consent form/cover letter.

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G. Assent (and Documentation of Assent) Requirement

The IRB requires that provisions be made for soliciting the assent of children, who, in the judgment of the IRB, are capable of providing assent. Aside from age, usually 7-17 years old, the potential participant’s maturity and psychological/physical state must be taken into account in determining the ability of obtaining assent. The IRB may require submission of an assent document that states, in very simple terms, the purpose of the study, what is expected of the minor, the risks, the benefits, the voluntary nature of participation, the right to leave the study at any time, and to whom the minor can speak (parent and/or investigator) if he or she has questions about the study. Assent refers to agreement by a minor or incompetent adult to participate in research. Assent must be accompanied by consent from the parent or guardian. Assent must be sought from the child unless:

1. The child is incapable of providing assent (due to age or condition), or 2. The intervention provides the prospect of direct benefit to the child and the

intervention is available only in the research context. In these two situations, consent from the parent(s) is sufficient.

H. Checklist For Review Of Consent Forms � Statement that activities are related to research

� Title of research

� Name(s), Address, Phone number of investigator(s)

� Name(s), Address, Phone number of faculty advisor (if applicable)

� Statement that participation is voluntary

� Freedom to withdraw without penalty

� Purpose of research

� Description of procedures in lay terms

� Appropriate alternative procedures that may be advantageous (if applicable)**

� Expectation of duration of participant’s participation

� Description of any reasonably foreseeable risks and/or discomforts

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� Contact in case of distress or discomfort related to research participation (if applicable)

� Statement regarding expected benefits to participant or others that may be reasonably

expected

� Compensation (if applicable)

� Explanation regarding the extent of confidentiality. One of the following three must be stated: “The participation and responses will be made public.” OR, “The results of this participation will be anonymous.” OR, ”The results of this participation will be confidential, and will not be released in any individually identifiable form without my prior consent, unless required by law.”

� Procedures for maintaining confidentiality or anonymity.

� Disposition of tapes/photos (if applicable)

**Alternatives must be accompanied by a description and justification.

� An explanation of the circumstance that could end the participant’s participation

being terminated by the investigator without regard to the participants consent (if applicable)

� Deception Statement (if applicable): “In order to improve the validity of the current

study, some information about my (or my child’s) participation will be withheld until after the study.”

� Offer to answer any questions or to accept any comments and a phone number for

that contact.

� Participant’s signature and date line

� Investigator’s signature and date line

� Final agreement and consent form copy statement

� Verbatim IRB oversight paragraph

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SECTION 9 RECORDS, HANDLING VIOLATIONS OF HUMAN PARTICIPANTS COMPLIANCE POLICY The following records will be maintained by the IRB:

A. A current list of the IRB membership

B. Minutes of meetings, which shall include: 1. Member attendance

2. Agenda 3. Information on discussions

4. Decisions made 5. Voting results

C. Hardcopies of relevant and important email correspondence (as the Chair shall deem as important).

1. From the Chair to the membership 2. From members to the committee

D. Hardcopies of all proposals, applications, supporting documentation and correspondence in support of IRB applications, including notifications from the committee regarding proposals.

IRB records shall be maintained by the Chair of the IRB and shall be maintained for a period of no less than four years following the inactivation or cessation of a project. VIOLATIONS OF HUMAN PARTICIPANTS COMPLIANCE POLICY (HSCP)

A. Alleged violations of the GHC HSCP shall be considered with objective seriousness and discretion by the IRB. In confronting an allegation of policy violation, the IRB shall:

1. Request additional information from any involved person or entity,

2. Request additional information from any third person or entity, and/or 3. Conduct interviews of involved persons.

B. Alleged violations of the GHC HSCP will be identified, explored, and deliberated on by the IRB at a convened meeting, at which point, the following determinations may be made:

1. If there is a need for additional information relevant to the alleged violation,

2. If there is a need for additional deliberation and discussion relevant to the alleged violation,

3. If there is a dismissal of the allegations in light of information relevant to the alleged violation,

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4. If a suspension of the project is required pending the implementation of substantive changes in the research project in question,

5. If there is a need to terminate the project, 6. If it is prudent to notify the Vice President for Academic Affairs (and Grant

Committee if one exists) that scholarly or ethical improprieties may have occurred.

7. Research that has been approved by the IRB may be subject to further appropriate review and approval by officials of the College. College officials may not approve the research if it has been disapproved by the IRB.

C. It should be noted that any research approved by the IRB, or any decision reached by the IRB based on HSCP investigations are ultimately participant to the review by, and approval or disapproval by the GHC administration.

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SECTION 10 COURSE-DIRECTED HUMAN SUBJECTS ACTIVITY (CDHSA)

A. Definition: CDHSA is interpreted by the instructor as any data collected that solely serves the teaching or administrative functions of the course, and is therefore not research that falls under the purview of the GHC IRB and does not require IRB review.

B. If CDHSA is determined, it is the responsibility of the course instructor to:

1. Ensure that the rights and welfare of human participants are not violated, 2. Communicate to students the nature and extent of the research, including any

design features that are necessary to ensure adherence to ethical principles, 3. Require that such design features be integrated into any CDHSA research project,

4. Review student proposals and research protocols to ensure that human participants are protected,

5. Determine if CDHSA proposal and research protocols require IRB review and approval,

6. Maintain complete records of any CDHSA conducted under the auspices of his/her course.

C. Student research projects that are not submitted to the IRB must fall within the parameters below:

1. Full disclosure to the research participant and the participant’s (or participant’s legal guardian’s) competent, voluntary and informed consent,

2. No person shall be put at risk as a consequence of CDHSA. The only acceptable level of risk is minimal risk,

3. If there is deception involved in the research then the IRB must review the proposal and approve it,

4. The benefits and burdens to participants should not be unjustly distributed. The recruitment and selection of participants should be reasonably related to the course related research. Participant selection should be equitable and shall not unfairly benefit or burden any segment of society,

5. Special consideration and protection should be given in student research to persons who may lack full capacity to secure their own rights and interests due to age, mental capacity, involuntary custody, language barriers, or other special circumstances. Projects that involve these participant populations MUST be submitted to the IRB for review and approval,

6. Student researchers must complete an Application to Engage in Course-Directed Human Participants Activity, which shall be reviewed, approved, and retained by the instructor for a period of one academic year after the cessation of the research project,

7. Student researchers must have their participants’ (or their legal guardians’) complete informed consent forms. These forms shall be reviewed, approved and

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retained by the instructor for a period of one academic year after the cessation of the research project,

8. The instructor shall maintain a file on each CDHSA conducted under the auspices of his/her course. This file shall include the title of the project, the names of the student researchers, the dates covered by the research project, and the date approved. This file shall also include all other relevant documentation mentioned above.

D. Categories of CDHSA research include:

1. Research conducted in established or commonly accepted educational settings involving normal educational practices, such as:

a. Research on regular and special educational strategies, b. Research on the effectiveness of comparative instructional techniques,

curricula, or classroom management methods, 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, or

achievement), 3. Research involving survey or interview procedures EXCEPT:

a. Where responses are recorded in such a way that the participants or their responses can be identified to the extent that the participant could be placed at risk for criminal prosecution, or said responses could be damaging to the participant’s financial standing, employability, reputation, or be damaging to the participant’s standing with any private or public entity,

b. Surveys that in any way pertain to topics that could cause emotional or physical distress to participants, including spousal abuse, child abuse, sexual assault, abuse, or harassment,

4. Research involving observation of public behavior, if such information is recorded in a manner that the participants cannot be identified.

5. Research involving the collection of existing data, documents, records, pathological specimens, or diagnostic specimens, if such sources are publicly available or if the information is recorded such that the participants cannot be identified.

E. IRB Review of research proposals. Unless the research project includes categories 1. Research proposals must be reviewed by the IRB if they meet any of the

stipulations that warrant IRB review. 2. Once approved by the IRB, the proposed research protocol may continue to be

used by students without further review by the IRB unless: a. The protocol is changed,

b. There is a complaint from a participant, c. There is an adverse reaction by a participant,

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d. There is a change in the CDHSA environment or new information that would indicate greater than minimal risk to human participants than that assumed when the protocol was initially reviewed and approved,

3. The project extends beyond one year, or

4. Instructors may require their students to submit an application to the IRB for review and approval regardless of the project’s CDHSA qualification status .

F. Recommended Format to Obtain Consent from Participants in Class Projects

Dear Participant, You are invited to participate in a project conducted as part of the requirements for a class in the (insert appropriate class) at Georgia Highlands College. For this project I will be (insert data collection methods to be utilized. EXAMPLE: some interviews and collecting information) to examine (insert your research data interest). The research will be supervised by the course instructor:____________________________________.

The purpose of this research project is to help beginning researchers learn more about (insert appropriate topic. EXAMPLE: qualitative research methods). The information generated will not be used for academic research or publication. Should I desire to use the data collected during this research for purposes beyond the course project identified here, I will contact you again and request your permission to include your data. For the moment, this is only for training purposes. All information obtained will be treated confidentially as allowed by laws governing this state.

You are free to withdraw you participation at any time during this research project. If you have any questions or concerns, feel free to contact me at (insert phone number) or my instructor at (insert GHC office phone number here). I hope you enjoy this opportunity to share your experiences and viewpoints with me. Thank you very much for your help.

Sincerely,

(insert your name) (insert name of Instructor of course)

(insert title, division)

Please sign both copies, keep one copy and return one to the researcher. _______________________________________________________________________

Signature of Researcher/Date Signature of Participant/Date

For questions or problems about your rights, please call or write: (Name of chairperson of IRB), Institutional Review Board, Georgia Highlands College, Office of Strategic Planning, Assessment and Accreditation, Rome, GA 30161; (Telephone number of Chair), (E-mail Address of Chair).

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NOTE: Written consent may be waived if the HSA is a normal part of the daily teaching that a teacher would do and the identity of the participants will not be disclosed. However, if participants are invited to respond to questions (in questionnaire or interview format) or are to be targeted for observation, written consent must be obtained. Although written consent from participants and parents may be waived for normal education practices, the policies regarding consent specified by principals and/or school districts regarding parental consent and student assent must be followed. Within the particular district policies, researchers must obtain authorization from their school principal and/or their school district to conduct research and to waive signed parental consent.