University of Georgia
Institutional Review Board (IRB)
Human Subjects Office (HSO)
Guidelines for Researchers

(Click here to return to the main Guidelines page)

Introduction and Policy

• I. Categories of Research Requiring Approval
• II. Materials Required for Submission to the IRB
• III. Time Considerations for Review
• IV. Criteria for IRB Approval of Research
• V. Responsibilities of Researchers
  • Reporting Adverse Events
• VI. IRB Disapproval and Appeals Process
• VII. Research Involving Minors
• VIII. Informed Consent - General Requirements
  • Required Format for Consent Forms
    • (Click HERE for a separate printout of these consent form guidelines)
  • Consent Checklist
    • (Click HERE for a separate printout of the checklist)
  • Sample Consent Forms
    • Sample Consent Form
    • Sample Parental Permission Form
    • Minor Assent Form
    • Child Assent Script
    • Sample Class Project Consent Form
    • Informational Letter
• IX. Continuing Review
• X. IRB Records
• XI. Violations of IRB Policy
• XII. Class Projects Exemption
• XIII. Internet Research

Guidelines for Researchers
University of Georgia IRB Policies and Procedures
Updated April 2004

Introduction

The University policy on activities involving human subjects is to fully comply with regulations of the Office for Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA), and to implement the principles outlined in the Belmont Report.

The University of Georgia has a signed compliance agreement with the Office for Human Research Protections (OHRP), a subdivision of the Department of Health and Human Services. The assurance document provides written assurance that all federally-funded research conducted at this institution which involves human subjects will be in compliance with the Code of Federal Regulations (CFR) Title 45, Part 46. These regulations have been adopted by UGA to cover all research activities involving human subjects. The institution also abides by the regulations of the U.S. Food and Drug Administration Code of Federal Regulations, Title 21, Part 50 and Part 56.

At the University of Georgia (UGA), all human subjects research activities come under the purview and oversight of the Human Subjects Office and the Institutional Review Board, irrespective of whether the research is funded or non-funded, minimal risk or more. The human subjects policies apply to all UGA affiliated faculty, staff, and students conducting human subjects research on or off-campus (domestic or international sites) as well as visitors conducting research at UGA.

The IRB is charged with the responsibility of protecting the rights and welfare of human subjects involved in research. The composition of the IRB and the number of members on the committee are in accordance with federal regulations. IRB members are appointed by the Vice-President for Research on the recommendation of the Chairperson of the IRB. Members are appointed for renewable, three-year terms and include faculty with expertise in the various disciplines engaged in human subjects research on campus as well as community members. All members, whether regular or alternate, have full voting rights. There is no remuneration for individuals serving as IRB members. No IRB members participate in the review of any study on which they are a Principal researcher or Co-researcher.

The Chairperson of the IRB conducts an orientation for new members which includes review of relevant materials provided (Belmont Report, Federal Regulations, University Policy, IRB Guidelines), and details concerning committee function and procedures. Each new member attends at least one IRB meeting for the purpose of observation, before participating in the actual review of studies.

The IRB may, at its discretion, invite individuals with competence in special areas (consultants) to assist in the review of complex issues that require expertise beyond, or in addition to that available on the committee. The consultant does not take part in voting. Similarly, researchers may request, or be invited, to attend IRB meetings to clarify issues concerning their proposed research activity. These researchers do not take part in committee deliberations or voting.

The IRB reports to the Vice-President for Research. The Administrator of the Human Subjects Office serves as the liaison between the researchers and IRB.

The Human Subjects Office provides administrative and secretarial support for the IRB, and assists researchers through the application and approval process. The Administrator acts on behalf of the IRB and the University when providing assurance of human subjects approval to sponsoring agencies, or when dealing with regulatory agencies. The Human Subjects Office staff is responsible for regularly monitoring IRB compliance, and updating IRB procedures with current and/or new relevant federal or state regulations.

Correspondence (including application materials) to the IRB should be directed to:

Human Subjects Office
Office of the Vice-President for Research
612 Boyd Graduate Studies Research Center
The University of Georgia
Athens, Georgia 30602-7411
Telephone: (706) 542-3199
Fax: (706) 542-3360
e-mail: IRB@uga.edu

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SECTION I
CATEGORIES OF RESEARCH REQUIRING IRB OR HUMAN SUBJECTS OFFICE APPROVAL

A. Administrative Review Category

Research in this category is considered exempt from full committee review, however, UGA requires that such activities be reviewed and approved by the Human Subjects Office. Research in this category includes the following:

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

• Research on regular and special education instructional strategies, or
• Research on the effectiveness of, or the comparison among instructional techniques, curricula, or classroom management methods.

Note: This category does not allow any research with minors other than mere observation.

2. Research with adult subjects involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, UNLESS BOTH OF THE FOLLOWING CONDITIONS EXIST:

• Information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, AND
• Any disclosure of the human subjects' response outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing employability, or reputation.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under #2 above, if:

• The human subjects are elected or appointed public officials or candidates for public office: OR
• Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or the information is recorded by the researcher in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

5. Research and demonstration projects which are conducted by or subject to the approval of Federal Department or Agency Heads, and which are designed to study, evaluate, or otherwise examine; (a) public benefit or service programs; (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.

6. Taste and food quality evaluation and consumer acceptance studies; (a) if wholesome foods without additives are consumed; or (b) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration, approved by the Environmental Protection Agency, or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

If it is determined that an application falls into the Administrative Review Category, the primary reviewer for that application will be the Human Subjects Program Coordinator. Once the review has been completed, the Program Coordinator will notify the researcher via email of any modifications and will notify the researcher in writing regarding the status of the application once the modifications are submitted and approved. Notification will indicate that the application was fully approved, and the approval period.

B. Expedited Review Category

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedures. The activities listed will not be considered to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. Categories one through seven pertain to both initial and continuing IRB review.

Notes: The categories in this list apply regardless of the age of subjects, except as noted. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

• (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
• (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

• From healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
• From other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples:

• hair and nail clippings in a non-disfiguring manner;
• deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
• permanent teeth if routine patient care indicates a need for extraction;
• excreta and external secretions (including sweat);
• uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
• placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
• supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
• mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
• sputum collected after saline mist nebulization.

4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples:

• 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 subject or an invasion of the subject privacy;
• weighing or testing sensory acuity;
• magnetic resonance imaging;
• electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography;
• moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be reviewed under the administrative category listed above. This listing refers only to research that may not be reviewed under the administrative procedures.)

6. Collection of data from voice, video, digital, or image recordings made for research purposes.

7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

8. Continuing review of research previously approved by the convened IRB as follows:

• Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
• Where no subjects have been enrolled and no additional risks have been identified; or
• Where the remaining research activities are limited to data analysis.

9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

An expedited review procedure consists of a review by the IRB chairperson and/or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

C. Full Review Category

All other applications will be reviewed by IRB at one of its convened meetings. The IRB is normally scheduled to meet at noon on the last Friday of each month (excluding November and December). Please see online information for dates and deadlines. A quorum (majority) of members, including at least one non-scientific member, must be present for voting purposes. Full copies of all applications to be reviewed at the meeting are distributed to the members approximately two weeks before the meeting. After the meeting, the researcher is notified regarding the status of the application. The application may be approved, require clarifications/modifications in order to secure approval, tabled (i.e., response from researcher must be brought back to full committee), or disapproved.

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SECTION II
MATERIALS REQUIRED FOR SUBMISSION TO THE IRB

Applications to conduct research activities, which involve human subjects, must be filed with Human Subjects Office and must be approved prior to commencement of the activity. Materials required for submission include:

A. An IRB application, complete with the following signatures:

1. Signature of the researcher, who ensures accuracy of the information contained within the submitted materials, and, upon approval, assures compliance with all aspects of Section V titled "Responsibility of Researchers".

2. If applicable, the signature of the supervisor of the student principal researcher, who assumes complete responsibility for the student's research including:

• Ensuring accuracy of the information contained within the submitted materials.
• Assuring compliance with all aspects of Section V entitled "Responsibility of Researchers".

B. Answers to the Application questions. Clearly discuss, in lay language, the research protocol. Do not cut and paste from a grant proposal. The following must be included:

1. Complete answers to all questions.

2. All advertisements (i.e., newspaper, radio, flyers, etc.) to be used.

3. Inclusion/exclusion criteria for subject entry including notification to the IRB if an researcher proposes to include themselves, or members of their family as subjects in the proposed research.

4. If access to research subjects is gained through cooperating institutions not under the control of the University, the institution(s) must be identified on the IRB form and evidence provided that the authorized official of that institution has approve the research application.

C. When funding is being sought from an external agency (NIH, NSF, pharmaceutical company, etc.), the number assigned by the Office for Sponsored Programs, or the proposal number assigned by the funding agency should be inserted on the cover page of the application.

D. Consent and assent form(s) or consent scripts/letters. Section VIII provides detailed information about the informed consent process and contains guidelines for writing consent forms.

E. If a proposed project involves a component of research that falls under the jurisdiction of the Animal Care and Use and/or the Biosafety Offices, approval must be obtained from the appropriate Compliance Office(s) prior to review by the Human Subjects Office/IRB.

F. Supplemental Materials:

1. If access to research subjects is gained through other institutions, those institutions must be identified on the IRB form and an authorization letter or IRB approval must be provided prior.

2. All advertisements related to recruitment (i.e., newspaper, radio, flyers, etc.) to be used.

3. A debriefing form if appropriate. This is required for all studies that recruit from the psychology RP Pool.

4. All the instruments to be used for the research, e.g. questionnaires, interview or focus group protocols, scales, medical history forms, demographic forms, phone screens, MRI screens, etc.

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SECTION III
TIME CONSIDERATIONS FOR INITIAL REVIEW

*Allow 4-6 weeks from date of submission to IRB*

The IRB recommends that the researcher consult with the Human Subjects Office early in the planning stages of research in order to facilitate the coordination of the various grant and committee deadlines to which the research may be subject for review. There are separate campus committees that are also mandated to review research for compliance with a variety of other regulations including the use of animals, recombinant DNA, Radioisotopes, and hazardous chemicals.

A. The length of time required for review of an application by the IRB is largely dependent on the review category into which a given application falls:

1. Administrative Review category applications are reviewed, and researchers are generally notified within three weeks of the receipt date by the Human Subjects Office.

2. 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.

3. The agenda for applications requiring full committee review at a convened meeting of the IRB is prepared at least two weeks prior to the meeting date. Applications for research that may require this level of review should be submitted to the IRB at least 1 month prior to the scheduled meeting, unless other arrangements have been made with the Human Subjects Office. Early submission may help to secure a place on the agenda of the desired meeting but review at that meeting cannot be guaranteed since Board meetings are often booked a couple of months in advance. The Human Subjects web site should be consulted for specific meeting schedules and application submission deadlines to help ensure a timely review.

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SECTION IV
CRITERIA FOR IRB APPROVAL OF RESEARCH

In order to consider approval of applications for human subjects research, the IRB must determine that all of the following requirements are satisfied:

A. Risks to subjects must be minimized by:

• Using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk.
• Using procedures already being performed on the subjects for other purposes, whenever this opportunity exists.

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

C. Selection of subjects 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 subjects will be recruited.

D. Appropriate measures must be taken to obtain and document the informed prior consent of the subject, or the subject's legally authorized representative, to participate in the research. See Section VIII.

E. Where appropriate, the research plan must include adequate provisions for monitoring data collection to ensure safety of the subjects.

F. Adequate provisions must be made for monitoring data collection to ensure safety of subjects and to protect their privacy by maintaining anonymity or confidentiality of the data.

• In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the researcher obtains the express permission of the subject to do otherwise. All instruments and procedures must be carefully designed to limit personal information to only that which is essential for the research. Data that could reveal a subject's identity should be stored in files which are accessible only to the project researcher and authorized staff.
• The data on subjects should be coded to remove all personal identifying information.
• When research protocols use audio and video taping of research subjects, subjects should always be told 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 the normal confidentiality of research data.
• There have been instances in which the identities of subjects or research data have been sought by law enforcement agencies. This includes some studies, which involve collection of data on sensitive matters such as sexual behavior or criminal activities. Under federal law, researchers can obtain a Certificate of Confidentiality that will provide some protection against subpoenas of research data.

G. Where subjects 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 subjects. Such subjects include persons with acute or severe physical or mental illness, and persons who are economically or educationally disadvantaged.

RESEARCH THAT HAS BEEN APPROVED BY AN IRB MAY BE SUBJECT TO FURTHER APPROPRIATE REVIEW AND APPROVAL OR DISAPPROVAL BY OFFICIALS OF THE INSTITUTION.

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SECTION V
RESPONSIBILITY OF RESEARCHERS

A. Once a project is approved by the IRB, the researcher must:

1. Conduct the project as approved by the IRB.

2. Promptly report any revisions or amendments to the research activity for review and approval by the IRB prior to commencement of the revised protocol. The only exception to this policy is in situations where changes in protocol are required to eliminate apparent, immediate hazards to the subject.

3. Promptly report any unanticipated problems involving risks to subjects or others to the IRB. Reportable events include any harm or injury (physical, psychological, social or economic) or other unexpected events occurring as a result of participation in a research study. Such events, unless considered serious, must be reported in writing to the IRB within 72 hours of any member of the investigative team becoming aware of the event. All events may be reported by phone (706)-542-3199 and followed in campus mail by a written explanation.

• Serious Adverse Events are defined as death due to any cause, a permanent or substantial disability, hospitalization (inpatient admission or overnight stay) or prolongation of hospitalization, an immediately life-threatening event, report of overdose, or report of congenital anomaly. Such events must be reported in writing to the IRB within 24 hours of any member of the investigative team becoming aware of the event. All events may be reported to the IRB at (706) 542-3199 or faxed (706) 542-5638 and followed in campus mail by an original written explanation. These events must also be reported to the sponsor as described in the study protocol or agreement. Serious adverse events occurring at sites other than UGA that are reported to the researcher by a sponsor [usually referred to as IND Safety Reports] must be submitted to the IRB within 72 hours of receipt by any member of the investigative team. IND safety reports should be carefully reviewed to determine if any changes are needed to the IRB approved protocol. An addendum may be appropriate for this information.
• All reports (Reportable Events, Serious Adverse Events or IND Safety Reports) must include the IRB project number, the protocol title, the Principal researcher's name and the name of the person submitting the report.
• The IRB will review all reports of unexpected and adverse events and make decisions regarding the need to halt the research and or modify procedures and consent forms.
• If there are any questions about whether an event is reportable, contact the Human Subjects Office at 706-542-3199.

4. Request an extension of the approval period prior to the expiration date if data collection is not complete.

5. Notify the Human Subjects Office when data collection is complete.

B. The IRB has the authority to suspend, terminate, or place restrictions on any study in which the researcher has not met the above requirements, or in the event where information is disclosed to the IRB that indicates that the rights and/or welfare of human subjects are at risk.

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SECTION VI
IRB DISAPPROVAL

A. Disapproval of an activity is determined at meetings including a quorum of the IRB.

B. The principal researcher will be notified in writing if the IRB has not approved their research application. The principal researcher has the right to appeal that decision in writing or in person at an IRB meeting. If the researcher is not satisfied with the decision subsequently reached by the IRB, the researcher may request a re-review by the IRB whenever significant changes are made to the application or significant new information becomes available.

C. Institutional officials may not approve any research that has not been approved or disapproved by the IRB.

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SECTION VII
RESEARCH INVOLVING MINORS (LESS THAN 18 YEARS OLD)

Note: Children or minors are defined in the federal regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted". According to Georgia State law, anyone under 18 is a minor.

A. Categories of Review

1. The 'administrative' category, and corresponding review procedure, as outlined in Section I.A, applies to research involving minor subjects with the exception of administrative category 2. Category 2 does NOT apply to research involving minors except when the research activity involves the observation of public behavior, as long as the researcher does not participate in the activities being observed.

2. The 'expedited' review category, and corresponding review procedure, as outlined in Section I.B, is applicable to research involving minor subjects, as long as the particular activity in that section does not require that the subject be 18 years old or older.

3. All other research involving minor subjects must be reviewed by the full committee, as discussed in Section I.C.

B. Parental Permission/Assent

1. The IRB requires that parental or guardian permission be obtained prior to a minor's participation in a research study. Section VIII.

2. Depending on the age and maturity of the potential subjects, the IRB may require that the minor be presented with an assent form to review and sign. Otherwise the researcher should plan on using an assent script. Section VIII G. should be reviewed for full details concerning assent requirements

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SECTION VIII
INFORMED CONSENT: GENERAL REQUIREMENTS

A. Research Requiring Informed Consent
No researcher may involve humans as subjects in research unless the researcher has obtained the informed consent from the subject or from the subject's Legally Authorized Representative (LAR). The only exceptions to this requirement are: 1) Research in which the only involvement of human subjects in that of anonymous observation, as discussed in Section I.A.2 and in some cases, 2) research that is conducted in established educational settings, involving normal educational practices as described in Section 1.A.1.

B. Circumstances Under Which Consent Must be Sought
Consent must be sought under circumstances where the subject or representative is given 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 subject or representative must be written in simple language, so 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 has approved a waiver of consent.

D. Waiver of Signed Consent
The IRB may waive the requirement for the researcher to obtain a signed consent form for some or all subjects if it finds that:

1. The only record linking the subject 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 subject be asked whether s/he wants documentation linking the subject with the research, and the subject's wishes will govern; OR

2. The research presents no more that minimal risk of harm to subjects 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, the IRB may require that the researcher provide the subject with a written statement regarding the research.

E. REQUIRED FORMAT FOR CONSENT FORMS: ADULT SUBJECTS (18 YEARS OLD AND OLDER) AND PARENTAL PERMISSION FOR MINORS (Click HERE to get a separate print-out of these consent form guidelines)

1. This format guide for consent forms contains the minimum elements that are required.

2. This format is required unless the researcher has a valid reason for using a different format. The IRB recommends the use of the consent check list for the latter to ensure all the required elements of consent are included.

3. If you are mailing a questionnaire/survey to participants, a cover letter may usually be used rather than a consent form. Cover letters should include at least the information required in a consent form.

4. It may be necessary in some cases 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 your participants or their parents. 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 the 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. You should plan to explain the research, answer questions, and conduct a debriefing if appropriate.

7. Ensure that your contact information is prominently displayed in consent forms/cover letters/surveys etc. Correspondence/calls intended for researchers are often misdirected to the Human Subjects Office and most often the information provided is not enough to redirect it.

NOTE TO RESEARCHERS: Do not distribute consent forms or begin your research until you receive approval from the IRB. You must retain consent forms for a period of at least three years after completion of the research.

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 (Researcher’s name, department, institution, and phone number where researcher can be contacted) under the direction of (UGA faculty advisor, department, institution and phone number). My (OR my child’s) participation is voluntary; I (OR I and my child) can refuse to participate orstop taking part at any time without giving any reason, and without penalty. I can ask to have information related to me (OR to my child) returned to me, removed from the research records, or destroyed.

NOTE: INFORMATION RELATIVE TO YOUR STUDY SHOULD BE INSERTED AS INDICATED IN THE PARENTHESES of the opening paragraph. You should remove the parentheses from the final 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 subjects/participants.

Item #2: BENEFITS
The benefits that I may expect from it are:

OR
I will not benefit directly from this research.

• Describe direct benefits to the subject only.
• If there are no direct benefits associated with a subject's participation, the consent form should include such a statement.

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 (i.e. "My 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. List audio or videotaping.
• If blood collection is involved, reference should be made to the amount (e.g., in ml. and teaspoons or tablespoons) of blood that is to be drawn.
• Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject, must be disclosed.

Item #4: DISCOMFORTS OR STRESSES
The discomforts or stresses that may be faced during this research are:

• Describe the reasonably foreseeable discomforts that may be expected from each of the procedures that a subject will be undergoing for research purposes.
• Each discomfort should be accompanied with an indication of the probability of occurrence (i.e., 'rare', 'common')
• If no discomfort is foreseen, the entire comment for #3 should read:

No discomforts or stresses are expected.

Item #5: RISKS
Participation entails the following risks:

• Describe the reasonably foreseeable risk (physical, psychological, social, or legal) that may be expected from each of the procedures that a subject will be undergoing for research purposes.
• Each risk should be accompanied with an indication of the probability of occurrence (i.e., '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 subjects must be provided, if appropriate.
• Describe any anticipated circumstances under which the subject's participation may be terminated by the researcher without regard to the subject's consent.
• If no risks are foreseen, the entire comment for #5 should read:

No risks are expected.

Item #6: DECEPTION
(Use only if applicable)

• If deception is necessary, state: "In order to make this study a valid one, some information about my (or my child's) participation will be withheld until after the study"

Item #7: CONFIDENTIAL, ANONYMOUS, OR PUBLIC

• Procedures regarding anonymity OR confidentiality should be described here as appropriate.
• 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 whom 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 subject's right to review/edit the tapes, who will have access, if they will be used for educational purpose, and when they will be erased.
• Describe the extent, if any, to which confidentiality of records that identify the subject will be maintained.
• Add how long the master list with identifiers will be maintained.
• Consent forms for research that involves data collection that takes place over the internet must contain the following statement: "Internet communications are insecure and there is a limit to the confidentiality that can be guaranteed due to the technology itself. However once the materials are received by the researcher, standard confidentiality procedures will be employed.” Describe the standard procedures.
• Examples of such wording:
  • The only people who will know that I am a research subject are members of the research team. No individually-identifiable information about me, or provided by me during the research, will be shared with others, except if necessary to protect my rights or welfare (for example, if I am 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 me will remain confidential unless required by law.
  • Any individually-identifiable information about me will be kept confidential. An exception to confidentiality involves information revealed concerning suicide, homicide, or child abuse which must be reported as required by law or if the researchers are required to provide information by a judge.
  • My identity and the results of this participation will be made public.
  • The results of this participation will be anonymous.

Item #8: FURTHER 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 #9: 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 volunteer for this study. I have been given a copy of this form.
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 #10: CONSENT FORM SIGNATURE LINES FORMAT:

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

PARENTAL PERMISSION FORM SIGNATURE LINES

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

Item # 11: IRB OVERSIGHT PARAGRAPH
Additional questions or problems regarding your rights as a research participant should be addressed to The Chairperson, Institutional Review Board, University of Georgia, 612 Boyd Graduate Studies Research Center, Athens, Georgia 30602-7411; Telephone (706) 542-3199; E-Mail Address IRB@uga.edu

OR
Additional questions or problems regarding your child’s rights as a research participant should be addressed to The Chairperson, Institutional Review Board, University of Georgia, 612 Boyd Graduate Studies Research Center, Athens, Georgia 30602-7411; Telephone (706) 542-3199; E-Mail Address IRB@uga.edu

• This oversight paragraph MUST be included VERBATIM at the bottom of each consent form/cover letter. We recommend that you use a smaller font size for this paragraph (see sample consent forms for format). This is because participants often mistakenly assume this is the contact information for the researcher and most often will not have enough information for us to be able to redirect their correspondence/calls.
  

F. Consent Checklist (Click HERE for a printout of the checklist)

G. Assent (and Documentation of Assent) Requirement

1. The IRB requires that provisions be made for soliciting the assent of children, who, in judgment of the IRB, are capable of providing assent. Aside from age, usually 8-17 years old, the maturity and psychological/physical state must be taken into account in determining the ability of obtaining assent. Assent refers to agreement by a minor or incompetent adult to participate in research. Assent must be accompanied by permission from the parent or guardian. Assent must be sought from the child unless:

• The child is incapable of providing assent (due to age or condition), or
• The intervention holds out the prospect of direct benefit to the child and the intervention is available only in the research context. In these two situations, permission from the parent(s) is sufficient.

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SECTION IX
CONTINUING REVIEW OF IRB-APPROVED ACTIVITIES

The IRB has the authority to observe, or have a third party observe the consent process and the activity of any application that is approved.

Projects must be renewed annually, unless otherwise stated on the approval form. The IRB can approve studies for no more than 365 days at a time.

Depending on the degree of risk associated with a given project, the IRB may require continuing review more often than once per year.

New applications are required every five years for ongoing projects.

Annual renewal/revision procedures:

1. The Principal researcher (PI) is sent a blue form (Researcher Request Form) in the approval packet for the purpose of renewing, changing or closing projects.
2. Approximately four weeks prior to the end of the approval period, the PI will also be sent a green reminder form.
3. PI can use either the blue form or the green form to request renewals, changes or closures.
4. No action by the PI at the end of the approval period will automatically result in a closure.

Materials required for renewal:

1. Blue Researcher Request Form (to be found in the approval packet) or the green form (Reminder to Renew) sent 4-6 weeks before the expiration date , completed and signed by PI.
2. Consent form(s) for the study
3. Adverse event report if applicable.

Materials required for changes to the protocol:

1. Blue Researcher Request Form (to be found in the approval packet), completed and signed by PI.
2. A cover letter detailing the changes.
3. Consent form(s) for the study. If changed, submit revised version.
4. Any changed instruments, documents etc.
5. Any relevant authorizations, approvals, permission letters etc.

Continuing reviews:

Unless the 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 as the original application. Allow a week for the paperwork to be processed.

Failure to respond to a renewal notice:

Projects are closed by the IRB if the renewal materials are not received by the renewal date. Once the researcher receives a purple notice of closure, all activities involving human subjects must stop immediately.

Reactivating projects:

The Human Subjects Office must be contacted if and when the researcher wishes to reactivate the project. Reactivations will not be considered if more than a month has elapsed since the expiration of the approval. No human subjects research can be conducted during the lapsed period. New applications will be required after a month has lapsed.

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SECTION X
IRB RECORDS

A. The Human Subjects Office maintains the following IRB records:

1. A current list of IRB membership and qualifications.
2. Minutes of meetings, including information regarding member attendance, discussions held, decisions made, and voting results.
3. All materials submitted to the committee for initial and continued review of each study including: IRB applications, protocols, submitted and final consent forms, adverse reaction reports, proposed amendments, progress reports, correspondence generated between the committee and the researchers, and, where applicable, correspondence from sponsoring agencies.

B. All records are retained for a period of at least three years following the inactivation or closure of a project.

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SECTION XI
VIOLATIONS OF UGA HUMAN SUBJECTS COMPLIANCE POLICY

A. Alleged violations of this policy will be deliberated by the IRB at a convened meeting. The IRB will make a determination regarding the need for additional information, or further investigation.

B. The Dean and Department Heads will be copied on all correspondence between the committee and the involved parties.

C. Upon determination that a violation of this policy has occurred, the IRB may require that the activity in question be discontinued until such time that corrective action is taken.

D. If the IRB determines that the violation involves possible scholarly or scientific misconduct, the Vice President for Research will be notified, and appropriate action will be taken in accordance with established University assurances, policies, and procedures.

E. The IRB has the authority to suspend or terminate approval of any research conducted at or sponsored by the UGA that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects.

F. Any suspension or termination of approval will include a statement of the reasons for the IRB's action and shall be reported promptly to the researcher and to the appropriate institutional officials. All RELEVANT Federal Agencies will be notified of terminations and suspensions.

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SECTION XII
CLASS PROJECTS EXEMPTION

"Class Projects" refers to any class related work that involves human participants. Even though this work is not regarded as research (defined in the federal regulations as “a systematic investigation designed to contribute to generalizable knowledge”) the Human Subjects Office must be notified prior to initiation to ensure that it falls within the parameters given below and is exempt from IRB review.

A. Parameters for Class Projects:

1. NO MINORS: The project cannot include minors or any other vulnerable populations like pregnant women, prisoners, those who lack the capacity to consent, non-English speaking individuals etc.
Exception: Projects conducted in established or commonly accepted educational settings, involving normal educational practices, such as: work on regular and special education instructional strategies, or work on the effectiveness of, or the comparison among instructional techniques, curricula, or classroom management methods.

2. NO MORE THAN MINIMAL RISK: "Minimal risk" is the probability and magnitude of harm that is normally encountered in the daily lives of healthy individuals. This also precludes the study of any illegal activities or the collection of private information that could put the participants at risk through a breach of confidentiality.

3. NO DECEPTION: The class project cannot include any deception. Individuals must be fully informed and given the opportunity to voluntarily consent to participation.

4. NO PUBLICATION: Data from class projects approved under this exemption cannot be used for publication or for thesis/dissertation research.

5. NO VIDEOTAPING: Audio taping is allowed only if the recording is erased upon transcription or no later than the end of the semester.

If a class project does not fall within the above parameters and qualify for an exemption, the instructor will be notified of the decision. The instructor may then submit an IRB application that will go through the regular review and approval process. Such applications will be reviewed in the order they were received and will not be eligible for the fast track exemption accorded to class projects that fall under this section.

Course instructors have primary responsibility for ensuring that the rights and welfare of human subjects are not violated. This responsibility includes communicating to students the ethical principles for the protection of human subjects, reviewing student class project applications, monitoring their activities and consent procedures. All adverse incidents must be reported to the Human Subjects Office within 48 hours.

1. Course instructors are responsible for completing an Instructor Exemption for Class Projects and forwarding it together with the class roll to the Human Subjects Office. Allow at least one week for a notice of exemption. The exemption is valid only for the academic semester during which the class project will be conducted.

2. Instructors are responsible for training students in human subjects research ethics and the relevant institutional policies and procedures.

3. Instructors are responsible for prior review of student applications to ensure compliance with the above-stated IRB parameters.

4. Instructors are responsible for reviewing and approving Student Applications for Class Projects and for retaining the paperwork for a period of one academic year.
These applications are only for the use of the instructors – the IRB does not review them.

5. Instructors must review and approve informed consent procedures. A sample consent form is provided below.

6. Instructors must review and approve instruments, methods, and procedures prior to use by students.

7. Instructors are responsible for ensuring that students obtain authorization for access to other institutions. This is very important!

C. Recommended Format for Consent for Class Projects:
NOTE: This consent form is only for use in class projects. This does not meet the minimum necessary federal standards for regular research. Please use the format recommended in Section VIII for research projects.

Dear Participant,

You are invited to participate in a project conducted as part of the requirements for a class in the {Insert appropriate department or school} at the University of Georgia. For this project I will be doing {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. All information obtained will be treated confidentially.

For this project, you will
{Insert the participant's actions here}

For this project, I will
{Insert researcher's actions here}

You are free to withdraw your participation at any time should you become uncomfortable with it. If you have any questions or concerns, feel free to contact me at {Insert phone number}. I hope you will enjoy this opportunity to share your experiences and viewpoints with us. Thank you very much for your help.

Sincerely,

{Insert your name}

{Insert name of Instructor}
Professor, {Insert appropriate department or school}

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

For questions or problems about your rights please call or write: The Chairperson, Institutional Review Board, University of Georgia, 612 Boyd Graduate Studies Research Center, Athens, Georgia 30602-7411; Telephone (706) 542-3199; E-Mail Address IRB@uga.edu.

(Click here for printable version of this form)

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SECTION XIII

INTERNET RESEARCH

Internet data collection via email, list servs, electronic bulletin boards and web surveys falls under the purview of the Institutional Review Board.

The Internet is an insecure medium as data in transit is vulnerable. So, internet data collection is rarely private, anonymous or even confidential 1. The potential source of risk is harm resulting from a breach of confidentiality. This risk is accentuated if the research involves data that places subjects at risk of criminal or civil liability or could damage their financial standing, employability, insurability, reputation or could be stigmatizing.

The following procedures are required for Internet research:

A. IRB Application:

1. Question 3c, to post a survey on a listserv, obtain permission from the listserv manager or "list owner" as well as "community consent". A posting to a UGA listserv must follow all the UGA policies regarding SPAM. To observe a chat room, obtain authorization from the chat room manager. No lurking or deception, like pretending to be a member!
2. Question 6a, state the procedures to be employed to authenticate that the participants are adults. State plans to use a secure server (SSL 2 or S-HTTP 3). Stripping identifiers from data, storing identifiers and data in separate files, auditing the security if data directories should be routine procedures.
3. Question 8, request an IRB waiver of signed consent.

B. Consent Document:

• An Internet consent document should be written like a cover letter and should include all the elements of the regular signed consent, including the confidentiality disclaimer given below. The consent line should say, "By completing the survey you are agreeing to participate in the research". For web based surveys add a click through button.
• Include the following confidentiality disclaimer in the consent document, "There is a limit to the confidentiality that can be guaranteed due to the technology itself." While the researcher may ensure the confidentiality of a participant by utilizing standard procedures (pseudonyms etc.) when the researcher writes up the final research product, the researcher cannot ensure confidentiality during the actual Internet communication procedure.
• For a chat room that is not open to the public, inform participants that an "observation" is taking place, and that any information exchanged may be used for research purposes.
• Provide an alternative means of filling out the survey. For example, allow the participant to complete it and send it via snail mail to the researcher. Ensure that the researcher's contact information is prominently displayed on both the cover letter and the survey instrument to avoid having the survey misdirected to the IRB.
• Online consent may not be suitable for high risk studies.

C. Survey:

1. The instrument should be formatted in a way that will allow participants to skip questions if they wish to or provide a response like "I choose not to answer".
2. At the end of the survey, there should be two buttons: one to allow participants to discard the data and the other to submit it for inclusion in the study

D. Tips:

1. Consider using gift certificates from online retailers and displaying the unique certificate redemption number to respondents at the completion of a questionnaire. This allows participants to receive an incentive without revealing their identity.
2. The level of security should be appropriate to the risk. For most research, standard security measures like encryption and secure socket layer (SSL) will suffice. However, with sensitive topics additional protections include certified digital signatures for informed consent, encryption of data transmission, technical separation of identifiers and data, and strong verification of assent.
3. Researchers working with children online are subjects to Children's Online Privacy Protection Act (COPPA) (add link http://www.ftc.gov/ogc/coppa1.htm) in addition to the human subjects regulations. Researchers are prohibited from collecting personal information from a child without posting notices about how the information will be used and without getting verifiable parental consent.
4. Screen out minors by checking for Internet Monitoring software like SafeSurf and RSACi ratings or using Adult Check systems.
5. Research that places human subjects at greater risk may not be appropriate for the Internet.

E. References:

Kraut, R. et al 2004 Psychological Research Online: Report of Board of Scientific Affairs Advisory Group on the Conduct of Research on the Internet. American Psychologist February/March 2004.

1. Every computer connected to the Internet has a unique identifier called an IP (Internet Protocol) address. On many networks, the IP address of a computer is always the same i.e. fixed or static. On other networks, a random IP address is assigned each time a computer connects to the network i.e. dynamic. Knowing a fixed IP address is tantamount to knowing the identity of its users. (Return to text)

2. SSL: Secure Sockets Layer is a protocol developed by Netscape for transmitting private documents via the Internet . SSL works by using a public key to encrypt data that's transferred over the SSL connection. Both Netscape Navigator and Internet Explorer support SSL, and many Web sites use the protocol to obtain confidential user information, such as credit card numbers. By convention, URLs that require an SSL connection start with https: instead of http :. (Return to text)

3. Another protocol for transmitting data securely over the World Wide Web is Secure HTTP (S-HTTP) . Whereas SSL creates a secure connection between a client and a server , over which any amount of data can be sent securely, S-HTTP is designed to transmit individual messages securely. SSL and S-HTTP, therefore, can be seen as complementary rather than competing technologies. Both protocols have been approved by the Internet Engineering Task Force (IETF) as a standard. (Return to text)

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Human Subjects
The University of Georgia
Office of the Vice President for Research