Human Subjects

IRB Guidelines

Contents:

Introduction & Policy

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. 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 Director of the Human Subjects Office serves as the liaison between the researchers and IRB.

The Human Subjects Office provides administrative support for the IRB and assists researchers through the application and approval process. The Director 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 to the IRB should be directed to:

Human Subjects Office
Office of the Vice-President for Research
609 Boyd Graduate Studies Research Center
The University of Georgia
Athens, Georgia 30602-7411
P 706-542-3199
F 706-542-3360
irb@uga.edu


I. Categories of Research Requiring Approval

Section I: Categories of Research Requiring IRB or Human Subjects Office Approval

A. Exempt Review

The University of Georgia requires that all research involving human subjects receive review and approval before the research begins. The federal regulations, however, allow specific categories of research to be exempt from the requirements of 45 CFR 46. It does not mean that the proposed research is exempt from being reviewed. Research activities in which the only involvement of human subjects will be in one or more of the following categories may be considered for exempt review. The exempt categories do not apply to research involving prisoners.

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. Note: Exemption category (2) does not apply to research with minors, except for research involving observations of public behavior when the investigator(s) does not participate in the activities being observed.

  1. 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 paragraph (b)(2) of this section, if:

(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

  1. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
  2. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:

(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

  1. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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 or 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 a research project falls into the Administrative (Exempt) Review Category, the primary reviewer for that application will be the IRB Coordinator. The Principal Investigator (PI) will be notified via email of any modifications and/or additional information needed in order to complete the review.

B. Expedited Review

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 procedure. The activities listed should not be deemed 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 (1) through seven (7) pertain to both initial and continuing IRB review. Note: 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.

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

(a) from healthy, nonpregnant 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 (b) from other adults and children2, 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.

  1. Prospective collection of biological specimens for research purposes by noninvasive means.

Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) 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;(f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

  1. 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: (a) 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=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

  1. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
  2. Collection of data from voice, video, digital, or image recordings made for research purposes.
  3. 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. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
  4. Continuing review of research previously approved by the convened IRB as follows:

(a) 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 (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.

  1. 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 Board Review

All other applications will be reviewed by the IRB at one of its convened meetings. The IRB is normally scheduled to meet once per month. Please see information for meeting dates and submission deadlines. A quorum of members, including at least one member whose primary concerns are in nonscientific areas, must be present for voting purposes. All relevant materials pertaining to the studies to be reviewed at the meeting are made available to the members approximately two weeks before the meeting. After the meeting, the PI is notified regarding the review status of the study. The IRB may approve, require clarifications/modifications (in order to secure approval), table, defer approval , or disapprove the research project.

II. Materials Required for Submission to the IRB

Section II: Materials Required for Submission to the IRB

Requests to conduct research activities which involve human subjects, must be submitted to the IRB and must be approved prior to commencement of the activity. Materials required for submission include:

  1. Study protocol definition.
  2. Answers to online submission form questions. Clearly discuss the relevant aspects of the proposed study. Do not cut and paste from a grant proposal. All recruitment materials (i.e., newspaper, radio, flyers, etc.) to be used.
  3. If access to research subjects is gained through cooperating institutions not under the auspices of the University, the institution(s) must be identified. If available, submit evidence that the authorized official of that institution has approved the research. If not available at the time of submission, indicate that this is pending.
  4. When funding is being sought from an external agency, the number assigned by the Office for Sponsored Programs, or the proposal number assigned by the funding agency should be provided along with a copy of the funding proposal.
  5. Consent, parental permission or assent form(s) or consent scripts/letters. Section VIII provides detailed information about the informed consent process and contains guidelines for creating consent documents.
  6. 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).
  7. A debriefing form if appropriate. This is required for all studies that recruit from the psychology RP Pool and any study where the design includes deception or incomplete disclosure.
  8. All the data collection 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.

III. Time Considerations for Review

Section III: Time Considerations for Initial Review

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. Submissions qualifying for non-committee review (Exempt determinations and review of studies meeting criteria for Expedited review) are reviewed, and researcher is generally notified, within three to four weeks of the receipt date by the Human Subjects Office.
  2. The agenda for submissions requiring committee review at a convened meeting of the IRB (full board review) 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 Office website should be consulted for specific meeting schedules and application submission deadlines to help ensure a timely review.

IV. Criteria for IRB Approval of Research

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

  • In all research involving human subjects, confidentiality of individually-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 research staff.
  • When appropriate to protect the privacy of subjects and/or the confidentiality of data obtained, data should be coded to remove all names or other directly identifiable information.
  • When research protocols use audio and video recording of research subjects, subjects should always be told that recording will occur. Explicit consent must be obtained for any future use of the recordings such as use in the classroom or as part of a public presentation of the research results.
  • 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.

F. 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.

V. Responsibility of the Principal Investigator

Section V: Responsibility of Principal Investigator

A. The Principal Investigator (PI) bears direct responsibility for the implementation of the research and for ensuring the protection of human research participants. Once a project is approved by the IRB, the researcher must:

  1. Conduct the project as approved by the IRB.
  2. Request IRB review and approval of any amendments or modifications to the research activity before they are implemented. The only exception to this policy is in situations where changes in protocol are required to eliminate apparent immediate hazards to the human participants.
  3. Promptly report any unanticipated problems or incidents 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 (see below), must be reported to the IRB within 72 hours of any member of the investigative team becoming aware of the event.
    1. A Serious Adverse Event is defined as any event that results in any of the following outcomes: death, a permanent or substantial disability, hospitalization (inpatient admission or overnight stay) or prolongation of hospitalization, an immediately life-threatening event, report of overdose, or congenital anomaly/birth defect. 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 must be reported to the IRB at 706-542-3199 and followed with submission of Reportable New Information (RNI) via Click IRB. 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.
    2. The IRB will review all Incident/Adverse Event Reports and make decisions regarding the need to halt the research and/or modify procedures and consent forms.
    3. If there are any questions about whether an event is reportable, contact the Human Subjects Office at 706-542-3199.
  4. Request to continue the study if data collection and/or analysis of individually-identifiable information will continue after the expiration date.
  5. Maintain all pertinent protocol-related records (regardless of media type) for at least three (3) years after completion of the study including, but not limited to, copy of approved protocol, raw data, continuing reviews, amendments, correspondence to and from the IRB, signed consent form(s) for each research participant (if applicable), and other related documents. Any protocol that involved collecting identifiable health information is subject to HIPAA (Health Insurance Portability and Accountability Act) requirements. As a result, records must be retained for a minimum of six (6) years after each subject signed an authorization.
  6. Notify the Human Subjects Office when study is completed, or in the event that the study was never initiated.

B. The IRB has the authority to suspend, terminate, or place restrictions on any study in which the PI 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.

VI. IRB Disapproval and Appeals Process

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.

VII. Research Involving Minors

Section VII: Research Involving Minors

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 categories for exemption, and corresponding review procedure, as outlined in Section I.A, apply to research involving minor subjects with the exception of Exempt 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 categories, and corresponding review procedure, as outlined in Section I.B, are 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

VIII. Informed Consent – General Requirements

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) unless the IRB has waived the requirement to obtain informed consent per 45 CFR 46.116(d) (see below).

B. Waiver or alteration of the elements of consent or waiver of the requirement to obtain informed consent 45 CFR 46.116 (d)

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

(1) The research involves no more than minimal risk to the subjects;

(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

(3) The research could not practicably be carried out without the waiver or alteration; and

(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

C. 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 provided in simple language, where all aspects of the research (e.g., purpose, risks, and benefits) are clearly stated.

D. Documentation of Informed Consent

Documentation of informed consent is required in all cases, unless the IRB has approved a waiver of the requirement to document informed consent per 45 CFR 46.117(c) (see below).

E. Waiver of the Requirement to Document Informed Consent 45 CFR 46.117(c) (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. Helpful hints:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Ensure that your contact information is prominently displayed in consent forms/cover letters so participants can contact you for questions related to the study. Correspondence/calls intended for researchers are sometimes misdirected to the Human Subjects Office and most often the information provided is not enough to redirect it.
  6. The IRB recommends that consent documents be written in second person.
  7. Carefully review consent documents to ensure information is consistent with the IRB protocol and other supporting documents; also, review for spelling and grammatical errors.
  8. If subjects do not read English and you will be translating the consent documents to another language, submit the English version for initial review.  After any requested revisions have been made and reviewed, the translated documents should be submitted.

Note to researchers

Do not distribute consent forms or begin your research until you receive approval from the IRB.

F. Consent Checklist

Informed Consent Elements

  1. Statement that activities are related to or for research
  2. Title of research study
  3. Name(s), Department, Institution, Phone number of researcher(s)
  4. Statement that participation is voluntary
  5. Statement that refusal to participate or withdrawal from the study at any time will not result in penalty or loss of benefits to which the subject is otherwise entitled
  6. Description of the retention and use of data obtained up to the point of withdrawal and or the intention of the researcher to honor a subject’s request for return or destruction of his/her data
  7. Purpose of research study
  8. Description of procedures in lay terms
  9. Appropriate alternative procedures or course of treatment that may be advantageous or other information regarding the option of obtaining the treatment outside of research (if applicable)
  10. Expected duration of subject’s participation
  11. Contact in case of distress, discomfort or research-related injury related to research participation (if applicable)
  12. Statement regarding direct benefits to subjects
  13. Statement regarding potential benefits to others (society) that may reasonably be expected
  14. Financial or other compensation/incentive (if applicable).  This may include any compensation, incentive, or reimbursement (money, student pool credits).  Indicate how any payment will be prorated, in case the subject withdraws from the study prior to completing his/her participation in it.
  15. Explanation regarding the extent to which confidentiality of records identifying the subject will be maintained
  16. Disposition of audio/video recordings and/or photos (if applicable)
  17. An explanation of the circumstances under which the subject’s participation will be terminated by the researcher without regard to the subject’s consent (if applicable)
  18. Deception statement (if applicable):  “In order to make this study a valid one, some information about the study or my participation will be withheld until after the study.”
  19. Who to contact with questions about the research (the researcher)
  20. Subject’s signature and date lines
  21. Researcher’s signature and date lines
  22. Consent statement
  23. Statement that a copy of the form will be provided to the subject
  24. IRB oversight statement

G. Assent (and Documentation of Assent) Requirement

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, 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.

IX. Continuing Review

Section IX: Continuing Review of IRB-Approved Activities

A project approved by the IRB that will continue beyond the expiration date must receive review and approval again before any human subjects activities may continue; this renewal of the approval process is referred to as “Continuing Review.”  Projects must receive annual Continuing Review, unless otherwise stated in the approval notification. The IRB can approve studies for a maximum of 365 days.  Depending on the degree of risk associated with a given project, the IRB may require continuing review more often than once per year.  New submissions are required every five years for ongoing projects.  It is the Principal Investigator’s responsibility to keep track of when a study is nearing expiration and to submit a Continuing Review in a timely manner to allow the IRB enough time for review.

Continuing Review Procedures:

  1. Approximately 90 days, 60 days, and 30 days prior to the end of the approval period, the PI will be sent a notification that the study will expire.  The PI should submit a request for Continuing Review within 30 days of expiration.
  2. A Continuing Review request should be submitted if one or more of the following applies:
  • Continue recruitment/accrual of subjects
  • Continue with data collection
  • Long-term follow-up of previously recruited subjects
  • Analysis of individually-identifiable information
  • Close the study when the human research is completed, terminated (e.g., due to lack of funding), or in the event that the study was never initiated.
  1. A request to modify (amend) a study that is near its expiration can be combined with the request for Continuing Review.
  2. Unless the information received during the prior approval period, or at the time of continuing review, suggests that a project’s review category (expedited, full committee) will be changed, the request to continue will be reviewed in the same category as the initial submission. For studies previously approved via expedited procedure, allow 1-2 weeks for the request to be processed.
  3. If Continuing Review of a study does not occur prior to the end of the approval period, IRB approval expires and this will automatically result in a study closure.  All research activities (e.g., recruitment, data collection, analysis of individually-identifiable information) must cease until a new approval period has been granted.

Materials required for modifications/amendments to the protocol:

  1. Any revised instruments, recruitment materials, consent documents, etc.
  2. Any relevant new authorizations, approvals, permission letters, etc.

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 lapsed since the expiration of the approval.  No human subjects research can be conducted during the period where there is no IRB approval.  New applications will be required after a month has lapsed.

X. IRB Records

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.

XI. Violations of IRB Policy

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.

XII. Student Class Projects Policy

Section XII: Student Class Projects

Purpose

The purpose of this policy is to define which class projects require review and approval from the University of Georgia’s Institutional Review Board (UGA IRB).  This policy also defines the responsibilities of UGA-affiliated individuals (i.e., class instructors and their students) who are overseeing or conducting classroom activities that do not require submissions to UGA IRB.

Definitions

Class Projects or Activities. Course assignments/projects conducted by students for training and education in the use of particular methods (e.g., qualitative research methods), devices or equipment with no intent to contribute to generalizable knowledge.

Generalizable.  Activities designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.

Human Subject or Participant.  A living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Human Subjects Research.  A systematic investigation designed to develop or contribute to generalizable knowledge that involves gathering/obtaining data about living individuals through intervention or interaction with the individual or by obtaining identifiable private information about the living individual.

Interaction.  Includes communication or interpersonal contact between investigator and subject.

Intervention.  Includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

Research.  A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Systematic Investigation. For the purposes of this policy, a systematic investigation is an activity that involves a prospective study plan which incorporates data collection, both quantitative and qualitative, and data analysis to answer a study question or prove/disprove a hypothesis.

Policy

The IRB will NOT review classroom projects or activities as defined above.  Class projects are generally conducted for education or training solely to fulfill a course requirement; as such, an element of the definition of research—the intent to develop or contribute to generalizable knowledge—is lacking so these activities do not meet the regulatory definition ofresearch.  Therefore, as a rule, student class assignments do not fall under the jurisdiction of the IRB and will not require an IRB application, approval, or oversight.

For a class project or activity to be research that will require IRB review, it must be designed with the intent to develop or contribute to generalizable knowledge.  Most classroom activities are designed to teach or educate and have no such intent.  However, when class projects or activities are intended to collect information systematically with the intent to develop or contribute to generalizable knowledge, the project or activity meets the definition of research and will fall under the jurisdiction of the IRB.  The intent to publish or otherwise disseminate the results of the activity is one clear indication that the activity is regulated as research.

Accordingly, masters or doctoral theses involving human participants are considered human subjects research and must be submitted for IRB review.

Faculty and Student Responsibilities

It is the responsibility of the course instructor to determine whether an assigned project involving human participants can be classified as a course-related student project.  Faculty should contact the Human Subjects Office if assistance in making this determination is needed.  Faculty who require students to do course-related projects assume responsibility for the conduct of those projects and for ensuring that the rights and welfare of participants are protected.  This includes discussing the general principles of ethical research with human subjects with the class prior to the initiation of the project.  It also includes reviewing student research plans and monitoring research activities to ensure that human participants are protected.  At a minimum, best practices include informing participants of the voluntary nature of participation and employing measures to protect privacy and confidentiality, if applicable.  The completion of the CITI on-line IRB training by the students who will conduct the projects is also highly recommended.

Finally, instructors/advisors must convey to students that the data may not be used or shared beyond the circumstances described below:

  1. In the classroom;
  2. If the project involves gathering data from or about a company, agency, or organization, the data/results are shared only with that company, agency, or organization; and/or
  3. Project results are presented at departmental, interdepartmental, or college seminars designed to exhibit coursework or to continue the learning process related to presentations.

Disclosure to Participants

All students conducting projects under this policy must disclose important information to the participants.  If an Informed Consent Document or Consent Cover Letter is used, the following will be included:

  1. The student identifies him/herself as a UGA student who is performing the activity to fulfill a course requirement, and the course is specifically identified.
  2. The name and contact information for the course instructor or supervising faculty member to contact for questions is provided.
  3. The persons who have access to the individual data and/or summarized results are specified (e.g., instructor only, company/agency/organization).
  4. Participants are informed that their participation is completely voluntary, that they do not have to participate in the study if they don’t want to, and that they can stop participating at any time.
  5. The disclosure should not state that the project has been approved by the UGA IRB.

Future Use of Data

It is very important that careful consideration be given to the possibility of any publication, presentation, or use of any collected data for future research studies.  Retroactive approval cannot be granted for studies conducted without IRB approval.  For example, if a class project was conducted without IRB approval and resulted in unexpected but important findings or data, those findings or data may not be presented at a national meeting or used in a future project or research study.

Reference(s)

Protection of Human Subjects, Title 45 Code of Federal Regulations, Part 46.

Questions: Please contact the Human Subjects Office (706-542-3199 or irb@uga.edu) for any questions or guidance related to this policy.

XIII. Internet Research

Section XIII: Internet Research

Internet data collection via email, listservs, 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 confidentialThe 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. Section O: 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. Sections H and S: 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 of data directories should be routine procedures.
  3. Section M: Request an IRB waiver to document informed 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) 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.
  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 websites 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.
  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.