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 or stop 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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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

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