If You Require This Document in Another Format Please Contact the IRB Chair At

If you require this document in another format please contact the IRB Chair at

Institutional Review Board (IRB) / IRB Guidelines 3.1
Informed Consent Checklist and Guidelines

Basic Information

The Informed Consent Form must be on UNG letterhead and include these required elements (please see IRB Form 3.1). Please use the following two checklistsand information as your guideline.

Title of the study, exactly as it appears on the IRB application
Affiliation with the University of North Georgia (identify who you are & your project role)
Investigator contact information (and advisor contact information, if investigator is a student)
Purpose of the study
Procedures to be followed
Discomforts or risks (This may be no more that the normal risks associated with normal daily activities. Do not over state or under state the risk.)
Benefits of the study to participants and society (There may be no benefit to the individual.)
Duration/timeframe of participation (for the individual participants – not the entire study.)
Compensation (if applicable – must be reasonable and equitable)
Statement that participation is voluntary
Statement of confidentiality indicating the ways the data may be used and stored. (e.g., data will be reported in aggregate form so individual answers will not be identifiable.) How long will the data be maintained. (No less than 7 years from completion per the Board of Regents retention policy.)
Statement that participants may withdraw their participation at any time (if data collection is not anonymous). If compensation or incentive is offered and there is a penalty for not completing the study, explain the consequence.)
Statement that participants can decline to answer specific questions, if applicable.
If participants are students where the survey is administered in a group or class setting, a statement allowing students to place a blank survey in the collection envelope with the other surveys if they choose not to participate and do not want to self-identify.
Confidentiality assurances, procedures (How the data will be kept secure and confidential. Please remember that Georgia is an “Open Records” state and you cannot guarantee confidentiality.)
Statement that participants must be 18 years of age or older to participate. If subjects are minors, parental consent and minor’s consent is required.
Signature and date lines (for participants and investigators), unless using passive consent
Connecting page numbers if more than one page (e.g. Page 1 of 2, Page 2 of 2)
Contact information for the IRB Chair and/or the Assistant Director for Research compliance. This project has been reviewed and approved by the UNG IRB under tracking number ______.

Research InvolvingProtected Health Information (PHI)

If you research involves protected health information you may also need to fill out IRB Forms 6.1, 6.2, 6.3 and/or 6.4. Please refer to the IRB Website for more information.

Expiration date for consent to use the data. (This may say end of data analysis for this project. You may include an option to de-identify data for use in future reanalysis.)
“Uses and Disclosures Covered by this Authorization” – List every known person, class of persons, or organizations (including the sponsor agency or company, known subsidiaries of the sponsor, cooperative data groups, etc.) that may create, disclose, receive, and/or use protected health information in connection with the study.
Provide a “specific and meaningful description” of the information that will be accessed by this study.
Provide locations from which the information will be accessed, (E.g., patient charts at XYZ clinic; ABC hospital admission records; ABC health department clinic records and the XYS data warehouse.)
Notification that you may withdraw from the study at any time by sending a request in writing to the PI. If you withdraw, the researcher may use and share only the information that has been gathered prior to the date of collection.

Additional Considerations

All wording should be appropriate to participants (rule of thumb: strive for an 8th grade reading level or below). Also, any layperson or someone unfamiliar with your research should easily understand it. Avoid highly technical terms, jargon, etc.
Injury clause should be included if any risk of injury exists (physical or psychological):

"I understand that medical care is available in the event of injury resulting from research but that neither financial compensation nor free medical treatment is provided. I also understand that I am not waiving any rights that I may have against the university for injuries resulting from negligence of the University or investigators."

*Referral information (including a phone number) for those who wish to seek assistance should also be included (e.g. Counseling and Psychological Services)

For surveys that are anonymous, also known as passive consent, the Informed Consent Form does not need to be signed, but the following statement must be included.

“Completion and return of the survey, questionnaire, etc. implies that you agree to participate and your data may be used in this research.”

NOTE: If there is any means of identifying a participant, a signed consent form is required.)

If surveys are to be administered electronically, but not anonymously,
state that there is only limited assurance of confidentiality due to the technology of the Internet;
space for participants to type their names and the date will replace the signature lines
If audio- or videotaping will be used, state:
where tapes will be stored;
when tapes will be destroyed (within a definitive time frame such as “by the year 2019” or tapes will be destroyed immediately following transcription);
who will have access to the tapes.
If deception is involved and the full purpose of the study will not be disclosed to participants until their participation has ended, a statement such as the following needs to be included:

Because the validity of the results of the study could be affected if the purpose of the study is fully divulged to me prior to my participation, I understand that the purpose of the study cannot be explained to me at this time. I understand that I will have an opportunity to receive a complete explanation of the study's purpose following the completion of the study.

If the consent statement will affect the outcome of the research, a through description of the debriefing as well as justification statement should be inserted in the methodology section of the proposal.

Participants must receive a copy of the consent document for their records. Therefore, unless passive, it cannot be attached to or be part of the instrument.
If extra credit or course credit is offered as compensation for participation, the consent form must state what the alternatives to participating are to earn equivalent extra credit or course credit.
If compensation is offered, the following statement may need to be included in the consent form,

“If you are an employee of University of North Georgia, the compensation you receive for participation will be treated as taxable income and therefore taxes will be taken from the total amount. If you are not employed by University of North Georgia, total payments within one calendar year that exceed $600 will require the University to annually report these payments to the IRS. This may require you to claim the compensation that you receive for participation in this study as taxable income.”

**For a sample of an informed consent, please go to the IRB forms webpage. Do not simply copy a sample if your study is significantly different from the sample provided.

Note:Please only include IRB Form 3.1 with your IRB application and not these guidelines!

If you require this document in another format please contact the IRB Chair at

Institutional Review Board (IRB) / IRB Form 3.1
Informed Consent Form

Title of the Study:(Insert title)

Researcher:(Insert name of researcher, department, phone/e-mail, and advisor if necessary)

Introduction:

For a faculty or staff project state the following:

You are being asked to participate in a research study being conducted by (researcher’s name), a faculty member in the Department of (department) at the University of North Georgia.

For a student project state the following:

You are being asked to take part in a research study being conducted by (student name) for a (indicate whether this is a class project, thesis, dissertation) under the supervision of (faculty advisor) in the Department of (insert department) at the University of North Georgia.

You have been approached to (Explain why the person is being asked to participate. For example, if the person is being asked because he or she is a member of a particular group or has had a particular experience, explain this).

Purpose:

The goal of this project is to (give specific purpose and scope).

Procedures:

The [study] will take approximately (indicate length of time). During the interview you will be asked questions about (give general information about subject matter and nature of questions).

If tape recording used:

The interview will be audio-taped (if videotaped, state that as well) and transcribed. The results of your interview will be (give information about how the interview might be used in thesis or dissertation work, publications, or other scholarly work).

Note: If the study involves deception or incomplete disclosure which necessitates a debriefing process, a general statement may be added here or in the Benefits discussion that more information will be given to subjects at the conclusion of the study, e.g., "At the end of the study, we will explain in greater detail what we hope to learn from this research." If the investigator believes that such a statement would bias study results, he/she should discuss this in the protocol as part of the justification for use of deception or incomplete disclosure.

Risks/Benefits:

Explain any benefits to the participant or to society. If the participant will not benefit directly, simply state: “There are no direct benefits to you from participation, but your willingness to share your knowledge and experiences will contribute to (indicate how the results may be helpful to others or to society).”

Any financial compensation should not be discussed here, but should be in the next section.

Explain any foreseeable risks or discomforts. If necessary, provide resources in which participants may access such as a counseling center or hotline.

If there are no foreseeable risks, you may simply state: “The risks associated with participation in this study are minimal.”

Compensation:

Identify and explain any compensation participants will receive in exchange for participating, including monetary compensation, opportunities to win a prize (e.g., though a drawing), and/or partial course credit or extra credit. If participants will not be compensated, you may simply state: “You will not receive any compensation in exchange for participating in this study.”

Confidentiality:

Since there is no legal privilege between investigator and subject, a "guarantee" of “complete” or "strict” confidentiality should not be given or implied in the consent form. This section should explain how the researchers will minimize the risk of breach of confidentiality. Any regulatory or other agencies which may have access to the research records should also be noted, e.g.:

Your study data will be handled as confidentially as possible. If results of this study are published or presented, individual names and other personally identifiable information will not be used (if appropriate, add phrase such as "unless you give explicit permission for this below").

To minimize the risks to confidentiality, we will...(Explain data security measures to be taken, e.g., storage, coding, encryption, limited access to study records, etc.)

Sensitive/Reportable Research Information:

If there is NOT a reasonable expectation (from the topic under study and/or the subject population) that reportable information may be disclosed to the researcher during the study, omit this section.

If there IS a reasonable expectation (from the topic under study and/or the subject population) that reportable information may be disclosed to the researcher during the study, an appropriate statement should be added, e.g.:

We will keep your study data as confidential as possible, with the exception of certain information that we must report for legal or ethical reasons, such as child abuse, elder abuse, or intent to hurt yourself or others.

Voluntary Participation:

Your participation in this study is voluntary. Even if you decide to participate, you may withdraw from the study without penalty at any time during or after the study. You may have the results of your participation, to the extent that the can be identified, returned to you, removed from the research records or destroyed.

Contacts and Questions:

If you have any questions about this research project or interview, feel free to contact (give name of researcher) at (insert business phone or email). If this is a student project, give contact information for both the student researcher and the faculty advisor,(e.g. “If you have questions about this research project or interview, feel free to contact___ at___ or the faculty sponsor___ at___.”).

Statement of Consent:

I agree to participate in this project / study / interview, and to the use of this project / study / interview as described above. The signature below indicates that you have read the information in this document and have had a chance to ask any questions you have about the study.

Participant’s Signature / Date
Researcher’s Signature / Date

Questions or problems regarding your rights as a participant should be addressed to thechair of the Institutional Review Board () or the Assistant Director for Research Compliance, Dr. Troy Smith, 3820 Mundy Mill Road, Oakwood, GA 30566, 678-717-3670, .

If you need this document in another format, please email r call 706-867-2969.