NORTH CAROLINA AGRICULTURAL AND TECHNICAL STATE UNIVERSITY
INSTRUCTIONS FOR DEVELOPING A STANDARD CONSENT FORM
§ The information should be in lay language, defined as language understandable to the people being asked to participate (usually at an 8th grade reading level). The final version should be checked for reading level.
§ Use the second person (“You will receive…”). First person ("I understand that...") is generally not allowed.
§ The informed consent should state facts rather than require attestations on the part of the subject.
§ The final version should be spell checked and carefully proofread to ensure correct spelling, sentence construction, information flow, readability, and formatting.
USING THE CONSENT FORM TEMPLATE
The consent form template is designed to provide guidance in the construction of informed consent documents. Investigators must include all study-specific information that a potential research subject should be aware of in order to make an informed, voluntary decision about taking part in the study. This template addresses the general requirements for informed consent. Therefore, it is the investigator’s responsibility to include areas that are addressed in this template.
All black text is required. You may modify the wording to fit your situation as needed, but the section headings and formatting of the document should remain about the same. The bottom margin MUST be one inch or more.
Blue text within the form indicates instructions and alternatives/suggestions. Delete this from the final version.
Headings found within the consent form template:
(Red = required for all; Black = required if applicable)
1. Study Title, Principle Investigator, and Faculty Advisor: These are to appear as the very first items, flush left as shown.
2. Purpose of the Study and Procedures: A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental. [45 CFR 46.116(a)(1)] If there is funding, state the source and add the statement provided in the template.
3. Risks and Discomforts: A description of any reasonably foreseeable risks or discomforts to the subject. [45 CFR 46.116(a)(2)] Mild psychological or emotional discomfort is not more than minimal risk, but if applicable, state this as a risk and provide a phone number for A&T’s counseling center. If there will be sensitive questions, state that. (A “minimal risk” statement is included in the template. Leave this statement only if minimal or no risks are expected. If applicable, change to “greater than minimal risk” and list the significant risks the participant may experience, and the information under #4, next.)
4. Research Involving More Than Minimal Risk: For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. [45 CFR 46.116(a)(6)]
5. Benefits: A description of any benefits to the subject or to others which may reasonably be expected from the research. [45 CFR 46.116(a)(3)] Extra credit or an incentive for participation is not a benefit. If there are no direct benefits to subjects, state so. Examples: “There are no direct benefits to participants, but we hope to learn….” or “Although you may not receive direct benefit from your participation, others may ultimately benefit from the knowledge obtained from this research.”
6. Compensation: If you are providing an incentive such as a gift card or a drawing for a gift card, indicate the total amount as well as the amount paid for each phase of the study, and the amount compensated if the participant chooses to withdraw. Be mindful that monetary incentives can be coercive if excessive! Contact the Office of Research Compliance and Ethics at 336-334-7995 if you need assistance.
7. Alternative Procedures: A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. [45 CFR 46.116(a)(4)]
8. Confidentiality: A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. [45 CFR 46.116(a)(5)]
9. Questions About the Study: An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject. [45 CFR 46.116(a)(7)] This should include a phone number and/or email address to reach the Principle Investigator as well as the phone number for the Office of Research Compliance and Ethics (as shown in the template).
10. Voluntary Participation/Withdrawal: A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. [45 CFR 46.116(a)(8)]
11. Signatures and Initials: A signature line should be provided at the end of the form for the subject and, as appropriate, for his or her legal representative. The researcher should also sign the form. For projects that are more than minimal risk, the subject and the researcher should initial each page of the form in a space that is clearly marked for this purpose. (Witnesses are sometimes required to attest to the consent process and sign the consent document in cases where nonstandard consent procedures are used. Contact the Office of Research Compliance and Ethics for more information.)
Other elements in the Code of Federal Regulations which should be added if appropriate:
[45 CFR 46.116(b)(1) through (6)]
§ Unforeseeable Risks: A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus if the subject is or may become pregnant) which are currently unforeseeable.
§ Termination of Participation: Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.
§ Costs: Any additional costs to the subject that may result from participation in the research.
§ Withdrawal Consequences: Consequences of discontinuing research participation and procedures for orderly termination of participation by the subject.
§ Significant New Findings: Notification of significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.
§ Number of Subjects: The approximate number of subjects involved in the study.
Other elements that should be added if appropriate:
§ A statement that the Food and Drug Administration may inspect the records
§ An explanation of whether the results will be made available to the subject
NORTH CAROLINA AGRICULTURAL AND TECHNICAL STATE UNIVERSITY
INFORMED CONSENT TO PARTICIPATE
IN A RESEARCH STUDY
Study Title:
Principle Investigator:
Faculty Advisor: Delete if not applicable.
Purpose of the Study
You have been asked to participate as a subject in a research study about ______. The purpose of this research is to ______. You have been asked because you [insert participation criteria, such as age, program of study, student at A&T, etc].
If funded include the following: This research is sponsored by ______.
Procedures
If you choose to participate in this project, you will be asked to ______.
Include a description of the research procedures, identifying any that are experimental. Include the participant’s time commitment for each component.
Risks and Discomforts
The Institutional Review Board at North Carolina A&T State University has determined that participation in this study poses minimal risk to participants. This means the risk of harm or discomfort that may happen as a result of taking part in this research study is not expected to be more than in daily life or from routine physical or psychological examinations or tests.
If sensitive questions will be asked, state that here. If anything asked could elicit emotional or psychological discomfort, please include a referral to the A&T counseling center with the phone number. If there are other risks, describe them. Research involving more than minimal risk must also include an explanation as to whether compensation or medical, psychological, or other types of treatments are available if injury or a stressful situation occurs.
Benefits
State any benefits to the participant or to society/scientific knowledge. (Compensation is not a benefit.) If there are no direct benefits to the individual, state so.
Compensation or Costs to Study Participants
If there is an incentive or reimbursement, specifically state what it is. State any costs associated with participating in the study. If none, state so. If students will be given extra credit, please include an alternative to earning the same amount of credit.
Audio/Video Recording Only if applicable.
We will be using an audio recorder in order to accurately capture what is said. The recordings will be transcribed, but your name will not be included in the transcription. The audio recordings and transcription will be kept on a password-protected computer. Include a statement about when the recordings will be transcribed and the audio recordings destroyed. Best practice is to transcribe the recordings as soon as possible and destroy the audio to minimize a breach of confidentiality since voices are potentially identifiable to anyone who hears the recording. Transcriptions must be kept at least three years after the close of the study. Reports of study findings will not include any identifying information.
Confidentiality
All information collected in this study will be kept completely confidential to the extent permitted by law.
If information will be collected anonymously, state so. If it will not be collected anonymously, but you will remove identifiers and code the data, please explain this.
Please also describe how information will be kept confidential. For example, data will be stored in a locked file cabinet or on a password-protected computer, it will be encrypted, and/or it will be collected anonymously.
If the data is not de-identified: Information that identifies you personally will not be released without your written permission, and if the results of this research are published or discussed in conferences, no information will be included that would reveal your identity. Describe when and how you will eventually dispose of identifiable information. (Remember that all data must be kept at least three years after the close of the study.)
If data is collected via the Internet and is NOT collected anonymously, include the following statement: Please note that absolute confidentiality cannot be guaranteed due to the limited protections of Internet access. Your participation in this online survey involves risks similar to a person’s everyday use of the Internet.
If you are collecting email addresses in an otherwise anonymous study, such as for a drawing, include the following statement: Your email address will be requested so that we ______. However, it will be stored separately from any data collected in the study.
Questions About the Study
If you have any questions about your involvement in this project, you may contact me at xxx-xxx-xxxx or by email at xxxx. If you have any study-related concerns or any questions about your rights as a research study participant, you may contact the Office of Research Compliance and Ethics at North Carolina A&T State University at 336-334-7995.
Voluntary Participation/Withdrawal
Your participation is voluntary, and you may end your participation at any time. Refusing to participate or leaving the study at a later time will not result in any penalty or loss of benefits to which you are entitled. If participants are students: Your grade, record, academic standing, or relationship with the University will not be affected if you choose not to participate or withdraw.
Statement of Consent
I have read the above information and have received answers to any questions I had. I am at least 18 years of age or older and voluntarily consent to take part in this research study. If your research will be conducted through an online survey, remove the signature lines below. Add a button such as “I agree.”
Signature Date
Using language that is understandable and appropriate, I have discussed this project and the items above with the subject and/or authorized representatives.
Signature of Principal Investigator Date