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Elements of the Informed Consent Document

FSU faculty, staff, and students must obtain the informed consent of any potential human participant before involving that person in research that is not determined by the IRB to be "exempt." Typically, you do this by providing the participants with an informed consent document written in simple, lay language. The IRB may waive the consent form requirement under federal regulation section 45 CFR 46.116 and 46.117. See Federal Policy for the Protection of Human Subjects

After the participant and the investigator have signed the informed consent form, give a signed copy to the participant and keep the original in your files for three years after the completion of the study. Consent forms must be kept in a secure and locked place.

Oral informed consent may be approved by the IRB in some cases if all elements of consent are given and witnessed or, in certain cases, taped. In such cases, a transcript of the consent process must be provided to the IRB with the application and a copy must be given to any participant who requests one.

The following pertain to all consent forms:

General Language: The informed consent form should be written in simple, lay language. "Although not prohibited by the FDA regulations, use of the wording, 'I understand...' in informed consent documents may be inappropriate... Consent documents are more understandable if they are written just as the clinical investigator would give an oral explanation to the subject, that is, the subject is addressed as 'you' and the clinical investigator as 'I/we.' This second person writing style also helps to communicate that there is a choice to be made by the prospective subject. Use of the first person may be interpreted as presumption of subject consent, i.e., the subject has no choice." (From the FDA's "A Guide to Informed Consent")

Purpose and Description: The opening paragraph should state that it is a research study and give sufficient details for participants to be informed of the purpose of the study along with such details as where the study will be conducted, its duration and dates, the nature of participant's participation, and the number of participants in the study. Do not include a statement such as "I agree to what has been verbally described." You must describe the study and its procedures in the informed consent document.

Procedures: Describe the procedures to be followed, including any that are experimental, and any discomforts and risks. Specify the amount of time participation will take.

Participant Benefits: Describe any benefits, if any, to the person participating and, if significant, any available alternatives to obtaining these benefits. If there are not any benefits for participation, indicate this also. (Do not include benefits to society or benefits to the researcher.)

Participant Risks: Describe any risks--psychological, emotional, physical, etc.--however slight. Include a statement, if appropriate, that a particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable.

Voluntary Participation and Withdrawal: Include a statement that participation is voluntary and that participants can withdraw from the study at any time. Clearly state the consequences of withdrawing. For instance, if applicable, state that withdrawing from the study will or will not affect such things as medical treatment, employment, benefits, grades, payment, course credit, etc. If there will be no such consequences, say so.

Confidential or Anonymous: State if the study is confidential or anonymous. Note that it is impossible for it to be both. "Confidential" means that the information provided by the participants may be connected to the participants, but that identities will be protected. "Anonymous" means that the information provided cannot be connected to the participant. For confidential research, explain how you will maintain confidentiality of records and data (e.g. by using coded responses or secure storage). To protect yourself legally in studies involving sensitive areas such as drug/alcohol abuse, prison research, etc., you can apply for a certificate of confidentiality.

Contact Information: Include your name, address, and telephone number, as well as the following statement: "This research study has been reviewed by the Institutional Review Board (IRB) of Frostburg State University. For research-related problems or questions regarding participants' rights, contact the IRB through the Director of the Office of Sponsored Programs at 301-687-3101."

Final Statement: The final statements of the informed consent form should include the following:
"I have read and understand the explanation provided to me and have been given a copy of this consent form. I have had all my questions answered to my satisfaction, and I voluntarily agree to participate in this study."

Signatures: The informed consent must be signed and dated by both the participant and the principal investigator or authorized representative.

Page Numbering: Consent forms with more than one page should be initialed and dated by the participant on each page and the pages should be numbered like this: "page 2 of 3"

Please review the following, which apply to particular situations.

Refusing to Answer Questions: For survey, questionnaire, or other similar measurements, a statement informing participants that they may refuse to answer (without loss of participant benefits) any questions that make them feel uncomfortable. If not answering a question automatically results in withdrawal from the study, be sure to note this.

Personal Data: Include a statement informing participants if medical records, grades, exam scores, or other personal documents will be examined or used. Permissions from the participant to use educational records must be obtained in writing and signed by the participant.

When Child Abuse May Be Uncovered: In all non-anonymous situations (that is, whenever the personal identifying information is collected, regardless of whether it is kept confidential or not), the following statement must be included: "In accordance with legal requirements and/or professional standards, we will disclose to the appropriate individuals and/or authorities information that comes to our attention concerning (past or present) child abuse or neglect or potential harm to you or others."

Parents Informed Consent: For parent's informed consent, include a line for the printed name of the child.

Assent Forms for Minors: A separate assent form should be developed for minors (even if parental consent is obtained). It should be written in age-appropriate language, but with all the essential elements. Both the child and investigator need to sign the form.

Compensation: Specify if compensation will be given to the participant, what the schedule of payments will be, and if compensation will be given even in the event of early withdrawal from the study. If participants are to receive course credit, explain how much will be received, (full, partial, none) and how much will be received if the participant withdraws from the study. Indicate any alternate to compensation that might be available to the participant such as writing a paper, etc. Any alternate means of obtaining compensation or equivalent credit must take approximately the same length of time as participating in the study.

Participant Costs: Include a list of any additional costs the participant may incur while participating in the research, (e.g. parking fees, travel costs, medical costs, loss of work time).

Audio and Video Taping: For permission to make audio or video tapes,specify how and by whom the tapes will be used. You must let the participants know how long the tapes will be kept and how the tapes will be destroyed or erased. If a participant refuses to be taped, but may still participate in the study, a separate form must be developed stating the options with a signature line for each option (e.g., one for taping, one for no taping). If your study includes the videotaping of classrooms, you must provide options to people who do not wish to participate or be videotaped, such as allowing them to sit out of the videotape range, in back of the classroom, or letting them leave the room. (NOTE: A separate Audio/Video Tape release form should only be used in 1) deception studies in which participants are not informed that they have been taped until after their participation, or 2) if the participant can still participate without being taped.)

Sensitive Topics: For research involving sensitive topics (such as, depression, sex, AID/HIV, drug or alcohol abuse, suicide, abusive behavior, child abuse, etc.), the investigator must include sources where the participant can obtain assistance, such as counselors, treatment centers, or hospitals. Emphasize the plan of action for identified behaviors involving the risk of injury to self or others, and for compliance with State and Federal reporting laws. A Certificate of Confidentiality often should be obtained in these instances to legally protect the participant's anonymity.

When Injury Is Possible: Specify any medical treatment available if injury should occur and, if so, the type and amount of treatment or where further information can be obtained. In those cases where emergency medical attention for research-related injuries is arranged, a disclaimer for extended care should be included in the consent form, such as "continuing medical care and/or hospitalization for research-related injury will not be provided free of charge nor will financial compensation be available, or be provided by Frostburg State University or the investigator."

High Risk: The IRB may request the following statement for projects judged to involve high risk: "I have not been requested to waive or release the institution, its agents or sponsor from liability for the negligence of its agents or employees."

Significant Findings Affecting Participation: If it is possible that significant new findings uncovered during the course of the research may relate to the participant's health, welfare, or willingness to participate, state that they will be provided to the participant immediately upon discovery so that the participant can decide to continue participation in the study or not.

FDA-sponsored trials: Include a statement, informing the participant that the Food and Drug Administration (FDA) may inspect the records of FDA-sponsored trials or research.

Medical research: For medical research, you must thoroughly explain procedures such as biopsy, extra blood testing, etc., so that participants will be well informed.

Electrode use: For electrode use, include a statement noting the possibility of allergic reaction to the gel, describing the safety of the equipment, and indicating where the electrodes will be placed.

Collection of Biospecimens: If your research involves the collection of biospecimens, include a statement of whether the subjects’ data may be used for commercial profit and whether it will be shared with the participants. Also, explain whether the research might involve whole genome sequencing.