Informed Consent Guidelines
The central mission of Sterling Institutional Review Board is to protect the rights, privacy and welfare of individuals who volunteer to participate in research studies. An essential tool for ensuring that protection is the Participant Informed Consent Form (ICF). An ICF is a written document that seeks to inform a potential research participant of the essential facts of a research study, including the purpose, procedures, potential benefits and risks. The ICF also explains how the participant's medical information will be used and who may see it. All of this information is presented so that a potential research participant may reach an informed decision as to whether they will volunteer to participate. Investigators may seek consent only under circumstances that provide the participant sufficient opportunity to consider whether to volunteer for the study and in an atmosphere / presentation that minimizes possible coercion or undue influence. Apart from very limited exceptions, investigators may not involve a human participant in clinical research without the legally effective written informed consent of the participant (or of the participant's legally authorized representative).
The following information is provided as a guideline to compose a complete ICF that contains all of the federally-required elements (including "additional" elements, where needed) as detailed in 21 CFR 50.25 and 45 CFR 46.116, as well as elements required by the Guidelines for Good Clinical Practice (“GCP”) established by the International Conference on Harmonisation (“ICH”). This guideline also incorporates HIPAA required elements, so a separate HIPAA authorization form would not be necessary if these guidelines are followed in composing the ICF. Sterling IRB may require disclosures beyond those detailed below when the information would add to the protection of the rights, privacy and welfare of the participants.
Please note: The ICF is more than just a form or document; it is one of the tools used in the informed consent process, which involves oral explanation to the participant, question and answer discussions between the participant and the investigator/study staff, recruitment materials, and so forth. Please reference Sterling IRB's Investigator Handbook for a more complete explanation of the Informed Consent Process.
One of the most important elements to consider when writing an ICF is the use of language and terminology.
Essential guidelines for language/terminology are as follows:
- The ICF should be written in simple language understandable to the participants; for most studies this would be at an 8th grade reading level (or lower).
- The ICF should be written in the second person, as if it were talking to the participant. (e.g., "You" and "Your" instead of "I" and "My").
Please note: The only section that should be written in the first person is the Informed Consent statement, where the participant signs:
"I, (participant name), have read the information contained in this document..."
The informed consent statement should be included at the end of the document after all other information has been given.
- Do not use phrases that attempt to define what a participant understands, as an ICF can only seek to inform a participant (not verify their understanding). Limit the ICF to accurate descriptions of fact.
- Incorrect: "I understand that my participation in this study is voluntary."
- Correct: "My participation in this study is voluntary." OR "I have been told that my participation in this study is voluntary."
- Avoid long, complex and/or run-on sentences.
- Keep paragraphs simple and concise.
- Pay attention to the overall length of the document. The ICF should be as short as possible while still including all relevant study information.
- Avoid language that appears to ask a participant to waive or give up any of their legal rights (this includes avoiding statements that ask the participant to release the sponsor, investigator, or study institution from responsibility for any negligence or misconduct that might occur during the study).
- Refer to current and potential research volunteers as "participants" (not "patients"), as the relationship of a participant to an investigator is not the same as that of a patient to a doctor.
- In the risk section of the ICF, if a technical term must be listed, it should be in parentheses after the lay definition (i.e. the lay definition should come first if a technical term is referenced).
- Incorrect: "The study drug may also cause pruritis (itching)."
- Correct: "The study drug may also cause itching (pruritis)."
- Include an instrument/tool to document that the participant receives the ICF in its entirety (e.g. “initials” line for the participant on each page, or a prompt for the participant to write in the number of consent form pages they received).
- Words to Avoid
- understand (use "I have been told")
- patient (use "participant")
- treatment (use "procedure" or "study drug/device," especially for placebo-controlled studies or studies of investigational products)
- trial (use "research study")
- Clearly distinguish between the study doctor, and the participant's primary care physician. Do not refer to the study doctor as simply "doctor."
1. Cover Page
On the ICF cover page, the following information should be provided:
- Protocol title (usually a short description/explanation of the research study and the drug(s)/device(s) involved)
- Protocol number (if applicable)
- The name and title of the investigator(s) conducting the study
- The contact information (i.e., address and telephone number) of the site(s) where participants may present for study visits; a 24-hour phone number for reporting research-related injuries should be listed, where appropriate.
- The name of the sponsor
2. Introductory Statement
This section should include all of the following:
- A statement explaining that the participant is being asked to take part in a research study.
- A statement explaining that participation in the research is strictly voluntary (by choice).
- A general list of what the ICF explains (e.g., purpose, procedures, possible benefits, risks, how a participant's medical information will be used and who may see it, etc.).
- A statement explaining that a copy of the ICF will be given to the participant to review at his/her leisure and that he/she should feel free to ask questions from the study investigator/staff and seek advice from others.
- A statement informing the participant that the study investigator/staff will answer any questions that he/she has about the ICF.
- A statement explaining that the participant, after reading the ICF in its entirety, will be asked to sign the form if he/she would like to participate, and that a copy of the signed and dated form will be provided to the participant for his/her records.
If a parent or legally authorized representative is signing the Permission/Informed Consent Form on behalf of the participant, add a statement explaining that the pronouns "you" and "your" should be read as referring to the participant rather than the parent or legally authorized representative who is signing the form to give consent for the participant.
3. Background / Nature of the Study
In this section, provide a general, non-technical overview or background of the study drug/device and/or type of research being performed.
4. Purpose / Objective of the Study
In this section, provide a general, non-technical statement outlining the exact purpose/objective of the research study. It is important to follow the guidelines below in the description of the purpose/objective of the study:
- Include a clear statement of why the participant is being asked to take part in the study (e.g., "You are being asked to participate in this study because you have been diagnosed with anemia.").
- Do not include inclusion/exclusion criteria in this section.
- Do not describe the study procedures or study drug/device with terms that might coerce or promise benefits that are unknown (such as "new" or "groundbreaking"). Acceptable descriptions for research procedures/drugs/devices include "investigational" and "experimental."
- Define the FDA status of any procedure/drug/device in the study (e.g., "Drug xxx is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA)").
- If a drug has been approved for any other treatments or groups, list which ones.
- Include the type of study being performed (e.g., double-blind, open-label, etc.).
- Make sure that the description of the study purpose/objective accurately reflects what is presented in the study protocol.
- Avoid the term "treatment" when describing procedures/drugs/devices, particularly those which are investigational.
- State the approximate number of participants expected to be enrolled in the study.
- State the approximate number of research sites that are participating in the study, and in how many countries.
5. Duration of the Study
State approximately how long the participant is expected to be involved in the study.
In this section, provide a detailed explanation of all procedures and visits that will occur throughout the duration of the study. Guidelines for this section include the following:
- If possible, organize this section by visit number, and under each visit, describe all procedures that will occur (both experimental and standard of care). Study procedures include, but are not limited to: blood draws, questionnaires, electrocardiograms, etc. Use of a table to describe the procedures performed at each visit may be effective.
- If blood is to be drawn, specify the amount of blood to be taken at each draw, preferably in easily understood units (e.g., teaspoons, cups, etc.).
- Specify the approximate duration of each study visit.
- Specify the approximate duration of study procedures, if applicable.
- Include the dose of the study drug(s), if applicable.
- Distinguish between procedures that are experimental versus those that are standard of care.
- If a participant is to be randomized, a lay description of this term should be provided (e.g., "by chance", "like the flip of a coin," etc.).
- Explain the probability of a participant being assigned to each group (e.g. assigned to a treatment arm versus a placebo arm), if applicable.
- Where applicable, explain a blinded study design and information available in emergency situations.
- List and describe all of the responsibilities of the participant. Participant responsibilities may include activities such as:
- Arriving at each study visit on time.
- Completing a study diary and bringing it to each study visit.
- Taking study drug as prescribed.
- Reporting side effects/adverse events.
- Not giving the study drug to any other person.
- Returning all unused study drug.
- Fasting for a period of 8 hours before each study visit.
7. Potential Side Effects, Risks, Discomforts or Inconveniences
In this section you will describe in simple, lay language all of the potential risks of each procedure and/or drug/device that is involved with the study. Information that must be listed in this section includes:
- Risks associated with all drugs (including drugs that may be part of the research design and those approved by the FDA).
- Where applicable, disclosure if animal studies have not been conducted.
- Risks associated with all procedures, even those that are part of standard of care, such as blood draws, electrocardiograms, etc.
- Risks associated with stopping current medication, if applicable.
- A statement explaining that the study drug and/or study procedure may be ineffective.
- Specific birth control/contraception information for females and/or males, if applicable.
- A statement explaining that the study may involve risks to the participant that are currently unforeseeable or unknown.
- If applicable, reasonably foreseeable risks to an embryo, fetus or nursing infant.
- A statement that the particular treatment or procedure may involve risks that are currently unforeseeable to an embryo or fetus, if the participant is or may become pregnant.
- Where inclusion of language concerning the pregnancy of a partner is applicable, a statement that the particular treatment or procedure may involve risks that are currently unforeseeable to an embryo or fetus.
- If a participant may be on a placebo arm, a statement of how long he/she may be off any treatment for his/her condition.
- If applicable, a statement regarding the risk of allergic reaction to any drugs that are used in the study, and a list of the symptoms of allergic reaction, including the risk of death.
- Where applicable, warnings regarding keeping study articles out of reach of children (alternatively, it may be appropriate to list this content in the Procedures section).
Cross check the "Procedures" section with the "Risk" section to ensure that all potential risks are listed in the ICF.
8. Potential Benefits
The purpose of this section is to inform the participant of the benefits, if any, of participating in the research study. Potential benefits may include: a possible direct benefit from being given a study drug or intervention, collateral benefits (such as the ability to get extra testing or treatment at no cost), or benefits to scientific knowledge or future patients. When writing this section:
- Do not use the word "free" to describe any study procedure, as this word can be considered coercive.
- Do not discuss participant compensation, if applicable.
- Indicate if participants will receive study results/lab results, and when.
- Any direct benefits should always be qualified as "possible" or "potential."
- When there is no intended clinical benefit to the participant, this should be disclosed.
9. Alternative Treatments
To make an informed decision, a participant should be made aware of any alternative treatments that are available to him/her if he/she should choose not to participate in the research study.
In this section, please provide:
- A listing of any alternative procedures or courses of treatment that may be advantageous/available to the participant, including the important potential benefits and risks of the alternative(s).
- A statement that one of the alternatives is to not participate in the study.
If there are no alternative treatments, this should be stated. If a study drug/device is FDA-approved, a participant should be informed that this drug/device is available to him/her and that he/she does not have to participate in the study to have access to it.
10. New Information
In this section, provide a clear statement explaining that the study investigator/staff will inform the participant (or their LAR) of any new findings that develop during the research that may relate to the participant’s willingness to continue participation in the study.
Describe any payments or forms of compensation that participants will receive for participation. Explain all of the conditions that must be fulfilled by a participant to receive payment (e.g., completing a certain number of visits, coming to visits on time, etc.), including prorated payments. List when and how payments will be distributed to participants.
12. Costs to the Participant
In this section, explain any additional costs/expenses to the participant that may result from their involvement in the study, including who or what entity will cover the costs of procedures and necessary follow-ups associated with the study (e.g., sponsor(s), research grant(s), participant insurance, out-of-pocket, etc.). Clearly list what is not covered by the study, and what is covered by the study.
13. Voluntary Participation / Withdrawal
An essential ICF element is that a participant must be informed that he/she is freely volunteering to participate in the study. In this section, provide the following information:
- A statement explaining that a participant's decision to participate in the study is entirely voluntary and that he/she may withdraw from the study or decide to receive an alternative treatment at any time.
- A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled (including ongoing medical care).
- A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled (including ongoing medical care).
- A statement explaining the consequences of a participant's decision to withdraw from the study and the procedures for orderly termination of participation by the participant (e.g. at closure of active treatment, study closure or if they withdraw from participation).
- A statement explaining that a study investigator/sponsor may withdraw a participant from the study for any reason including if it is deemed to be in the best interest of their health or if the study is discontinued or put on hold. Explain instances wherein this might occur, and that termination may occur without regard to the participant’s consent.
14. Study Complications and Compensation
Because study-related injuries are possible, explain in this section what will happen to the participant if such an event occurs. Include the following information:
- A statement explaining the types of medical care that will be made available to the participant in case of an injury that occurs as a direct result of the study. Include how the participant will obtain this care and who will pay for it.
- A statement explaining that the participant will agree to cooperate in obtaining any proceeds from insurance or third party coverage that may be available, if applicable.
- A statement explaining what forms of compensation will be offered, if applicable.
- A statement explaining that the participant is not giving up any legal rights or releasing anyone from liability for negligence.
15. Confidentiality and Authorization to Collect, Use and Disclose Participant Medical Information (HIPAA)
In addition to federal regulations for protection of human subjects and ICH GCP guidelines regarding confidentiality, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires that study participants legally authorize the use of their protected health information (PHI). For this section, include:
- A statement that records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available.
- A statement explaining that the participant has the right to decide who can use his/her personal health information and that, by signing the form, he/she is agreeing to allow the use of this information.
- A list of all types of information that will be collected (e.g., name, address, medications, physical exam information, etc.).
- A list of all parties who will have access to the participant's records and information, such as the sponsor, study staff, institutional review board, and other third parties (e.g., the FDA, scientific communities, agencies in other countries, etc.).
- A statement that the monitor(s), auditor(s), IRB and regulatory authority(ies) (specifically the Food and Drug Administration and/or Department of Health and Human Services, if applicable) will be granted direct access to the participant’s original medical records for verification of clinical trial procedures and/or data, without violating the participant’s confidentiality to the extent permitted by applicable laws and/or regulations, and that, by signing the consent form, the participant (or legally authorized representative) is authorizing such access.
- A statement that the study sponsor (or sponsor representatives) and other doctors, health care professionals or research staff who are involved in the study will be granted direct access to the participant’s original medical records for verification of clinical trial procedures and/or data, without violating the participant’s confidentiality to the extent permitted by applicable laws and/or regulations, and that, by signing the consent form, the participant (or legally authorized representative) is authorizing such access.
- A clear statement explaining that a participant's medical information may, after being released, be "re-disclosed," and no longer fall under federal privacy laws, and hence, confidentiality cannot be guaranteed.
- A statement explaining that a participant's health information may be used in written publications, or presented in meetings, however the participant will not be identified by name.
- A statement explaining the date/event when the authorization to use and disclose the participant's PHI expires (e.g., when the study ends, after all data is collected, XX years after the end of the study, etc.).
- A statement explaining that the participant has the right to see and review his/her records (and when that can occur, usually after the study is ended).
- A clear statement that the participant may withdraw his/her authorization to use his/her PHI at any time, and that this withdrawal can take place at any time by writing to the study investigator (include address).
- A statement explaining that information that has been collected and sent to the sponsor cannot be taken back.
- A statement informing the participant that if he/she does not give permission, he/she cannot participate in the study.
- A statement informing the participant that his/her medical care or relationship to his/her health care provider will not be affected by a decision not to participate in the study.
The following statement must be included in the informed consent document for applicable clinical trials:
"A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."
FDA has provided guidance on what is considered an “applicable clinical trial.”
In this section (included just before the statement of consent/signature page) include an explanation of whom to contact for answers to pertinent questions (include name, address and phone number):
- Questions, concerns or complaints about the study to be made to the research staff.
- Questions, concerns or complaints about the study to be made to someone unaffiliated with the study (Sterling IRB contact information below).
- Reports of study-related injury (the Principal Investigator).
- Questions about participant’s rights; questions, concerns or complaints about the research; requests for information; or offers of input (Sterling IRB contact information below).
Sterling IRB Mailing Address:
Sterling Institutional Review Board Regulatory Department
6300 Powers Ferry Road, Suite 600-351
Atlanta, Georgia 30339
Sterling IRB Phone: 1-888-636-1062 (toll free)
17. Statement of Consent/Signature Page
In this final section, provide a short statement, written in the first person (e.g., "I, (participant name), have read the information contained in this document...") that includes the following information:
- The participant has read the Informed Consent Form
- All questions have been answered to the participant's satisfaction
- The participant freely volunteers to participate in the study
- The participant has been informed that they are not waiving any legal rights by participating in the study
- The participant authorizes the use and disclosure of his/her medical records.
Provide a place for the participant (or the legally authorized representative), participant’s parent(s)/legal guardian(s) (where applicable), the person obtaining consent, and any third parties (such as witnesses) to sign and date after the consent statement. Dated signatures should reflect that consent was obtained prior to participation in any study-related procedures.
If applicable, also include a section to document the participant’s consent to notify their physician that they are in the study.
Finally, note that Sterling IRB also requires that ICFs adhere to local and state laws and regulations concerning informed consent, and requires that this information be detailed in the application submitted for IRB review.
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