- Do not use phrases that attempt to define what a participant understands, as an ICD can only seek to inform a participant (not verify their understanding). Stick 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 ICD 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 ICD, if a technical term must be listed, it should be in parentheses after the lay definition. In other words, the lay definition should come first if a technical term is listed as well.
Incorrect: "The study drug may also cause pruritis (itching)."
Correct: "The study drug may also cause itching (pruritis)."
- Include a space on each page for participants to initial after reviewing each page of the ICD. This space is usually at the bottom right-hand corner.
- Words to Avoid
understand (use "I have been told")
patient (use "participant")
treatment (use "procedure" or "study drug/device")
- 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 ICD 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 contact information (i.e., address and telephone number) of the Sponsor and/or Monitor
- The name and title of the investigator(s) conducting the study (if applicable)
- The contact information (i.e., address and telephone number) of the site(s) where research may take place with a participant (if applicable)
- Version date of the ICD.
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 ICD 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 ICD 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 ICD.
- A statement explaining that the participant, after reading the ICD in its entirety, will be asked to sign the form if he/she would like to participate, and that a copy of the signed form will be provided to the participant for his/her records.
If a parent or legally acceptable representative is signing the Permission/Informed Consent Document 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 acceptable representative who is signing the form to give consent for the participant.
3. BACKGROUND / NATURE OF THE STUDY
In this section, you should 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, you should provide a general, non-technical statement outlining the exact purpose/objective of the research study. It is important that you follow the guidelines below in your 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.). In the case of a blind or double-blind study, include a statement explaining what information will be available in an emergency situation.
- 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.
5. DURATION OF THE STUDY
- State approximately how long the participant is expected to be involved in the study.
- 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.
6. PROCEDURES
In this section, you will 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 investigational and standard of care). Study procedures include, but are not limited to: blood draws, questionnaires, electrocardiograms, etc.
- 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
- Specifiy the approximate duration of study procedures, if applicable
- Include the dose of the study drug(s), if applicable
- Distinguish between procedures that are investigational and 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.).
- The probability of a participant being assigned to a treatment arm or a placebo arm should be provided, if applicable.
- List and describe all of the responsibilities of the participant. Participant responsibilities may include activities such as:
1. Arriving at each study visit on time.
2. Completing a study diary and bringing it to each study visit.
3. Taking study drug as prescribed
4. Reporting side effects/adverse events
5. Not giving the study drug to any other person
6. Returning all unused study medication.
7. Fasting for a period of 8 hours before each study visit.
7. POTENTIAL SIDE EFFECTS, RISKS, AND DISCOMFORTS
In this section you will describe in simple, lay-person 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)
- 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
- A section concerning risks to unborn children, and pregnant women, even if risks are unknown.
- 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 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.
Be sure to cross check the "Study Procedures" section with the risk section to ensure that all potential risks are listed in the ICD.
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 costs), 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."
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 medications and/or treatments that are available
- 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, you should provide a clear statement explaining that the study investigator/staff will inform the participant of any new finding about the drug/device if there is a possibility that the new information may affect a participant's willingness to continue in the study.
11. COMPENSATION
Describe any payments or forms of compensation that participants will receive for participation. Be sure to 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.). List when and how payments will be given to participants.
12. COSTS TO THE PARTICIPANT
In this section, explain who or what will be covering the costs of all 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 ICD 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 explaining the consequences of a participant's decision to withdraw from the study and what procedures will be in place to make his/her withdrawal as easy and safe as possible.
- A statement explaining that a participant's ongoing medical care will not be affected by a decision to participate, a decision to withdraw from the study after participating, or a decision not to participate at all.
- 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.
14. STUDY COMPLICATIONS AND COMPENSATION
Because study-related injuries sometimes occur on a study, in this section you should explain what will happen to the participant if such an event occurs. You should 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 (and who will pay for said medical care)
- 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 YOUR MEDICAL INFORMATION (HIPAA)
Under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), study participants must legally authorize the use of their protected health information (PHI). For this section, be sure to include:
- A statement explaining that personal information about the participant's health will be collected (and to what extent this information will be kept confidential)
- 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, social security number, 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 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.
16. QUESTIONS
In this section (included just before the statement of consent/signature page) list the contact information should a participant have questions about the study or need to report a research-related injury. A 24-hour number should be given to report research-related injuries.
In addition, explain that if a participant has questions about his/her rights as a research participant, he/she may contact:
Mailing Address:
Rev. Paul E. Gamber, J.D.
Chairman of Sterling Institutional Review Board
6300 Powers Ferry Road, Suite 600-351
Atlanta, Georgia 30339
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 Document
- 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 acceptable representative), the person obtaining consent, and any third parties (such as witnesses) to sign and date after the consent statement.
If applicable, also provide a place for consent to notify the participant's physician that they are in the study.
|
