IRB - Guidelines for Preparing Research Consent Forms
Please note: The Health System has announced that the Children's Hospital will now be known as the Steven and Alexandra Cohen Children's Medical Center of New York (CCMC). Click here for important information regarding the one page addendum to be used in conjunction with research consent forms at the Cohen Children's Medical Center.
Required and Suggested Language
Informed consent is a process that involves a comprehensive discussion between the investigator and subject in order to ensure the subject's understanding of a proposed research study. This process is documented and reinforced by a written consent form.
Informed consent is not valid unless the subject or the subject's legally authorized representative comprehends the information in the consent document. Consent forms should be written in simple language that is understandable to a lay person (as close to an eighth-grade reading level as possible). They should also be written in an easy to follow format. The patient/subject should be identified as "I/my" or "you/your" consistently throughout the consent form. If the consent form is written for a third party who is consenting on behalf of an individual (parent, legally authorized representative, etc.) then a sentence explaining that "you" or "I" refers to the patient should be included in the introduction. (It is best not to use "you/your child" throughout). Bold-faced or underlined paragraph headings should be used for clarity.
Investigators must use consent forms approved by the Institutional Review Board (IRB) when involving human subjects in research.
Re: HIPAA
The Health Insurance Portability and Accountability Act (HIPAA) contains additional privacy regulations governing the use and disclosure of an individual's protected health information (PHI). Individuals must give authorization for use and/or disclosure of PHI. This authorization should be combined with the research consent form. The suggested wording for the sections entitled "confidentiality" and "voluntary participation" incorporates the requirements under HIPAA.
The following is an outline of the required elements of a research consent form. All elements with a red arrow must be incorporated into the consent form. Sample language and guidance for preparing each section is provided. Unless otherwise indicated, suggested language should be tailored for individual protocols.
These guidelines are consistent with the requirements set forth in both 45 CFR Part 46 (DHHS regulations), 21 CFR Parts 50 and 56 (FDA regulations) and 45 CFR Part 164 (HIPAA regulations).These regulations are available at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm and
http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00.html and http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr60_00.html and http://www.hhs.gov/ocr/privacy/index.html
Required Elements of a Research Consent Form
- First Page Header
- Footer Format (Revised 3/1/07)
- Introduction
- Purpose of Study
- Expected Duration of Subject's Participation
- Description of Procedures
- Possible Benefits
- Possible Risks/Discomforts
- Alternatives to Participation
- Costs/Compensation
- Compensation for Research-Related Injury
- Withdrawal from Study
- Privacy/Confidentiality
- Contacts for Questions/Access to Consent Form
- Summation/Signature
- Physician's Statement
Additional Guidelines: Special Issues
Research with Children
Name Change from SCH to CCMC Addendum to Consent for Research
Sample Child Assent Form
Research with Decisionally Impaired
Sample Adult Assent Form
Sample Research Review Questionnaire
Addendum to Consent by Research Proxy for Continuing Participation in a Research Study
North Shore-Long Island Jewish Health System
Campus: __________________
Consent for Participation in a Research Study
Title:___________________________________
Principal Investigator:______________________
Co-investigators (Optional):_________________
Sponsor: ____________________
Footer Format (Revised 3/1/07)
Each page of the consent form must be numbered at the bottom of the page. The version date of the consent form must be put on every page of the consent form. Example:
| Current Version Date: 6/20/02 | Page 5 of 5 |
An opening paragraph is appropriate to introduce the research study.
(Suggested language)
You are being asked to join a research study. The following information will explain the purpose of the study, what you will be asked to do, and the potential risks and benefits. It will also explain that you do not have to be in this study to receive medical care. You should ask questions before deciding whether you wish to participate, or at any time during the course of the study. You will be told of any new findings that may change your decision to continue to participate.
Additional text for introduction when the subject is a minor or decisionally impaired adult:
(Suggested language)
This consent form is written from the point of view of a research subject. If consent will be obtained from (the parent or legal guardian of a minor or a legally authorized representative), the words "you" and "your" should be read as ("your child" or "the research subject").
Additional text when subject is temporarily decisionally impaired:
(Suggested language)
As the subject's legally authorized representative or next of kin, you are being asked to give consent for the subject to be in a research study. You are being asked to do this because the subject is not able to give consent. When making this decision you should take into account the wishes of the subject. If you agree to allow the subject to take part in this research, the subject will also be asked to give consent, but only if he/she regains the ability to make healthcare decisions.
Additional Text for Cooperative Group Studies
For cooperative group studies (i.e., CALGB, GOG, RTOG, COG, SWOG, ACTG, NSABP, etc.) the following paragraph is appropriate:
(Suggested language)
This study is sponsored by ____, a group doing clinical research in the field of ____.____ is a cooperative treatment group working with a network of national medical centers, hospitals and private physicians funded by______. Their research is aimed at improving treatment for _____and finding new ways to detect and prevent ____.
Back to Table of Contents
Purpose of Study
The objectives and goals of the protocol should be concisely and clearly stated in lay terms. It should be clear that the study involves research, and that there is not only an immediate purpose, but ultimately, a larger purpose for conducting the research. It is important to inform the potential participant why they are being asked to participate (because they have a particular condition, or they are a healthy volunteer to be used as a control, etc.) Remember that the purpose of the study is not to improve the health of the specific patient. The purpose should be stated in general terms. If your protocol involves genetic research, refer to the section entitled Genetic Testing and Tissue Banking for additional guidance.
(Suggested language)The purpose of this study is to _______. You are being asked to participate because _____.
Back to Table of Contents
Expected Duration of Subject's Participation
Include how long participation will last and approximately how long visits will last. The subject should be informed of the number of visits required by the study, as well as the total number of subjects expected to enroll. If there are a large number of visits required for the study, a table or outline with study visit details may be helpful. Many research protocols involve active study procedures as well as follow-up. Express the time period in terms of both so the patient knows how much time he/she must commit to the study.
(Suggested language)
If you choose to participate in this study, the study procedures will last for______ (days, weeks, months, years), and you will be followed for another ________ (days, weeks, months, years). You will be asked to attend ___ visits that will last ___ hours each for a period of ____ (days, weeks, months, years).
For studies involving a one-time procedure, data collection, etc., indicate approximately how long the session/visit will take.
This section should include a detailed explanation of the study and should encompass all procedures involved. The consent form should never state that some procedure will be described in greater detail at another time. However, for some studies where standard procedures are involved, it may be appropriate to say that a separate surgical (or other) consent will be signed.
A clear distinction must be made between standard practice and research.
The purpose of standard practice is to provide diagnosis, preventative treatment, or therapy, interventions solely to enhance the well-being of the patient/subject. These interventions are undertaken because there is a reasonable expectation of a successful outcome. Research constitutes activities designed to contribute to generalizable knowledge. Typically, in research, a set of activities is consistently applied to groups of individuals in order to test a hypothesis and draw conclusions. The activities are not necessarily therapeutic in nature. The consent form should describe which procedures are research-related and which are considered standard practice for the subject's present condition. Avoid technical language whenever possible. A scientific explanation of procedures to be used is not appropriate if they do not directly affect the subject's participation (such as the science used in certain laboratory tests or procedures).
The following are all important to note:
- Explanation of study design including randomization, crossover, double blinding, placebo use, washout periods, open label, etc.
- Information to describe any drugs and devices
- Screening or examinations
- Blood drawings (including the volume to be drawn described in lay terms, e.g. tablespoons) NOTE: 5cc = 1 teaspoon
- Ancillary tests, including explanations(e.g. Electrocardiogram, MRI, CAT scan, urinalysis, etc.)
- Pregnancy testing/Birth control requirements
- Physical exams
- Medical history
- Questionnaires, diaries of activities, rating scales, etc.
- Dietary restrictions
- Medication restrictions (including herbal/supplement restrictions)
- Follow-up visits, phone calls, etc.
- Genetic sub-studies (including separate consent, if appropriate). See Genetic Testing and Tissue Banking
- Description of HIV testing, if appropriate, including a reference to the required New York State Dept. of Health consent form for HIV testing
The following sections provide additional guidance on some of the above elements.
Randomized, Cross-Over, Double-Blinding, Open Label, and Placebo Controlled Studies
These terms need to be noted and defined, if relevant:
(Suggested language)
Randomization is a procedure used to assign research subjects, by chance, to a study group in a clinical trial. It is used to make sure study results are not influenced by the selection of subjects in one group as compared to another. In this study, you have a ____ chance of being assigned to one group or another.
Crossover is a method used to switch subjects from one study group to another.
Double Blinding is a process used to prevent the researcher and the subject from knowing which study group a subject is in. It is used to make sure the study data will not be biased.
Open-Label Study - A study in which all parties, (patient, physician and study coordinator) are informed of the drug and dose being administered. In an open-label study, none of the participants are given placebos. These are usually conducted with Phase I & II studies.
Placebo is a product with no active drug in it, often called a "sugar pill" or "dummy pill." It is compared to a drug in a clinical trial to see if the drug has a real effect. A placebo is often used in clinical trials in order to "blind" the study so that the doctor and the subject are not biased by knowing the subject's study group. The study can be "un-blinded" in case of an emergency.
The following wording is appropriate for studies involving placebo and randomization:
(Suggested language)
During this study there is a __ in __ chance that you will receive placebo, an inactive substance. This could lengthen the amount of time before you receive a treatment that may be effective. During this time you may experience worsening of your condition, including increased symptoms such as ___. Your doctor will carefully monitor your condition. If your symptoms worsen and make you uncomfortable, you can withdraw from the study. You can do this at any time during the study.
The following wording is appropriate for studies involving a washout period:
(Suggested language)
During this study the medication you normally use for your condition will/may be stopped for up to ____(days/weeks/months). You will/may receive no medication, or medication at a dose which may not help your condition. As a result, you will/may have an increase in symptoms including _______ (i.e. for schizophrenia: agitation, hallucinations; for hypertension: high blood pressure, nausea, lightheadedness, etc.)
The "will/may" depends on the study design being employed.
For studies involving drugs or devices the following information must be included as appropriate:
(Suggested language)
- The route of administration: intravenous, oral, etc. (define intravenous - through a needle placed in a vein).
- The drug/device is considered investigational (define investigational - not yet approved for general use) by the Food and Drug Administration (FDA).
- If the drug/device is FDA approved but being used off-label - The drug/device's use in this study is investigational because it is not approved by the FDA for_____. However, it is approved for use in _____.
- If placement of an investigational device involves a surgical procedure and/or anesthesia it should be described.
| NOTE: Drug names should be spelled out in full and include both the generic and trade name consistently, when appropriate. Dosage should NOT be abbreviated. It must be written out (i.e., milligrams, not mg). |
Additional Procedures, Contraindicated Medications and/or Foods
- If participation entails any additional procedures [spinal tap, endoscopy, EKG, X-ray, blood draws (include the amount of blood in lay terms, e.g. 5cc= 1 tsp.), biopsy, etc.] details regarding how these are done should be included. If the subject needs to be accompanied home from visits, or will require home assistance with injections, etc., include that information.
- Any other requirements should be detailed including, but not limited to: video taping, keeping a diary, wearing a holter-monitor, responding to questionnaires, follow-up visits, etc.
- For routine procedures, e.g., part of standard care for the patient, only the briefest description should be given. Where applicable, indicate that the subject will sign a separate consent form (cardiac catheterization, lumbar punctures, surgery, etc.) when standard care is involved. You should include a sentence explaining that the procedures as described are considered routine care for any patient with the condition and are not being done solely for research purposes.
- If certain foods or medications must be avoided, explain which ones and why. This includes alternative remedies, such as over-the-counter herbal supplements, vitamins, etc.(e.g., St. John's Wort, Echinacea, Saw Palmetto, etc.).
- Any phone calls to the subjects, including who will call, why, and when should be detailed.
- If surveys or questionnaires will be utilized, subjects should be informed and told that they may review the survey tools prior to agreeing to participate (if appropriate).
Birth Control
The consent form should indicate whether there is a need for using birth control in the study. This may apply to males as well as females. Depending on the age of minors to be enrolled, this information may also be added to the Assent by a Minor form. The following section may be used as is or amended as appropriate:
(Suggested language)
The risk of the study agent to an unborn baby is not known at this time. As a result, women should not be in this study if they are pregnant, breast-feeding, or trying to become pregnant.
If you are a woman of childbearing age, you should use birth control for the entire duration of the study and for___ months afterwards. Hormonal methods (birth control pill, etc.), double-barrier methods (condoms with spermicidal, sponge with spermicidal, or diaphragm with spermicidal), or abstinence may be used. Your doctor will discuss these with you.
| NOTE: There are studies where hormonal methods are not appropriate because of the potential interaction with the study drug or decreased effectiveness when used in conjunction with the study drug. In this case, the consent form should clearly state that hormonal methods are not considered an acceptable method of birth control while on the study. Likewise, if one or more of the methods listed above are not appropriate for a particular protocol, the section above should be amended appropriately. |
The issue of birth control sometimes applies to males who are taking study drug and who may impregnate a partner. In this case, the following wording is suitable:
(Suggested language)
If you are a male with a partner who could become pregnant, you should use condoms and make sure your partner is also using effective birth control methods.
For studies involving drugs with known teratogenic effects, the following wording is also sometimes employed:
(Suggested language)Even if you have had your tubes tied, you must agree to use birth control approved by your doctor during this study.
If pregnancy testing is to be done as part of the protocol the consent form should detail the type (blood or urine test) and the frequency, and that a female subject may be withdrawn from the study if it is found that she is pregnant. It should be clearly stated that the subject should notify the principal investigator immediately if she thinks she may be pregnant.
If the protocol will enroll minors, the Assent Form must include information to inform the minor that pregnancy testing will be done and should indicate whether results of that test will be shared with parents.
| As per NYS law: The results of pregnancy testing may not be shared with parents without the express consent of the minor. Any person, male or female, who is the parent of a child or has married, may give effective consent for medical, dental, health and hospital services for himself, herself, or the child. No other person needs to give consent. Any person who is pregnant may give effective consent for medical, dental, health and hospital services relating to prenatal care. |
For studies involving patients with HIV or other sexually transmitted diseases, it is important to include a reminder to practice "safe sex" in addition to other birth control methods utilized. A separate New York State, Department of Health consent form must be signed if the protocol involves HIV testing. This must be described in the research consent.
Incomplete Disclosure/Deception
In some research studies, it may be necessary to withhold information from the subject including the true purpose of this study. If deception will be used, it must be specifically justified in the protocol and IRB forms. In addition, the IRB must be provided with a debriefing plan. As informed consent is not a one-time event, the debriefing plan is considered part of the informed consent process and should be detailed in the protocol section on obtaining informed consent as well as in the section on informed consent on IRB form 4. The plan should contain a script for debriefing as well as a debriefing consent outlining the true purpose of the study, why deception was used, and phone numbers to contact for follow-up as well as the Office of the IRB.
List and explain the potential benefits the research subject, or society in general, might derive from their participation. Keep in mind that not all benefits are physical or immediate.
If no personal benefit is to be derived, but the subject's participation might result in increased medical knowledge, the following statement is appropriate:
(Suggested language)
This research will not benefit you directly. However, knowledge gained may help patients in the future. [Detail any potential direct benefit, but do not promise results that the study is trying to assess.]
For randomized studies only
(Suggested language)
Your group might receive more effective treatment and/or have fewer side effects than the other treatment group(s).
Back to Table of Contents
Possible Risks/Discomforts (Revised 8/18/08)
Include all risks/discomforts that are reasonably foreseeable, listing the most significant risks first. Only include risks that are related to the study - not standard care. Keep in mind that not all risks are physical or immediate. Likewise, not all risks are to the individual. Some risks may be delayed or may impact a class of people or specific group. Each item mentioned in the procedure section should be addressed, e.g., anesthesia, blood draws, medication side effects, surgical risks, etc., even for something that seems innocuous (such as the use of a topical anesthetic, or the potential contraindication of herbal therapies or alternative therapies). If there is risk of symptoms worsening, especially while on a washout or placebo, this needs to be detailed. Risks to pregnant/nursing women or a fetus must also be addressed (see Procedures section for additional information on birth control).
(Suggested language)
Your blood will be drawn ___ times to collect about ___ (teaspoons, tablespoons, etc.) of blood for this study. Some risks of blood drawing are pain from the needle going through your skin into the vein, bruising, clots under the skin, light headedness, possible fainting, and rarely, infection.
Click on Arterial Blood Gas Sample for suggested language for that procedure (edited from WebMD).
(Suggested language)
Your group may receive less effective treatment or have more side effects than the other treatment group.
Magnetic Resonance Imaging (MRI)Studies
Some or all of the following paragraphs may be appropriate for your study:
(Suggested language)
If you have any metal in your body such as a pacemaker or surgical pins or clips, or if you work with material or tools that could leave small pieces of metal in your eyes or skin, you may not be in the MRI/study.
If you feel anxious or scared when in an enclosed space, these feelings could occur while in the MRI. If you become too uncomfortable you should tell the researchers and the procedure will be stopped.
These scans are being performed for research purposes only; the results will not be used to make decisions related to your diagnosis or treatment.
If the scan reveals a condition that could affect your health, you will be referred for appropriate follow-up care.
Collection of Sensitive Information (Suggested language)
Some of the questions that you will be asked are of a personal nature and may cause you embarrassment or stress. You may ask to see the questions before deciding whether or not to participate in this study.
Since there is often the risk of unknown side effects, a statement such as the following is required when appropriate.
(Suggested language)As with any _____ (drug, device, procedure, etc.), there might be side effects that are unknown at this time. You will be monitored for the occurrence of side effects and should report any unusual events to the study staff.
Standard of Care/No Additional Expected Research Risk
Sometimes a study may involve the collection of data from patients who are receiving standard treatment for a particular condition. If there are no additional risks imposed by the research and ALL of the testing done is part of the standard of care, the following statement is appropriate:
Your part in this research study consists solely of allowing the researcher to use data from your medical record. The tests and treatments you will receive are part of the standard of care for your condition. This study does not require you to have any additional procedures or treatments. Therefore, being in this study does not involve any risks that you would not face during your routine treatment.
Drug Availability After Completion of StudyA statement regarding the drug's availability at the end of the study may be valid as well. (NOTE: This could be a risk or a benefit if the patient is doing well).
Alternatives to ParticipationList specifically any medication or treatment options that the subject might choose as an alternative to participation, including other investigational treatments, alternative treatments, and non-pharmaceutical treatments. Both the generic and trade names of any alternative drugs should be given.
The consent form should clearly state that the subject does not have to participate in the study to receive the treatments that are already available. If, for example, the protocol involves a comparison between two drugs that are commercially available, an alternative would be to receive either one without participating in the study. A statement such as "your doctor will discuss alternative treatments with you" is not sufficient. If no other treatments are available to treat the condition under study, the consent form should make that clear.
NOTE: Not all treatments are pharmacological, and sometimes, "no treatment" or palliative care is the other option. (Suggested language)
An alternative section must be included, even if the only alternative is NOT TO PARTICIPATE, in which case the following line is appropriate:You may choose not to participate and continue to receive standard care.
Back to Table of Contents
Costs/CompensationIf subject or his/her insurance carrier will be responsible for the tests, procedures, etc. included in the study or if the drug and/or all study related procedures will be paid by the sponsor of the study, this shall be detailed in this section. It may be appropriate to state that taking part in the study may lead to increased costs to the subject or his insurance company, if applicable. Using the term "at no cost" is preferable to saying "free" as it is considered less coercive.
For studies in which the sponsor is paying for all the costs of doing the study, the subjects should be advised.
(Suggested language)You will not have any added costs from being in this study. All study related visits, procedures and medications will be provided at no cost to you. Costs related to your standard care will be billed as usual to you or your insurance company.
For studies in which the sponsor is only paying for the study medication, the subjects should be advised so that there are no misunderstandings.
(Suggested language)The study medication will be provided to you at no cost. All other costs will be billed to you and your insurance company in the usual way, as part of your standard care.
Detail any payments to research subjects. If the subject will be compensated for their time, travel, etc. by the sponsor of the study this needs to be explained. Remember that if a subject withdraws from a study, they are entitled to a prorated reimbursement for the portion of the study they have completed. Any compensation should be in amounts that are appropriate and which would not be considered coercive. Vulnerable subjects must not be placed into a study in which they would not participate if there were no compensation. (The IRB will make the determination of the appropriateness of the amount of any payments to research subjects).
If the subject will receive compensation/reimbursement from the study, the following is appropriate.
(Suggested language)You will be paid $_____ for your time and travel expenses for being in this study. If you do not complete the entire study, you will be paid for the number of visits that you did complete. Payment will be made at the end of the study or when you end your participation.
For research involving children, it may be appropriate to compensate them directly in the form of toys, stickers, etc., in order to ensure that they are indeed receiving the compensation personally, in a form that they appreciate.
If there is a potential for marketed products resulting from the research, a statement such as the following should be included:
(Suggested language)
If this research produces a marketable product, there are no plans for you to share in any profits.
Back to Table of Contents
Compensation for Research-Related Injury (Revised 8/18/08)
(Only include this section if your study involves greater than minimal risk.)
If the study involves greater than minimal risk, the following language is required verbatim:
| If you are hurt from being in the study, you will receive medical care and treatment as needed from the North Shore-Long Island Jewish Health System. However, you will be responsible for the costs of such medical treatment, directly or through your medical insurance and/or other forms of medical coverage. No money will be given to you. |
Additional Wording for Industry-Sponsored Studies
If a pharmaceutical/device company sponsors the study, in most cases the sponsor will assume the responsibility for the costs of treatment of research-related injury to the extent that the subject's third party payer does not cover the costs. (This would be outlined in the study contract). If so, this must be detailed in the consent form following the above-cited institutional policy statement. (Using the word "however" to introduce the sponsor's policy following the Institutional policy statement can help to clarify this for the subject.) For example:
(Suggested language)
However, although the institution will not be responsible for the costs of treatment caused by the study procedures or study product, the sponsor (xyz company) has agreed to pay for treatment for any research-related injury.
Back to Table of Contents
Withdrawal from Study
The following sample language may be used for this section.
(Suggested language)
Your participation in this project is voluntary. The quality of your medical care will be the same, whether you join, refuse to join, or decide to leave the study.
If you do not join the study you will not be penalized or lose benefits to which you are entitled. If you join the study you may withdraw at any time without prejudice to your future care at the North Shore-Long Island Jewish Health System. Follow-up examinations may be needed to assure your well-being.
It is also possible that your participation in this study may end without your consent. This decision may be made by an investigator, study sponsor or the IRB. Reasons for withdrawal may include: failure to follow instructions, failure to show up for study visits, it is not in your best interests to continue on this study, or the study may be cancelled.
If you withdraw from this study or if you are withdrawn from the study, any data (or samples) already collected will continue to be used. However, no new information will be collected.
It may be appropriate to tell a subject that, for safety reasons, if he withdraws from the study, he will be urged to return for final testing and possible selection of an alternative treatment.
When a study does not entail the creation, use, or disclosure of PHI, the following language is appropriate.
Any study information about you will be kept private and will only be given out with your permission. If the results of this study are published, your name will not be used. Your research records will be private to the extent allowed by law. In order to make sure the research is done properly, the Institutional Review board (IRB - the committee that oversees research at this institution) may need access to information about your participation in this study.
When a study does entail the creation, use, or disclosure of PHI, the following paragraphs provide sample language for your confidentiality section consistent with federal regulations, including HIPAA. You may tailor this language to be consistent with an individual project.
(Suggested language)
If you agree to be in this study, we will collect health information that identifies you. We may collect the results of tests, questionnaires and interviews. We may also collect information from your medical record. We will only collect information that is needed for the research. This information has been described in this consent form. If you sign this consent form, you are giving us permission to collect, use and share your health information. This permission is called authorization.
Study records that identify you will be kept private. You will not be identified in study records or publications disclosed outside the North Shore-Long Island Jewish Health System, except as detailed below. (If applicable)
Investigators will share the results of your study tests and procedures with:
[List all outside agencies that may require access to PHI, such as:
study sponsor and/or its agents,
other researchers,
accrediting agencies,
data safety monitoring board,
clinical staff not involved in the study who may be involved in subject's treatment, health insurers or payers]
In addition, your records may be reviewed in order to meet federal or state research regulations. Reviewers may include [representatives from government agencies,i.e., the Food and Drug Administration, NIH, NIMH, etc.], representatives from [sponsor], the NS-LIJHS Institutional Review Board (IRB - the committee that reviews research at this institution), and [add others as appropriate].
If your research record is reviewed by any of these groups, they may also need to see your entire medical record.
Please be aware that once private information is disclosed, it is subject to re-disclosure by the recipient and can no longer be considered protected.
If your research records are used for decisions related to your clinical care, then you have the right to review this information and request changes. This is limited to information about your treatment, and does not include information related to procedures or tests that are for research purposes only. You may access this information only after the study analysis is complete. You have the right to know who has and who will see your records. To request this information, or for any questions related to your health information, you may contact the Research Privacy Officer at 516-562-2018.
If you change your mind about being in the study, you may withdraw at any time. If you want us to stop collecting your health information, you need to send a letter to the researcher at the following address:
Dr.______________
Address
Your letter needs to say that you have changed your mind and do not want the researcher to collect and share your health information. You may also need to leave the research study if we cannot collect any more health information. We may still use the information we have already collected. We need to know what happens to everyone who starts a research study, not just those people who stay in it.
The information that is collected for research will be analyzed for many years and it is not possible to know how long this analysis and follow-up will take. Therefore, you are allowing access to this information indefinitely.
Data from this study may be used in medical publications or presentations. The information will be de-identified so that individual subjects cannot be recognized and the information will no longer be considered Protected Health Information (PHI).
If this research study is a clinical trial of a drug or medical device, then add: A description of this clinical trial will be available on http://www.Clinical Trials.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 website at any time.
If the researchers learn about potential serious harm to you or someone else or other public health concerns, it will be shared with the appropriate authorities.
| Note: Once the Certificate of Confidentiality is obtained, a copy must be forwarded to the IRB. |
Back to Table of Contents
Contacts for Questions/Access to Consent Form:
The key contact names and telephone numbers must be included in the consent form as well as a statement that a copy of the signed consent form will be provided. Federal regulations require that a contact name and phone number be given for 1) questions regarding the study, 2) questions regarding side effects or a research-related injury and 3) questions regarding the subject's rights as a research subject. The following is an acceptable paragraph.
(Suggested language)
If you have any questions about the study, you may call (the Investigator) at (XXX) XXX-XXXX. If you have questions about side effects or injury caused by research you should call (the Investigator) at (XXX) XXX-XXXX. If you need emergency care, dial 911 or go to the nearest Emergency Room. If you have questions about your rights as a research subject, or concerns about being in the study, you may contact the Office of the Institutional Review Board (the committee that oversees research at this institution) at (516) 562-3101. A signed copy of this consent form will be given to you.
Back to Table of Contents
Summation/Signature
A summation/signature section should follow which allows the subject to form a conclusion before they make a decision about participating. The words "I understand" should not be used. Since study subjects are not in a position to judge whether or not the information is complete, they should not be asked to certify completeness of disclosure (e.g., "This study has been fully explained to me").
(Suggested language)
You have read the above description of the research study. You have been told of the risks and benefits involved and all your questions have been answered to your satisfaction. A member of the research team will answer any future questions you may have. You voluntarily agree to join this study and know that you can withdraw from the study at any time without penalty. By signing this form, you have not given up any of your legal rights.
| Dated signatures that are required are as follows:
______________________ ________________________________ ________________________________ ______________________ |
|
If the subject is a child, or is decisionally impaired, the signature of a legally authorized representative or next-of-kin may be allowed. The IRB may also require that both parents consent for a child's participation in a study. This will depend on the IRB's decision as to whether it is appropriate for the protocol. (Please refer to the IRB Policies and Standard Operating Procedures for the policy on Research Involving Children and Research Involving Incapacitated or Decisionally Impaired Adults).
When additional signatures are required, the consent form must include additional signature lines as appropriate, as well as a description of the signer's authority to act on behalf of the subject.
Dated signatures required when subject is a child or is decisionally impaired are as follows:
___________________________________
Subject's printed name
________________________________________________
Parent's or Legally Authorized Representative's printed name
_________________________________________________________
Parent's or Legally Authorized Representative's signature Date/Time
Description of signer's authority to act on behalf of subject
____________________________________
Witness's Signature Date
(Preferably someone not connected with the research project)
Witness's Printed Name:____________________________
|
NOTE: 2. For research involving children, based upon the risk/benefit ratio, the IRB may request signatures from both parents. |
When permission from both parents is required, the following format may be used:
___________________________________
Subject's printed name
| Parent1 | Parent2 | ||
| _________________________________________ | _________________________________________ | ||
| Print Name | Print Name | ||
| ______________________________ | ___________ | ____________________________ | _____________ |
| Signature | Date | Signature | Date |
Physician's Statement (Suggested language)
In addition to advising the above subject of other forms of treatment and therapy which are appropriate, I have offered an opportunity for further explanation of the risks and discomforts which are, or may be associated with this study and to answer any further questions relating to it.
_____________________________________________
Physician's signature Date
| NOTE: For studies that do not involve any medical intervention, the Physician's Statement and signature can be replaced by "Investigator's Statement" and signature. |
KEEPING CONSENT FORMS: A consent form must be maintained at NS-LIJHS for at least 6 years after the completion of the study. All original consent forms should be kept with the research records. Also, if the research procedures are important to the individual's clinical care, a copy should be placed in the medical record. |
Additional Guidelines: Special Issues
When minors are the subjects of research, regulations require that they 'assent' to participation. This requirement can only be waived under special circumstances. For more information regarding these circumstances please refer to the Code of Federal Regulations 45 Part 46.408.
The requirement for assent should be based upon the maturity, age and physiological state of the subject. As a guide, children above the age of seven (7) to nine (9) years of age are usually considered mature enough to assent. If assent of the minor subject is determined to be required for the study the following format is recommended for documentation of the assent process.
| NOTE: Assent is not just a form, it is a process involving a discussion between the investigator and child. While the assent form example may be used verbatim, investigators should consider whether certain sensitive information, such as requirements for pregnancy or drug testing, should be conveyed in writing. In addition, investigators should list any study requirements the child must perform on their own, such as keeping a diary, monitoring activity levels, etc. |
Research with Decisionally Impaired Adults
Federal and state recommendations include the requirement to obtain assent from individuals who do not have the capacity to provide consent for themselves. This may be due to a condition that renders them permanently incapable of consenting, or a temporary condition that makes it impossible to obtain their informed consent at the time that enrollment must occur.
Determination regarding the competence of decisionally-impaired adults should follow Institutional Policies and Procedures. If a protocol includes the recruitment of subjects whose capacity is questionable, it is recommended that a series of review questions be administered following the informed consent process in order to assess individual understanding. In addition to the suggested questions on the review sheet, it may be appropriate to add a few protocol-specific questions in order to assess a subject's understanding of an unusual or complex aspect of the research.
Sample Research Review Questionnaire
| NOTE: Assent is not just a form, it is a process involving a discussion between the investigator and the decisionally impaired adult. While the assent form example may be used verbatim, investigators should consider whether certain sensitive information, such as requirements for pregnancy or drug testing, should be conveyed in writing. In addition, investigators should list any study requirements the decisionally impaired adult must perform on their own, such as keeping a diary, monitoring activity levels, etc. |
If a subject regains his/her ability to make healthcare decisions, he/she should be given the opportunity to provide consent. That consent should be documented using the Addendum to Consent by Research Proxy for Continuing Participation in a Research Study.
Genetic Testing and Tissue Banking
In genetic research and research using stored tissue samples there are potential health, societal,emotional and legal issues to consider. Many subjects may be naive to these issues and it is therefore necessary to include a complete description of the procedures and the associated risks in the consent form. Many times the genetic testing or tissue banking portion of a study is a small part, or a sub-study, of a much larger study. It is important that the issues related to genetic testing and tissue banking do not get lost in the body of a consent form which describes the main portion of the study. Therefore, it is advisable to separate the genetic testing portion into either a separate consent form (including all required elements) or an addendum to the consent form.
As this new science develops and laws evolve, it is important to continuously rethink and refine the issues and the way that they are presented to subjects. The following definitions may be helpful in determining what falls under this category and how to describe certain terms in the consent form. The protocol must justify the storage of samples for future research.
Definitions
Genetic tests:The analysis of human DNA, RNA, chromosomes, proteins or other gene products to detect disease-related genotypes, mutations, phenotypes, or karyotypes for clinical purposes.
Types of Studies:
Prospective: Studies in that the collection of the new samples is part of the study design.
Retrospective: Studies that utilize previously obtained samples collected for a purpose that is different from that of the current study samples 'on the shelf'.
Types of Samples:
Anonymous: Biological materials that were originally collected without identifiers and are impossible to link to their sources.
Anonymized: Biological materials that were initially identified but have been irreversibly stripped of all identifiers and are impossible to link to their sources. (This process does not preclude linkage with clinical, pathological and demographic information before the subject identifiers are removed. Caution must be exercised so that the amount and type of linked information does not invalidate anonymity.)
Coded or linked: Biologic materials that are de-identified for research purposes, but can be linked to their sources through the use of a code. Decoding can only be done by the investigator, another member of the research team or a 'gatekeeper' (i.e., someone in charge of at tissue bank).
Identified: Biological material to which identifiers, such as name, patient number, or clear pedigree location, are attached and available to the researchers.
Research Using Prospectively Collected Samples
In prospective research, the investigators have the responsibility to communicate with the potential subject and obtain informed consent. Additionally, the investigator has the obligation to maintain confidentiality to the extent permitted by law. (This is necessary unless the samples are collected anonymously or anonymized.)
The consent forms for such research should clearly indicate what information could result from the research, what the implications and limitations are, that unexpected findings may result, and what follow-up information they will receive (if any, as many studies are preliminary and results may not be meaningful or validated).If results are to be given to the subjects, they should be offered counseling, since results from such research could lead to adverse psychological outcomes, social stigmatization and discrimination. In certain cases they should be given the option to determine whether they want the results of their testing. The disposition of their samples should be included in the consent process and form (including how long the samples will be kept); if samples are to be stored for future studies, subjects need to be informed.
| NOTE: In no case should results from agenetic test be given to subjects without proper validation of the test and certification of the laboratory performing the test. Laboratories performing such genetic testing must be certified under the New York State Department of Health in compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). |
Retrospective Studies of Existing Samples
When retrospective research is done using anonymous or anonymized samples, there is no need to obtain consent from the subjects. For research using samples that are identifiable, consent must be obtained. In certain cases the investigator may seek a waiver as detailed in 45CFR46.116. The IRB will make the final determination as to whether the waiver is allowable.
Sample Consent Language for Genetic Research and Tissue Banking
The investigator should select or modify appropriate portions of the following suggested language based on the nature of the research, stage of testing, use of family members, etc.
Purpose
(Suggested language)
You (and possibly members of your family) have been selected to be in this genetic research study because you and/or your child, parent, sibling or spouse have or are suspected of having a gene for a trait/disorder. We are requesting that you allow us to obtain a sample of your blood (or ______ ) to further our understanding of the trait/disorder. The purpose of obtaining the sample is to learn about the gene that causes the trait/disorder. These efforts may lead to abetter understanding of why the condition develops (and eventually lead to improved treatment or management). The research may also eventually produce a test that can predict who is likely to be affected by the trait/disorder and to what degree.
Risks and Discomforts:
If results are to be given to the subject:
(Suggested language)
Your life could be affected by genetic testing. Some people may feel anxious, depressed or stressed by learning genetic information about themselves or their children. You may have similar feelings.
Relationships with other family members may be affected since people react to and cope with this type of sensitive information indifferent ways. Some people in your family may choose not to know any genetic information about themselves. You may make the same choice for yourself. You may feel pressured by other family members to be in the study or to receive information when you prefer not to.
General issues to include if appropriate: (Suggested language)
We will not give any information to you or family members or to any third party without your written permission. This includes your insurance companies and employer. Information you do not know about may be discovered by this research. Facts about adoption and fatherhood may be discovered. If we discover such information, we will not share it with you even if you ask unless it has direct medical or reproductive meaning for you and your family. We will not reveal this to any third party, including family members.
Confidentiality
This section must be descriptive in terms of who has access to the subject's information.
(Suggested language)
Any information collected about you or your family is strictly confidential and private. Research records with this information will be kept in locked and secured quarters in___________ (describe where). You control release of any information in these files. Access by others, including family members, is only allowed with your written approval. Results of any research tests that are not proven will not be available to you.
Collection, research and storage of genetic material: (Suggested language)
Your sample will only be used for research about ___________ . The samples collected will be stored in locked freezers. The samples will be inventoried and stored by codes defined by the researchers involved in this project. Samples will be stored for the period of this study/ or _________ . Other researchers may be interested in using your samples to pursue their own individual research projects. Since you have control over the use of your samples, we ask your guidance in considering their use in other studies. You do not have to consent to the future use of your samples in order to participate in this study.
NY State law allows for storage for up to 10 years unless a specific time frame is noted. The specific time frame can be stated as 'indefinitely'. |
Potential Benefits of Genetic Testing (Suggested language)
There may be no benefit to you from being in this study. The study may help us learn where a certain gene within DNA is located. Identifying changes in this gene could help us learn more about it and may give us information about disease linked to it. This might lead to better treatment and management of the disease. There may also be other benefits that we don't yet know about.
Inclusion of Family Members
There may be instances where family members of a research subject may also be asked to participate in the research. This may involve full participation by the family member, or the collection of information about the family member's medical history for informational purposes related to establishing a family history for a research subject. It is very important to consider confidentiality issues when recruiting family members for genetic studies. Confidentiality issues will differ depending on the type of research being conducted. (In one scenario the researcher may only be interested in those family members with a particular condition, in which case the family member might be distressed if they realize that an outsider has obtained information regarding their condition). The family member must express a willingness to participate in or learn more about the study before any contact is made. Ideally, the family member should contact the researchers to indicate their willingness to participate. Other methodologies may be employed, as appropriate, such as the use of a postcard that the family members can mail in if they are interested, or a toll-free number for them to call to enroll. In any case, each individual family member must provide consent prior to enrollment or collection of specific medical information, unless otherwise waived by the IRB after a formal request for such a waiver has been approved (See Policy 4 -
ASSENT BY MINOR SUBJECT TO PARTICIPATE IN RESEARCH
I have been asked to join this research study. I have the right to find out what will or might happen to me if I am in the study. I have the right to tell my parent(s)/guardian and the doctor whether I do or do not want to be in this study.
My parent(s)/guardian will also be asked to give permission for me to be in this study.
(Investigator's name)and my parent(s)/guardian have explained what I will have to do in the study.
(Investigator's name)and my parent(s)/guardian have also explained any discomforts, risks and inconveniences I may experience if I am in the study.
[Include any of the following italicized statements as applicable.]
I agree that I need to avoid using any alcohol, including beer and wine, while in this study, as it could make me sick and cause serious side effects.
I agree to use effective birth control if I am a male or female.
If I am female, I have been told that I will be asked to discuss sexual activity and birth control in private and my parents will only be involved in the discussion if I want them to be there.
If I am a female, I have been told that I will have pregnancy testing if I am able to have a child and the results will be kept private and not shared with my parents without my permission. I have been told that I need to remain pregnancy free throughout the study.
I have asked any questions I had, and all my questions have been answered.
______ I agree to be in this study.
______ I do not want to be in this study.
________________________________________
Subject's name Subject's age
_____________________________________ ________
Subject's signature Date
_____________________________________
Witness' signature Date
____________________________
Relationship of Witness to Subject
All procedures, risks and discomforts have been explained to the subject.
__________________________________
Investigator's Signature Date
ASSENT BY ADULT SUBJECT WITH A LEGALLY AUTHORIZED REPRESENTATIVE
I have been asked to join this research study. I have the right to find out what will or might happen to me if I am in the study. I have the right to tell the doctor and the person legally allowed to make decisions for me that I do or do not want to participate.
The person legally allowed to make decisions for me will also be asked to give permission for me to join this study.
(Investigator's name)and ___, the person legally allowed to make decisions for me, have explained what I will have to do in the study.
(Investigator's name)and ___, the person legally allowed to make decisions for me, have explained the discomforts, risks and inconveniences I may have if I join the study.
[Include any of the following italicized statements as applicable.]
I agree that I need to avoid using any alcohol, including beer and wine, while in this study, as it could make me sick and cause serious side effects.
I agree to use effective birth control if I am a male or female.
If I am a female, I have been told that I will have pregnancy testing if I am able to have a child and the results will be kept private and not shared without my permission. I have been told that I need to remain pregnancy free throughout the study.
I have asked any questions I had, and all my questions have been answered.
______ I agree to be in this study.
______ I do not want to be in this study.
_________________________
Subject's name
___________________________________________
Subject's signature Date
_____________________________________
Witness's signature Date
____________________________
Relationship of Witness to Subject
All procedures, risks and discomforts have been explained to the subject.
__________________________________
Investigator's Signature Date
Title:________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Principal Investigator:______________________________________
Sponsor:_________________________________________________
Please answer the following questions after reviewing the consent form for this study. The researchers doing this study want to be sure that you know what is involved in being in this research study. This questionnaire will help them make that decision. You may ask questions of the researcher and review the consent form again at any time.
|
I am being asked to be in a research study. This study involves the use of a drug or device not approved by the FDA. I have to participate in this research study to receive care. I can withdraw from participating in this study at any time. There are no risks to me from participation in this study. I am guaranteed to feel better from being in this study. |
True False True False True False True False True False True False |
__________________________________________
Printed Name of Subject
__________________________________________ _____________________
Signature of Subject/LAR/Next of Kin Date Time
_____________________________________________
Signature of investigator administering consent review
_________________________________________
Investigator's Signature Date
Addendum to Consent by Research Proxy
for Continuing Participation in a Research Study
Title:_______________________________________________________
___________________________________________________________
___________________________________________________________
Principal Investigator:______________________________________
Sponsor:________________________________________________
- I have been told that my research proxy gave consent for me to be in the above titled research study.
- I am now able to give my own consent to be in the research study.
- I have been told of the purpose of the research, what my participation will entail, as well as all of the potential risks and benefits.
- I have discussed the research study with the study doctor and have received satisfactory answers to any questions.
- I have been told that I may ask more questions at any time.
- I do not have to stay in this research study. My decision to continue is completely voluntary. If I wish to leave the study, I may have to undergo final follow-up tests to assure my well-being. If I leave the study I will not suffer any penalty or loss of benefits to which I am entitled.
- I have been told that all of the elements of informed consent in the attached consent form, signed by my research proxy, are still applicable.
I have reviewed the consent document and have discussed all of the elements of informed consent with the study doctor. I agree to stay in the above titled research study.
_________________________________________________________
Signature of Subject Date
_________________________________________________________
Printed Name of Subject
__________________________________________________________
Witness Signature Date
__________________________________________________________
Printed Name of Witness
I have advised the above subject of other forms of treatment and/or therapy that may be appropriate, I have offered an opportunity for further explanation of the risks and discomforts which are, or may be associated with the study, and to answer any additional questions relating to the research.
_________________________________________________________
Physician's Signature Date