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· The consent form is only one part of the ongoing dialogue between researchers and participants. It is important to remember that obtaining the consent of each participant is a process that lasts throughout the study.
· The consent process and recruitment should be described in the protocol in specific detail.
· The consent form should be written at an eighth grade level and give the participant a clear understanding of the experience they can expect to have if they agree to participate. The form should be as easy as possible to read and understand. Grammar, sentence structure, spelling, and the format of the document combine with the content to accomplish this goal. Avoid complex or lengthy sentences, medical, scientific, and/or technical terms, and dense paragraphs. Use “bullets” or simple tables to explain topics or regimens clearly. Drawings or pictures might be necessary to help explain complex procedures or interventions.
· The information in the consent document should be limited to the study question.
· Avoid describing study visits, treatments, and procedures in lengthy narrative form. If the visits, treatments, and procedures are lengthy or complex, consider using a separate page that can be attached to the consent document, similar to the lay version of the schedule of events from the sponsor’s protocol, to describe the study visits, procedures, and treatments in detail for the participant. The body of the consent document should summarize the study visits, procedures, or treatments in a simple, concise format, using headers and bullets where possible.
· To help avoid unnecessary delay, please proof read the document before submitting it to the IRB for review.
· For ease of reading, the consent document should be a single sided document, printed with a minimum of 1 inch margins, (leaving a 1.5 x 1.5 inch space in the lower right corner of each page for the IRB approval stamp), using the same font type and size (13 or larger) throughout, double space between the paragraphs, and bold or underline the section headers.
· Suggested wording is contained in the consent template. The document should be written in the second person, using the present or future tense. Do not begin sentences with “You understand that”, “It has been explained to you that”, or similar assumptive phrases. To avoid confusion, use “study doctor” throughout the document, instead of “doctor” and “participant” instead of “patient” or “subject”.
· For studies with optional tissue or specimen banking, this information should not be included in the main consent document but added as an addendum, with a full signature block.
· For studies enrolling minors between the ages of 9 and 17:
1) an age appropriate Child Assent Form to document obtaining the assent of the minor participant, or document the reason(s) assent was not obtained and 2) a parental permission document (similar in format to a consent document).
Minimal risk studies
One type of assent document may be used for all minor participants (9 through 17 years of age), however, it must be written in language that will be easily understood by the youngest participants.
Greater than minimal risk studies
Two different types of assent documents will be used based upon the age of participants.
v For minors 9 through 13 years of age, a child assent document will be used. The document should be written on a 2nd- 3rd grade level, be age appropriate and contain at a minimum the following elements in simplified language:
o Study purpose
o Common risks
o Expected benefit(s)
o Statement that participation is voluntary
v For minors 14 through 17 years of age, an adolescent assent document will be used. The document should be written at most on an eighth grade level. The document can follow the same format as the parental permission document described above, but the term ‘you’ should be used throughout the document.
· Please review all language in the consent document to ensure that the correct information specific to your project is relayed to potential participants.
· A copy of the signed consent form must be filed in your study file and in the participant’s medical record, and a copy must be given to the participant.
· Each page of the consent document must be numbered and contain a header or footer with the study title and the name and title (Principal Investigator) of the Principal Investigator, version date, and, for studies with multiple consent documents, a short description of the document.
· HIPAA: The Health Insurance Portability and Accountability Act requires all consent documents to contain the following information:
Description of health information to be gathered;
Who may use or disclose the information;
Who may receive the information;
Description of the purpose of the use or disclosure;
Expiration date of authorization (for example, end of study);
Statement of right to revoke authorization;
Statement of right to refuse to sign authorization;
Statement regarding re-disclosure;
Individual’s dated signature
Suggested language is included in the consent template.
· Any change to the consent document must be submitted to the IRB for review and approval before the new document may be used.
· The IRB office staff will pre-review any consent document upon request.
You are being invited to be in an experimental research study, because. . . explain the specific reason(s) in lay language. Please ask us about anything in this document or that we tell you that you do not understand.
Note: If the study includes minors only, use “Your child” in place of “You” in the parental permission document.
We are doing this study to learn about . . . explain in lay language the basic purpose(s) of the study.
Briefly explain in lay language the tasks, procedures, therapies, tests, etc. involved in this study. When applicable, clearly describe:
· whether the drugs or devices are being used in ways that are not FDA approved;
· the use of placebo;
· whether all participants will receive the same therapy;
· the process of randomization, “by chance, like the flip of a coin”, if there are two study groups, or “like pulling numbers out of a hat”, if there are more than two study groups;
· if blood will be drawn, state the amount in teaspoons or tablespoons;
· what will occur at each study visit;
· identify any procedures, therapies, and/or tests that are considered experimental, and include a list of the tests/procedures being done for research purposes only. For example, “If you enroll in this study the following additional tests or procedures will be performed:”;
· the expected duration of study participation.
Use tables and/or charts to simplify this section. If there are multiple study groups, explain this by listing the groups as follows:
If you decide to join this research study you will be assigned by chance, like the flip of a coin, to one of the following groups:
Group A – receives xxx
Group B – receives xxx
Neither you nor your study doctor will know ahead of time what group you will be in.
Identify all reasonably foreseeable side effects, risks, discomforts, or complications that could occur.
For drug studies involving a multi-drug regimen, list the problems associated with the entire regimen, or, if that is not possible, list separate information for each individual medication. Whenever possible, risks should be grouped (either bulleted or in a chart) and identified by severity, likelihood and duration. For example, “common but not serious”, “unlikely but serious”, “occasionally” or “rare”, and “temporary” or “permanent” may be used. Avoid using specific numbers to describe a risk, e.g., “one person experienced”, which would necessitate a revision to the consent document each time an adverse event is reported or experienced. Whenever possible, using a table to summarize risk information should make the document easier to read and understand.
Be sure to include the risks of being in a placebo or observation group. If participants will be taken off medication they are currently receiving, either during a washout phase or because they will receive a different medication, you must include these risks, along with information describing how they will be monitored.
Note: When the study involves therapy or procedures that would be recommended if the medical care were delivered outside the setting of a research protocol, it is appropriate to explain that the risks associated with such therapy will not be avoided by choosing not to participate in the study.
Sample wording for the final paragraph in the Risks section:
We do not know how your body might respond to the (medications or procedures) used in this study. We will discuss the risks identified above with you and the chances that they will happen. There may be risks that we do not know about at this time. Unknown problems, ranging from a mild inconvenience to some severe enough to result in death (indicate highest severity level if death is not applicable), may occur. If you experience any problems you should report them immediately to the study doctor, (PI name, telephone number, and after-hours contact information).
Pregnancy (only include this information as appropriate to the study)
The risks of name of drug to an unborn child are unknown. You may not be pregnant, trying to become pregnant or breastfeeding a baby while taking part in this research study. Pregnancy tests (identify if blood or urine) will be done on all women of child bearing potential before beginning the study and every …xxx… (Who will be responsible for the costs of the pregnancy test(s), study sponsor or participant, should be included in the Costs section.)
All women of child bearing potential must use an acceptable method of birth control, such as (identify the acceptable methods) while being treated on this study (if necessary to continue after treatment ends add, and for ___ after treatment ends)..
(If appropriate to the study) Men should avoid fathering a child while participating in the study, and for (identify the appropriate time period) after participating.
Choose one of the following as the first sentence, whichever is applicable to your specific study:
· You will not receive a direct benefit from being in this research study.
· You may or may not receive a direct benefit from being in this research study. (Describe the benefit participants can reasonably expect to receive from the research. Free medical care or study drug are not considered benefits of participating in the study.)
We hope to learn information that may help others in the future.
Explain alternatives in lay language. For treatment studies, identify and explain the alternative procedures or courses of treatment reasonably available to the participant.
Explain whether the research therapy or treatment can be obtained off study:
· You do not have to be in this experimental study to receive the study treatment/drug/therapy.
· The study treatment/drug/therapy is experimental. This means that you can only receive it by enrolling in this study.
Clearly explain the costs that the participant will be responsible for, versus the charges that will be paid for by the sponsor, and include any additional costs the participant may incur because of study participation or that may result from participation in the study. Use suggested wording as appropriate:
There will (or will not) be additional costs to you if you participate in this study.
The (study medication) will be supplied by (sponsor name) at no cost to you. Any tests, examinations, or other procedures that are done solely for research purposes, including (identify the tests, examinations and procedures) as previously described will be paid for by the sponsor of this study (sponsor name). Insurance companies and other third party payers will not be billed for research procedures.
(If medical care will be provided as part of the study)The rest of the medical care that you will receive in this study is considered standard care for your situation and would be recommended whether or not you participate in this study. These costs will be billed to you or your insurance carrier.
In the case of injury or illness resulting from your participation in this study, medical treatment is available to you at the University of Mississippi Medical Center. You will be charged the usual and customary charges for any such treatment you receive.
(if the study has a sponsor the second paragraph should describe the sponsor’s policy) The sponsor of this research is XYZ Company. If you develop an illness or an injury happens because you are in this research study, the XYZ Company will …enter the appropriate information regarding the level of liability the sponsor will assume in case of research related injury or illness.
Do not include exculpatory language or statements, for example, “No other compensation will be provided[ ]”, or “The sponsor will not pay for anything else.”
You will not be paid for participating in this study.
You will receive . . . (describe the compensation, for example “$10.00 for each study visit you complete.” Compensation may not be conditioned upon completion of the study.)
Your participation is voluntary. If you decide not to participate in this study you will not suffer a penalty or loss of benefits to which you are otherwise entitled.
You may choose to stop
your participation in this study at any time. (If withdrawal could affect
medical treatment describe how/the consequences of a participant’s decision
to withdraw, and include a statement asking the participant to please talk to
the study doctor about this decision to ensure his/her safe withdrawal from the
study.) If you decide to withdraw
the information already collected about you may still be used in this study but
additional information will not be collected.
Your decision to stop your participation will have no effect on the quality
of medical care you receive at the
Include information about the possibility of termination from the study by the investigator without regard to the participant’s consent, and the anticipated circumstances that might cause this to occur.
New Information (only include this section if appropriate to the study)
You will be told of any information we learn during your participation in this study that may affect your willingness to participate.
Every effort will be made to keep the information we learn about you private. Study personnel, the study sponsor (if applicable), the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP) and the University of Mississippi Medical Center’s Institutional Review Board (IRB) and Office of Compliance may review the study records. (For sponsored studies) If the sponsor shares this information with others the information is no longer covered by the federal privacy regulations. Study data may be submitted to regulatory agencies in other countries but you will not be identified. If study results are published your name will not be used.
Protected Health Information
Protected health information is any personal health information through which you can be identified. (If protected health information will not be collected in the study the rest of the paragraph should read: Your name and signature will be on this document but we will not collect any other protected health information for this study.) (If protected health information will be collected for the study the rest of the paragraph should be:) The information collected in this study includes: (describe here). A decision to participate in this research means that you agree to the use of your health information for the study described in this form. This information will not be released beyond the purposes of conducting this study. The information collected for this study will be kept (indefinitely or until the study is complete or insert an expiration date or describe an event upon which the authorization will expire). While this study is ongoing you may not have access to the research information, but you may request it after the research is completed.
Number of Participants
We expect (## of) participants to enroll in this study here and (##) nationwide.
If you have questions about this study or need to report any problems, side effects, or injuries, please call . . . at . . . After hours and on weekends please call . . .
You may discuss your rights as a research participant with
the Chairman of the University of Mississippi Medical Center’s Institutional
You will be given a copy of this consent document (to take home and review or for your records or if you agree to participate in this study or after it has been signed), whichever is appropriate.
Statement of Participation
(PLEASE NOTE: The Principal investigator is responsible for ensuring all participants enrolling in the study have given legally effective informed consent and/or assent.)
(For treatment studies)
I have been told about this study, including the experimental treatment I may receive, and the possible risks and benefits. I agree to participate in this study, to follow instructions, and to report any side effects to my study doctor. My participation is voluntary and I may withdraw at any time without any penalty or loss of benefits to which I am entitled, including medical care at the University of Mississippi Medical Center.
(For non-treatment studies)
I have been told about this study and the possible risks and benefits. My participation is voluntary and I may withdraw at any time without any penalty or loss of benefits to which I am entitled, including medical care at the University of Mississippi Medical Center.
By signing this form I am not giving up any legal rights (I or my child, whichever is applicable) may have.
Participant’s Printed Name
(Additional signature lines, described in Option 1 and 2 below, should be inserted here – before the line for the name of the person obtaining consent)
Printed Name of Person Obtaining Consent
I acknowledge that the participant identified above has been entered into this study, with properly obtained informed consent.
Signature of Principal Investigator
*Absent extenuating circumstances, the investigator’s signature should be obtained within 48 hours of the participant’s signature.
OPTION I – if the study includes adult (18 years of age or older) participants only:
Signature of Parent or Legally Authorized Representative