Telephone
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Instructions
·
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
Procedures
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.
Study Title:
Principal Investigator:
_____________________________________________________
Introduction
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.
Purpose
We are doing this study to learn about . . . explain in
lay language the basic purpose(s) of the study.
Procedures
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.
Risks
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.
Benefits
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.)
Second sentence:
We hope to learn information that may help others in the
future.
Alternatives
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.
Costs
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.
Research-related injury
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.”
Compensation
You will not be paid for participating in this study.
Or
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.)
Voluntary
Participation
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.
Withdrawal
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.
Confidentiality
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.
Questions
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
Review Board,
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:
________________________________
____________________________
Date
______________________________________________________________
______________________________________________
Signature of Parent or Legally Authorized Representative
___________________________________
Date