OHR-8I
12/11/2013
OHR-8I (GUIDANCE FOR COMPLETING THE OHR-8 UNIVERSAL CONSENT TEMPLATE)
General considerations
The language in the TJU template for informed consent has been accepted/approved by
AAHRPP, the FDA and OHRP as being more than adequate and there are no ethical, safety, or
regulatory reasons to add to it or substantively change it.
Please pay attention to formatting. Don’t split tables or signature page. For final version, make
sure that all highlighted italicized instructions are deleted.
PLEASE NOTE: FDA Guidance document “A Guide to Informed Consent - Information Sheet
Guidance for Institutional Review Boards and Clinical Investigators” explicitly states the
following: “Sample or draft consent documents may be developed by a sponsor or cooperative
study group. However, the IRB of record is the final authority on the content of the consent
documents that is presented to the prospective study subjects.”
The OHR-8 UNIVERSAL is a consent form template. Choose, modify and expand those sections
that are applicable to your study, and delete the rest. Per federal guidance, the consent form
should be written at a 6th grade reading level. Delete all instructions including those in italics
and use at least 12 point font for final.
Note that there is one consent form template that can be used for TJU, Rothman studies, and
parental consent. Please carefully review and delete all that does not apply (example, if
Parental Permission, delete “you” or “your” and keep “your child.” For your convenience,
sections that should be changed or deleted are highlighted in yellow.
The majority of the pronoun changes can be made with the edit/replace function (replace
“you/your child” with “you” or “your child). When you are ready for a “final” version, use the
edit function to “select all” click on the highlight function and select “none” to remove the
yellow highlighting. Make sure “track changes” is turned off before removing the highlighting.
Please insure that all acronyms and abbreviations are spelled out the first time they are
introduced. The “find” option in word is useful here since they are easily missed.
Please complete headers on all pages with information specific to your study and remember to
add in the IRB control# once you have it.
Please try to limit form to 12 pages or less. Remember it is a consent form and not an
educational brochure.
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Lay Title:
Mention name of study article and use general terms like surgery, radiation therapy,
chemotherapy, heart pacemaker, blood vessel stent rather than specific names.
Suggestion: “A research study to find out if adding radiation treatment to chemotherapy for
colon cancer is better than chemotherapy alone”
Purpose:
Please be brief and use lay language. Do not cut and paste from the investigator brochure or
protocol.
The purpose may be simply to see of drug A is better, not as good as, or the same as drug B, or
to see if adding study drug to standard of care improves treatment outcome. This section
should not have coercive undertones so avoid the information about the cost to society and
disease incidence information. “XX condition affects 99% of the population and costs the
taxpayers XX billions of dollars a year to diagnose and treat and is the third most cause of
suicide among IRB members in the United States” is not really relevant to the subject’s decision
to be in a research study.
What will happen during the study?
Describe randomization and blinding if appropriate. You can include a flow diagram to show
randomization into groups or arms of the study. Describe randomization as “like by the flip of a
coin” or something similar and state that neither the study doctor or study staff decides or
controls who is assigned to a study group.
You may use a diagram to show the arms and flow of a study but if the study design is clear in
prose, it is not necessary to reiterate it in a diagram.
If you include a table from the protocol or OHR-2 in the consent, please be sure the font size is
reasonable (readable) and that any table items or footnotes are in lay language.
When possible, combine study visits. Some examples follow:
“Before you can be in the study you will have the following tests and/or examinations:”
(provide bulleted list).
“If you qualify to be in the study, there will be XX study visits.”
“At weeks (or visits) 1,3,5,7 and the visit at 3 weeks after stopping study medication you will
have the following tests/procedures done:” (provide bulleted list).
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“At week 5 and 3 weeks after stopping study drug you will also have an electrocardiogram and
blood drawn for research tests.”
Alternative descriptions are also OK. An example would be as follows:” You will have blood
tests every month during year one, every 3 months during year two and every 6 months during
year three of the study. You will have CT scans of your abdomen and MUGA scans to look at
heart function every 6 months for three years.”
If applicable, include a statement indicating that for a standard of care procedure or treatment,
the subject will be asked to sign a separate consent.
What are the side effects or other risks or discomforts involved?
Please ensure that risks are written in lay language and that they are in general agreement with
those listed in the OHR2, the Investigator Brochure or, if applicable, the package insert. If
possible describe risks as indicated below. Risks reflect those associated specifically with the
research. Briefly describe any risk associated with a standard of care procedure or test that is
being done more frequently than usual because of the research. Please do not describe the
risks of standard of care procedures or treatment if subject is signing a separate consent for
these procedures.
Combine side effects of study articles when possible. For example: Drugs 1, 2 and 3 may have
the following side effects or risks. In addition, Drug 1 can cause XXX and XXX or use bulleted
list.
When describing possible risks, tell the subjects what to look for or what to expect. Here are
some examples:
Liver damage that may cause yellowing of the skin or the white part of the eyes
Kidney damage that may be mild and cause no symptoms or may be severe and cause puffiness
around the eyes or swelling in the legs and may require dialysis
Anemia which may cause fatigue or tiredness or require blood transfusions
Easy bruising or bleeding
Use lay terms See DHSP Policy Guidance G 603: “Guidance on Lay Terminology: Informed
Consent Glossary”
It is not necessary to provide both he lay term and the medical term for a side effect or risk
Use medical or scientific terms only if they are in common use by the general public.
Listing things like increased values for various lab tests is generally meaningless to subjects, so
avoid descriptions such as “Increased blood levels of bilirubin, AST and ALT.” Abnormal lab test
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results are covered in the template statement at the end of the risks section. This can be
modified, if necessary, to meet the needs of your study.
What are the risks to fetuses, infants and pregnant women?
There are three versions of the pregnancy section in the template. The first is for usual use in
studies involving experimental drugs or biologics. The second is for relatively low risk studies
enrolling adults and the third is for studies enrolling children who may be or may become
pregnant. Select the section that best fits your study and delete the other two.
Generally our template language provided in options 1 and 3 is sufficient. However, there may
be some required additional warning language for certain drugs – for example thalidomide or
other teratogenic compounds.
If the study involves a drug with known fetal toxicities (e.g., Thalidomide, Warfarin,
Methotrexate, isotretinoin, etc.) please list the known risks and also indicate that there are
unknown risks to fetal exposure.)
Are there benefits from being in this study?
Generally there is no expectation of benefit for an individual. Benefit is mostly to advance
knowledge and possibly benefit future patients with the condition being studied.
If there are benefits, use general terms such as “You may benefit by having physicians monitor
your medical condition more closely than usual.”
NOTE: Payment for visits is not a benefit; it is an inducement to be in the trial.
Are there alternatives to being in the study?
As possible alternatives include as appropriate
 Standard care (getting treatment without being in a study)
 Taking part in a different research study
 Getting no treatment
 Comfort care to improve how you feel (reduce pain, tiredness, appetite problems and
other problems caused by your disease) without actually treating your disease (note –
this is mainly relevant to cancer studies)
 If FDA approved drugs/devices are used in the study state that it is possible to get the
study drug(s) or device without being in the study.
How will privacy and confidentiality (identity) be protected?
Please use TJU template language.
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If sponsors insist on using their HIPAA language it can be included as an addendum to the
consent.
Remember to delete entities to receive PHI from bulleted list if not relevant, such as FDA if
research is not FDA regulated and DSMC if there isn’t one.
If this is a study where PHI will be shared with researchers at other institutions, add
“Researchers at (name of institution)” to the bulleted list of entities that may receive PHI. This
applies to collaborative research and not to multi-center commercially sponsored clinical trials
What happens in case of injury as a result of being in this study?
Please use TJU template language. It covers in lay language most things that are spelled out in
legal terms in the contract. The informed consent language does NOT have to exactly match
word-for-word what is written in the contract.
For certain minimal risk studies, injury language can be deleted entirely. Blood draw studies
usually keep injury language in the event of severe bruising or keloid/scar formation.
Are there costs related to being in this study?
As appropriate state “All research tests and procedures will be paid for by the study. Standard
of care tests and procedures that you would have whether or not participating in a research
study will be billed to your insurance.” Pre-certification would be appropriate under
circumstances where standard of care tests/procedures are to be billed to insurance.
Research tests and procedures should NOT be billed to insurance, nor should sponsors pay for
such studies/procedures if insurance denies. Subjects and their insurers should be treated
fairly (pay for one, pay for all).
Other notes and suggestions
Please be sure to reformat the “your/your child,” etc. on the signature page.
Watch for headers and footers, which may change as you add content. Always check the
headers and footer, particularly on the last and first pages. There should not be an initial/date
footer on the last (signature) page.
Optional Teach-back
Use as you wish. If you collect these, you may find it interesting to review them periodically to
determine where your consent process may need more attention.
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