THE IRB ITSELF |
1.
What is an Institutional Review Board (IRB)?
An Institutional
Review Board (IRB) is a group of people formally designated to review
and monitor research involving human subjects. The purpose of the IRB
is to protect, before and during the research study, the rights and
welfare of humans participating as subjects in the research. The IRB
has the authority to approve, disapprove, and require modifications
to research projects involving human subjects. In addition, the IRB
must review and approve or disapprove the investigator for the research.
Once approved, the IRB must monitor the progress of the ongoing research
and, if necessary, terminate a research project.
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2.
Who reviews my application?
Federal agencies
that govern human subject research, such as the U.S. Food and Drug Administration
(FDA) and the Department of Health and Human Services (HHS), require
that the IRB have at least five members with varying backgrounds. For
example, each IRB must include at least: one member who has no affiliation
with Columbia University other than their IRB membership; one member
who is a non-scientist; and one member who is a scientist. To satisfy
the requirement for at least one non-scientist, most IRBs include attorneys
or clergy. To satisfy the requirement for at least one scientist, most
IRBs include physicians and PhD level scientists.
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3.
Who has access to the IRB records?
Only investigators,
study staff, and authorized IRB members, officers and staff have access
to the materials provided to the IRB.
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4.
What criteria will the IRB use for reviewing my protocol?
An
IRB may approve research only after it has determined that the following
requirements, as described by federal regulations, have been satisfied:
1
- Risks to subjects are minimal;
2 - Risks to subjects are reasonable in relation to the anticipated
benefits and the importance of the knowledge that may be gained;
3 - Selection of subjects is reasonable in view of the purpose of the
research and the setting in which it will be conducted.
4 - Informed consent will be sought from each prospective subject, or
the subject's legally authorized representative, that provides the appropriate
information and is understandable to a lay person;
5 - Informed consent will be appropriately documented in a written consent
form;
6 - When appropriate, the research plan makes adequate provision for
monitoring the data collected to ensure the safety of subjects;
7 - When appropriate, adequate provisions exist to protect the privacy
of subjects and to maintain the confidentiality of data; and
8 - Additional safeguards have been included in the study to protect
the rights and welfare of vulnerable populations, such as children;
prisoners; pregnant women; mentally disabled persons; or, economically
or educationally disadvantaged individuals.
If any of these requirements are not met, the IRB will either disapprove
the study or recommend modifications that will ensure the study satisfies
these requirements.
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DO I HAVE TO? |
1.
If I don't have funding for my research, do I need IRB review?
Yes.
All research studies that involve human subjects are subject to IRB
review, irrespective of funding.
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2.
I'm working on a project with faculty from another university. If my
co-investigators receive IRB approval from their university, do I still
need to file?
For
a University researcher to participate in a research project at another
site, the project needs to be reviewed by the IRB as well as by the
other institution's IRB. Changes in protocol or consent forms required
by the other IRB should be brought to the attention of the University
IRB.
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3.
I've already started a research project and didn't realize that I needed
to receive IRB approval first. What should I do?
As
a general matter, there is no retrospective IRB review. However, you
should submit an application to the IRB for approval and include an
explanation for why you did not think you needed IRB approval. Based
on the information provided, the IRB will conduct an inquiry. The research
may be exempt from IRB review. If the research is not exempt, the research
would have required IRB approval in advance and, therefore, the research
is not in compliance with federal regulations.
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4.
What happens if I conduct human research without IRB approval?
Federal
regulations require that research on human subjects must include a prior
review of the project by an IRB. Any instances of non-compliance must
be reported to the appropriate governing agencies. The University's
policy states that non-compliance may result in, among other things,
suspension or termination of the study; and/or suspension of research
privileges at the University.
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5.
I intend to run a pilot study before my large research project begins.
Do I need IRB approval before starting the pilot study?
Pilot
studies and feasibility studies, including those involving only one
human subject, require the same scrutiny as full-scale research projects.
Pilot studies should be identified as such in applications to the IRB.
Ordinarily the data collected from subjects in a pilot or feasibility
study are not used for study findings.
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6.
I teach a course and several of my students want to conduct a research
project involving human subjects. Do they need to file with the IRB?
If
students are conducting human subject research as part of a class assignment,
or to satisfy a degree requirement, the IRB must review the proposed
research. When students conduct research as part of a course of study,
a faculty member ultimately is responsible for the protection of subjects,
even if the student is the primary researcher and actually directs the
project.
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7.
Do I need IRB approval to do a retrospective chart review?
As
a general matter, there is no retrospective IRB review. However, you
should submit an application to the IRB for approval and include an
explanation for why you did not think you needed IRB approval. Based
on the information provided, the IRB will conduct an inquiry. The research
may be exempt from IRB review. If the research is not exempt, the research
would have required IRB approval in advance and, therefore, the research
is not in compliance with federal regulations. Therefore, if there is
any chance that the chart review could turn into a research project,
and even publication, you should submit an application to the IRB for
approval in advance. Quality assurance activities or evaluation projects
designed for self-improvement or program evaluation, not meant to contribute
to "generalizable" knowledge, do not need IRB.
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8.Are
projects involving oral histories subject to review by the IRB?
Yes.
However, the research may qualify for an expedited review if it involves
materials (data, documents, records, or specimens) that have been collected,
or will be collected, solely for non-research purposes.
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9.
My research will be done in another country. Do I have to obtain IRB
review and approval?
Research conducted
by University investigators in foreign countries remains under University
purview and guidelines. While human subjects in foreign countries merit
the same level of protection as subjects in the United States, acceptable
practices vary from place to place. Different mores, traditions, and
institutions may require different research protocols, particularly
in informed consent, recruitment practices, and documentation. Research
projects must have been approved by the local equivalent of an IRB before
they are presented to the IRB. Where there is no equivalent board or
panel, investigators must rely on a review panel of local experts or
community leaders to provide approval. The IRB requires documentation
of this "local approval" before it will give approval. Researchers should
describe what if any, knowledge or experience they possess regarding
the language and culture of the country in question. Researchers proposing
international research should allow additional time for this review
process.
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10.
Will the IRB accept approval for research by a foreign country's review
panel?
No. After a research
project has been approved by a foreign country's review panel, the research
must be submitted for approval to the IRB. The IRB will independently
review the research.
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11.
I'm only interviewing a few people. Do I need to submit a protocol?
Yes. Research on
human subjects must include a prior review by the IRB, including those
studies involving only a few subjects.
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12.
Can I videotape children, in a classroom, as part of my research project
without consent since I won't be talking to the students?
Yes. The parental
consent form and the child or youth assent form should include the following
information: whether the tape will be used for studying the actions
of children doing certain projects; whether the tape will be used for
any other purpose; how will the tapes be kept confidential; where will
the tapes be stored; when will the tapes be destroyed.
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13.
If I am using data compiled by someone else such as a governmental agency
or another researcher, do I need IRB approval?
The research may
be exempt from IRB approval if the research involves the collection
or study of existing data, documents, records, pathological specimens,
or diagnostic specimens, if these sources are publicly available or
if the information is recorded by an investigator in such a manner that
subjects cannot be identified, directly or through identifiers linked
to the subjects. Additionally, if the data is not publicly available,
you must submit documentation that the original researcher has provided
permission.
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14.
I'm taking a course - is IRB approval needed for projects conducted
as a course requirement?
Courses in research
methods and class assignments that involve research with human subjects
require IRB approval even if the class exercise does not seem to qualify
as "true research": when, for example, the results are not intended
for publication, will not advance work in another area, or will not
contribute to generalizable knowledge. The IRB reviews research for
risk assessment and provisions for informed consent.
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15.
Do I need IRB approval if my work will be conducted off campus?
Yes. For a University
researcher to conduct a research project at another site, the project
needs to be reviewed by the IRB
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16.My
study doesn't involve any risk of any kind.Do
I still need to submit an application?
Yes. Research on
human subjects must include a prior review by the IRB, including those
studies that do not involve any risk.
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TRAINING/EDUCATION |
1.
Does everyone listed on my protocol have to have training?
All personnel listed
on the protocol that will have contact with participants involved in
the study are required to complete Human Subjects Training. Human Subjects Training
is available on the CITI Program Website.
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Does
the training requirement apply to students conducting interviews?
Yes, anyone contacting
the human subjects in any way needs to complete training.
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IRB
TERMINOLOGY |
1.
What is the definition of "research"?
"Research" is defined
as a systematic investigation, including research development, testing
and evaluation, designed to develop or contribute to generalizable knowledge.
(45
CFR 46.102(d)).
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2.
What is the definition of a "human subject"?
"Human subject"
is defined as a living individual about whom an investigator (whether
professional or student) conducting research obtains (1) data through
intervention or interaction with the individual, or (2) identifiable
private information. (45
CFR 46.102(f)).
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3.
What is "informed consent"?
"Informed consent"
is an ongoing process. It starts well before any consent forms are signed
and continues until the subject's participation is complete. If consent
is to be informed, the subjects must genuinely understand the study.
It involves meeting with a potential subject, finding out whether he
or she is capable of giving consent, and discussing the purpose, risks,
and benefits of participation. The informed consent process is different
from the consent form. The consent form formalizes the agreement to
participate and should be designed to document the process. Obtaining
informed consent is not just giving a prospective subject a consent
form and getting it signed.
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4.
What is the difference between "confidential" and "anonymous"?
Anonymous data can
never be linked to the subject (directly or indirectly) either because
the name/identity of the subject is never obtained by the investigator,
or because there is no code linking the data to the subject's name/identity.
Confidential data is recorded so that the information is not immediately
identified with the subject who supplied it, but such a link is possible.
Confidential data is usually "coded". That is, the subject is assigned
a unique identifier that will be used to identify the data. The code
identifies the data, and the subject's identity is kept separate from
the code and data. Coded data is not anonymous.
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5.
What is "minimal risk"?
"Minimal risk" means
that the probability and magnitude of harm or discomfort anticipated
in the research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical
or psychological examinations or tests.
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6.
What is a medical device?
A "medical device"
is defined as a diagnostic or therapeutic article that does not achieve
any of its principal intended purposes through chemical action within
or on the body. Such devices include diagnostic test kits, crutches,
electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic
pins or other orthopedic equipment.
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7.
Does exempt mean I don't have to apply to the IRB?
No. Only the IRB
may make the determination that research is exempt from IRB review.
Therefore, the investigator must submit an application to the IRB, which
details the research.
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8.
What is the difference between "exempt" and "expedited"
review?
Research studies
can be categorized by the amount of risk involved. If a research study
involves little or no risk to the subject, the research is exempt from
further IRB review. Exemption waives the need for further IRB review;
however, it does not negate the need for the consent of subjects where
applicable.
If the research
study presents no more than minimal risk, it may qualify for an expedited
review if the involvement of human subjects falls into one or more categories
approved by DHHS. An expedited review is conducted by a qualified member
of the IRB. The member reviews the appropriate materials and determines
to either approve the research or return it for modification. A research
study may only be disapproved by a full IRB meeting.
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THE
PROCESS |
1.
How long will it take for the IRB to review my application?
Depending on the
nature of the study, IRB review may take one day or as long as one month.
The IRB may request additional information from the investigator which
could lengthen the process.
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2.
How long is my approval valid?
Your approval is
valid for one year from the date of approval
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3.
Can I begin my research as soon as I file my application with the IRB?
No - research can
only begin once you have written approval from the IRB.
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4.
If I do begin my research before IRB approval, what will happen?
Under 45
CFR 46.103, the IRB must review and approve all non-exempt human
subject research. Failure to obtain IRB approval before conducting research
could result in the researcher being unable to use data and other information
collected through the research process.
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5.
Do I need to let the IRB know when I have completed the study?
Yes. An investigator
needs to inform the IRB that the study is being terminated or closed.
The IRB will continue oversight of the study for follow-up purposes.
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6.
Does the IRB continue to review my projects once it has been approved?
Yes. Under 45
CFR 46.111, the IRB must determine risks, potential benefits, informed
consent and safeguards for human subjects. According to the OHRP -IRB
members should receive and review a protocol summary and a status report
on the progress of the research including:
1. the number of subjects accrued
2. a summary of adverse events
3. unanticipated problems involving risks to subjects or others
4. any withdrawal of subjects from the research or complaints about
the research since the last IRB review
5. amendments or modifications.
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7.
My study is very short - can I get less than 12 months approval?
Yes.
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8.
Can I get approval for a five year study all in one application?
Yes, but it must
be reviewed at least on an annual basis.
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9.
Am I required to list all of the research faculty that might participate
on my protocol - or only ones giving significant time?
The Principal Investigator
(PI) must be listed along with all other research staff.
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WHILE MY PROTOCOL IS ACTIVE |
1.
What should I do if I receive a complaint from a participant about the
project or if a participant is injured in some way during the course
of the project?
Your consent form
should have a detailed account of compensation for injury, if any, as
well as what a subject should do in the event of a complaint. Complaints
and injuries should be dealt with promptly. Where a participant has
a question about their rights in the study, they should contact the
IRB. The IRB should also be informed of any complaints or dissatisfaction
on the part of the subjects.
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2.
Suppose I want to make a minor change in the study--add or remove a
new question or new task, put an ad in the newspaper to recruit more
participants, do I need to do anything?
You must send this
modification to the IRB for review and approval. While a minor change
may not need full board approval, the IRB does need to review and approve
such a change.
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3.
If I'm changing the study when do I need to tell my participants about
the changes?
As stated above,
changes to a study must be received and approved by the IRB before they
are implemented. Subjects enrolled and actively participating in the
study should be informed of the change if it might relate to the subjects'
willingness to continue their participation in the study (21 CFR 50.25(b)
(5)).
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CONSENT
FORMS |
1.
Who keeps the informed consent?
Informed consent
is drafted by the investigator, reviewed and approved by the IRB and
kept by the investigator and on file with the IRB.
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2.
What's the difference between an Assent Form and a Consent Form?
Study subjects who
cannot give consent, but who are able to participate in the process
to some degree can do so through the assent process. For older children,
for example, the assent process can be similar to the consent process
used with a competent adult. For a younger child, the process may be
less detailed.
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3.
How can I manage consent forms if the survey is conducted on a web page?
A survey on a web
page should include the elements of informed consent. As with a survey
that is not on a web page, a reply is considered to be implied consent.
If confidentiality is necessary, the survey could be printed and mailed
back to the investigator. Where subjects are to reply via e-mail, they
should be told that in the cover letter that the confidentiality of
their response can not be guaranteed.
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4.
Do I always have to get consent of everyone participating in the study?
The regulations
generally require that the investigator obtain informed consent from
subjects or, where warranted from a legally authorized representative
of the subject. There are circumstances where consent can be waived
(see
45 CFR 46.116) however waiver of consent requires IRB approval.
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5.
How do I obtain consent from children?
45
CFR 46.408(a) requires that "adequate provisions are made for soliciting
the assent of the children, when in the judgment of the IRB the children
are capable of providing assent." The section goes on to state that
"[i]n determining whether children are capable of assenting, the IRB
shall take into account the ages, maturity, and psychological state
of the children involved."
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6.
How can I get signed consent forms for the surveys that will be mailed
to research participants and still maintain confidentiality?
There should be
a cover letter that accompanies the survey and which contains the elements
of informed consent.
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7.
I'm doing research with a group of children, is it possible not to have
parental consent?
Under 45
CFR 46.404-407, researchers are required to obtain parental consent
in order to do research on children. However, pursuant to 45
CFR 46.116, there are certain situations where consent can be waived
(i.e. where waiving consent would be in the best interest of the child).
Waiving consent must be specific to the study and must detail what protections
will be put in place for the children in the study.
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8.
Can I obtain informed consent by telephone?
In general, under
45
CFR 46.117, written informed consent is required to comply with
federal regulations and standards. Where an investigator feels that
written consent is not feasible or otherwise not warranted, the investigator
can apply for a waiver of consent through the IRB. The investigator
should be detailed as to why written consent is not warranted. Generally,
however, written informed consent is necessary.
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9.
Who should be present when the informed consent interview is conducted?
Under 21
CFR 50.27(b), a third person is not required to witness the consent
interview unless the subject or representative is not given the opportunity
to read the consent document before signing. The person authorized to
conduct the consent interview should have adequate information about
the study to answer questions that may arise. Federal regulations do
not specify who this "authorized" individual should be. If someone other
than the clinical investigator conducts the interview and obtains consent,
this person should be authorized by the clinical investigator and the
person so delegated should have received appropriate training to perform
this activity.
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10.
How do you obtain informed consent from someone who speaks and understands
English but cannot read?
Study subjects are
given a copy of the consent to refer to and clarify the parameters of
the study.Under 21
CFR 50.20 the consent document must be in language understandable
to the subject. Where the subject is English-speaking, and the consent
interview is conducted in English, the consent document should be in
English. Where a large number of subjects are non-English speaking,
the PI should submit a translated consent form for IRB review. A copy
of the translated consent document must be given to each subject who
requires it.
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11.
Does a witness to the consent interview have to be there the entire
time or only to witness the signature of the participant?
Under
21 CFR 50.27 (b) (1) there is no requirement for a witness' signature
where the subject can read and understand the consent process. A witness
becomes necessary under 21 CFR 50.27(b) (2) where the subject has not
had the opportunity to thoroughly read and understand the consent document.
At that point, a witness is necessary to attest to the fact that the
consent was presented in a certain manner that the subject understood.
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COMPENSATION |
1.
How do I figure out what is a reasonable compensation for my participants?
The amount as well
as schedule of payments to research subjects should be presented to
the IRB at the time of initial review and under 21
CFR 50.20, the IRB should review the amount of payment and the proposed
method and timing of the disbursement of payment to assure that the
amount and method are fair to the subjects involved. (see also www.fda.gov/oc/ohrt/irbs/toc4.html#payment).
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2.
Can I reward my participants with items such as discount coupons, movie
tickets, or free food items?
This implies to
the subjects a certainty of favorable outcome of the study. Also, if
the study product is approved, the coupon may create a financial coercion
for the subjects for that specific product, which may not be sound for
them to take. ( see also www.fda.gov/oc/ohrt/irbs/faqs.html)
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OTHER |
1.
How do I submit a protocol?
Rascal is currently
only accepting new protocols.
Click on 'create
a protocol'
Complete and save the general page - when you save, links will be added
for additional pages you will need to complete
Complete (and save) all appriopriate pages
Attach your consent forms (see below to use Consent Form Builder), brochures,
questionnaires, funding information, additional documents, etc.
Add your department approvers if applicable, and notify them by clicking
on the 'Notify Approvers' link.
If you are the PI, approve your protocol (the system will automatically
ask you to complete a 'Protocol Specific Conflict of Interest' disclosure).
Submit your protoocol.
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2.
How do I create a consent form?
Use the Rascal Consent
Form Builder - it is located under the Compliance section on the Rascal
home page.
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3.
I have an approved 'paper' protocol - how do I do my renewal?
Rascal is currently
only accepting new protocols. In the next few months, Rascal will allow
you to have your approved protocol validated. Once validated, you will
be able to create your renewal in Rascal.
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4.
I need access to WebCIS?
In the next few
months, you will be able to use a module in Rascal to verify your approved
paper protocols, the personnel on them, and then access will be granted
to WebCIS.
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5.
What should I do if I am doing genetic testing as part of my protocol?
You should modify
and then insert the following language in your consent form. Note: this
text is also available in Consent Form Builder in sample pages for 'Additional
Information'.
Your blood or tissue
sample will be tested for genetic factors that may relate to [an increased
risk of developing a disease, an increased chance of disability, etc.]
in you or your offspring. [State the specific test(s) to be done, i.e.
specify phenotype.]. Genetic factors are personal traits or characteristics
that are inherited and run in families. The information obtained from
these tests will include genetic information about you. To protect your
identity, we will give your sample(s) a unique code number. Your name
will not be linked to this code number. Your sample(s) will be analyzed
with those of other research participants and the results will be combined
in such a way that your sample(s) cannot be specifically identified
and linked to you personally.
[If there is a level
of certainty that positive test results indicate the individual has
or is predisposed to the condition being tested for, use the following
statement.] If there is a positive test result, you may want to undergo
further independent testing and/or consultation with specialist physicians
and/or genetic counselors. Genetic consultation and counseling are not
provided through the study, however. You should be aware that insurance
companies sometimes use information from genetic testing to deny coverage
to applicants.
[If there is no level of certainty about the significance of positive
test results, use the following statement.] Because the possible significance
of any results of this genetic research is not known, the results of
these studies will not be given to you. You should be aware that insurance
companies sometimes use information from genetic testing to deny coverage
to applicants. This study involves research in genetics that could be
used to develop such genetic testing in the future. At present, any
information obtained from this research cannot be considered to provide
meaningful information about the health of a study participant. Therefore,
if you decide to participate in this research study and agree to genetic
research, and if you are asked, you should state that you have not had
a genetic test.
Please initial the
appropriate statement to indicate whether or not you give permission
for genetic testing.
YES __ NO __ I agree
to have my specimen [blood, tissue] used for genetic research as described
above.
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6.
If someone
on your study does not have a Columbia UNI?
Please contact Rascal @ 212-851-0213.
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