Docstoc

Affiliate

Document Sample
Affiliate Powered By Docstoc
					                                                                   Study Volunteer Initials ______


Affiliate          Rhode Island Hospital          The Miriam Hospital
                   Newport Hospital               Bradley Hospital



I.      AGREEMENT TO PARTICIPATE IN SPECIMEN BANKING
                            (INTERNAL BANK)

                                          (Insert title here)


You have agreed to participate in a study known as [insert name] (the “Main study”) sponsored
by (name of sponsor). As part of this study, [insert type of specimen to be gathered: blood/body
fluid/tissue] samples will be collected from you.

You are being asked to sign this second consent form to indicate if you are willing to allow the
samples collected solely for research purposes, which will be referred to as your 'Specimen', to
be saved or 'banked' for use in future research studies. At this time, we do not know what future
research studies may be done using your Specimen. The specimen bank will be maintained by
(insert name of PI or Lifespan hospital), a Lifespan hospital or researcher.

Your signature below will allow your Specimen to be stored in the specimen bank, with the
possibility that it will be used in future research studies. It is very unlikely that any future
research performed using your Specimen would benefit you directly, but it may provide
important medical knowledge that could help other patients with your medical condition or other
medical problems in the future. If you decide to participate in the specimen bank, you will be
given a copy of this consent form after you sign it. A copy will be kept with your records from
the Main Study and/or with your Lifespan hospital medical records. The rest of this consent form
provides additional information about how your Specimen will be used and protected.

     A. Confidentiality and Privacy of Medical Record

If you sign this form, you give Lifespan permission to store your Specimen in a Lifespan
controlled specimen bank, along with portions of your personal health information collected
related to the Main Study. This information could be used to link the specimen back to you.
Lifespan will protect your confidentiality by making sure that no information that could be used
to identify you will be used or disclosed by Lifespan without your authorization or without
legally required protections in place. The following rules will apply:

       The (PI or Lifespan Hospital) in charge of the specimen bank will determine for which
research studies to release all or part of your Specimen.

     1) In most cases, your Specimen will be 'de-identified'; that is, the researcher who is given
        your Specimen will not be given enough information to identify you. In these cases, you
        will not be contacted prior to your Specimen being released to the researcher.



ORP 07/09                               Page 1 of 3              Internal Specimen Banking Form
                                                                   Study Volunteer Initials ______


     2) Your authorization would not be required for researchers to use partially de-identified (in
        accordance with legal standards) Specimens for future research studies; however, such
        researchers would be required to sign a Data Use Agreement, which would protect your
        privacy by limiting how they could use your Specimen.

     3) If an approved researcher wants to use your Specimen and feels that is important that he
        or she be able to identify you to a) Collect information about you that was not collected
        as part of your participation in the Main Study; or, b) Collect additional samples of your
        blood/body fluid/tissue then this would be considered using an identifiable Specimen
        (meaning the Specimen could be linked back to you). In that case, someone associated
        with Lifespan will contact you to provide further information about the proposed study so
        you can decide whether you will agree to participate. If you decide to participate, you
        will then be contacted by a researcher for the new study and asked to sign a separate
        consent form for that study. Lifespan will apply state and federal legal standards in
        making decisions about who can review your records in preparing for the study and about
        who can contact you to provide information about the new study.

     4) It is possible that your Specimen could be used for future research purposes without your
        consent or authorization if a committee of people who know about research, privacy and
        medical ethics (such as a Lifespan Institutional Review Board or IRB) decided that use of
        your information is necessary and that use of it would be of low risk to you and your
        privacy.

Lifespan will ensure that all specimens stored at Lifespan will be kept confidential and only
shared by Lifespan in accordance with the above rules; no other people, including relatives or
your personal doctors, will have access to the stored samples or information about them without
your written consent; and appropriate physical and computer security measures will be
maintained to limit access to Specimens.

Papers or articles written by a Lifespan researcher which are based on studies involving your
Specimen will not identify you by name.

B.      Control and Ownership of the Specimen(s)

By consenting to participate in the specimen bank, you authorize the banking of your Specimen
for research conducted in accordance with the rules described above. There is a very remote
possibility that your Specimen may become part of a process or product that ultimately has
commercial value. For instance, the Specimen could be used to establish a cell line (a group of
cells that are able to reproduce, sometimes indefinitely) that could be patented and licensed.
There are no plans to provide financial compensation to you should this occur.

If you should have a need for the Specimen at some later date for a medical purpose, it usually
can be removed from the specimen bank for that purpose unless there is no specimen left.

C.      Withdrawal of Your Consent




ORP 07/09                               Page 2 of 3              Internal Specimen Banking Form
                                                                   Study Volunteer Initials ______


If you decide at some time in the future that you no longer wish your stored Specimen to be used
in future studies, you have the right to request that the Specimen be withdrawn from the
specimen bank. However, withdrawal cannot be guaranteed and may be impossible. For
example, it is possible that the Specimen might no longer be identifiable as belonging to you, or
that it might already have been released for research studies and used up. To request withdrawal
of the Specimen from the specimen bank, please write to [insert name and address of Principal
Investigator/Researcher].

D.     Length of Storage

Specimens in the bank will be stored for an indefinite period of time, until research funding is
exhausted or the Specimen is no longer usable. The sample may also be used to create a cell
line, which would also be stored for an indefinite period of time.

E.     Signature

You have the right to refuse to sign this form. If you do not sign this form, none of your health
care outside the study, or the payment for your health care, or your health care benefits will be
affected. Refusing to sign this form will not affect your ability to participate in the Main Study.
However, if you do not sign this form, you will not be able to enroll in the specimen banking
research study described in this form

If you chose to sign, your signature below indicates that you have read this form and discussed it
with researchers associated with the Main Study, and that you wish to participate in the specimen
bank in accordance with the terms described in this form.



Participant’s Signature                                              Date


                                                      ________________________
Witness (only if consent presented orally)                        Date



Participant’s legal representative                                   Date
(If patient unable to sign)




ORP 07/09                               Page 3 of 3              Internal Specimen Banking Form

				
DOCUMENT INFO