Consent for Cryopreservation
CRYOCARE FOUNDATION
1013 Centre Road
Suite 301
Wilmington, Delaware 19805-1297
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1. I, ______________________________ (the Client),
concurrent with an agreement to transfer my human remains to
the CryoCare Foundation (CryoCare), authorize CryoCare, its
agents, assistants, associates, employees, volunteers, and
physicians to provide and perform the experimental procedure
of post-mortem cryogenic preservation (cryopreservation) on
my human remains, in the hope that at some future date the
science of medicine will have advanced to the point where it
permits my restoration to life and health. I further affirm
my desire to have the procedure of cryopreservation begun as
soon as possible after the moment of my legal death, to limit
the deterioration of my human remains.
2. I also desire that the transfer of my human remains
should contribute to the scientific and medical research
needed in order to prove and perfect the process of human
cryopreservation.
3. I hereby authorize any procedures such as
cardiopulmonary resuscitation, anesthesia, pathology,
radiology, perfusion, blood transfusion or substitution;
organ transplantation (including transplantation of the
central nervous system in whole or in part into a host body);
cloning; augmented or tissue regeneration; disassembly,
repair, refabrication, or replacement of any body components
(including cells, tissues and organs); or any other ancillary
procedures judged necessary during my cryopreservation, long-
term cryogenic care, or, if it occurs, my restoration to life
and health.
4. I specifically authorize CryoCare and/or its assigns
to attempt revival of my human remains (unless otherwise
provided for in my Cryopreservation Agreement with CryoCare)
when, in CryoCare's best judgment, it is determined that
attempting revival is in my best interest.
Should such attempt to revive me fail, I authorize and
instruct CryoCare (if there are sufficient resources
available for CryoCare to do so) to return me to
cryopreservation or use whatever alternative preservation
technologies that may be available to CryoCare at that time
which in CryoCare's best judgment offer me continued hope for
restoration to life and health.
5. I authorize CryoCare to do non-destructive testing
on, and take non-vital samples from, my human remains after
legal death and/or cryopreservation and/or during my long-
term cryogenic care. It is understood that this testing
shall be carried out to improve cryopreservation techniques
and our understanding of cryobiology.
6. In the event that my cryopreservation must cease, I
authorize CryoCare to undertake alternative methods for
preservation of my human remains, including, but not limited
to, chemical preservation and conventional interment or
entombment.
7. I understand and accept that cryopreservation is not
consistent with contemporary medical or mortuary practice. I
understand that many physicians, cryobiologists, and
scientists in other disciplines discount any reasonable
possibility that cryopreservation will be successful. I also
understand that the legal status and tax status of
organizations performing cryopreservations and of those
persons whose human remains are cryopreserved are still being
tested and clarified in the courts.
8. I understand and accept that:
a) There are no guarantees that this procedure of
cryopreservation will be successful in preserving me
sufficiently well to permit me to be returned to life and
health;
b) due to the possibility of events beyond CryoCare's
control, there are no guarantees that my human remains will
ever be cryopreserved or will be in cryogenic care
indefinitely if they are cryopreserved;
c) there are no guarantees that any attempt will ever be
made to restore me to life and health or that any such
attempt will be successful;
d) CryoCare cannot predict the possible legal, economic,
and other changes or problems which might make
cryopreservation, long-term cryogenic care, or future
restoration to life and health illegal or impractical;
e) I am transferring my human remains and funds for an
experimental procedure for which there is no known
probability of success. It is possible that this
experimental procedure will benefit the advancement of
knowledge generally, without specifically benefiting me;
f) CryoCare is a corporation with limited resources.
9. I understand and accept that the dying process and
the process of cryopreservation will result in damage to my
body on the molecular, cellular, tissue, and organ levels
which is currently considered irreversible. I understand and
acknowledge that the damage experienced with the existing
cryopreservation techniques currently employed by my
cryopreservation service provider (as such damage is
currently understood) includes but is probably not limited to
the following:
9.1 Ischemic Injury. Currently, cryopreservation
procedures cannot begin until after the patient has been
pronounced legally dead by a qualified physician. In
practice this means that the patient will frequently
(although not always) experience an ante mortem period of
deep shock (inadequate blood flow: ischemia) which will be
injurious to most body organs, and especially the brain.
This ante mortem ischemic period can result in altered
capillary permeability (injury to small blood vessels
supplying body tissues), edema (fluid accumulation), and
injury to vital organs.
Following cessation of heartbeat and breathing (legal
death), there will likely be an interval of minutes to hours
(depending upon the individual circumstances) during which
blood circulation will be absent or inadequate. Disruptions
in cell and tissue functions and structures which are by
current medical criteria considered irreversible and which
may remain irreversible, may occur during this interval
despite CryoCare's and its cryopreservation service
provider's best efforts to prevent, minimize, or reverse
these insults.
Currently, the medically accepted limits for recovery of
humans from circulatory arrest (at normal body temperature)
without neurological deficits are in the range of 4 to 6
minutes. As it is practiced today, even under the best
conditions, it is probable that the patient will experience
an ischemic period of at least 6 to 10 minutes before
stabilization procedures which are designed to halt or
reverse ischemic injury can begin. Furthermore, the
effectiveness of such stabilization procedures for any given
patient is unknown. Injuries as a result of ischemia which
are currently known to occur include (depending upon
duration) but are probably not limited to:
a) clumping of the chromatin (genetic material) in the
cell nucleus;
b) altered permeability of the capillaries in the body
and in the blood-brain barrier, causing the leakage of blood
plasma proteins, and resulting in tissue swelling when
circulation is restored, thus interfering with distribution
of cryoprotective drugs during perfusion;
c) free radical damage to the cell membrane and other
cell components;
d) influx of calcium into the cells resulting in the
activation of phospholipases which degrade the cell membrane;
e) calcium precipitation in the mitochondria and
swelling of the mitochondria;
f) release of toxic levels of neurotransmitters which
exacerbate brain cell injury;
g) loss of critical balances and concentrations of cell
biochemicals such as ATP, sodium/potassium ratio, and Ph;
h) accumulation of injurious chemicals (lactic acid,
xanthine oxidase, free iron, and others) which directly or
indirectly injure the cell during ischemia and which can
cause added injury when circulation is restored;
i) spasm of arteries and arterioles resulting in failed
circulation when blood flow is restored, which can interfere
with adequate distribution of cryoprotective agents;
j) release of damaging lysosomal enzymes which can
degrade or destroy cell structures;
k) clotting of blood, which interferes with restoration
of circulation and distribution of adequate amounts of
cryoprotective agents.
9.2 Cryoprotectant Perfusion Damage. Even before
freezing begins, cryoprotectants are delivered to the brain
and other body organs in high concentrations. This process
requires considerable time and imposes stresses that may
include:
a) osmotic opening of the blood-brain barrier (tearing
of junctions between capillary cells);
b) likely washout of some protein from damaged or
ruptured cells;
c) derangements of the levels of critical cell
biochemicals and electrolytes;
d) osmotic injury to tissue between regions which are
well-perfused and those which may not perfuse well (i.e.,
cells may swell and become "leaky" if they absorb water from
poorly perfused "dilute" adjacent areas);
e) damage to the fine structure of the cell membrane,
such as the formation of blebs or blisters (separation of the
membrane from the cytoplasm (cell substance)) and alterations
in the arrangement of or loss of the proteins which are
normally present in the cell membrane.
f) loosening of the chromatin structure (which contains
DNA).
9.3 Biochemical/Biophysical Freezing Damage. The
combination of cellular shrinkage, lowered temperature, and
elevated concentrations of cryoprotective agents such as
glycerol may cause:
a) loss of lipids from the cell membrane. (In other
words, the cell membrane may be disrupted and lose material);
b) loss of key membrane proteins responsible for
regulating cell function and perhaps encoding memory;
c) damage to hydrophobic (water insoluble) membrane
proteins;
d) formation of deleterious chemical bonds (most
commonly disulfide bonds) between vital cell proteins or
other cell molecules;
e) leakage of important electrolytes and other molecules
into and out of body cells;
f) precipitation of some chemicals and proteins critical
to cell function (i.e., some enzymes, structural proteins,
and buffers);
g) release, during freezing, of destructive enzymes that
can break down cell structure and that could therefore pose
serious problems upon rewarming;
h) alteration of the arrangement of the lipids (fats) in
the cell membrane during cooling and freezing such that the
normal sheet-like structure of the membrane is re-organized
into patches of tangled tubules, rendering the membrane
nonfunctional and permeable (Hex II) reorganization.
9.4 Mechanical Freezing Injury. Several kinds of
mechanical injury to tissues, as a result of ice formation,
could occur, such as:
a) tissue level ripping, twisting, and fraying of the
ripped ends of nerve tracts by the contraction of brain cells
and by the push of extracellular ice (creating debris-strewn
gaps of perhaps 5 to 100 microns in width), (similar kinds of
damage can be expected in other organ systems as well, such
as the disruptions of muscle fiber bundles, rupture of kidney
tubules, etc.);
b) disruption of the junctions between cells;
c) fracture and separation of fractured halves of cells,
axons, dendrites, capillaries, and other brain elements by
gaps in the millimeter range after the temperature drops
below the glass transition point, (similar gross fractures in
the millimeter range will occur in other body organs as
well);
d) separation of capillaries from surrounding brain
tissue;
e) physical disruption of the capillaries due to
intracapillary ice formation (rupture of the capillary wall,
tearing of the capillary endothelial cells, and stripping of
the capillary endothelial cells from underlying capillary
wall material), resulting in incompetent vessels;
f) stripping of myelin from axons, formation of gaps
between the axon membrane and the myelin, unraveling of the
myelin, and possible tearing of the axolemma, resulting in
loss of intra- axonal material.
I understand and accept that if it is not possible to
carry out cryoprotective perfusion, the damage described
above as a result of the freezing process will be far more
serious.
10. I understand and accept that if I am revived from
cryopreservation I may experience a wide range of
psychological and social problems and traumas as a result of
the disease process which preceded cryopreservation, the
dying process, the cryopreservation procedure, and/or the
revival and restoration procedures, including but not limited
to:
a) complete or partial loss of memory, skills and life
experiences with consequent compromise of personal identity;
b) neurological deficits which may result in
depersonalization, and/or emotional, physical, or social
handicap;
c) loss of organ systems or body parts or substitution
by prosthetic organ systems or body parts which results in
psychological and/or emotional harm;
d) grief, loneliness, and social maladjustment as a
result of separation from and/or permanent loss of loved
ones, friends, and work or social position;
e) "culture shock," the inability to adapt to changed
social and cultural circumstances as a result of temporal
displacement while in cryogenic care;
f) poverty, as a result of inability to adapt to earn a
living, or as a consequence of physical or psychological
deficits secondary to cryopreservation and revival;
g) loss of personal freedom and/or indebtedness, as a
result of legal, social, and political conditions affecting
persons recovered from cryopreservation;
h) exposure to legal action, embarrassment, and/or loss
of privacy as a result of technology incidental to revival
which may allow access to personal memories.
11. I understand and accept that my choice of
cryopreservation may limit, interfere with, or exclude
completely my participation in programs of experimental
medical treatment/research. I understand that exclusion from
such treatment/research programs may result from my refusal
to consent to autopsy (since the requirements of medical
research may necessitate a post-mortem examination), from the
unwillingness of the treating institution to become involved
with cryopreservation, as a result of prejudice against
cryopreservation, or as a result of a combination of some or
all of these factors.
12. I understand and accept that my choice of
cryopreservation currently precludes my participation as an
organ donor for purposes of transplantation.
13. I understand and accept that my choice of
cryopreservation may affect the type and extent of the
medical care I receive. Some physicians or medical
facilities may refuse to treat or admit me because of my
arrangements for cryopreservation, or may require that I be
transferred to another, perhaps less suitable medical
facility for treatment and care.
Further, I understand and accept that CryoCare, my
Health Care Agent, my family, or others empowered to do so
may request the application of life-sustaining medical
treatment which may cause discomfort or extend the dying
process so as to prolong my life long enough to facilitate my
cryopreservation under good conditions (i.e., the use of
"heroic" measures to sustain me in order to allow the
cryopreservation team to arrive at my bedside).
Conversely, I also understand and accept that there may
be some risk that some physicians and medical facilities may
refuse to respect my requests for termination of life-support
technology or to grant me "no heroic measures" or "do not
resuscitate" (i.e., no-code) status as a result of fear,
ignorance, or prejudice against cryopreservation.
14. If I have selected the neuro-cryopreservation
option, I understand and accept the following:
a) Because my body will be discarded and destroyed
during the neuro-cryopreservation process, I will necessarily
have to rely upon the development of technology capable of
regeneration, regrowth, cloning and implantation, or grafting
of my head or brain into a host body. I understand and
accept that such technologies may never be developed.
b) I may be revived using a prosthetic body or life
support system which I may find undesirable or unacceptable.
c) There may be loss of identity-critical
structure/information when my body is discarded.
d) Technological advances required to revive and restore
neuro-cryopreservation patients may take longer and/or cost
more to develop than those required to revive and restore
whole body cryopreservation patients, resulting in my
remaining cryopreserved longer or failing to be revived from
cryopreservation at all.
e) Social, political, and ethical objections to neuro-
cryopreservation or to the technology required to revive
neuro-cryopreservation patients may result in problems which
could delay my revival.
15. If I have selected the whole body cryopreservation
option, I understand and accept the following:
a) I may be subjected to more injury from the
cryopreservation process as a result of longer perfusion and
cooling times.
b) Due to the greater costs and logistic difficulties
associated with whole body cryopreservation, I may not remain
cryopreserved under adverse political, economic, and/or
social conditions outside the control of CryoCare.
d) Due to the need to repair/rejuvenate the entire body,
it may require more resources to effect revival of whole body
cryopreservation patients or it may cost more, which could
delay or prevent my revival.
16. I understand and accept that, in the event that the
CryoCare Board of Directors determines that my continued
cryogenic care as a Whole Body Cryopreservation patient is
impossible, I may be converted from whole body
cryopreservation to neuro-cryopreservation as an emergency
procedure if, and only if, no other alternative exists to
continue my cryopreservation.
17. With full understanding of these conditions, I
consent to my cryopreservation upon my legal death, and to my
attempted restoration to life and health in the future.
SIGNATURE OF CLIENT
MY SIGNATURE BELOW CONFIRMS MY ACKNOWLEDGMENT THAT:
1. I have read, understood, and consented to all of the
foregoing provisions of this CONSENT FOR CRYOPRESERVATION.
2. I am fully aware of and accept the risks and
limitations explained in this document.
3. The proposed research procedure(s) have been
satisfactorily explained to me by the officers,
representatives, and/or other personnel of CryoCare.
4. I declare that the arrangement described herein, in
conjunction with the Cryopreservation Agreement and the
Authorization of Anatomical Donation, constitutes my last
wish as to the disposition of my human remains after legal
death.
5. I hereby give my authorization and consent.
_________________________ ______________________________
Signature of Client Responsible person if Client is
unable to sign or is an unemancipated
minor or otherwise incompetent.
_________________________
Date
__________________(a.m./p.m.) ______________________________
Time Relationship to Client
WITNESSES' SIGNATURES
Two (2) witnesses are required to sign in the presence of each other and
the Client. At the time of signing, witnesses must not be relatives of the
Client, health care providers of any kind, or officers, directors, or agents
of CryoCare.
YOUR SIGNATURE AS A WITNESS CONFIRMS YOUR ACKNOWLEDGMENT THAT:
1. You have witnessed the signature of the Client on this document and
that the Client has represented to you that s/he understands and agrees
to the purposes and terms of this document.
2. The Client has declared to you that cryopreservation is his/her last
wish as to the disposition of his/her body and person after legal death.
WITNESSED THIS _______ DAY OF _____________________, 19__________
TIME ______________(a.m./p.m.)
1. Signature ____________________________________________
Printed ____________________________________________
Address ____________________________________________
____________________________________________
2. Signature ____________________________________________
Printed ____________________________________________
Address ____________________________________________
____________________________________________