+-----------------+---+-------------------------------------------------+
|                 |   | Study on\                                       |
|                 |   | Informed Consent for                            |
|                 |   |                                                 |
|                 |   | Spaceflight Participants                        |
|                 |   |                                                 |
|                 |   | Document Number: APT-CFA-230-0001-02F           |
|                 |   |                                                 |
|                 |   | September 26, 2008                              |
+-----------------+---+-------------------------------------------------+

#  {#section .unnumbered}

#  {#section-1 .unnumbered}

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#  {#section-4 .unnumbered}

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# LIMITATIONS/DISCLAIMER:

Within the scope of the engineering analysis reported here, A-P-T
Research, Inc. warrants that we have exercised our best professional
efforts at analyzing hazards and formulating conclusions. However, we
must specifically disclaim any warranty, expressed or implied, that
hazards will be completely eliminated or mishaps will be completely
avoided or that any particular standard or criterion of hazard or mishap
elimination or risk reduction will be achieved if the information
presented here is taken as guidance. We do not accept liability for any
loss, damage, or injury resulting from the use of this information.

As regards the legal analysis presented here, it is important for you to
understand that the general opinions and commentary that are expressed
in this report and its attached materials are NOT intended to be legal
advice. The contractors have tried to identify appropriate cases and
areas of law that impact the general field of informed consent in the
context of the emerging commercial human space flight industry, but some
information may have been missed or may be misinterpreted by us.
Interpretations of the law are inherently subjective. Also, the law is
in a constant state of flux and may change by the time you view or read
these materials. Reading the attending materials is for educational
purposes only and does not establish any type of recommendations from us
to you on your own course of conduct nor does it establish any type of
attorney client relationship between the contractors and yourselves.
This information is intended to provide, to the best of our knowledge,
accurate and authoritative information; we do not nor can we, however,
guarantee the accuracy of the information contained in any of these
materials. You should work with experienced legal counsel to provide
advices on the law in your state or other related legal issues that may
impact matters specific to your operation(s).

TABLE OF CONTENTS

**LIMITATIONS/DISCLAIMER: [ii](#limitationsdisclaimer)**

1.0. PURPOSE [1](#purpose)

2.0. DEFINITIONS [1](#definitions)

2.1. Scientific/Mechanical [1](#scientificmechanical)

2.2. Legal [2](#legal)

3.0. BACKGROUND DISCUSSION [2](#background-discussion)

4.0. INFORMED CONSENT IN A LEGAL CONTEXT
[4](#informed-consent-in-a-legal-context)

4.1. The Phrase "Informed Consent" as it Derives from the Legal Context
[4](#the-phrase-informed-consent-as-it-derives-from-the-legal-context)

4.2. Combining "Informed Consent" in Commercial Human Spaceflight with
the Traditional Legal Framework of "Informed Consent" as Basis for
Recommendations
[7](#combining-informed-consent-in-commercial-human-spaceflight-with-the-traditional-legal-framework-of-informed-consent-as-basis-for-recommendations)

5.0. SUMMARY AND RECOMMENDATIONS FOR SATISFYING REGULATORY REQUIREMENT
[9](#summary-and-recommendations-for-satisfying-regulatory-requirement)

6.0. HAZARDS [15](#hazards)

6.1. Physical Hazards to Spaceflight Participants
[16](#physical-hazards-to-spaceflight-participants)

6.1.1. High G Forces [19](#high-g-forces)

6.1.2. Microgravity [20](#microgravity)

6.2. Psychological Response Hazards
[22](#psychological-response-hazards)

6.3. Summary of Identified Potential Effects on Spaceflight Participants
(SFPs)
[22](#summary-of-identified-potential-effects-on-spaceflight-participants-sfps)

7.0. FINAL SUMMARY AND "NEXT STEP" RECOMMENDATIONS:
[26](#final-summary-and-next-step-recommendations)

8.0. HAZARDS REFERENCE [27](#hazards-reference)

**List of TABLES**

[Table 1. **Summary of Physical Hazards to Spaceflight Participants**
16](#__RefHeading___Toc210194331)

[Table 2. **Summary of Psychological Response Hazards**
22](#__RefHeading___Toc210194332)

[Table 3. **Potential Hazards - Probability of Occurrence**
23](#__RefHeading___Toc210194333)

[Table 4. Potential Hazards - Severity of Consequence
25](#__RefHeading___Toc210194334)

# PURPOSE

This research project was initiated by FAA/AST to examine the issue of
what a commercial space flight operator will need to do to satisfy the
regulatory requirements of 14 CFR Part 460, specifically at
§460.45(a)(1). APT Research, Inc. and Knutson & Associates were asked to
research what is required to obtain or effectuate informed consent and
to help educate the commercial space flight industry on the requirements
of obtaining informed consent from space flight participants (SFPs). At
§460.45(a)(1) the federal regulations require that the spaceflight
participant be informed of each known hazard and risk that may result in
serious injury, death, disability or total or partial loss of physical
or mental function.

This study discusses, based on current industry practices and based on
current legal precedents, the level of detail which should be used to
describe the hazards and risks to a prospective space flight participant
in order to satisfy the regulatory requirements. Additionally, this
report describes the hazards and risks, as they are currently understood
and contemplated, associated with suborbital commercial human space
flight.

This study is not intended to be used as a legal template or considered
to be a final authoritative FAA/AST-approved document. It does not cover
any waiver of claims, exculpatory agreements, or similar agreements
between the participant and the company providing the launch service.
The purpose was to study the process of informing the participant of the
hazards and risks, not the process of waiving liability. Very
specifically, readers should understand that the mandate of informed
consent is statutory and regulatory, so the focus of this study is
simply how informed consent can be satisfied. This paper does not take
any position on whether fulfillment of that mandate provides risk
shifting or defenses from claims and this study makes no inquiry into
other areas of risk shifting or defense such as release and waiver
contracts or other common law defenses.

# DEFINITIONS 

## Scientific/Mechanical 

RISK -- Risk characterizes the degree of harm posed to an asset (person,
property, etc.) expressed as an Expectation of Loss that combines the
potential Severity and the Probability of a loss event.

PROBABILITY -- Probability is an expression of the likelihood of a loss
event. Probability has no dimension and is therefore meaningless unless
attached to a unit of exposure such as: hours of operation, miles
driven, flights flown, widgets produced, etc.

SEVERITY -- Severity is an expression of the magnitude of loss or harm
associated with a potential event.

## Legal

NEGLIGENCE - Negligence under the law is generally defined as the
failure to use ordinary care; that is, failing to do what a person of
ordinary prudence would have done under the same or similar
circumstances. Essentially we are looking to determine whether an
operator, guide or land administrator could or should have recognized an
unreasonable risk and then did nothing to warn the participant or to
reduce or eliminate the unreasonable risk. To examine negligence in
behavior or conduct, look for 2 things: was the risk foreseeable and was
the risk unreasonable.

DUTY - Duty generally refers to one party's responsibility to take
reasonable care for the protection of another party. Duty has 3 primary
origins: 1.) from a relationship inherent in the situation; 2.) from a
voluntary assumption; or 3.) from a duty mandated by a statute or
regulation of some sort.

INHERENT RISK - Providers or operators have no duty to protect
participants from inherent risks and no corresponding liability for
injury or loss resulting from those inherent risks. Courts vary in their
interpretation of this as a common law doctrine. Some hold that a
participant doesn't need to know and understand, in advance, the
particular inherent risk. Others hold that participants have to have
some type of subjective understanding of the specific risk causing the
injury before the doctrine applies.

# BACKGROUND DISCUSSION

*The Phrase "Informed Consent" as it Applies to Commercial Human
Spaceflight*[^1]

In drafting the Commercial Space Launch Amendments Act of 2004 (CSLAA),
Congress found that: space transportation is "inherently risky" and that
the public interest would be served by creating a "clear legal,
regulatory and safety regime."[^2] Congress also said that launch
licensees/permittees (the operators) would have to obtain written
"informed consent" from SFPs.[^3] On December 15, 2006, the FAA[^4]
published Human Space Flight Requirements for Crew and Space Flight
Participants[^5], as Congress required in the CSLAA.[^6] The FAA's final
rule, which became effective on February 13, 2007, expressly states that
"\...*before* receiving compensation *or* agreeing to fly a space flight
participant, an operator must inform each space flight participant *in
writing* about the risks of the launch and reentry vehicle type. For
each mission an operator must inform a space flight participant, *in
writing*, of the known hazards and risks that could result in a serious
injury, death, disability or total or partial loss of physical and
mental function\...\[and\] an operator should inform a space flight
participant that there are also unknown hazards\.... The operator also
must disclose that participation in space flight may result in death,
serious injury, or total or partial loss of physical or mental function.
An operator must inform each space flight participant that the United
States Government has not certified the launch vehicle and any re-entry
vehicle as safe for carrying crew or space flight participants."[^7]
(Emphasis added.) This constellation of warnings the operators must give
the space flight participants (SFPs) is what Congress and the FAA are
calling "informed consent."[^8] With respect to SFPs, the commercial
human space flight industry is not required to obtain medical clearance
on the space flight participants and must only give the written warnings
noted above and obtain the participant's written consent to
participate.[^9] But note that the regulations also require what appears
to be safety type discussions or question and answer sessions between
the operator and the SFP.[^10] These two things, written consent and
oral questioning of the operator, are clearly intended to achieve some
type of "cognizance test" or "\...affirmation that the space flight
participant understands what he or she is getting into before embarking
on a mission."[^11]

# INFORMED CONSENT IN A LEGAL CONTEXT

## The Phrase "Informed Consent" as it Derives from the Legal Context 

Informed consent documents derive most commonly from medical or
therapeutic regimes and these documents record that treatment risks have
been disclosed and consent to the treatment has been obtained.[^12] If
appropriate consent is in place then the medical or therapeutic provider
has some protection from claims made regarding the "inherent risks" of
the treatment, but no protections from negligence claims.[^13] What
makes informed consent unique is that something is *done to* the
participant by another party (usually the medical provider) with the
participant's consent.[^14]

The right of a patient to informed consent has been a staple of U.S.
medical malpractice law for over three decades.[^15] In order to
establish a (prima facie) case that he or she has been deprived of
informed consent, a claimant must prove that: 1) a doctor [failed to
disclose a material risk]{.underline} of the therapy undertaken or
reasonable alternatives to it; 2) that [the patient would have chosen
against]{.underline} the recommended therapy; and 3) that as a result of
the therapeutic intervention [the patient suffered
harm/injury]{.underline}.[^16] (Emphasis added to highlight application
to current discussion on human spaceflight.)

> Courts differ as to the standard that governs the determination of
> whether a risk is material such that it warrants disclosure to the
> patient. Some jurisdictions measure materiality based on what
> information a 'reasonable doctor' would provide. Others refuse to cede
> to the medical profession the decision of what risks ought to be
> disclosed. Emphasizing that at the heart of an informed consent right
> is patient autonomy, they opt for a 'reasonable patient' standard to
> determine materiality. With regard to causation, courts are also not
> in agreement. Some require that for the causal nexus to be met, a
> plaintiff must establish that a 'reasonable patient' would have chosen
> against the therapeutic intervention. Other courts take the position
> that if the patient herself would have chosen otherwise, causation is
> established.
>
> Commentators have argued that requiring the plaintiff to prove what
> decision would have been made had the material information been
> communicated to the plaintiff undercuts the goal of patient autonomy.
> The undeniable fact is that the patient was not provided with the
> information necessary to decide whether to undergo the therapy. The
> physician proceeded unilaterally. Though this argument is
> theoretically sound, as a practical matter the issue of decision
> causation is rarely decided against plaintiffs as a matter of law. It
> is almost always given over to the sound discretion of juries. The
> requirement that the plaintiff establish the causal connection between
> the therapeutic intervention and the injury actually suffered is
> almost never a matter of contention. Indeed it is only when the
> plaintiff suffers from the undisclosed risk that the plaintiff is
> moved to bring suit. The damages for failure to provide informed
> consent are measured by the unwarned-against adverse outcome that the
> plaintiff suffered.[^17]

It *is* generally accepted that the doctrine of informed consent is
rooted in the principle that every person has the right to determine
what shall be done to his (or her) own body. See, [Schloendorff v.
Society of New York Hospitals]{.underline}, 105 N.E. 92 (1914). "True
consent to what happens to oneself is the informed exercise of a choice,
and that entails an opportunity to evaluate knowledgeably the options
available and the risks attendant upon each." [LaCaze v.
Collier]{.underline}, 434 So. 2d 1039 (1983).

Looking at a few individual cases clarifies some of these issues and
highlights the effect of traditional informed consent. In a Louisiana
case entitled [Hondroulis v. John Schumacher, M.D.]{.underline}, 521 So.
2d 534 (1988) an appellate court examined the specificity that needed to
be in an informed consent document. The Hondroulis case involves a woman
who signed a consent form prior to undergoing a lumbar laminectomy; when
the procedure resulted in permanent complications the woman sued the
doctor, claiming among other things, that the doctor had not obtained
her informed consent because he had failed to disclose the specific
complication she suffered after the surgery (the consent form expressed
that she could suffer loss of function of bodily organs, paralysis and
loss of function of any arm or leg; she specifically experienced loss of
bladder control and left leg numbness). The Hondroulis court quoted from
a state statute defining informed consent (to medical treatment) as
being "*a consent in writing to any medical or surgical procedure or
course of procedures which (a) sets forth in general terms the nature
and purpose of the procedure or procedures, together with the known
risks, if any, of death, brain damage, quadriplegia, paraplegia, the
loss or loss of function of any organ or limb, of disfiguring scars
associated with such procedures or procedures, (b) acknowledges that
such disclosure or information has been made and that all questions
asked about the procedure or procedures have been answered in a
satisfactory manner and (c) is signed by the patient for whom the
procedure is to be performed."* The claimant, Hondroulis, then
challenged the court by saying that the statutory language (and
therefore the consent form which the doctor had required her sign and
which tracked the state statute language) was not adequate to obtain her
informed consent where it did not name the particular/specific organ or
limb that was damaged as a result of her surgery. The reviewing court
found that where the informed consent document that was given to
Hondroulis tracked the language of the state statute it was considered
legally adequate. Very specifically the reviewing court found that
"...*the requirement of specific disclosure of all organs that are known
to be at risk during a surgical procedure would do violence to the
legislative intent to provide a clear statutory test for informed
consent. If we place this requirement on health care providers, whatever
certainty was created by \[the statute\] would be destroyed, forcing
doctors and hospitals to compile long lists of every possible body organ
which could be affected by any given medical procedure.... Faced with
this list, which would resemble a book on anatomy, a patient's consent
would not be any anymore informed than if a form which tracks the
statutory language was read to or by the patient before consent was
obtained."* The Hondroulis decision also made clear that written
informed consent (under the LA statute) had to include an
acknowledgement that the medical care recipients' questions had all been
answered in a satisfactory manner.

The Hondroulis case stands for the proposition that both parties to a
transaction (here health care provider and patient) are involved in a
"give and take." Specifically, health care providers (at least at the
time the Louisiana legislature passed its medical informed consent
statue) were seeking some certainty in how they informed patients and
that, in exchange for them ensuring that basic information on risks were
transferred to the patient, then some relief from liability would be
afforded. The case recognizes the (Louisiana) legislature's earlier
statutory attempt to balance the rights of patients and the rights of
the physicians. The case also recognizes that too much information is
not helpful to a patient with limited medical knowledge and that,
because medicine is not an exact mechanical science, doctors may not be
able to predict each and every possible effect to a patient. And
finally, the requirement that a patient be given the opportunity to ask
questions and receive satisfactory answers must be acknowledged in the
written informed consent document.

In a 1995 case, a Texas court discussed the constitutionality of a state
statute that required only minimum style disclosures and found that
"*Disclosure of risks in compliance with the statute creates a
rebuttable presumption that the physician was not negligent..*."\[and\]
"...*only material risks need be disclosed; a physician cannot be
expected to disclose all risks, including those for which the risk is so
minimal that it would not influence a reasonable person's decision."*
See, [Pennick v. Chritensen, M.D., Pfizer Hospital Group, et
al]{.underline}. 912 S.W. 2d 276 (1996).[^18] The Pennick Court, quoting
the earlier case of [Peterson v. Shields]{.underline}, 652 S.W. 2d 929
(1983), expressly stated that the "...*disclosures provided by statute
are governed by the same standard as under common law: a patient is
entitled to know those risks that could influence a reasonable person in
making a decision to consent to the procedure in question*."

It is also notable that the legal cause of action for (violation of...)
the duty to obtain informed consent stands separate and apart from a
claim that the (physician) operator or defendant was negligent in either
recommending or performing a given action.[^19] As such, the use of the
phrase "informed consent" as it has been used by Congress and the FAA
(as opposed to simply requiring operators to comply with a negligence
based "duty to warn;" see, §3.2, below) has most likely created a
separate independent tort or cause of action against commercial
operators.

## Combining "Informed Consent" in Commercial Human Spaceflight with the Traditional Legal Framework of "Informed Consent" as Basis for Recommendations

It is first important to understand that Congress expressly stated that
the emerging commercial human space flight industry was not to be viewed
as highly regulated transportation like the airline industry but rather
was comparable to adventure travel;[^20] Congress even went so far as to
compare the participants to daredevils, visionaries and
adventurers.[^21] In stating that space flight is inherently risky,
Congress mandated at 49 USC §70105(b)(5)(A-C) (Supp. 2004) that space
flight participants must be informed of the risks of spaceflight and
must sign an informed consent form. It is fairly clear that Congress'
real concern with commercial human space flight was not in presenting
the infant space flight industry as a provider setting out to "do"
anything to participants (see, discussion above at §3.1, pg. 7) but
rather as a young industry that had no established community standards
or customary practices so that the importance of warning participants of
the risks and dangers was very recognizable. As such, it seems that
Congress really intended to impose on operators a statutory or codified
"duty to warn" when it used the phrase "informed consent." It is
important to note though, that we rarely see the phrase "informed
consent" actually used in the adventure sport context;[^22] more often
adventure sport operators (and the courts reviewing them when claims are
made) rely on negligence oriented principals or defenses such as
assumption of the risk and exculpatory documents like release and waiver
contracts. In the context of the emerging commercial human space flight
industry, however, because Congress used the phrase "informed consent"
and because that phrase has legal meaning, we extrapolate from the
common legal context in which informed consent normally appears (the
medical or therapeutic regimes).

According to the common law on negligence (standard duty to warn
analysis)[^23] as it has developed around the country, it is fair to say
that the *standard of care* for commercial recreation or adventure sport
operators is that they have a *duty* to inform/warn guests of the risks
that they are taking in participating in an activity.[^24] One of the
most common allegations in lawsuits against outdoor oriented operations
is that they "failed to warn" and "inform" participants of the risks
involved and/or failed to give adequate instructions. Operators must
inform guests of the risks that they are taking in participating in an
activity. It is clear that explaining/instructing/warning is really the
foundation of minimizing or mitigating risks associated with any
activity. Thus, the "standard of care" anticipates that a reasonable and
prudent commercial adventure operator carrying out the same activity
will inform a participant of the risks. With respect to delivering
warnings or informing participants (a form of risk management[^25]),
obviously there's a correlation in where you spend the most energy - at
the areas that produce the most frequent or the most severe risks.[^26]

With reference to the "informed consent" common law in the United States
and then with reference to the issue of a commercial adventure sport or
activity operator's "duty to warn," the following section provides
recommendations as to the level of detail and/or information that should
be provided or given to space flight participants to satisfy the
"informed consent" requisite found at 14 CFR §460.45 (2006).

# SUMMARY AND RECOMMENDATIONS FOR SATISFYING REGULATORY REQUIREMENT 

Again -- in the context of the developing commercial human space flight
industry, Congressional history and statutory interpretation make clear
that the purpose behind the current regulatory requirement that
commercial human space flight operators obtain written informed consent
from their perspective customers ("space flight participants" or
"SFP's") before exchanging funds or making further agreements or
contracts with them is intended to satisfy a more commonly recognized
"duty to warn." Specifically, it is intended to inform a SFP of risks
that may affect the SFP's own decision as to whether the activity and/or
the risks attendant with the activity are worth encountering. The clear
intent here is to arm the perspective SFP with enough information to
allow *them* to make the decision to participate and/or encounter these
risks.

A review of the case law and codified law (statutes) from around the
country[^27] on informed consent make the following premises clear.
First -- the basic parameters of informed consent are: "*a consent in
writing to any... procedure or course of procedures which (a) sets forth
in general terms the nature and purpose of the procedure or procedures,
together with the known risks, if any, of death, \[injury or other
damages\] (b) acknowledges that such disclosure or information has been
made and that all questions asked about the procedure or procedures have
been answered in a satisfactory manner and (c) is signed by the
\[participant\] for whom the procedure is to be performed."*[^28] As
such, the elements of a (prima facie) legal cause of action claiming
that an operator/provider breached the duty to obtain informed consent
and/or that a participant has been deprived of informed consent will
include claims that: 1) an operator/provider failed to disclose a
material risk of the activity undertaken or reasonable alternatives
(mitigation) to it; 2) that the participant would have chosen against
the activity had they been informed; and 3) that as a result of the
activity the participant suffered harm/injury.[^29] It is noteworthy
though, that courts find that only material risks need be disclosed; an
operator/provider cannot be expected to disclose all risks, including
those for which the risk is so minimal that it would not influence a
reasonable person's decision.[^30]

And, when considering whether informed consent has been obtained (and/or
given to the participant) courts routinely find that where there are
statutes or regulations in place that govern the amount of information
that must be given to a person from whom informed consent is being
sought and where a provider satisfies those statutory and regulatory
disclosure guidelines, there is created a presumption in favor of the
operator that informed consent was obtained.[^31] In other words,
compliance with statutory or regulatory wording is usually thought
sufficient to constitute informed consent. Second -- it is reasonably
clear that informed consent style disclosures are intended to contain or
discuss *material* risks, those risks that would influence a reasonable
person in making a decision to participate or to consent to
participation.[^32] Informed consent is not intended to include
disclosure of *all* risks and so will not require warnings for which the
risk is minimal enough that it wouldn't influence a reasonable person's
decision making process.[^33] Third, the regulations and case law on
informed consent also require that the participants be allowed an
opportunity to request information and to orally ask questions and
receive satisfactory answers to questions; that these opportunities have
been provided must be acknowledged in the written document.[^34]

The *express* language in the regulation currently states (paraphrasing)
that "\...*before* receiving compensation *or* agreeing to fly a space
flight participant, an operator must inform each space flight
participant *in writing* (the information has to be presented in a
manner that can be readily understood by a SFP with no specialized
education or training) about the risks of the launch and reentry vehicle
type. For each mission an operator must inform a space flight
participant, *in writing*, of the known hazards and risks that could
result in a serious injury, death, disability or total or partial loss
of physical and mental function\...\[and\] an operator should inform a
space flight participant that there are also unknown hazards\.... The
operator also must disclose that participation in space flight may
result in death, serious injury, or total or partial loss of physical or
mental function. An operator must inform each space flight participant
that the United States Government has not certified the launch vehicle
and any re-entry vehicle as safe for carrying crew or space flight
participants."[^35] According to the Final Rule, the written information
or warning must state that the vehicles being used will not have
undergone nearly the amount of testing that normal commercial travel
style vehicles undergo before they are licensed for commercial use and
must discuss the safety records of all launch and re-entry vehicles that
have carried one or more persons as well as the safety record of the
specific vehicle being used. Then, the Rule requires that operators
inform participants that they may request additional information and
must be given an opportunity to orally ask questions to better
understand the risks of the flight/mission. Standard acknowledgements
(dated signatures) must also be obtained[^36] as well as
acknowledgements that the SFP understands the risks and that the SFP
acknowledges that his/her participation or presence on the launch
vehicle is voluntary.[^37]

Beyond these express regulatory requirements and in concert with legal
intention of "informed consent," (notifying participants of material
risks that would influence a reasonable person's decision making on a
particular activity) where it is clear that one of the primary hazards
or risks associated with this young industry is that there *are* *no*
accepted standards guiding the industry regarding critical concerns like
the physical condition of the SFP, what gear the SFP should be required
to wear, what safety equipment should be in the vehicle, what is
required in a safety briefing, what type of vehicle is capable of
routinely traveling to suborbital space, or even what specific
categories of aircraft or specific instrument ratings a pilot must
have,[^38] SFPs should be appraised of this dearth of standardized
knowledge, awareness and response. Participants need to know that this
industry and the hybrid technologies it is creating are experimental at
best. The listing of risks that a SFP should be informed of needs to
*expressly* state or explain the fact that the safety of those on board
is largely unregulated and is considered by law makers to be the
province of "daredevils, visionaries and adventurers."[^39] The warnings
need to give the information that the reason there is little to no
regulation is because the industry is not seen by the Federal Government
as anything akin to the airline or transportation industry. SPFs should
be made to understand that they should not view their participation as a
definite ride from point A to point B, but rather as an experience where
the end result is getting to space,[^40] however briefly or momentarily.
Furthermore, the warnings need to *expressly* state that it has been
reliably estimated there will be somewhere in the neighborhood of a 1 in
200 failure rate or higher.[^41] As to the seeming disparity in these
figures, it should noted that, though space vehicle flight failures
usually result in death of the occupants, the vehicle failure rate is
expected to be lower than the fatality rate for two reasons: first,
Space vehicle failures may result in multiple fatalities (IE,
Challenger, Columbia, and, if included in the data set, the Apollo 1
ground fire would also be an example) and second, many of those who have
flown to space in the U.S. and Russian space programs have done so
numerous times. The warnings must say that the entire space industry is
really only 40 years old and in that time a fatality rate of just over 4
percent has emerged between the U.S. and Russian space programs with
fewer than 450 people having flown to space, 18 of whom perished,[^42]
demonstrating that the estimates of failure are reliable.[^43] To that
end, the SFPs should understand that they, quite literally, are part of
the testing process and they need to *see* *themselves* as visionaries
and daredevils who are willing to pay, beyond just the \$200,000 ticket
cost,[^44] the ultimate price.

The express warnings should also notify the SFP of their potential
financial liabilities for a catastrophic incident where the risk sharing
regime[^45] established in CSLAA declines to extend the conditional
governmental risk sharing regime provided to operators to the
SFP's.[^46] While informed consent law and the Final Rule require
warning participants that they, quite literally, may die participating
in suborbital spaceflight as we currently know/understand it, the issue
of abandonment and/or repatriation of mortal remains are topics that
rarely receive enthusiastic discussion. However, in the context of
providing and obtaining informed consent, the potential death of
participants should be discussed among all flight participants;
recalling that one of the most important preparations for adventure
style travel is full and complete warning/disclosure, it is necessary
that all participants clearly understand what the likelihood of
repatriation will be and what the potential cost to their families or
survivors will be if body repatriation is desired (or even possible).

This entire discussion, of course, also means that the more physically
oriented risks associated with space flight need to be outlined;
participants will need to be informed of and acknowledge things like
illness at certain g-force levels, the possibilities of radiation
exposure, the physical stresses of re-entry, the emotional or
psychological risks associated with space travel and of extreme or
adventure travel with fellow SFPs for whom the strains may be
unpredictable.[^47] (See generally, §5.0 below, listing physical risks
categorized by severity and frequency). It should be *plainly* *and*
*expressly* conveyed that the stresses to the human body of even
suborbital flight are, in and of themselves, still not completely
defined.

Again, where the intent here is to satisfy a more commonly recognized
"duty to warn," looking at how warnings are done in the traditional
adventure sport context is illustrative. Duty to warn can usually be
accomplished by: setting good policies or rules, posting warnings on
equipment or facilities, oral warnings, good documentation like release
and waiver documents, encouraging safe participation, making sure that
all participants and spectators are aware of the inherent risks of the
sport. An effective warning is thought to be: specific, obvious and
direct, unambiguous, easy to understand, simple and complete.
Suggestions include: laminating your instructions on cards so
guides/instructors don't forget something, recording or taping safety
briefings for consistency and creating (warning/instruction) witnesses
who mark off a checklist and then sign/acknowledge that the
guide/instructor has covered all of the requisites on the list.

Before participants actually engage in activities,
guides/instructors/staff generally conduct safety talks or briefings.
The basic outline of a good safety talk generally includes:[^48] 1)
specifics of the activity: area, weather, what can be expected on the
trip, inherent dangers/risks, proper equipment use, proper techniques
demonstration, what to do in the event of an emergency, that
clients/participants must follow the guide/instructors directions at all
times; 2) participant responsibilities: the level of physical
involvement, confirmation that no one has a medical or physical
condition that would prevent their participation or ability to help in
the event of an emergency, explanation that no drugs or alcohol are to
be consumed during activity, that guests must notify guides/operator of
any problems with equipment or other guests and that they must report
any incidents or accidents; and 3) a closing - confirm everyone signed
the informed consent, release and/or other forms the operation requires,
ask about additional questions they might have, arrive at consensus that
the group understands and accepts what is required of them in the
activity and that they accept the risks of the activity, provide an
"out" for participants who do not want to participate so that
participation is voluntary.

# HAZARDS

This section summarizes the hazards to Space Flight Participants (SFPs)
that have been identified by research of space flight experience. It is
understood that space flight is inherently risky and that adverse
physical and psychological effects can be experienced even during
successful space flights. There are also numerous vehicle or system
failures that could result in severe injury, dismemberment, or death of
the SFP.

Section 6.1 summarizes identified physical hazards and Section 6.2
presents potential psychological hazards that have been identified.
There are two tables in Section 6.3 that summarize these hazards from
two perspectives: Probability of Occurrence and Severity. In addition to
these identified hazards, the SFP may experience adverse effects that
have not been identified.

## Physical Hazards to Spaceflight Participants

Table 1 provides a listing of the identified physical hazards to SFPs.
Of the physical hazards listed, two in particular have potentially
complex effects on SFPs and warrant a more complete discussion of the
hazard mechanism: exposure to High G Forces and Microgravity (see
Sections 6.1.1 and 6.1.2).

[]{#__RefHeading___Toc210194331 .anchor}Table 1. Summary of Physical
Hazards to Spaceflight Participants

+--------------------+---------------------+---------------------------+
| **Source of        | **Mission Phase     | **Potential Physical      |
| Physical Hazard**  | and/or Failure      | Effects**                 |
|                    | Mechanism Causing   |                           |
|                    | Hazard**            |                           |
+====================+=====================+===========================+
| High Decibel Noise | Excessive engine    | Ear drum damage           |
|                    | noise               |                           |
|                    |                     | Temporary or permanent    |
|                    | Inadequate          | hearing loss              |
|                    | acoustical          |                           |
|                    | shielding           | Vestibular effects on     |
|                    |                     | balance                   |
|                    | Explosion on ground |                           |
+--------------------+---------------------+---------------------------+
| High Pressure      | Breached            | Loss of consciousness     |
|                    | high-pressure       |                           |
|                    | vessel              | Severe ear drum or tissue |
|                    |                     | trauma due to             |
|                    | Explosion           | overpressure              |
|                    |                     |                           |
|                    | In-flight           | Concussion                |
|                    | aerodynamic         |                           |
|                    | pressure            | Brain damage              |
|                    |                     |                           |
|                    |                     | Death                     |
+--------------------+---------------------+---------------------------+
| Low Pressure       | Explosive           | Trauma due to exposure to |
|                    | decompression       | vacuum:                   |
|                    |                     |                           |
|                    | Loss of cabin       | -   Brain or spinal cord  |
|                    | pressure due to     |     injury (temporary or  |
|                    | leak                |     permanent)            |
|                    |                     |                           |
|                    | Loss of atmospheric | -   Lung injury           |
|                    | control systems     |                           |
|                    |                     | -   Other tissue damage   |
|                    |                     |                           |
|                    |                     | -   Death                 |
|                    |                     |                           |
|                    |                     | Trauma due to pressure    |
|                    |                     | change and trapped gas:   |
|                    |                     |                           |
|                    |                     | -   Gastrointestinal pain |
|                    |                     |                           |
|                    |                     | -   Tooth, ear and sinus  |
|                    |                     |     pain                  |
|                    |                     |                           |
|                    |                     | -   Potential tissue      |
|                    |                     |     damage in affected    |
|                    |                     |     areas                 |
+--------------------+---------------------+---------------------------+
| High G-forces      | Acceleration during | G-Profile over flight may |
| (Sustained         | launch phase,       | have adverse              |
| Acceleration)      | de-acceleration     | physiological and/or      |
|                    | during descent      | pathological effects      |
|                    | phase (due to grab  | particularly on the       |
|                    | of aerodynamic      | cardiovascular response   |
|                    | control surfaces)   | of compromised            |
|                    |                     | participants.[^49] *(See  |
|                    |                     | details in section        |
|                    |                     | 6.1.1.)*                  |
|                    |                     |                           |
|                    |                     | -   Cardiovascular        |
|                    |                     |                           |
|                    |                     | -   Neurovestibular       |
|                    |                     |                           |
|                    |                     | -   Musculoskeletal       |
+--------------------+---------------------+---------------------------+
| Microgravity       | At high altitudes   | Short exposures to        |
|                    | during sub-orbital  | microgravity may cause    |
|                    | flight.             | acute physiological       |
|                    |                     | responses in several      |
|                    |                     | bodily systems (details   |
|                    |                     | of these are provided in  |
|                    |                     | Section 6.1.2) [^50]      |
|                    |                     |                           |
|                    |                     | • Cardiovascular          |
|                    |                     |                           |
|                    |                     | • Respiratory             |
|                    |                     |                           |
|                    |                     | • Neurological:           |
|                    |                     |                           |
|                    |                     | o Vestibular              |
|                    |                     |                           |
|                    |                     | o Motion Sickness         |
|                    |                     |                           |
|                    |                     | o Vision                  |
|                    |                     |                           |
|                    |                     | • Musculoskeletal         |
|                    |                     |                           |
|                    |                     | • Hematological           |
|                    |                     |                           |
|                    |                     | • Psychological           |
|                    |                     |                           |
|                    |                     | • Gastrointestinal        |
|                    |                     |                           |
|                    |                     | SFPs may expect these     |
|                    |                     | symptoms:                 |
|                    |                     |                           |
|                    |                     | \- Unfamiliar effects on  |
|                    |                     | physical movement         |
|                    |                     |                           |
|                    |                     | \- Internal displacement/ |
|                    |                     | entrapment of body fluids |
|                    |                     |                           |
|                    |                     | \- Decreased              |
|                    |                     | gravity-dependent         |
|                    |                     | circulation in lower      |
|                    |                     | extremities               |
|                    |                     |                           |
|                    |                     | \- Changes in the         |
|                    |                     | chemical makeup of blood  |
+--------------------+---------------------+---------------------------+
| High Temperature   | On-ground fire or   | Tissue damage             |
|                    | explosion           |                           |
|                    |                     | Serious burns --          |
|                    | In-flight fire or   | including third degree    |
|                    | explosion           |                           |
|                    |                     | Death                     |
|                    | Heat of re-entry    |                           |
|                    | and loss of heat    |                           |
|                    | dissipation systems |                           |
+--------------------+---------------------+---------------------------+
| Low Temperature    | Cabin breach, loss  | Frost-bite                |
|                    | of heating systems  |                           |
|                    |                     | Death                     |
+--------------------+---------------------+---------------------------+
| High Radiation     | Shielding not       | Radiation sickness        |
| levels             | adequate            |                           |
|                    |                     | Loss of bodily fluids     |
|                    | High radiation      |                           |
|                    | levels in space     | Increased long-term       |
|                    |                     | cancer risk               |
|                    |                     |                           |
|                    |                     | Death                     |
+--------------------+---------------------+---------------------------+
| Sunlight           | Prolonged looking   | Eye damage                |
|                    | at unfiltered       |                           |
|                    | sunlight            |                           |
+--------------------+---------------------+---------------------------+
| Physical Impact    | Crash or structural | Serious injury or death   |
| Trauma             | failure of          |                           |
|                    | spacecraft (due to  |                           |
| \- AIS 5,6[^51]    | system failure,     |                           |
|                    | pilot error,        |                           |
|                    | weapons fire,       |                           |
|                    | impact with space   |                           |
|                    | debris, etc.)       |                           |
+--------------------+---------------------+---------------------------+
| \- AIS 3,4         | Ground or In-flight | Moderate injury           |
|                    | -- numerous         |                           |
|                    | mechanisms          |                           |
+--------------------+---------------------+---------------------------+
| \- AIS 1,2         | Entry/exit from     | Minor injury              |
|                    | spacecraft          |                           |
+--------------------+---------------------+---------------------------+
| Exposure to Toxic  | Release of toxic    | Respiratory or skin       |
| Chemicals          | substance on-board  | damage                    |
|                    | or from ground      |                           |
|                    | storage tanks       | Death                     |
+--------------------+---------------------+---------------------------+
| Electrical shock   | Contact with        | Severe burns              |
|                    | exposed high        |                           |
|                    | voltage source of   | Electrocution / Fatality  |
|                    | electrical          |                           |
|                    | potential (on-board |                           |
|                    | or on ground)       |                           |
+--------------------+---------------------+---------------------------+
| Loss of breathable | Loss of atmospheric | Asphyxiation / Fatality   |
| atmosphere/change  | control systems and |                           |
| in composition of  | backup systems      | Brain and other organ     |
| atmos              |                     | damage                    |
| phere/contaminants | Cabin flooded with  |                           |
| and particulates   | non-breathable      | Death                     |
|                    | gases               |                           |
+--------------------+---------------------+---------------------------+
| Loss/damage of     | On-pad explosion    | Loss of assets            |
| personal effects   | and/or nominal      |                           |
| on board or at     | launch effects to   |                           |
| launch site        | participant         |                           |
|                    | property on ground  |                           |
|                    | (cars, jets,        |                           |
|                    | vehicles)           |                           |
+--------------------+---------------------+---------------------------+

### High G Forces[^52] 

The main risks for problems with acceleration in aerospace flight are
associated with the neurological, cardiovascular, and musculoskeletal
systems. To avoid the potential for compromising neurological function,
acceleration forces are preferably applied in the front-to-back (+Gx)
direction (eyeballs in). An individual is very tolerant to +Gx
acceleration, and with the heart and brain located at approximately the
same level within the acceleration field there is little risk for
acceleration (G)-induced loss of consciousness. Acceleration stress is
known to be dysrhythmogenic (changes in cardiac rate, rhythm, and
conduction). Higher and longer exposures to acceleration increase the
frequency of dysrhythmias. As long as the head, neck, and spine are
stabilized before the acceleration exposure and remain so until the
exposure is completed, the potential for musculoskeletal injury is
markedly reduced.

An individual's tolerance to head-to-foot (eyeballs down) acceleration
(+Gz) is dependent on the individual's anatomic and physiologic
characteristics and the nature of the acceleration profile. The maximum
+Gz level, exposure duration, and the rate of onset of the +Gz are
important determinants of the risk of neurologic compromise, cardiac
rhythm disturbances, and musculoskeletal (especially neck) injury.
Onset-rates greater than 0.1G/second are considered rapid, since they
exceed the ability of the cardiovascular system to fully respond to
preserve adequate central nervous system blood flow. Rapid-onset rates
of 1.0G/ second and greater can result in loss of consciousness without
visual warning symptoms.

Conservative relaxed, unprotected tolerance of completely healthy humans
to +Gz acceleration is considered approximately +3Gz (normal range 3.1
to 4.0) for rapid onset profiles and increases to approximately +3.5Gz
(normal range 3.7 to 5.6) with gradual-onset profiles. Individuals with
compromised cardiovascular anatomy or function may have reduced
tolerances. Care should be exercised with rapid-onset profiles to +3Gz
or more, sustained for 5 seconds or longer.

### Microgravity[^53] 

On the basis of the existing data and the known effects of acceleration
and microgravity on human physiology, the most important human
biological system parameters to be monitored before, during, and after
flight are cardiac, pulmonary, musculoskeletal, neurovestibular, and
psychological.[^54] Gastrointestinal issues must also be addressed.
Interestingly, the reported illness frequency seen in commercial
aviation indicates the most common illness is gastrointestinal (22.3%),
with cardiovascular (21.8%) and respiratory (10.2%) illnesses still
relatively prevalent. Since space flight participants are likely to
reflect the general aviation public, we may see a similar distribution
of illness.[^55] This information supports evaluation of the likelihood
of various effects of space flight.

[Cardiovascular and Respiratory Systems]{.underline}

The cardiovascular system will be immediately affected by suborbital
short-duration flight, as discussed earlier. As a result, this is the
most significant physiological data point that should be monitored to
characterize effects on space flight participants. This will, when
possible, include in-flight monitoring of cardiac function. The
commercial jet aircraft cabin altitude pressurization limit is 8,000 ft
above MSL pressure, which is also likely in suborbital spacecraft. SFPs
with compromised conditions such as chronic obstructive pulmonary
disease (COPD) should be aware that participation in space flight may
adversely affect their respiratory system. A recent study concluded that
a substantial proportion of older passengers - up to 44 percent of
healthy passengers aged 65 years or more - may have inadequate arterial
oxygen levels at 8,000 feet above MSL pressure, while breathing cabin
air. However, it is important to put this in perspective. In the context
of civil commercial aviation, it is accepted in general that passengers
who can walk 50 meters on the level or climb 10 steps without dyspnea
should be able to tolerate the relative hypoxia at commercial aircraft
pressurization levels.[^56] This information supports evaluation of
personal risk levels by potential SFPs -- especially those having less
than robust respiratory systems.

[Neurovestibular and Muscular Systems]{.underline}

The dynamic force environment of space flight will also manifest itself
with effects on the neurovestibular and muscular system. While short
term, they may have a significant impact on participants. This is
particularly relevant as participants are likely to have an active role
in aspects of vehicle operations related to health and safety. For
example, participants may be expected to return to their designated
seats after a period of weightlessness and reattach their own harness
for reentry. In addition, they may be expected to egress the vehicle
without assistance upon landing, or take particular action in an
emergency situation. Avoiding adverse neurovestibular effects is
important to ensure that the participants are able to comply with safety
instructions especially during reentry and at landing. SFPs should be
informed of the hazards associated with the potential inability to
perform these functions.

[Hematological System]{.underline}

Previous space flight experience has shown that there are unlikely to be
significant changes to the endocrine, hematological, and immunological
systems as a result of short-duration suborbital flight, except where
extreme change in volume status (i.e. dehydration/volume overload) plays
a significant role. SFPs should be informed of the additional hazards
associated with dehydration during space travel and the importance of
proper hydration prior to embarking.

[Psychological Effects]{.underline}

Previous space flight and analogs have shown that some experienced crew
suffered from acute anxiety to disabling psychosis in reduced gravity
and/or confined environments. The potential for similar effects on
non-professional SFPs should be disclosed to potential SFPs to support
personal evaluation of the associated hazards.

[Gastrointestinal Effects]{.underline}

Experiences of previous space flight and commercial airline participants
have shown that the most common acute illness encountered is
gastrointestinal in nature. Potential SFPs should be informed that their
participation will likely result in some degree of gastrointestinal
distress. In a microgravity environment such illnesses may represent an
additional collective risk to all occupants in the vehicle from
uncontrolled release of bio-hazardous material. SFPs should be informed
that they may be exposed to the results of other participant's
illnesses.

## Psychological Response Hazards

Spaceflight participants may experience excessive
physiological/psychological response(s) during the spaceflight.
Participants prone to responses that could be hazardous to themselves or
others should be identified and appropriate measures taken to minimize
the risk of the hazards. Table 2 provides some examples of this type of
hazard.

[]{#__RefHeading___Toc210194332 .anchor}Table 2. Summary of
Psychological Response Hazards

+-----------------------+-----------------------+-----------------------+
| **Source of           | **Potential Cause of  | **Potential Effects   |
| Physio                | SFP Response**        | of                    |
| logical/Psychological |                       | Physio                |
| Response Hazard**     |                       | logical/Psychological |
|                       |                       | Response**            |
+=======================+=======================+=======================+
| Claustrophobia        | Prolonged enclosure   | Excessive agitation   |
|                       | in confined space     |                       |
|                       |                       | Possible inability to |
|                       |                       | perform required      |
|                       |                       | duties                |
+-----------------------+-----------------------+-----------------------+
| Exci                  | Response to           | Commit irrational and |
| tement/Agitation/Fear | unexpected            | possibly violent,     |
|                       | occurrences.          | acts. Produce anxiety |
|                       |                       | in other              |
|                       | Response to known     | participants.         |
|                       | risks.                |                       |
|                       |                       | Possible inability to |
|                       | Mental instability.   | perform required      |
|                       |                       | duties/               |
|                       |                       | incapacitation        |
+-----------------------+-----------------------+-----------------------+
| Motion Sickness       | Spacecraft in dynamic | Nausea, vomiting.     |
|                       | motion                |                       |
|                       |                       | Possible inability to |
|                       |                       | perform required      |
|                       |                       | duties/               |
|                       |                       | incapacitation        |
+-----------------------+-----------------------+-----------------------+
| Vertigo - loss of     | Spacecraft in dynamic | Nausea, vomiting.     |
| bearing or balance    | motion                |                       |
|                       |                       | Possible inability to |
|                       |                       | perform required      |
|                       |                       | duties/               |
|                       |                       | incapacitation        |
+-----------------------+-----------------------+-----------------------+
| Rapid pulse/Increased | Excitement            | Cardiac arrhythmia    |
| blood pressure        |                       |                       |
|                       |                       | Possible inability to |
|                       |                       | perform required      |
|                       |                       | duties/               |
|                       |                       | incapacitation        |
|                       |                       |                       |
|                       |                       | Possible heart        |
|                       |                       | failure               |
+-----------------------+-----------------------+-----------------------+

## Summary of Identified Potential Effects on Spaceflight Participants (SFPs)

As noted by Congress in drafting the Commercial Space Launch Amendments
Act of 2004 (CSLAA), space transportation is inherently risky.
Approximately 4% of those who have flown in space to date have lost
their lives doing so. Commercial space travel opportunities clearly pose
the risk that a system or vehicle failure might result in serious injury
or death. Such failures have a wide variety of potential causes -- a few
examples include: propulsion system or structural failures, explosion of
propellants on the ground or in the vehicle, loss of vehicle control,
ground impact, and collision with space debris.

The identified potential hazards of participation in space flight have
been more fully described in Sections 6.1 and 7.2. Tables 3 and 4 rank
these effects based on their probability of occurrence and the severity
of the resulting consequence. These subjective rankings are based on
typical expectations and may vary from one operator to another as well
as from an individual space flight participant to another.

[]{#__RefHeading___Toc210194333 .anchor}Table 3. Potential Hazards -
Probability of Occurrence

+-----------------------------------------------------------------------+
| **PROBABILITY of OCCURRENCE**                                         |
+=======================================================================+
| **PROBABLE / CERTAIN**                                                |
|                                                                       |
| -   Gastrointestinal issues -- microgravity                           |
|                                                                       |
| -   Dysrhythmia (changes in cardiac rate, rhythm, and conduction) -   |
|     acceleration stress                                               |
|                                                                       |
| -   Excitement and euphoria                                           |
|                                                                       |
| ```{=html}                                                            |
| <!-- -->                                                              |
| ```                                                                   |
| -   Exposure to actions of other SFPs                                 |
+-----------------------------------------------------------------------+
| **SOMEWHAT LIKELY**                                                   |
|                                                                       |
| -   Motion sickness - microgravity                                    |
|                                                                       |
| -   Faint feeling -- acceleration                                     |
|                                                                       |
| -   Headaches -- low pressure                                         |
|                                                                       |
| -   Fatigue -- low pressure                                           |
|                                                                       |
| -   Muscle strain -- acceleration                                     |
|                                                                       |
| -   Minor injury during entry / exit from craft                       |
|                                                                       |
| -   Panic / Fear / Fright                                             |
|                                                                       |
| ```{=html}                                                            |
| <!-- -->                                                              |
| ```                                                                   |
| -   Electrical shock                                                  |
|                                                                       |
| -   Loss / damage to personal effects on ground                       |
+-----------------------------------------------------------------------+
| **POSSIBLE**                                                          |
|                                                                       |
| -   Loss of consciousness -- acceleration                             |
|                                                                       |
| -   Moderate injury -- ground failure or impacts within craft         |
|                                                                       |
| -   Connective tissue damage -- acceleration                          |
|                                                                       |
| -   Vertigo -- loss of bearing / balance                              |
|                                                                       |
| -   Exposure to dangerous wildlife -- launch site locality            |
|                                                                       |
| -   Significant pulmonary/respiratory effects -- microgravity         |
|                                                                       |
| -   Severe weather -- launch site locality                            |
|                                                                       |
| ```{=html}                                                            |
| <!-- -->                                                              |
| ```                                                                   |
| -   Cardiovascular effects -- acceleration/microgravity               |
|                                                                       |
| -   Claustrophobia                                                    |
|                                                                       |
| -   Inability to think rationally                                     |
|                                                                       |
| -   High altitude sickness -- launch site locality                    |
|                                                                       |
| ```{=html}                                                            |
| <!-- -->                                                              |
| ```                                                                   |
| -   Heatstroke / Dehydration / Sunburn -- launch site locality        |
|                                                                       |
| -   Vestibular effects -- vertigo / balance -- noise                  |
+-----------------------------------------------------------------------+
| > **RARE -- MOST LIKELY CAUSED BY VEHICLE OR SAFETY SYSTEM FAILURE**  |
|                                                                       |
| -   Death / Critical injury / Dismemberment -- failure                |
|                                                                       |
| -   Asphyxiation -- loss of cabin atmosphere                          |
|                                                                       |
| -   Temporary or permanent hearing loss                               |
|                                                                       |
| -   Bone fractures -- acceleration                                    |
|                                                                       |
| -   Eye damage -- unfiltered sunlight                                 |
|                                                                       |
| -   Burns due to ground accident                                      |
|                                                                       |
| -   Ear drum damage                                                   |
|                                                                       |
| -   Radiation sickness -- exposure to space radiation                 |
+-----------------------------------------------------------------------+

[]{#__RefHeading___Toc210194334 .anchor}Table 4. Potential Hazards -
Severity of Consequence

+-----------------------------------------------------------------------+
| **SEVERITY of CONSEQUENCE**                                           |
+=======================================================================+
| **CRITICAL**                                                          |
|                                                                       |
| -   Death / Critical injury / Dismemberment                           |
|                                                                       |
| -   Asphyxiation                                                      |
|                                                                       |
| -   Permanent hearing loss                                            |
|                                                                       |
| -   Bone fractures                                                    |
|                                                                       |
| -   Loss of consciousness                                             |
+-----------------------------------------------------------------------+
| **SIGNIFICANT**                                                       |
|                                                                       |
| -   Moderate injury due to ground failure or impacts within craft     |
|                                                                       |
| -   Connective tissue damage due to acceleration                      |
|                                                                       |
| -   Exposure to dangerous wildlife                                    |
|                                                                       |
| -   Eye damage -- unfiltered light                                    |
|                                                                       |
| -   Ear drum damage                                                   |
|                                                                       |
| ```{=html}                                                            |
| <!-- -->                                                              |
| ```                                                                   |
| -   Temporary hearing loss                                            |
|                                                                       |
| ```{=html}                                                            |
| <!-- -->                                                              |
| ```                                                                   |
| -   Heatstroke / Dehydration / Sunburn                                |
|                                                                       |
| -   Burns due to ground accident                                      |
|                                                                       |
| -   Radiation sickness -- exposure to space radiation                 |
|                                                                       |
| -   Vestibular effects -- vertigo / balance                           |
|                                                                       |
| -   Electrical shock                                                  |
+-----------------------------------------------------------------------+
| **NUISANCE**                                                          |
|                                                                       |
| -   Exposure to actions of other SFPs 9depending on situation --      |
|     could be significant)                                             |
|                                                                       |
| ```{=html}                                                            |
| <!-- -->                                                              |
| ```                                                                   |
| -   Dysrhythmia (changes in cardiac rate, rhythm, and conduction) --  |
|     could be significant in certain SFPs                              |
|                                                                       |
| ```{=html}                                                            |
| <!-- -->                                                              |
| ```                                                                   |
| -   Motion sickness                                                   |
|                                                                       |
| -   Faint feeling                                                     |
|                                                                       |
| -   Headaches                                                         |
|                                                                       |
| -   Fatigue                                                           |
|                                                                       |
| -   Muscle strain                                                     |
|                                                                       |
| -   Panic / Fear / Fright                                             |
|                                                                       |
| -   Minor injury during entry / exit from craft                       |
|                                                                       |
| -   Claustrophobia                                                    |
|                                                                       |
| -   Inability to think rationally                                     |
|                                                                       |
| -   Loss / damage to personal effects on ground                       |
|                                                                       |
| -   High altitude sickness                                            |
|                                                                       |
| ```{=html}                                                            |
| <!-- -->                                                              |
| ```                                                                   |
| -   Severe weather                                                    |
+-----------------------------------------------------------------------+

There is significant variation in the human response to the conditions
encountered when preparing for or participating in space flight; some
SFPs may be more or less susceptible to these conditions/reactions. In
addition to hazards and risks identified in this section, the
inaccessibility of medical care at the remote sites utilized for
commercial space flights is a consideration when assessing personal
risks of participation in commercial space flight.

Finally, there are numerous adverse effects that could arise from
participation in a successful space flight. Many of these are known
risks, but there may be other risks that have not yet been identified.

# FINAL SUMMARY AND "NEXT STEP" RECOMMENDATIONS:

Because the regulation mandates written informed consent and, legally
speaking, informed consent only provides legal protection (defense) from
the inherent risks of an activity and not from negligence, there is some
confusion as to whether any private contract (release and waiver
document) that seeks pre-activity exculpation from inherent risks *and*
negligence (standard in the adventure world) would be valid. Where the
Appendices to the Final rule provide exculpatory style documents in
favor of the government as the permitting agency, there is reason to
believe that exculpatory documents between a commercial operator and a
SFP would be allowed. How these documents would legally interact with
and/or be affected by the requisite of written informed consent needs to
be clarified. An additional issue is how the requisite of written
informed consent may affect other defenses that would normally be
available to a commercial operator -- like assumption of the risk.

It is clear that the Courts differ as to the standard that governs the
determination of whether a risk is material such that it warrants
disclosure to the patient. Specifically, materiality is sometimes based
on what information a 'reasonable doctor' would provide and in other
jurisdictions the 'reasonable patient' standard determines materiality.
Clarification of how materiality gets satisfied -- either by what the
operator believes is material or by what the SFP thinks is material
should be provided.

Collaboration with industry may well be necessary or expedient at this
point. Where it has been widely publicized that a leading suborbital
provider has signed up literally thousands of prospective SFP's and has
begun working with them, or at least working with some of their
"founders," using this early group to determine or establish materiality
may well be revealing for industry.

Finally, this report and these recommendations are provided as an
example only and are not intended to be used as a legal template or
considered to be a final authoritative or FAA/AST approved document.
Individual operators should work with experienced legal counsel to
provide advices on how the law in your state or other related legal
issues may impact matters specific to your operation(s).

# HAZARDS REFERENCE

-   Antunano, M.J., et al., "Guidance for Medical Screening of
    Commercial Aerospace Passengers," DOT Office of Aerospace Medicine,
    Washington D.C., January 2006.

-   Bagshaw, M., "Telemedicine in British Airways,*" J Telemedicine
    Telecare*, 1996;2(1); pp36-8.

-   Cummings R.Q., et al, "In-flight deaths during commercial air
    travel," *I Am Med Assn*, 1998;259;1983-8.

-   Hanada et al., Arrhythmias Observed During High-G Training: Proposed
    Training Safety Criterion. R. Aviation, *Space, and Environmental
    Medicine*, Vol. 75, No. \*, pp.688-691, Aug 2004.

-   Johnston R., "Clinical Aviation Medicine: safe travel by air,"
    *Clinical Medicine*, Vol. 1, No. 5, 2001.

-   Jurist, J. "Human factors in commercial suborbital flight: What does
    acceleration do to the human body?" The Space Review,
    [www.thespacereview.com/article/402/1](http://www.thespacereview.com/article/402/1),
    Tuesday, July 5, 2005.

-   Lugan, B.F. and White, R.J., "Human Physiology in Space," National
    Space Biomedical Research Institute,
    [www.nsbri.org/HumanPhysSpace](http://www.nsbri.org/HumanPhysSpace),
    undated.

-   McDonald, P.V., et al., "AST Commercial Human Space Flight
    Participant Biomedical Data Collection," Wyle Laboratories, Inc.,
    Technical Report #LS-09-2006-001, February 1, 2007.

[^1]: Please note: a limited amount of the background material contained
    herein is similar to material contained in The Journal of Space Law
    (Tracey L. Knutson*, \"What is \'Informed Consent\' for Space-Flight
    Participants in the Soon-to-Launch Space Tourism Industry?\"* 33 J.
    Space L. 105 (2007)). The Report\'s authors would like to
    acknowledge the Journal and the Journal\'s Executive Editor, who
    early-on recognized the topic as important and timely, and whose
    recommendations resulted in foundational research for this Report.

[^2]: Id. at 70101(a)(12 & 14).

[^3]: Id. at 70105(b)(5)(A-C).

[^4]: The 1984 Commercial Space Launch Act established the Department of
    Transportation (DOT) as the Federal Agency responsible for
    regulating and overseeing the private commercial launch vehicle
    industry. See, 49 U.S.C. §2604 (1984). In 1984, DOT established the
    Office of Commercial Space Transportation (OCST) which reported to
    the Secretary of Transportation; then in 1995 OSCT oversight was
    delegated to the FAA Administrator who created the Office of the
    Associate Administrator for Commercial Space Transportation (now,
    "AST"). Currently the FAA has oversight and regulatory authority for
    this industry. The FAA's authority to issue rules on commercial
    space transportation safety is found in Title 49 of the United
    States Codes, section 322(a), which authorizes the Secretary of
    Transportation to carry out Subtitle IX, Chapter 701, 49 U.S.C.
    70101-70121 (Chapter 701).

[^5]: 71 Federal Register 241 (Dec. 15, 2006).

[^6]: Commercial Space Launch Amendments Act of 2004, Pub. L. No.
    108-492, 118 Stat. 3974 (2004); Human Space Flight Requirements for
    Crew and Space Flight Participants, Final Rule, 71 Federal Register
    241 (Dec. 15, 2006).

[^7]: 14 CFR §460.45 (2006).

[^8]: CFR §460.65 (2006); 49 U.S.C. §70105(b)(5)(A-C) (Supp.2004).

[^9]: See generally, 14 CFR 460.45 (2006).

[^10]: The Final Rule issued by the FAA also requires that before actual
    flight, licensed operators must also give SFP's an opportunity to
    orally ask questions to enable them to better understand the hazards
    and risks of the "mission." Id. at (f).

[^11]: Again, see, Human Space Flight Final Rule, Description of Final
    Rule and Discussion of Comments II(C)(2)(a) on Launch and Re-entry
    With a Space Flight Participant, Informed Consent and the Space
    Flight Participant's Ability to Be Informed, 71 Federal Register 241
    (Dec. 15, 2006).

[^12]: See generally, Law For Recreation and Sports Mangers, Third
    Edition, Doyice J. Cotten, John T. Wolohan, Chapter 2.24 on Inherent
    Risk Related Defenses: Informed Consent Agreements & Agreements to
    Participate. Kendall/Hunt Publishing Co., Dubuque, Iowa.

[^13]: Id.

[^14]: For other contexts in which courts have used the phrase "informed
    consent", see also: [Watkins v. Ford Motor Co.]{.underline}, 190
    F.3^rd^ 1213, 1219 (11^th^ Cir. 1999) (holding that purchaser of SUV
    should have been warned of rollover characteristics of the vehicle
    allowing him to make an informed choice whether to take the risks
    warned against); [Borel v. Fibreboard Paper Prods.
    Corp.]{.underline}, 493 F.2d 1076 1089 (5^th^ Cir. 1973) (holding
    that asbestos benefits may outweigh risk but defendant is liable for
    failing to give workers an informed choice as to whether they wish
    to expose themselves to the risk); [Williams v. Lederle
    Labs.]{.underline}, 591 F.Supp 381, 383 (S.D. Ohio 1984) (holding
    that beneficial but dangerous drugs must be accompanied by adequate
    warnings of risk).

[^15]: See, Margaret A. Berger and Aaron D. Twerski, [Uncertainty and
    Informed Choice: Unmasking Daubert]{.underline}, 104 Michigan L.
    Rev. 257, 270-72 (2005), citing Allan H. McCoid, [A Reappraisal of
    Liability for Unauthorized Medical Treatment,]{.underline} 41 MINN.
    L. REV. 381, 426-30 (1957). Prior to the McCoid article, there was
    no mention of informed consent in any of the major treatises or
    court decisions.

[^16]: See, [Canterbury v. Spence]{.underline}, 464 F.2d 772, 787-9
    (D.C. Cir 1972), *cert denied*, 409 U.S. 1064 (1972); [Williams v.
    Boyle]{.underline}, 72 P.3d 392, 397 (Colo. Ct. App. 2003); B[arton
    v. Estate of Buckley]{.underline}, 867 So. 2d. 271, 272 (Miss. Ct.
    App. 2004); [Grasser v. Kitzis]{.underline}, 553 A. 2d 346 (N.J.
    Super. Ct. App. Div. 1988); [Scott v. Bradford]{.underline}, 606 P.
    2d 554, 559 (Okla. 1979).

[^17]: See, Margaret A. Berger and Aaron D. Twerski, [Uncertainty and
    Informed Choice: Unmasking *Daubert*]{.underline}, 104 Michigan L.
    Rev. 257, 270-72 (2005). Citations omitted.

[^18]: See also, [Spar v. Jin S. Cha, M.D.]{.underline}, 881 N.E. 2d 70
    (Indiana 2008), holding that "*Physicians have a duty to make a
    reasonable disclosure of material facts relevant to the decision the
    patient is required to make."* And, *"The doctrine of informed
    consent is based on the patient's right to intelligently accept or
    reject treatment."* Citations omitted.

[^19]: See, Aaron D. Twerski & Neil B. Cohen, *Informed decision Making
    and the Law of Torts: The Myth of Justiciable Causation,* 1988 U.
    ILL. L. Rev. 607, 616-17 (1988).

[^20]: See, 70 Federal Register 249, 77269 (Dec. 29, 2005) wherein the
    FAA expressly states that the CSLAA characterization of "Space
    Flight Participant" "\...signifies that someone on board a launch
    vehicle or re-entry vehicle is not a typical passenger with typical
    expectations of transport, but someone going on an adventure ride."
    This section of the Proposed Rule also quoted Michael Kelly as
    "\...characterizing the experience as an adventure ride." And the
    Proposed Rule stated at that section that "\[O\]thers have compared
    it to mountain climbing, skydiving, not wearing a helmet while
    riding a motorcycle, and other risky endeavors."

[^21]: See, Space Travel Law and Politics: The Evolution of the
    Commercial Space Launch Amendments Act of 2004, Timothy Robert
    Hughes and Esta Rosenberg, Journal of Space Law Volume 31 (2005),
    quoting at pg. 46 Rep.(s) Boehlert and Rohrbacher as testifying,
    respectively, in the Congressional Record that the commercial human
    space flight industry "\...is like a baby in its crib\..." and the
    "\...industry is at the stage when it is the preserve of visionaries
    and daredevils and adventurers\...who will fly at their own risk
    \[and\]\...who do not expect and should not expect to be protected
    by the government."

[^22]: But see, [B&B Livery, Inc. v. Riehl]{.underline}, 960 P.2d 134,
    140 (1998), a Colorado case examining a contractual release
    agreement in the context of a suit for damages deriving from a fall
    from a rented horse, wherein the dissent mentions the phrase
    informed consent in discussing of scrutiny of the language of the
    release contract.

[^23]: Negligence under the law is generally defined as the failure to
    use ordinary care; that is, failing to do what a person of ordinary
    prudence would have done under the same or similar circumstances.
    Essentially we are looking to determine whether an operator, guide
    or land administrator could or should have recognized an
    unreasonable risk and then did nothing to warn the
    participant/student or to reduce or eliminate the unreasonable risk.
    To examine negligence in behavior or conduct, look for 2 things: was
    the risk foreseeable and was the risk unreasonable. See, [Law For
    Recreation and Sports Managers, Third Edition]{.underline}, Doyice
    J. Cotten, John T. Wolohan, Chapter 2.10 on Negligence Law.
    Kendall/Hunt Publishing Co., Dubuque, Iowa.

[^24]: Duty generally refers to one party's responsibility to take
    reasonable care for the protection of another party. Duty has 3
    primary origins: 1.) from a relationship inherent in the situation;
    2.) from a voluntary assumption; or 3.) from a duty mandated by a
    statute or regulation of some sort. See generally, [Law For
    Recreation and Sports Mangers, Third Edition]{.underline}, Doyice J.
    Cotten, John T. Wolohan, Chapter 2.11 on Elements of Negligence.
    Kendall/Hunt Publishing Co., Dubuque, Iowa. And see, [Licato v.
    Eastgate]{.underline}, 499 N.Y.S. 2d 472 (A.D. 3 Dept. 1986);
    [Saffro v. Elite Racing Inc.]{.underline}, 98 Cal. App. 4^th^ 173
    (Ct. App. California, May 7, 2002)(rev. denied, 2002 Cal. Lexis 5268
    (July 2002)).

[^25]: It's important to grasp the concept that the level of risk
    management correlates to the tolerance of any given group/operator
    *[and its guests]{.underline}* for risk. If risk is mitigated to a
    point below a particular level of tolerance, guest or student or
    participant experiences and satisfaction will be affected or
    changed. [See]{.underline}, [Legal Liability and Risk Management in
    Adventure Tourism]{.underline}, Ross Cloutier with Daniel Garvey,
    Will Leverette, James Moss and Gilles Vadade, 2000, Chapter Eight on
    Risk Management, page 96. Bhudak Consultants, Kamloops, British
    Columbia. Remember, it is not that you have a duty to ensure your
    participants/guests are kept away from [all]{.underline} risk,
    rather that they are not exposed to risks which in your business
    would be considered unreasonable.

[^26]: [See]{.underline}, [Legal Liability in Recreation and Sports,
    Second Edition]{.underline}, Bruce B. Hronek and John O. Spengler,
    2002, Chapter One on Overview of Trends, Risk and Legal Liability,
    quoting from pages 22-23. Sagamore Publishing, Champaign, Illinois.

[^27]: Please note that informed consent statutes, case law and law
    review articles exist in abundance and are, quite literally, too
    numerous and exhaustive to be reviewed and/or discussed in this
    report; illustrative cases have been selected and discussed with the
    intention of conforming to the limited inquiry and to the limited
    resources assigned to this project.

[^28]: See, [Hondroulis v. John Schumacher, M.D.]{.underline}, 521 So.
    2d 534 (1988).

[^29]: See, [Canterbury v. Spence]{.underline}, 464 F.2d 772, 787-9
    (D.C. Cir 1972), *cert denied*, 409 U.S. 1064 (1972); [Williams v.
    Boyle]{.underline}, 72 P.3d 392, 397 (Colo. Ct. App. 2003); B[arton
    v. Estate of Buckley]{.underline}, 867 So. 2d. 271, 272 (Miss. Ct.
    App. 2004); [Grasser v. Kitzis]{.underline}, 553 A. 2d 346 (N.J.
    Super. Ct. App. Div. 1988); [Scott v. Bradford]{.underline}, 606 P.
    2d 554, 559 (Okla. 1979).

[^30]: See, [Pennick v. Chritensen, M.D., Pfizer Hospital Group, et
    al]{.underline}. 912 S.W. 2d 276 (1996).

[^31]: [Id.]{.underline} at 521 So. 2d 534, 536 (1988), citing [Leonard
    v. New Orleans East Orthopedic Clinic]{.underline}, 485 So. 2^nd^
    1008 (La. App. 4^th^ Cir. 1986); and. [Pennick v. Christensen,
    M.D.]{.underline}, 912 S.W. 2d 276, 284 (Tex. App. 1995).

[^32]: See, discussion above at §4.1, pg. 10, above.

[^33]: Id.

[^34]: The Final Rule issued by the FAA also requires that before actual
    flight, licensed operators must also give SFP's an opportunity to
    request additional information on accidents and incidents and must
    be allowed to orally ask questions to enable them to better
    understand the hazards and risks of the "mission." 14 CFR §460.45
    (e) and (f).

[^35]: 14 CFR §460.45 (2006).

[^36]: See, §460.45(b)&(c).

[^37]: See, 14 CFR Part 460.45(f).

[^38]: The FAA flight crew guidelines simply recommend that pilots have
    a pilot's license with instrument rating and aeronautical
    experience, a second class airman medical certificate and be
    thoroughly trained in all aspects of the flight systems. It is
    notable too that pilots and crew on carrier aircraft, if any, will
    not be considered crew for purposes of the regulations. See, 14 CFR
    §460.5 and Description of Final Rule and Discussion of Comments at
    II B 3 (2006). And see, The Safety Dance by Jeff Foust, February 21,
    2005 Volume of the Space Review, available at pointing out that one
    of the key aspects of the CSLAA is the limitation on the FAA to
    regulate crew and passenger safety, that FAA/AST guidelines and
    drafts are not specifications and quoting former Secretary Norman
    Mineta saying that the FAA does not want "\...to stifle
    industry\..." with over-regulation.

[^39]: See, supra, note 18; and see, Space Tourism and Informed Consent:
    To Knowingly Go, by Laura Montgomery as published in the
    Transportation and Transportation Security Law Section's newsletter,
    Translaw, Spring 2004 Issue.

[^40]: Id.

[^41]: See, Weighing the Risk of Human Spaceflight by Jeff Foust, July
    21, 2003 available at and One Former Astronaut's Perspective
    available at with former astronaut and space shuttle pilot Rick
    Hauck stating that he doubts he would have flown to space if he had
    known of the 4% fatality rate then.

[^42]: Id.; and see, Supra Notes 27 & 29.

[^43]: In the later portions of the warning document where
    *acknowledgments* are made, the SFP should be required to
    acknowledge that they have been advised to prepare or update their
    wills and to otherwise put their affairs in order. See, Space
    Tourism and Informed Consent: To Knowingly Go, by Laura Montgomery
    as published in the Transportation and Transportation Security Law
    Section's newsletter, Translaw, Spring 2004 Issue wherein Greg
    Maryniak, executive director of the X-Prize Foundation is quoted as
    having stated/contemplated during an FAA conference that prospective
    space flight participants should receive pre-flight notices advising
    them to make out their wills.

[^44]: See, Space Tourism Survey Targets Cost Factor by David Leonard,
    October 23, 2006 on MSNBC, available at quoting a basic price tag
    for a Virgin Galactic space liner seat at roughly \$200,000.

[^45]: See, Space Tourism and Informed Consent: To Knowingly Go, by
    Laura Montgomery as published in the Transportation and
    Transportation Security Law Section's newsletter, Translaw, Spring
    2004 Issue, stating that "\...by excluding space flight participants
    from eligibility for indemnification by the federal government
    against third party claims, H.R. 3752 declines to subsidize the
    passenger." And quoting testimony from Raymond Duffy Jr., a senior
    vice president for Willis InSpace Underwriters during committee
    testimony that "\[i\]f someone is willing to participate in
    commercial human space flights at this stage of its development then
    the risk should be dealt with solely between the passenger and the
    launch provider." And quoting a House report that notes: "\...space
    flight participants wishing to ride on board a launch vehicle have
    chosen to undertake a risky venture of their own accord. As such,
    they do not merit the financial security provided by the promise of
    indemnification. Moreover, space flight participants are not subject
    to any substantive government regulation." And see, Space Travel Law
    and Politics: The Evolution of the Commercial Space Launch
    Amendments Act of 2004, Timothy Robert Hughes and Esta Rosenberg,
    Journal of Space Law Volume 31 (2005), at pg. 59 stating that "The
    2004 Space Act allows individuals to undertake space flight at their
    own physical and financial risk. Space flight participants are
    excluded from indemnification eligibility under the 2004 Space Act
    and are not entitled to the benefits of liability insurance
    coverage."

[^46]: Does the public really understand this yet? How many of the
    millionaires who will likely make up the first wave of space tourism
    will actually be willing to bet the farm, or the kids' financial
    future knowing this fact?

[^47]: See, Supra, Note 38, The Safety Dance by Jeff Foust, February 21,
    2005 Volume of the Space Review, available at discussing the Medical
    memorandum released by the FAA. See also, Making Space Happen --
    Private Space Ventures and the Visionaries Behind Them by Paula
    Berinstein, Plexus Publishing 2002, Chapter 3 You Can't Throw Your
    Socks on the Floor in a Spacecraft by Harvey Wichman and Chapter 4
    Space and the Body: Are We Robust Enough to Venture Out?

[^48]: See, State of Risk, Risk Management in the Outdoor Industry,
    produced by Knutson & Associates;
    [www.traceyknutson.com](http://www.traceyknutson.com/)

[^49]: The duration of acceleration exposure is a critical factor in
    evaluating human tolerance to high accelerations. In general,
    acceleration pulses of less than 200 milliseconds are considered to
    be "impacts," and greater accelerations can be tolerated as the
    duration decreases. For acceleration exposures beyond a couple of
    seconds, it is physiological fluid dynamics that show the greatest
    negative effect. See Wyle Lab Technical Report #LS-09-2006-001, AST
    Commercial Human Space Flight Biomedical Data Collection (2007), pp.
    15 & 23.

[^50]: See Wyle Lab Report, p.17.

[^51]: The Abbreviated Injury Scale (AIS) is commonly used to rate the
    severity of an injury.

[^52]: See DOT/FAA/AM-06/01, Guidance for Medical Screening of
    Commercial Aerospace Passengers (2006), p.1.

[^53]: See Wyle Labs Report, p.17-18.

[^54]: Johnston R., "Clinical Aviation Medicine: safe travel by air",
    *Clinical Medicine*, Vol. 1, No 5, 2001.

[^55]: Cummings R.Q., et al, "In-flight deaths during commercial air
    travel", *I Am Med Assn*, 1998.

[^56]: Muhm J. M. "Predicted Arterial Oxygenation at Commercial Cabin
    Altitudes," *Aviation, Space, and Environmental Medicine*, Vol. 75,
    No. 10, pp. 905-912, Oct. 2004.