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Study on Informed Consent for Spaceflight Participants

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					Study on
Informed Consent for
Spaceflight Participants


Document Number: APT-CFA-230-0001-02F


September 26, 2008
(this page intentionally left blank)




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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).




                                                                                         ii
                                                    TABLE OF CONTENTS
LIMITATIONS/DISCLAIMER: ......................................................................................................... ii
1.0.      PURPOSE ............................................................................................................................. 1
2.0.      DEFINITIONS........................................................................................................................ 1
   2.1.         Scientific/Mechanical ....................................................................................................... 1
   2.2.         Legal................................................................................................................................ 2
3.0.      BACKGROUND DISCUSSION ............................................................................................ 2
4.0.      INFORMED CONSENT IN A LEGAL CONTEXT ................................................................. 4
   4.1.    The Phrase “Informed Consent” as it Derives from the Legal Context ........................... 4
   4.2.    Combining “Informed Consent” in Commercial Human Spaceflight with the Traditional
   Legal Framework of “Informed Consent” as Basis for Recommendations ................................... 7
5.0. SUMMARY       AND RECOMMENDATIONS FOR SATISFYING REGULATORY
REQUIREMENT .............................................................................................................................. 9
6.0.      HAZARDS ........................................................................................................................... 15
   6.1.    Physical Hazards to Spaceflight Participants ................................................................16
     6.1.1. High G Forces ........................................................................................................... 19
     6.1.2. Microgravity............................................................................................................... 20
   6.2.    Psychological Response Hazards ................................................................................21
   6.3.    Summary of Identified Potential Effects on Spaceflight Participants (SFPs) ................22
7.0.      FINAL SUMMARY AND “NEXT STEP” RECOMMENDATIONS: .................................... 25
8.0.      HAZARDS REFERENCE ................................................................................................... 26




                                                         LIST OF TABLES


Table 1. Summary of Physical Hazards to Spaceflight Participants............................... 16
Table 2. Summary of Psychological Response Hazards ............................................... 21
Table 3. Potential Hazards - Probability of Occurrence ................................................. 22
Table 4. Potential Hazards - Severity of Consequence ................................................. 24




                                                                                                                                                   iii
1.0. 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.
2.0. DEFINITIONS

   2.1. 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.




                                                                                              1
      2.2. 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.

3.0. BACKGROUND DISCUSSION
The Phrase “Informed Consent” as it Applies to Commercial Human Spaceflight1
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 FAA4 published Human Space Flight




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


                                                                                            2
Requirements for Crew and Space Flight Participants5, 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



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


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4.0. INFORMED CONSENT IN A LEGAL CONTEXT

      4.1. 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 of the therapy undertaken or reasonable alternatives to it; 2) that
the patient would have chosen against the recommended therapy; and 3) that as a result of
the therapeutic intervention the patient suffered harm/injury.16 (Emphasis added to
highlight application to current discussion on human spaceflight.)



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., 190 F.3rd 1213, 1219 (11th 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., 493 F.2d 1076 1089 (5th 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., 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, 104 Michigan L. Rev. 257, 270-72 (2005), citing Allan H. McCoid,
A Reappraisal of Liability for Unauthorized Medical Treatment, 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, 464 F.2d 772, 787-9 (D.C. Cir 1972), cert denied, 409 U.S.
1064 (1972); Williams v. Boyle, 72 P.3d 392, 397 (Colo. Ct. App. 2003); Barton v.


                                                                                          4
               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, 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, 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., 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



Estate of Buckley, 867 So. 2d. 271, 272 (Miss. Ct. App. 2004); Grasser v. Kitzis, 553 A.
2d 346 (N.J. Super. Ct. App. Div. 1988); Scott v. Bradford, 606 P. 2d 554, 559 (Okla.
1979).
17
 See, Margaret A. Berger and Aaron D. Twerski, Uncertainty and Informed Choice:
Unmasking Daubert, 104 Michigan L. Rev. 257, 270-72 (2005). Citations omitted.


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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.



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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. 912 S.W. 2d 276 (1996).18 The Pennick Court, quoting the earlier case of Peterson
v. Shields, 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.

     4.2. 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




18
  See also, Spar v. Jin S. Cha, M.D., 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.”


                                                                                            7
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




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, 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, Doyice J. Cotten, John T. Wolohan, Chapter 2.10 on
Negligence Law. Kendall/Hunt Publishing Co., Dubuque, Iowa.


                                                                                             8
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 management25), 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).

5.0. 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



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, Doyice J. Cotten, John T. Wolohan, Chapter 2.11 on Elements of Negligence.
Kendall/Hunt Publishing Co., Dubuque, Iowa. And see, Licato v. Eastgate, 499 N.Y.S. 2d
472 (A.D. 3 Dept. 1986); Saffro v. Elite Racing Inc., 98 Cal. App. 4th 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 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, Legal Liability and Risk Management in
Adventure Tourism, 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 risk, rather that they are not exposed to risks
which in your business would be considered unreasonable.
26
  See, Legal Liability in Recreation and Sports, Second Edition, 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.


                                                                                             9
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 country27 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



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., 521 So. 2d 534 (1988).
29
  See, Canterbury v. Spence, 464 F.2d 772, 787-9 (D.C. Cir 1972), cert denied, 409 U.S.
1064 (1972); Williams v. Boyle, 72 P.3d 392, 397 (Colo. Ct. App. 2003); Barton v.
Estate of Buckley, 867 So. 2d. 271, 272 (Miss. Ct. App. 2004); Grasser v. Kitzis, 553 A.
2d 346 (N.J. Super. Ct. App. Div. 1988); Scott v. Bradford, 606 P. 2d 554, 559 (Okla.
1979).
30
  See, Pennick v. Chritensen, M.D., Pfizer Hospital Group, et al. 912 S.W. 2d 276
(1996).


                                                                                          10
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



31
  Id. at 521 So. 2d 534, 536 (1988), citing Leonard v. New Orleans East Orthopedic
Clinic, 485 So. 2nd 1008 (La. App. 4th Cir. 1986); and. Pennick v. Christensen, M.D., 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).


                                                                                              11
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 obtained36 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




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 http://www.thespacereview.com/article/326/1
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.


                                                                                           12
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 regime45 established in CSLAA declines to



40
     Id.
41
   See, Weighing the Risk of Human Spaceflight by Jeff Foust, July 21, 2003 available at
http://www.thespacereview.com/article/36/1 and One Former Astronaut‟s Perspective
available at http://www.thespacereview.com/article/36/2 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 http://www.msnbc.msn.com/id/15120091/ 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


                                                                                            13
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



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 http://www.thespacereview.com/article/326/1 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?




                                                                                           14
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.

6.0. 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.




48
 See, State of Risk, Risk Management in the Outdoor Industry, produced by Knutson &
Associates; www.traceyknutson.com


                                                                                         15
In addition to these identified hazards, the SFP may experience adverse effects that have
not been identified.

   6.1. 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).

         Table 1. Summary of Physical Hazards to Spaceflight Participants
   Source of Physical Hazard   Mission Phase and/or Failure           Potential Physical Effects
                               Mechanism Causing Hazard
  High Decibel Noise           Excessive engine noise         Ear drum damage
                               Inadequate acoustical          Temporary or permanent hearing
                               shielding                      loss
                               Explosion on ground            Vestibular effects on balance
  High Pressure                Breached high-pressure         Loss of consciousness
                               vessel                         Severe ear drum or tissue trauma
                               Explosion                      due to overpressure
                               In-flight aerodynamic          Concussion
                               pressure                       Brain damage
                                                              Death
  Low Pressure                 Explosive decompression        Trauma due to exposure to
                               Loss of cabin pressure         vacuum:
                               due to leak                             Brain or spinal cord injury
                               Loss of atmospheric                      (temporary or permanent)
                               control systems                         Lung injury
                                                                       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




                                                                                                      16
      Source of Physical Hazard   Mission Phase and/or Failure           Potential Physical Effects
                                  Mechanism Causing Hazard
     High G-forces (Sustained     Acceleration during            G-Profile over flight may have
     Acceleration)                launch phase, de-              adverse physiological and/or
                                  acceleration during            pathological effects particularly on
                                  descent phase (due to          the cardiovascular response of
                                                                                             49
                                  grab of aerodynamic            compromised participants. (See
                                  control surfaces)              details in section 6.1.1.)
                                                                          Cardiovascular
                                                                          Neurovestibular
                                                                          Musculoskeletal


     Microgravity                 At high altitudes during       Short exposures to microgravity
                                  sub-orbital flight.            may cause acute physiological
                                                                 responses in several bodily
                                                                 systems (details of these are
                                                                                            50
                                                                 provided in Section 6.1.2)
                                                                 • 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




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.


                                                                                                        17
      Source of Physical Hazard   Mission Phase and/or Failure           Potential Physical Effects
                                  Mechanism Causing Hazard
     High Temperature             On-ground fire or              Tissue damage
                                  explosion                      Serious burns – including third
                                  In-flight fire or explosion    degree
                                  Heat of re-entry and loss      Death
                                  of heat dissipation
                                  systems
     Low Temperature              Cabin breach, loss of          Frost-bite
                                  heating systems                Death
     High Radiation levels        Shielding not adequate         Radiation sickness
                                  High radiation levels in       Loss of bodily fluids
                                  space                          Increased long-term cancer risk
                                                                 Death
     Sunlight                     Prolonged looking at           Eye damage
                                  unfiltered sunlight
     Physical Impact Trauma       Crash or structural failure    Serious injury or death
     - AIS 5,6
                 51               of spacecraft (due to
                                  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 spacecraft     Minor injury
     Exposure to Toxic            Release of toxic               Respiratory or skin damage
     Chemicals                    substance on-board or          Death
                                  from ground storage
                                  tanks
     Electrical shock             Contact with exposed           Severe burns
                                  high voltage source of         Electrocution / Fatality
                                  electrical potential (on-
                                  board or on ground)
     Loss of breathable                                          Asphyxiation / Fatality
     atmosphere/change in         Loss of atmospheric            Brain and other organ damage
     composition of               control systems and
     atmosphere/contaminants                                     Death
                                  backup systems
     and particulates
                                  Cabin flooded with non-
                                  breathable gases




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


                                                                                                      18
      Source of Physical Hazard   Mission Phase and/or Failure        Potential Physical Effects
                                  Mechanism Causing Hazard
     Loss/damage of personal      On-pad explosion and/or        Loss of assets
     effects on board or at       nominal launch effects to
     launch site                  participant property on
                                  ground (cars, jets,
                                  vehicles)



          6.1.1. High G Forces52
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.




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


                                                                                                   19
         6.1.2. Microgravity53
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
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
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



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.


                                                                                           20
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
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
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
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.

   6.2. 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.

                 Table 2. Summary of Psychological Response Hazards
           Source of             Potential Cause of SFP Response          Potential Effects of
   Physiological/Psychological                                        Physiological/Psychological
        Response Hazard                                                       Response

Claustrophobia                   Prolonged enclosure in            Excessive agitation
                                 confined space
                                                                   Possible inability to perform
                                                                   required duties
Excitement/Agitation/Fear        Response to unexpected            Commit irrational and possibly
                                 occurrences.                      violent, acts. Produce anxiety
                                                                   in other participants.



                                                                                                21
           Source of                 Potential Cause of SFP Response           Potential Effects of
   Physiological/Psychological                                             Physiological/Psychological
        Response Hazard                                                            Response

                                    Response to known risks.            Possible inability to perform
                                                                        required duties/ incapacitation
                                    Mental instability.
Motion Sickness                     Spacecraft in dynamic motion        Nausea, vomiting.
                                                                        Possible inability to perform
                                                                        required duties/ incapacitation
Vertigo - loss of bearing or        Spacecraft in dynamic motion        Nausea, vomiting.
balance
                                                                        Possible inability to perform
                                                                        required duties/ incapacitation
Rapid pulse/Increased blood         Excitement                          Cardiac arrhythmia
pressure
                                                                        Possible inability to perform
                                                                        required duties/ incapacitation
                                                                        Possible heart failure


   6.3. 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 6.2. 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.


                 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
      Exposure to actions of other SFPs




                                                                                                     22
                                            PROBABILITY of OCCURRENCE

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
       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
       Cardiovascular effects – acceleration/microgravity
       Claustrophobia
       Inability to think rationally
       High altitude sickness – launch site locality
       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




                                                                        23
                    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
       Temporary hearing loss
       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)
      Dysrhythmia (changes in cardiac rate, rhythm, and conduction) – could be significant in certain SFPs
       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
       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


                                                                                                       24
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.

7.0. 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).




                                                                                        25
8.0. 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,
    Tuesday, July 5, 2005.
   Lugan, B.F. and White, R.J., “Human Physiology in Space,” National Space
    Biomedical Research Institute, 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.




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