INSTRUCTIONS FOR AUTHORSUNDERSEA and HYPERBARIC MEDICINEThe Journal of the Undersea & Hyperbaric Medical Society, Inc.
As of 1 December 2022
OVERVIEW
Original manuscripts and subsequent revisions must be submitted electronically in MS WORD throughManuscript Manager® at: https://www.manuscriptmanager.net/uhm

UHM will not consider simultaneous submissions nor papers that have not been released from consideration
by other journals. In the case of papers that have been reviewed and released by another journal, UHM
reserves the right to request reviews and editor comments from the other journal(s) during its considerationof the paper.
Only manuscripts written in the English language will be considered.
Submissions that are not consistent with these guidelines will be returned to the corresponding author forrevision before being reviewed.
Uncorrected proofs will be posted on the Journal’s webpage after acceptance until they appear in the
Journal. All articles will be open access 12 months after publication.
LANGUAGE
The language of the journal is standard American English. Papers must be written in a clear, concise style forthe best chance of acceptance. UHM does not provide translation or writing services; authors who are notfluent in the language should have the manuscript edited before submission by a native English speaker or
professional language editor.

The journal will decline to review manuscripts that are not written clearly enough for an informed reader tofollow the line of arguments.
MANUSCRIPT GUIDELINES
Membership in the Undersea and Hyperbaric Medical Society is not a prerequisite for publication in UHM.
Manuscripts are accepted for publication on the condition that they are contributed solely to UHM. Authors
submitting a manuscript do so with the understanding that if it is accepted for publication, copyright is
assigned exclusively to the UHMS.

Acceptance of a manuscript is based on originality and quality of the work as well as clarity of presentation.
An editor will review the manuscript and one or more external, impartial reviewers will be asked to evaluateeach manuscript for significance and scientific soundness.
PROOFS and FEES
Proofs are sent to corresponding authors via email in a PDF format and are to be checked carefully. The
corresponding author is the responsible party for signing off on proofs. During this process UHM makes thereasonable assumption that the corresponding author will consult with all co-authors or be designated by
the co-authors to act on their behalf.

Necessary changes must be clearly indicated on the galley or an accompanying Word document, withcorrections set in color text or highlighting. Proofs must be sent back within the time specified. A paper may
be rescheduled if delay warrants. Authors whose original papers are accepted for publication in UHM canpublish for no fee.
TREATMENT OF SUBJECTSThe UHMS endorses the principles of the Declaration of Helsinki on the treatment of human subjects andthe guiding principles in the care and use of animals approved by the Council of the American PhysiologicalSociety. For more on these topics see the sections entitled “Scope of the Journal” and “Recommendations
from the Declaration of Helsinki.” Studies using human subjects or animals must clearly indicate in that the
study was reviewed and approved by the appropriate group or agency.
TYPES OF ARTICLES IN THE JOURNALThe Undersea and Hyperbaric Medicine Journal strives to provide unbiased scientific information and fairanalyses through its publication of the following types of papers.
Research articles/reports should not exceed 6,000 words and have approximately 25 references, four tables
and four figures. Papers in this category should cover results of experimental, theoretical and clinicalinvestigations on topics important to the understanding of undersea, submarine and hyperbaric medicine.
Short reports that make a substantial scientific contribution as well as extensive studies will be considered.
Review articles should not exceed 6,000 words and have up to 150 references. Longer reviews ofexceptional quality and relevance should be considered. These texts may cover scientific and practicalsubjects and may express personal opinions of the author, backed by documentation. Systematic reviews
must be registered prospectively with PROSPERO (https://www.crd.york.ac.uk/prospero/) or similar and theregistration number included in the abstract and methods. For systematic reviews, it is strongly
recommended that a medical librarian be involved with the development and execution of the literaturesearch. Systematic reviews and meta-analyses must be reported using the most recent PRISMA guidelines(currently the 2020 edition).
Short communications should not exceed 3,000 words, with approximately 12 references and a combined
total of four tables/figures. This category includes:
Clinical communications and clinical case reports should not exceed 3,000 words, with approximately 12
references and a combined total of four tables/figures. These papers should comprise observations of an
exceptionally revealing nature and include a short introduction to provide perspective, details of the case,and discussion that includes references to pertinent literature.
Letters to the editor should not exceed 400 words and contain no more than five references. Letters
include discussion of scientific papers that have appeared in the journal or scientific issues of interest to thejournal’s readers. Letters should include an informative title and be as short as possible. A letter can besigned by no more than three authors.

PREPARATION OF MANUSCRIPTS
The overriding principles for papers considered for UHM are that the text is correct and unambiguous, clear
and concise. When writing, the active voice is generally preferable to the passive voice. Parallel constructionof groups of like items and/or concepts aids in comprehension. Abbreviations and acronyms should not be
overused, be clearly defined at first appearance in the abstract as well as in the text, and avoided in the title.
There should be no repetition of information in the Discussion section that has already appeared in Results.

Figures should be uncomplicated and legible. Figures should be high-quality (1200 dpi for line art, 600 dpi
for grayscale and 300 dpi for color, at the correct size). Specific items of information should appear only
once in the manuscript. There should be no verbatim repetition of Copyright© [date] Undersea andHyperbaric Medical Society, Inc. in the text of material that appears in a table or figure. Avoid duplication ofdata in graphs and tables.
Authors are encouraged to use papers that have appeared in recent issues of UHM as models for theirmanuscript preparation. All accepted manuscripts are subject to final editing by the editors to improvereadability and to conserve space.

MANUSCRIPT REQUIREMENTS:
Submission. Manuscripts must be submitted electronically through the online submission and review
system Manuscript Manager at: https://www.manuscriptmanager.net/uhm. Individuals submitting papers
will be guided in the submission process, including full and short titles, keywords, conflict of interest
statements, plus author names, affiliations and email addresses. Direct submission enquiries to theManaging Editor.
Text requirements: Undersea and Hyperbaric Medicine participates in the agreement established by theinternational Committee of Medical Journal Editors as set forth in Uniform Requirements for Manuscripts
Submitted to Biomedical Journals: Ann Intern Med. 1988; 108:258-265 and Br Med J 1988; 296:401-405.
Title page: A title page that is separate from the manuscript should include the following.
• title of no more than 85 characters, including spaces;• - each author’s full name- highest clinical degree/certification followed by the highest academic degree and the following:
CHT, CHRN, DMT;
- laboratory or institution of origin;- city, state and country• a running head, not to exceed 50 characters, including spaces;• full contact info for the corresponding author including telephone, complete postal address, and email• the maximum numbers number of authors is eight without justification by the corresponding author
and approval of the editor

Titles should be informative. The implication that a manuscript is one of a series of related papers is
discouraged (e.g., “Decompression sickness studies I”). Avoid titles that are posed as questions.

Funding details: Please supply all details required by your funding and grant-awarding bodies as follows:
For single agency grants: This work was supported by the [Funding Agency] under Grant [number xxxx].
For multiple agency grants: This work was supported by the [Funding Agency #1] under Grant [numberxxxx]; [Funding Agency #2] under Grant [number xxxx]; etc.
Place this information on the title page.
Abstracts: An informative abstract of 250 words or fewer, suitable for abstracting agencies without
rewording, should state the purpose of the research, what was done, what was found, and what was
concluded. Titles should contain indexable words.
Keywords: Include three to six keywords that are not contained within the title.
Key points: An informative summary of two to three lines describing the content of the paper should be
provided for use in the table of contents.
Manuscript: The UHM Journal review is single-blind.
Sections: The manuscript should be divided into Introduction, Methods, Results and Discussion. A
limitations section should be included in the discussion section. Long stretches of text should be broken
into suitable paragraphs and by subheadings, but subheadings should not be overused. Obscure symbols
and excessive use of abbreviations should be avoided.
Statistical methods: These should be described in the Methods section. Information about presentation of
statistical material can be found in: Bailar J, Mosteller F. Guidelines for statistical reporting in articles for
medical journals: amplifications and explanations. Adv Intern Med 1988; 108: 268-273.
Figures: Figures may not be embedded in the manuscript; however, please indicate within the text where
they should be placed. Figures should be high-quality (1200 dpi for line art, 600 dpi for grayscale and 300
dpi for color, at the correct size). Figures should be supplied in one of our preferred file formats: PDF, JPEG or
TIFF. Microsoft Word (.doc or .docx) files are acceptable for figures that have been drawn in Word. Color
images are allowed only in cases where their removal makes the image uninterpretable, such as diagnostic
images. Figures created in Microsoft Excel are discouraged.
Depiction of animals: Animals must be depicted only by line drawing or other form of animation. It is thejournal’s policy not to publish photographs of animal subjects.
Depiction of patients: UHM publishes only photos of subjects who have provided express written
permission to the author to do so. UHM will insert an editorial comment in articles in which such photos areincluded, specifically documenting that consent was obtained. The terms of the subject/patient consent
determine whether a de-identified photo (i.e., with a black box obscuring the identity of the subject) would
be used.

Tables: Tables should present new information rather than duplicating what is in the text. Readers shouldbe able to interpret the table without reference to the text. Tables may not be embedded in the manuscript.
Please supply editable tables in a Microsoft Word (.doc or .docx) files.
REFERENCES
Citations in the reference list are to be in the form used by the U.S. National Library of Medicine (PubMed).
Authors are responsible for supplying complete references and verifying them against the original
documents. References must be numbered consecutively in the order in which they first appear in the text,
and identified in the text by Arabic numerals in parentheses or brackets. References cited only in tables orlegends should be numbered in accordance with a sequence corresponding to the first mention of the tableor figure in the text.

When citing weblinks in the text please consider them as references as seen below and number them as
noted above.
• NASA Astrophysics Data System. <http://adswww.harvard.edu/>• The Handle System. <http://handle.net/>
Manuscripts that have been accepted but are not yet in print should be cited in the reference list as regularreferences, with “Forthcoming + publication year” in place of journal pages. Manuscripts listed electronically
before they are printed should be cited as “epub ahead of print.” Citations such as unpublished observations,personal communication, manuscript in preparation or to be published are not to appear in the reference list,
although reference to such a communication, if it exists in written form, may be cited in the text inparentheses. References to government reports should not be cited unless such reports are easily available toall readers.
Authors: List names and initials of all authors when six or fewer; when seven or more, list only the first threeauthors followed by et al. Examples:• Kemper TCPM, de Jong VM, Anema HA, van den Brink A, van Hulst RA. Frostbite of both first digits of thefoot treated with delayed hyperbaric oxygen: a case report and review of literature. Undersea Hyperb Med.
2014 Jan-Feb; 41(1): 65-70.
• Lee CH, Choi JG , Lee JS, et al. Seizure during hyperbaric oxygen therapy: experience at a single academic
hospital in Korea. Undersea Hyperb Med. First-Quarter 2021;48(1):43-51.
• Hempleman HV. History of decompression procedures. In: Bennett PB, Elliott EH, eds. The physiology andmedicine of diving. London: WB Saunders, 1993: 324-375.
• Kindwall EP, Goldmann RW. Hyperbaric medicine procedures. Milwaukee, WI: St. Luke’s Medical Center,
1970.
Equations: Equations should appear in the text in an appropriate type style (italics, bold, etc.). Authors
should carefully distinguish between capital- and lower-case letters, Roman and Greek characters, andletters and numerals. Number equations sequentially, in parentheses on the left edge of the text. Allconstituent terms should be defined when they initially appear. Authors are responsible for correctformatting of each term in the equation. Equations should be considered camera-ready when they aresubmitted.
Acknowledgments: Acknowledgments of persons who aided in the work and of funding agencies, alongwith any other special considerations about the paper, should appear at the end of the text, before
references. This information will be blinded during the review process.
Footnotes: Footnotes to material in the text are not allowed. Footnotes to tables are acceptable and should
be identified in sequence by lowercase letters of the alphabet in italic superscript.
Units of measure: The Systéme Internationale d’Unités (SI units) format should be used to express
measurements of pressure, depth, length, weight, time, temperature, energy, power, force andconcentration per: Standard Practice for Use of the International System of Units (SI) Document E380-89a,
American Society for Testing and Materials, Philadelphia, Pa. 1989.

If the subject matter makes it appropriate to use non-SI units such as fsw, msw, atm or bar, a parentheticalconversion to pascals, kilopascals or megapascals should accompany the first mention of a pressure value inthe abstract and in the text. Units of fsw and msw should not be used to express partial pressure or when
the nature of the subject matter requires precise evaluation of pressure. After all units, authors must include
a parenthetical (a) or a parenthetical (g) to indicate whether units are in absolute or gauge terms.
The proper method for the expression of other units or appreciations may be found in Br Med J. 1978;
1:1334-1336 and Aviat Space Environ Med. 1984; 55: 93-100.
AUXILIARY PUBLICATIONS
Axillary information includes detailed tables, appendices, mathematical derivatives, extra figures and othersupplementary matter deemed too voluminous to be included in the journal article. Such material may besubmitted for deposition with the American Society for Information Sciences (ASIS), National Auxiliary
Publication Service, at no charge. The information is deposited by the editorial office with the consent of theauthor, and a footnote will appear in the published article to the effect that photoprint or microfiche copies
are available at a moderate cost.
In some instances additional material will be posted in the online version of the paper.

Revised February 2023

SCOPE OF THE JOURNAL

Undersea and Hyperbaric Medicine Journal accepts manuscripts for publication that are related to theareas of diving research and physiology, hyperbaric medicine and oxygen therapy, submarine medicine,
naval medicine and clinical research related to the above topics. To be considered for UHM scientificpapers must deal with significant and new research in an area related to biological, physical and clinicalphenomena related to the above environments.
The following types of papers are published: research article/reports (theoretical and experimental); review
articles; short communications (which may include current issues and technical communications); clinicalcommunications and clinical case reports; proceedings from symposiums or workshops; letters to theeditor; and book reviews. For specific information see ‘Instructions for Authors.’
Reports of major contributions or symposiums will be considered and may be published as supplements
to regular issues. Authors are referred to “Instructions for Authors” for more details on the categories of
papers.
Undersea and Hyperbaric Medicine is abstracted and/or indexed in Chemical Abstract Service, Excerpta
Medica, Oceanic Abstracts, Bioscience Information Service of Biological Abstracts, Current Contents, Index
Medicus, PubMed, EBSCO, Scopus, and Current Awareness in Biological Sciences.
On file in the administrative offices of the Society are two documents pertaining to Institutional Review
Board regulations CFR50 and21cfr56. The UHMS, as publisher of the UHM journal, acknowledges that all
human research requires informed consent and IRB approval in accordance with the laws of the country inwhich the work was performed. This includes abstracts as well since they are published in UHM.
The Society endorses the principles embodied in the Declaration of Helsinki (following) and expects that
all investigations involving man reported in its journal will have been conducted in conformity with theseprinciples.
DECLARATION OF HELSINKI
Preamble
1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethicalprinciples for medical research involving human subjects, including research on identifiable human material
and data.

The Declaration is intended to be read as a whole and each of its constituent paragraphs should be appliedwith consideration of all other relevant paragraphs.
2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA
encourages others who are involved in medical research involving human subjects to adopt theseprinciples.
General Principles
3. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will
be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act
in the patient’s best interest when providing medical care.”4. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients,
including those who are involved in medical research. The physician’s knowledge and conscience arededicated to the fulfilment of this duty.
5. Medical progress is based on research that ultimately must include studies involving human subjects.
6. The primary purpose of medical research involving human subjects is to understand the causes,
development and effects of diseases and improve preventive, diagnostic and therapeutic interventions(methods, procedures and treatments). Even the best proven interventions must be evaluated continually
through research for their safety, effectiveness, efficiency, accessibility and quality.
7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects
and protect their health and rights.
8. While the primary purpose of medical research is to generate new knowledge, this goal can never takeprecedence over the rights and interests of individual research subjects.
9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity,
integrity, right to self-determination, privacy, and confidentiality of personal information of researchsubjects. The responsibility for the protection of research subjects must always rest with the physician orother health care professionals and never with the research subjects, even though they have given consent.
10. Physicians must consider the ethical, legal and regulatory norms and standards for research involving
human subjects in their own countries as well as applicable international norms and standards. No national
or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections
for research subjects set forth in this Declaration.
11. Medical research should be conducted in a manner that minimizes possible harm to the environment.
12. Medical research involving human subjects must be conducted only by individuals with the appropriate
ethics and scientific education, training and qualifications. Research on patients or healthy volunteers
requires the supervision of a competent and appropriately qualified physician or other health care
professional.
13. Groups that are underrepresented in medical research should be provided appropriate access toparticipation in research.
14. Physicians who combine medical research with medical care should involve their patients in research
only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if thephysician has good reason to believe that participation in the research study will not adversely affect thehealth of the patients who serve as research subjects.
15. Appropriate compensation and treatment for subjects who are harmed as a result of participating inresearch must be ensured.

Risks, Burdens and Benefits
16. In medical practice and in medical research, most interventions involve risks and burdens.
Medical research involving human subjects may only be conducted if the importance of the objective
outweighs the risks and burdens to the research subjects.

17. All medical research involving human subjects must be preceded by careful assessment of predictablerisks and burdens to the individuals and groups involved in the research in comparison with foreseeable
benefits to them and to other individuals or groups affected by the condition under investigation.
Measures to minimize the risks must be implemented. The risks must be continuously monitored, assessedand documented by the researcher.
18. Physicians may not be involved in a research study involving human subjects unless they are confident
that the risks have been adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive
outcomes, physicians must assess whether to continue, modify or immediately stop the study.
Vulnerable Groups and Individuals
19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being
wronged or of incurring additional harm.
All vulnerable groups and individuals should receive specifically considered protection.

20. Medical research with a vulnerable group is only justified if the research is responsive to the healthneeds or priorities of this group and the research cannot be carried out in a non-vulnerable group. In
addition, this group should stand to benefit from the knowledge, practices or interventions that result fromthe research.
Scientific Requirements and Research Protocols
21. Medical research involving human subjects must conform to generally accepted scientific principles, bebased on a thorough knowledge of the scientific literature, other relevant sources of information, andadequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for researchmust be respected.

22. The design and performance of each research study involving human subjects must be clearly describedand justified in a research protocol.
The protocol should contain a statement of the ethical considerations involved and should indicate how the
principles in this Declaration have been addressed. The protocol should include information regarding
funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects andinformation regarding provisions for treating and/or compensating subjects who are harmed as aconsequence of participation in the research study.
In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.
Research Ethics Committees
23. The research protocol must be submitted for consideration, comment, guidance and approval to theconcerned research ethics committee before the study begins. This committee must be transparent in its

functioning, must be independent of the researcher, the sponsor and any other undue influence and must
be duly qualified. It must take into consideration the laws and regulations of the country or countries inwhich the research is to be performed as well as applicable international norms and standards but thesemust not be allowed to reduce or eliminate any of the protections for research subjects set forth in thisDeclaration.
The committee must have the right to monitor ongoing studies. The researcher must provide monitoring
information to the committee, especially information about any serious adverse events. No amendment to
the protocol may be made without consideration and approval by the committee. After the end of thestudy, the researchers must submit a final report to the committee containing a summary of the study’s
findings and conclusions.
Privacy and Confidentiality
24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of
their personal information.
Informed Consent
25. Participation by individuals capable of giving informed consent as subjects in medical research must be
voluntary. Although it may be appropriate to consult family members or community leaders, no individual
capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.

26. In medical research involving human subjects capable of giving informed consent, each potential
subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts ofinterest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study
and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The
potential subject must be informed of the right to refuse to participate in the study or to withdraw consent
to participate at any time without reprisal. Special attention should be given to the specific informationneeds of individual potential subjects as well as to the methods used to deliver the information.
After ensuring that the potential subject has understood the information, the physician or anotherappropriately qualified individual must then seek the potential subject’s freely-given informed consent,
preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be
formally documented and witnessed.
All medical research subjects should be given the option of being informed about the general outcome andresults of the study.
27. When seeking informed consent for participation in a research study the physician must be particularly
cautious if the potential subject is in a dependent relationship with the physician or may consent underduress. In such situations the informed consent must be sought by an appropriately qualified individual who
is completely independent of this relationship.
28. For a potential research subject who is incapable of giving informed consent, the physician must seek
informed consent from the legally authorized representative. These individuals must not be included in a
research study that has no likelihood of benefit for them unless it is intended to promote the health of thegroup represented by the potential subject, the research cannot instead be performed with persons capableof providing informed consent, and the research entails only minimal risk and minimal burden.
29. When a potential research subject who is deemed incapable of giving informed consent is able to giveassent to decisions about participation in research, the physician must seek that assent in addition to theconsent of the legally authorized representative. The potential subject’s dissent should be respected.
30. Research involving subjects who are physically or mentally incapable of giving consent, for example,
unconscious patients, may be done only if the physical or mental condition that prevents giving informed
consent is a necessary characteristic of the research group. In such circumstances the physician must seek
informed consent from the legally authorized representative. If no such representative is available and if theresearch cannot be delayed, the study may proceed without informed consent provided that the specificreasons for involving subjects with a condition that renders them unable to give informed consent havebeen stated in the research protocol and the study has been approved by a research ethics committee.
Consent to remain in the research must be obtained as soon as possible from the subject or a legallyauthorized representative.
31. The physician must fully inform the patient which aspects of their care are related to the research. The
refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never
adversely affect the patient-physician relationship.
32. For medical research using identifiable human material or data, such as research on material or datacontained in biobanks or similar repositories, physicians must seek informed consent for its collection,
storage and/or reuse. There may be exceptional situations where consent would be impossible or
impracticable to obtain for such research. In such situations the research may be done only after
consideration and approval of a research ethics committee.
Use of Placebo
33. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of thebest proven intervention(s), except in the following circumstances:
Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; orWhere for compelling and scientifically sound methodological reasons the use of any intervention lesseffective than the best proven one, the use of placebo, or no intervention is necessary to determine theefficacy or safety of an intervention
and the patients who receive any intervention less effective than the best proven one, placebo, or nointervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving
the best proven intervention.
Extreme care must be taken to avoid abuse of this option.
Post-Trial Provisions
34. In advance of a clinical trial, sponsors, researchers and host country governments should makeprovisions for post-trial access for all participants who still need an intervention identified as beneficial in
the trial. This information must also be disclosed to participants during the informed consent process.

Research Registration and Publication and Dissemination of Results
35. Every research study involving human subjects must be registered in a publicly accessible database
before recruitment of the first subject.

36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the
publication and dissemination of the results of research. Researchers have a duty to make publicly available
the results of their research on human subjects and are accountable for the completeness and accuracy of
their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative andinconclusive as well as positive results must be published or otherwise made publicly available. Sources offunding, institutional affiliations and conflicts of interest must be declared in the publication. Reports ofresearch not in accordance with the principles of this Declaration should not be accepted for publication.
Unproven Interventions in Clinical Practice37. In the treatment of an individual patient, where proven interventions do not exist or other known
interventions have been ineffective, the physician, after seeking expert advice, with informed consent fromthe patient or a legally authorized representative, may use an unproven intervention if in the physician’s
judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention
should subsequently be made the object of research, designed to evaluate its safety and efficacy. In allcases, new information must be recorded and, where appropriate, made publicly available.