RESEARCH PROTECTIONS UPDATE Vol. 2 Number 1 January 2007

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by  U.S. Navy. Department of the Navy Human Research Protection Program

RESEARCH PROTECTIONS
UPDATE
News and Comment on the Protection of Human Subjects and Animals in Navy Research
Volume 2, Number 1 [email protected] January 2007

Comment

New HRPP Instruction Clarifies Command Responsibilities
The Navy’s newly approved pol- Para. 6a(4)(a) declares that involvement duties, and responsi-
icy for protection of human sub- “human subject research shall not bilities.”
jects, provided in SECNAVINST be initiated until the institution The DON HRPP has developed a
3900.39D, highlights five critical holds a valid Assurance for the Pro- number of training modules that are
areas of responsibility for com- tection of Human Research Sub- accessible through the Collabora-
mands that conduct research with jects, the research protocol has been tive Institutional Training Initiative
human subjects: (a) maintaining an reviewed by an IRB, and approved (CITI) website
approved DoD Navy Assurance; (b) by an appropriate research approval (www.citiprogram.org). See Re-
education and training of all per- authority.” search Protections Update October
sonnel involved in human subject SECNAVINST 3900.39D defines 2006.
research; (c) designating an Institu- an Assurance as a “document origi- The instruction says (Para. 8e)
tional Review Board (IRB) to re- nated by the institution engaged in that “the primary role of the IRB is
view research; (d) monitoring of human subject research that states to ensure the safety and welfare of
research; and (e) ensuring effective that it will comply with federal, human research subjects,” adding
communications among principal DoD, and DON requirements for that IRBs make recommendations
investigators, scientific reviewers, human subject protections.” to the approval authority for re-
IRB members, and command staffs. It continues that “Key require- search protocols.”
The instruction provides the ments of the DoD Navy Assurance Compliance with HRPP policy
foundation for the Navy’s new are completion of research ethics requires commands to monitor re-
HRPP policy. In coming months, training, designation of IRB(s) to search being conducted by observ-
Research Protections Update will review research protocols, and the
(Continued on page 2)
explore in-depth key new directions institution’s plan for monitoring
defined in the new instruction. human research.” Commands are
Para. 6a(4) of the instruction accountable for allocating resources Also in this Issue:
highlights the responsibilities of adequate to ensure compliance with
DDR&E Report on DON
commands, encompassing roles for their Assurance (para. 8c(19)).
HRPP
all personnel involved in human The requirement for education

subject research: “Commanders, and training (para 6a(2)) stipulates Pace Picks Up for Adden-
Commanding Officers, Officers in that “all personnel involved in re- dums
Charge, heads of activities, scien- viewing, approving, supporting,
Animal Research Protection
tific and technical program manag- conducting, managing, or oversee-

ers, project directors, IRB mem- ing research involving human sub- New, Renewed Assurances
bers, IRB support staff, and investi- jects must complete initial and on-
Q&As: Focus on Training
gators shall maintain concern for going research ethics and human

the safety and welfare of volunteer subject protections training appro- Vet Director Honored
subjects.” priate to each individual’s level of
RESEARCH PROTECTIONS UPDATE 2 January 2007

DDR&E Report

DON HRPP: “A New Message and Tone”
The Office of the Director of Defense Research and areas, it also looked at Navy recommendations for
Engineering (DDR&E), in a late-December report on changes to the DoD Human Research Protections regu-
the Navy’s human research protection program, said lation, DoDD 3216.2, and at the implementation of
that “the Navy has made significant improvements in policies and procedures since approval of the Navy’s
their HRPP” since DDR&E’s approval of the Navy HRPP Management Plan.
HRPP Management Plan in May 2005. The report cited Navy recommendations for modify-
ing DoDD 3216.2 to allow non-federal employees to
“High-Caliber Program, Highly Regarded” serve as members of Institutional Review Boards
(IRBs). DDR&E plans to discuss this recommendation
The report said that “Navy senior leadership is ex- and others with the DoD Coordinating Committee for
tremely committed to a high-caliber program that is Human Subject Research Protections.
highly regarded not only within the DoD, but also the The DDR&E report also discussed DON HRPP pro-
non-federal organizations.” posals for changes to DoDD 3216.2 regarding medical
The report, by the DDR&E BioSystems directorate, monitors, undue influence, and indemnification of re-
which oversees human research protections for the search subjects from expenses incurred due to partici-
military services and DoD agencies, is based on pation in any research, rather than only research that is
DDR&E’s review of the DON HRPP carried out in greater than minimal risk.
June 2006.
In mid-June, BioSystems Director Dr. Robert Foster New SECNAVINST
and Ms. Patty Decot, Assistant Director for Regulatory
Affairs and International Programs, met with Surgeon A key element of the DON human research protec-
General of the Navy Vice Adm. Donald C. Arthur, tion program is the approval by Secretary of the Navy
DON HRPP Director Capt. Eileen Villasante, and Dr. Donald C. Winter of SECNAVINST 3900.39D. Secre-
Tim Singer, then-Acting Director of the Research Pro- tary Winter signed the instruction on November 6,
tections Division at the Office of Naval Research 2006. The new Navy program, DDR&E said, provides
(ONR). Singer became director of the division in Au- “clearer lines of authority from the institutions to BU-
gust 2006. The DON HRPP program resides at the MED and ONR,” and that “oversight from these two
Navy’s Bureau of Medicine and Surgery (BUMED). offices has been strengthened and harmonized.”
The December DDR&E report evaluated the DON The report also discussed the role of the CNR, a two-
HRPP’s progress in such areas as education and train- star admiral, in overseeing research activities at three-
ing; stability of policies and procedures; and initiatives star commands. It recognized the specific role of the
for improvement of the program. Among many other
(Continued on page 5)

New HRPP Instruction Clarifies Command Responsibilities
volved in human subject research informed and up-to-
(Continued from page 1)
ing and/or meeting with investigators and auditing date. IRBs must report suspensions or terminations of
their research documents, such as approvals letters and approved research, unanticipated problems, among
copies of subjects’ consent forms. others. Commanders, Commanding Officers, and Offi-
Commands with IRBs must monitor their function- cers-in-Charge also must follow procedures to report
ing and review their SOPs at least annually to ensure suspensions or terminations of research, unanticipated
that they follow current guidance. Communication be- problems and incidents of non-compliance, among oth-
comes a critical command responsibility. Command- ers, to the DON HRPP.
ers must establish methods for keeping personnel in-
January 2007 3 RESEARCH PROTECTIONS UPDATE

FWA Addendums

DON HRPP Steps Up Pace of Addendum Approvals
The Surgeon General of the Navy, acting on recom- ciated with manipulation of various features of a peda-
mendations by the DON HRPP, approved eight Ad- gogical agent used in educational software. Another
dendums to Federalwide Assurances (FWA) in No- research project will test an “expert performance ap-
vember and December of 2006 to non-Navy proach” to development of expertise and professional
“extramural” research performers, including some of skills, with the goal of identifying how best to acquire
the nation’s top universities, enabling them to start and train relevant skills.
work on Navy-supported research involving human A number of additional Addendums from extramural
subjects in a wide range of science and technology ar- research performers are awaiting review and approval
eas. at the DON HRPP.
In order to conduct research with human subjects, ONR’s Research Protections Division coordinates
Naval commands are required to hold a DoD-Navy the handling of extramural performers’ Addendums for
Assurance approved by the Surgeon General. Non- the SG’s review and approval. The addendum requires
Navy extramural sites that hold an FWA may obtain an (a) documentation of approval from an Institutional
Addendum to the FWA that addresses additional Navy Review Board (IRB); (b) an IRB-approved research
and DoD requirements for human subject research. protocol; (c) an IRB-approved informed consent docu-
ment, when applicable; (d) an executive summary of
planned research (one-half to one page in length); (e)
Institutions Receiving Addendums
proof of completed human research training (training
Arizona State University
certificate, institutional verification of training, etc.);
Carnegie Mellon University
and (f) a completed DoD Navy Addendum. If the re-
University of Central Florida
search is determined to be greater than minimal risk,
Florida State University
the documentation provided to ONR must include the
Boston University
name and contact information for a medical monitor.
University of Pittsburgh
Further information on the Addendum process is
Clemson University
available on the DON HRPP web site at http://
University of Illinois at Chicago
navymedicine.med.navy.mil/humanresearch/ or on the
ONR Research Protections Division website (http://
The extramural research sites that received Adden- www.onr.navy.mil/sci_tech/34/343/). Contact the
dums all are funded through the Office of Naval Re- DON HRPP at [email protected] or
search (ONR), which sponsors much of the Navy’s [phone], or ONR at [phone].
research in combat casualty care and human-machine
integration, as well as in weapon, sensor, communica-
tions, and command-and-control systems.
For the human subject research efforts planned at the
institutions receiving Addendums, principal investiga-
tors (PIs) will design, develop, and test reconfigurable
and deployable prototype systems, and examine the
transfer of training from “virtual” to “real-world” envi-
ronments for military operations in urban terrain.
In other ONR-funded extramural research efforts
with human subjects, PIs expect to develop predictive
models of human motion as a foundation for real-time
kinematic tracking and recognition of human move-
ment.
Other research funded by ONR involving human The original Naval Observatory Dome, part of the
subjects will look at the effectiveness of learning asso- BUMED campus, viewed from the DON HRPP office
RESEARCH PROTECTIONS UPDATE 4 January 2007

DON Animal Research Protection

The Animal-Care Facility Inspection
By Col. Mark Gold
The most important part of any animal use program (IO). Under DoD guidance, we should ensure that
is the local Institutional Animal Care and Use Commit- non-affiliated members participate in the FIPRs to pro-
tee (IACUC). The IACUCs are bound by a basic set of vide “community participation” in this essential IA-
requirements set out in the Animal Welfare Act Regula- CUC review process.
tions (9 CFR) as well as by other guidelines of funding The law requires that no fewer than two IACUC
and oversight agencies. One of the key requirements members conduct each FIPR; ad hoc consultants are
of 9 CFR is that the animal-use programs of research acceptable supplements. Maximum participation helps
sites be reviewed and their facilities inspected at least bring as many “eyes” as possible to the process of ex-
every six months. SECNAVINST 3900.38C, The Care amining facilities and programs. This is the one best
and Use of Animals in DoD Programs, also requires chance for the IACUC to identify issues that need at-
periodic program reviews and facility inspections. tention or deserve recognition. Additionally, it may be
Each facility inspection / program review (FIPR) one of the few times in the year to secure critical re-
should follow a strict six-month cycle. DoD research sources for animal care and use programs that are un-
sites are not inspected by the USDA, but animal re- der-funded or unfulfilled.
search programs must ensure that they comply with 9 Once the IACUC identifies a deficiency it must stick
CFR. We should keep in mind that some facilities re- to the plan for correction described in the FIPR report.
quire several days to complete their FIPR. Should the IACUC fail to do so, and the failure results
in a “significant deficiency,” it must report the defi-
ciency to the USDA, the Association for the Assess-
The most important part of any animal use
ment and Accreditation of Laboratory Animal Care
program is the local Institutional Animal
(AAALAC) International (required by the SECNAV-
Care and Use Committee (IACUC).
INST for DOD facilities), the Bureau of Medicine and
Surgery (for DON facilities), and any other funding or
SECNAVINST 3900.38C requires each DoD facility assuring agencies (e.g., the NIH Office for Laboratory
to use Appendix D to the instruction—a checklist—to Animal Welfare). The IACUCs must ensure that their
document IACUC findings and distinguish between plans are reasonable in terms of scope and schedule to
minor and significant deficiencies (those that threaten produce the most successful outcome.
the health or safety of the animals). Any additional The IACUC, not the assigned veterinarian, performs
means of documenting deficiencies or plans for correc- the FIPR. The IACUC also completes the FIPR report
tion are at the discretion of the individual facility; this and prescribes a plan for corrections. The veterinarian,
often can be done with an easily updated computerized while perhaps responsible for resolving individual defi-
spreadsheet. In cases where the IACUC identifies de- ciencies identified by the IACUC, is unlikely to be the
ficiencies, facilities are required to provide a “… rea- sole “fixer” of FIPR deficiencies. Animal oversight is
sonable and specific plan and schedule with dates …” a most sacred IACUC responsibility. The FIPR is one
for correcting each deficiency. of the most important parts of carrying out that respon-
Once the IACUC drafts the FIPR report, a majority sibility at each animal-care facility.
of the IACUC members must sign the document. Any
IACUC member may provide a minority view or ab- Col. Mark Gold, USA, is Director of Veterinary
stain from signing. Once a majority have signed, the Affairs in the Office of Research Protections at
document is forwarded to the Institutional Official the Bureau of Medicine and Surgery.
RESEARCH PROTECTIONS UPDATE is published monthly by the Department of the Navy Human Research Protection
Program. email address: [email protected]. Captain Eileen Villasante, publisher, Edward J. Walsh, editor.
Telephone: [phone]; E-mail: [email protected]. Material appearing in RESEARCH PROTECTIONS
UPDATE is not copyrighted and may be redistributed in electronic or printed form.
January 2007 5 RESEARCH PROTECTIONS UPDATE

New Navy Assurance Holders

DON HRPP Renews Six Assurances; New Assurances Approved
The DON HRPP has renewed Navy Assurances for Norfolk, Va.
research with human subjects at the Naval Medical

Center, San Diego; Naval Medical Research Center
Detachment (NMRCD Lima, Peru); U.S. Naval Hospi-
tal, Naples; and Naval Hospital Corpus Christi, Tex.
The Space and Naval Warfare Systems Center San
Diego and the Naval Experimental Diving Unit
(NEDU), Panama City, Fla., also received renewals.
DON HRPP staff members have conducted site vis-
its to NMRCD Lima, the National Naval Medical Cen-
ter, and NEDU.
DON HRPP also approved new Assurances for the
First Marine Expeditionary Force, Camp Pendleton,
Mr. Roberto Fernandez, entomologist at the Naval
Calif., and the Naval Air Force, U.S. Atlantic Fleet, Medical Research Center Detachment, Lima Peru

DON HRPP: “A New Message and Tone”
standardizing the review procedures.”
(Continued from page 2)
CNR, defined in the new SECNAVINST, as The DDR&E report observed that BUMED and
“providing support and expertise to the SG for human ONR “are successfully working with small institutions
research protections at the Systems Commands, opera- (small in number of annual protocols) to partner them
tional forces, training commands, and DON-supported with larger institutions that have robust IRB[s].”
extramural performing institutions.” The DDR&E re-
port noted that the SG retains final authority for non- “Well-Established in the Medical Community”
medical research.
Commenting on Navy efforts to comply with DoD
“A Model Process” HRPP training requirements, the DDR&E report said
that the DON HRPP has developed training modules,
The DDR&E report pointed out that the Navy pro- residing on the Collaborative Institutional Training Ini-
gram has developed many new forms to implement tiative (CITI) website, for Navy HRPP personnel, in-
their HRPP process: a Navy Assurance; Addendum to cluding researchers, IRB members, and commanding
the Federalwide Assurance; and Joint Research Review officers.
Agreement (JRRA). It said that the DON HRPP “has The report concluded that “Vice Adm. Arthur recog-
standardized the submittal and review processes of nizes that the Navy HRPP is well-established in the
these documents,” and added that “these forms seem medical community and attention is needed in the re-
reasonable in the context of DoD’s overall implemen- mainder of the Navy research portfolio to ensure poli-
tation of HRPP policy and are being modified for cies are complied with.”
DoD-wide use.” DDR&E added that “The Navy is beginning to es-
DDR&E noted that DON HRPP requires all human tablish a new message and tone—one of working with
subject research, including research determined to be the institutions to establish a positive and collaborative
exempt per 32 CFR 219.101(b) to go through head- relationship, to strengthen the quality of the HRPP at
quarters-level review at either BUMED or ONR. The the foundation, and to tailor the HRPP to the institu-
study said that “Navy has created a model process not tion.”
only for criteria of what is to be reviewed, but also for
RESEARCH PROTECTIONS UPDATE 6 January 2007

HRPP Questions and Answers

HRPP Training: Biomedical or Social-Behavioral?
Why are there different tracks for biomedical ing education. Future DON HRPP modules will ad-
(BIO) and social-behavioral research (SBR) on the dress unique Navy and DoD requirements.
DON HRPP training program [the DON HRPP on-
line training provided on the Collaborative Institu- Which type of learner group should I select on
tional Training Initiative (CITI) website, CITI, Biomedical or Social-Behavioral?
www.citiprogram.org]?
It depends on what you study, and how you study it.
The dual tracks of the DON HRPP training program For example, biomedical protocols often include ele-
reflect differing definitions, practices, and regulatory ments of SBR, which is why we include SBR content
concerns of SBR and clinical research. Although the in BIO training modules. Vaccine research and diving
human subjects protection course structure divides the research study the body’s response to physical stimuli
course into SBR and BIO, the DON HRPP has devised and have a biomedical focus, whereas human factors
“learner groups” that blend both SBR and biomedical and human cognition research tend to emphasize so-
content. cial-behavioral questions and measurements. Combat-
For example, if you select the “Investigators and related stress is a good example of a research area that
Key Research Personnel–Biomedical” learner group, may be studied from either perspective or both.
your “Grade Book” generates a list of required mod-
ules, including “SBR for Biomedical Researchers” and I’m an investigator, but I’m also on the IRB.
“Privacy and Confidentiality–SBR.” Which learner group should I select?
Researchers and IRB members whose focus includes
both types of research should select the appropriate The IRB member track. It’s more comprehensive.
learner group under the BIO track. Personnel involved In order to advise commanding officers and Institu-
only in SBR with human subjects may select the ap- tional Signatory Officials effectively, IRB members
propriate learner group in the SBR track. All modules need information and understanding to apply ethical
not included in the required portion of your Grade principles and regulatory requirements when reviewing
Book are available to you for information or continu- research protocols.

Director of Veterinary Affairs Honored

Director of Veterinary Affairs, Col. Gold, Honored
Col. Mark Gold USA, Director of Veterinary Affairs
in the Office of Research Protections at the Bureau of
Medicine and Surgery, was inducted into the Order of
Military Medical Merit at the Annual Veterinary Ser-
vices Holiday Ball on December 16.
Throughout his career Col. Gold has advanced the
Army Medical Department’s biomedical research pro-
grams with unique contributions as a researcher, in-
structor, and veterinarian.
Col. Gold has served as Animal Use consultant to
the Air Force and Navy Surgeons General, providing
expert advice on USAF and USN animal-based re-
Col. Gold (right) with Brig. Gen. Michael Cates, Chief of the
search, development, training, and education programs.
Army Veterinary Corps, at the OMMM induction ceremony.