Summary of Significant Changes …

                                  Summary of Significant Changes
                                     SECNAVINST 3900.39C
                                               to
                                     SECNAVINST 3900.39D
                                         22 June 2007

This chart is a summary of significant changes made in SECNAVINST 3900.39D to reflect
current regulations and unify the Department of Navy Human Research Protection Program
(DON HRPP).

Topic             Paragraph       Description of Change
Subject line      N/A             Changed from "Protection of Human Subjects" to "Human Research
                                  Protection Program" to reflect the national standard. Throughout the
                                  instruction changed "human use" to "human research" or "research
                                  with humans" depending on the context.

Scope: Test       4(a)4           Revised paragraph: Test pilots and experimental divers who become
pilots and                        subjects in research (i.e., not their normal assignment) are covered by
experimental                      this instruction.
divers
Scope:            4b(4)           New paragraph: This instruction does not apply to research using
Cadaver                           cadavers. However, an ethics review by an IRB is required when
research                          there is a link to private identifiable information between deceased
                                  and living individuals.
Investigational   4b(5)           New paragraph: This instruction does not apply to use of
drugs,                            investigational drugs, biologicals, or devices for the purposes of
biologics, and                    Force Health Protection. Such use is governed by DoDD 6200.2.
devices ­
Force Health
Research          6a(2),          New paragraphs: Delineate research ethics and human subject
Ethics            6a(4)(b),       protections education and training for COs, Institutional Review
Education and     8a(2),          Board members, investigators, etc.
Training          8a(3), 8c(1),
                  8c(2),
                  8d(1)(f),
                  8e(2), 8f(1),
                  and 8g(2)
Research-         6a(5)           Revised paragraph: Expanded the concept of research-related injury
related Injury                    to consider provisions for minimal risk research. Research-related
                                  injury provisions may be appropriate for some minimal risk research.
                                  In these cases, IRBs should make a determination based on the
                                  review of the research itself. For example, written or oral surveys, or
                                  interviews on sensitive topics (child abuse, suicide, domestic
                                  violence, for example) may trigger severe, unpredictable
                                  psychological reaction that may require emergency treatment and
                                  follow-up.


SECNAVINST_3900.39C.doc                       1
Topic           Paragraph      Description of Change
Additional      6a(6).         New information: Added "deployed active duty personnel" to list of
Protections -                  examples of groups warranting additional protection.
Active Duty
Personnel
Chemical &      6a(7)          New paragraph: Addresses research involving testing chemical or
Biological                     biological agents.
Testing
Captured or     6a(8)         New paragraph: Addresses the prohibition of research involving
Detained                      prisoners of war (POW) and detainees. Added definition of POW to
Personnel                     enclosure (1), item #21. .
Expedited       6d, 7a(8)(a)- New paragraphs: The intent is to ensure consistency within the DON
Review of       (b), and      of the review and approval processes for all research involving
Research        7b(2)         human subjects, including research eligible for expedited review. In
                              addition, this preserves the historical checks and balances between
                              the review and approval functions.
Survey          6e            New paragraph: Addresses survey research that meets the dual
Research                      requirements of the OPNAV instruction on surveys (OPNAVINST
                              5300.8B) and human research protections.
Extramural      6g            New paragraph: Addresses DON-supported extramural research
Research                      performed outside the DON and includes areas covered by ONR's
                              policy (ONRINST 3900.34B) on human research for DON-supported
                              extramural research. DoD-sponsored extramural human subject
                              research must comply with appropriate federal and DOD human
                              research protection regulations and policies.
Investigational 6h            New paragraph: Addresses research involving the use of
Drug/Device                   investigational agents. This paragraph was extracted from
Sponsorship                   BUMEDINST 6710.69 to incorporate the intersection of IND/IDEs
                              with human research protections in a SECNAV level policy
                              statement. The requirements have not changed with regard to COs
                              and investigators; however, the paragraph adds the option that the SG
                              may be the IND/IDE sponsor.
Classified      6j            New paragraph: Addresses review of classified research to reflect
Research                      the SECDEF 1993 memorandum and guidance in the federal
                              regulation.
Public Release 6m             New paragraph: Addresses public release of research information.
of Research
Information
Research that 7a(1)           Revised paragraph: Adds the Secretary of the Navy as the approval
Requires                      authority for research, involving:
Approval of                         (a) Waivers of the requirement for informed consent under 10
Secretary of                        USC 980.
the Navy                            (b) Exceptions from informed consent requirements for
                                    emergency research under 21 CFR 50.24 and in accordance
                                    with the requirements of 10 USC 980.
                                    (c) Requests for waiver of requirements of DON policy


SECNAVINST_3900.39C.doc                                                               2
Topic            Paragraph     Description of Change
                                    regarding human research protections.
Research the  7a(2)            New paragraph: Adds the Under Secretary of the Navy as the
Under                          approval authority for certain types of research involving human
Secretary of                   subjects for which, under SECNAVINST 3900.39C, the Assistant
the Navy Must                  Secretary of the Navy for Research, Development and Acquisition
Approve                        served as the approval authority.

Navy Surgeon     7a(5)         Revised paragraph: Revised the role of the Navy SG. The Navy SG
General                        is the single authority for policy development, oversight, compliance,
                               and ongoing monitoring concerning human research protections in
                               the DON
Requirements 8a(14)            New paragraph: Addresses items the SG must report to DDR&E
for SG to
Report
Chief of Naval 8b              Revised paragraph: Revised the role of the Chief of Naval Research
Research Role                  (CNR). The CNR provides support and expertise to the SG for
                               human research protections in the System Commands, operational
                               forces, training commands, and DON-supported extramural
                               performing institutions.
Commanding       8c(21),       New paragraphs: Address COs' requirement to review and report
Officer          8c(22),       research misconduct and non-compliance with human research
Responsibility   8c(23)(c) ­   protections to the SG
                 (f)
IRB Members      8e(1)         New paragraph: Limits IRB members to current federal employees,
                               consultants, and "appointed" vs. "detailed" IPAs. Status as a
                               contractor or federal retiree is not sufficient to qualify as a federal
                               employee.
Principal        8g            New paragraph: Emphasizes the definition of Principal Investigator
Investigators                  in enclosure (1) limiting eligibility for Principal Investigators status
                               for DON-supported intramural research to federal employees.




SECNAVINST_3900.39C.doc                                                                    3