ATTACHMENT C Excerpts from Navy Bureau of Medicine and Surgery, Manual of the Medical Department, 1951 on Human Experimentation Date received _______ Department of the Navy Date made ___________ Bureau of Medicine and Surgery Signature ___________ Washington 25, D. C. 26 September 1951 MANUAL OF THE MEDICAL DEPARTMENT ADVANCE CHANGE 1-3 The changes listed herein are effective upon receipt. Insert this change in front of the Manual of the Medical Department, and mark '1-3" opposite the below listed articles and subarticles in the Manual text. The symbol "1- 3" indicates that this is the third advance change issued in advance of printed change 1. H. L. Pugh Chief, Bureau of Medicine Surgery Summary of Articles and Subarticles Affected 1-13 through 1-19 5-10 16-7(1) 22-21 (3)(a) 23-106(1) 23-106(1) 3-36 16-3(1) 16-24 23-2 (MONTHLY, MED-08)_ 1-13 through 1-19 New articles Section IV. RESEARCH Article Statement of Policy 1-13 Scope 1-14 Laboratories and Facilities 1-15 Projects 1-16 Experimentation on Personnel 1-17 Trials of Commercial Items, Specialties, and Pharmaceutical Products 1-18 Technical Reports and Public Releases 1-19 1-13. Statement of Policy (1) The fundamental policy of the Bureau is to encourage and support research and development in medical, dental, and allied sciences directed toward the solution of problems affecting the health, safety, selection, and efficiency of the personnel of the Department of the Navy and other branches of the Department of Defense. (2) The direction of the research activities of the Medical Department of the Navy shall be centralized in the Research Division of the Bureau. (3) Development, testing, and evaluation shall be the responsibility of the Bureau Coordinator for Research and Development (art. 1-12 (25)). (4) There shall be no fixed apportionment of basic research and applied or developmental research. 1-14. Scope (1) The fields of research studies in medicine, dentistry and allied sciences shall include the broadest aspects of medical and dental problems related to submarine, shipboard, aviation, amphibious, and field activities, sea transport, and military personnel. (2) Research and development shall be concerned primarily with pertinent operational requirements of the Navy as promulgated by the Chief of Naval Operations. A continuous program of research in the basic sciences that affect military medicine and dentistry, and their ancillary branches, shall be directed to the practical application of improved methods of medical and dental defenses against the weapons, health hazards, and agents of modern warfare. (3) Naval hospitals and other naval medical activities are encouraged to conduct clinical research, including studies of diseases and injuries, statistical records of series of cases, appropriate therapeutic trials, and other phases of clinical investigation. The research projects and the therapeutic trials must be authorized by and reported to the Bureau of Medicine and Surgery, through its Research Division. Application may be made ADVANCE CHANGE 1-3 on form NAVMED-98 or on other official forms that may be provided for this purpose. 1-15. Laboratories and Facilities (1) In addition to the usual installations, in hospitals, infirmaries and dispensaries, and in the medical and dental facilities of ships and stations, the Bureau will maintain research laboratories and facilities separately and in cooperation with other bureaus, the Office of Naval Research, and the Marine Corps. 1-16. Projects (1) In general, projects will be selected by individual investigators who shall submit their proposals, via official channels, to the Bureau for consideration for approval. However, the Bureau may assign projects t any of the various facilities, when strategic or tactical problems presented by any of the bureaus of the Navy so warrant. Cooperation with other services may be effectuated by individual investigators upon the Bureau's approval or direction. (2) The selection and approval of projects will depend on the desires, initiative, and competence of the research workers; the available facilities; and the special opportunities offered by the location and environment of particular establishments. In the conduct of their studies, investigators will be given the greatest possible freedom consistent with naval policies and the security regulations as administered by their commanding officers. Investigators will be encouraged to arrange through the Bureau for consultation with civilian scientists, for collaboration with civilian institutions of learning and research, and for interservice cooperation. The Bureau will cooperate in facilitating the exchange of information, the authorization of contract research through the Office of Naval Research, and provision of medical and dental intelligence to proper authorities, via official channels, and will maintain liaison with research activities in foreign countries. (3) At command research units and/or laboratories under the Bureau's management control, pilot studies may be undertaken at the discretion of the commanding officer, who shall be responsible for the conduct of such studies and reporting of same to the Chief of the Bureau of Medicine and Surgery. 1-17. Experimentation on Personnel (1) Experimental studies of a medical nature involving persons in the Naval Establishment are forbidden except when the experimental design in each case has received the prior approval of the Secretary of the Navy. All such requests shall be forwarded via the Bureau for consideration and recommendation to the Secretary of the Navy. In the case of military personnel or their legal dependents, recommendations on requests received shall be made by the Bureau and forwarded to the Chief of Naval Personnel, the Commandant of the Marine Corps, or the Commandant of the Coast Guard, as appropriate, prior to submission to the Secretary of the Navy. (2) Participation by personnel of the naval Establishment (military and civilian) shall be on a voluntary basis only. Volun- teers will not be required to execute a release from future liability for negligence attributable to the Navy. Such studies shall in no way interfere with the training or other performance of normal duties of the personnelinvolved. (3) For each instance a statement shall be entered into the individual's Health Record indicating the project number and the physical and psychological effect, or lack of same, resulting from the investigation. In case of civilian volunteers, the command- ing officer shall cause a similar entry to be recorded in the individual's personnel file. 1-18. Trials of Commercial Items, Specialties, and Pharmaceutical Products (1) Authority to conduct clinical, laboratory, or field trials at naval medical activities of drugs, materials, or devices presented by commercial firms may be granted by the Bureau of Medicine and Surgery, if facilities are available and provided that such trials will sufficiently contribute to naval operations to warrant approval Requests for Bureau review, coordination, and approval of such trials shall be made on form NAVMED-98 or on other official forms that may be provided for this purpose. Reports shall be marked "For Official Use Only" and shall be submitted to the Bureau. All such reports become the property of the Bureau which assumes no obligation to or for any commercial firm. Commanding officers shall take appropriate steps to prevent the unauthorized release of information on trials which might be utilized for advertising purposes to promote sales of commercial products. 1-19. Technical Reports and Public Releases (1) The Bureau of Medicine and Surgery requires interim and final reports on all projects or subtasks conducted under a project. Interim reports shall be submitted semiannually, as of 30 June and 31 December and at such other times as significant phases APPENDIX 7 MANUAL OF THE MEDICAL DEPARTMENT Manual of the Medical Department, 26 September 1951, Section IV, Research Articles 1-13 through 1-19 are reproduced below: 1-17. Experimentation on Personnel (1) Experimental studies of a medical nature involving persons in the Naval Establishment are forbidden except when the experimental design in each case has received the prior approval of the Secretary of the Navy. All such requests shall be forwarded via the Bureau for consideration and recommendation to the Secretary of the Navy. In the case of military personnel or their legal dependents, recommendations on requests received shall be made by the Bureau and forwarded to the Chief of Naval Personnel, the Commandant of the Marine Corps, or the Commandant of the Coast Guard, as appropriate, prior to submission to the Secretary of the Navy. (2) Participation by personnel of the Naval Establishment (military and civilian) shall be on a voluntary basis only. Volunteers will not be required to execute a release from future liability for negligence attributable to the Navy. Such studies shall in no way interfere with the training or other performance of normal duties of the personnel involved. (3) For each instance a statement shall be entered into the individual's Health Record indicating the project number and the physical and psychological effect, or lack of same, resulting from the investigation. In case of civilian volunteers, the commanding officer shall cause a similar entry to be recorded in the individual's personnel file. CHAPTER 1. MEDICAL DEPARTMENT 1. __of laboratory employment in an effort to produce a creative atmosphere and conditions con- ducive to conscientious scientific productivity. Em- ployee development programs shall be effected and the professional-grade personnel shall be encour- aged to participate in the activities of professional societies. 1-8. Scope (1) The fields of research studies in medicine, denistry, nursing, and allied sciences shall include the broadest aspects of medical, dental, and nurs- ing problems related to submarine, shipboard, aviation, amphibious, and field activities, sea transport, and military personnel. (2) Research, development, testing, and evaluation shall be concerned principally with pertinent Naval Research Requirements as promulgated by the Chief of Naval Research. A continuous program of research in the basic sciences that affect military medicine, dentistry, and nursing, and their ancillary branches, shall be maintained. In time of war and national emergency, the major effort and attention shall be directed to the practical application of improved methods of medical and dental_____ against the weapons, health hazards, and agents of modern warfare. (3) Naval hospitals and other naval medical ac- ____ are encouraged to conduct clinical research, including studies of diseases and injuries, statistical records of series of cases, appropriate therapeutic trials and other phases of clinical investigation. The research projects and the therapeutic trials must be authorized by and reported to BUMED through its Research Division. Application may be made on form NAVMED-1436 or on other official forms that may be provided for this purpose. 1-9. Laboratories and Facilities (1) In addition to the usual installations, in hospitals and dispensaries, and in the medical and dental facilities of ships and stations, BUMED will maintain research laboratories and facilities separately and in cooperation with other bureaus, the Office of Naval Research, and the Marine Corps. 1-10. Projects 23-43(1) (1) Projects for research will be established by ___in accordance with Naval Research Requirements as promulgated by the Chief of Naval Research. Tasks under the project will be assigned to research activities by BUMED or at the request of the activity. Proposals for research will be submitted by individual investigators via official channels for consideration and technical approval. Cooperation with other services may be effectuated by individual investigators upon BUMED approval or direction. (2) The selection and approval of research pro- posals will depend on the desires, initiative, and competence of the research workers; the available facilities; and the special opportunities offered by the location and environment of particular estabishments. In the conduct of their studies, investigators will be given the greatest possible freedom consistent with naval policies and the security regulations as administrered by their commanding officers. Investigators will be encouraged to arrange through BUMED for consultation with civilian scientists, for collaboration with civilian institutions of learning and research, and for interservice cooperation. BUMED will cooperate in facilitating the exchange of information, the authorization of contract research through the Office of Naval Research, and provision of medical and dental information to proper authorities, via official channels, and will maintain liaison with research activities in foreign countries. (3) At command research units and/or laboratories under BUMED management control, pilot studies may be undertaken at the discretion of the commanding officer, who shall be responsible for conducting such studies and reporting them to the Chief BUMED. 1-11. Experimentation on Personnel (1) Experimental studies of a medical nature involving persons in the Naval Establishment are for- bidden except when the experimental design in each case has received the prior approval of the Secretary of the Navy. All such requests shall be forwarded via BUMED for consideration and recommendation to the Secretary of the Navy. In the case of military personnel or their legal dependents, recommendations on requests received shall be made by BUMED and forwarded to the Chief of Naval Personnel, the Commandant of the Marine Corps, or the Commandant of the Coast Guard, as appropriate, prior to submission to the Secretary of the Navy. (2) Participation by personnel of the Naval Establishment (military and civilian) shall be on a voluntary basis only. Volunteers will not be required to execute a release from future liability for negligence attributable to the Navy. Such studies shall in no way interfere with the training or other performance of normal duties of the personnel involved. (3) For each instance a statement shall be entered in the individual's Health Record indicating the project number and the physicial and psychological effect, or lack of same, resulting from the investigation. In case of civilian volunteers, the commanding officer shall cause a similar entry to be recorded in the individual's personnel file. 1-7 Change 13 CHAPTER 20. RESEARCH AND DEVELOPMENT 20-7 shall inform his listeners of his unofficial status. Military authors are reminded of the require- ment of article 1252.3 of NAVREGS to submit one copy of each published article to SECNAV. 20-7. Navy Laboratory Funds (Independent Research) (1) Objectives. - The principal objectives of the Navy Laboratory Funds Program are to en- hance the competence of a laboratory; permit it to grow in scientific stature; improve its ability to attract competent investigators' initi- ate challenging work and ultimately improve its capability to make new ideas and fresh ap- proaches pay off in terms of its directed pro- grams. (2) Funds. - Subject to the current avail- ability of funds, BUMED will provide major research and development command activities with Navy Laboratory Funds to conduct inde- pendent research. The Funds will be furnished to provide flexibility for the investigation of new ideas generated during the year for which there is no provision for funding in the formal program. The Navy Laboratory Funds will be in addition to those provided for approved or as- signed work units, and since they are primarily to augment and exploit technical competence, they shall not be used to make up deficits in directed parts of the program, nor normally to sponsor contract research. (3) Controls. - Prior BUMED approval is not required for studies undertaken with these funds. The commanding officer of the laboratory will direct the use of these funds and may set up a board of senior investigators to assist him in the selection of studies to be conducted. These studies should normally have a 2-year limitation, to be extended only with specific BUMED approval. Projects showing promise shall be incorporated into the regular research or development program at any time by sub- mitting them as a proposal in accordance with article 20-6 (4). (4) report. - Activities provided Navy Labo- ratory Funds shall submit a letter report, report of Independent Research Funds (Report Sym- bol MED 3920-1), TO REACH BUMED (Code 71) no later than 15 July each year. The reporting period shall be the fiscal year in which funds are received. The content of the report shall include the identification of studies undertaken, progress or results and obligations and expendi- tures against the studies. 20-8. Use of Volunteers in Medical or Other Hazardous Experiments (1) Approval.- Experimental studies of a medical nature or experiments which pose any unusual hazard to the subjects are forbidden except when the study or experiment, and the use of volunteer human subjects, has been ap- proved by the Secretary of the Navy. Such studies or experiments shall be approved via their chain of command. In each case the ex- perimental design and medical support shall be reviewed by the Chief, BUMED, to determine the adequacy of the safety factor. (2) Volunteer Policy - Participation shall be on a volunteer basis only. Volunteers, after full information, shall consent in writing but shall not be required to execute a release from future liability for negligence attributable to the Navy. (3) Administrative Procedures. - Requests for the use of volunteers as subjects for medical or other potentially hazardous experiments shall be submitted in accordance with SECNAV In- structions and such implementing Instructions as may be promulgated by lesser authority. (4) Record. - For each instance a statement shall be entered in the individual's medical rec- ord indicating the work-unit number and title, and a notation of the physical and/or psycho- logical effect, or lack of same resulting from the investigation. 20.9. Experimental Animals (1) Department of defense Instruction 3216.1 of 7 August 1967 establishes the policy governing the procurement, transportation, use, and care of laboratory animals involved in the research, development, test, and evaluation pro- grams of DOD Components, and certain public information aspects pertaining thereto. Per- tinent portions are quoted below for com- pliance: IV. BACKGROUND AND POLICY A. Pursuant to PL 89-544 (reference (e)), the De- partment of Agriculture has published Regulations and Standards on Laboratory Animal Welfare (reference (d)). These regulations and standards require licensing of dealers, registration of research facilities, maintenance of records, identification of dogs and cats, and com- pliance by dealers and research facilities, including laboratory animal facilities of the United States, with the minimum standards for the humane handling, care, treatment, and transportation of various categories of animals. B. It is the fundamental policy of the Department Defense that animals intended for use in research are provided humane care and treatment. C. The following DoD policies on the procurement, transportation, use, and care of laboratory animals are consistent with the references (c), (d) and/or (e): 1. In all research and development programs per- formed or sponsored by Department of Defense Com- ponents involving the use of laboratory animals in the United States, both the standards for the humane handl- 20-5 Change 46 CHAPTER 20. RESEARCH AND DEVELOPMENT 20-9 20-7. Navy Laboratory Funds (Independent Research) (1) Objectives.- The principal objectives of the Navy Laboratory Funds Program are to enable laboratories to enhance the competence; to permit their growth in scientific stature ; to attract highly competent in- vestigators; initiate challenging work; and ul- timately improve its capability to make new ideas and fresh approaches pay off in terms of its regular programs. (2) Funds. - Subject to the current availability of funds, BUMED will provide major research and development command activities with funds to conduct independent research. The funds will be furnished to provide flexibility for the investi gation of new ideas generated during the year for which there is no provision for funding in the formal program. The Navy Laboratory Funds will be in addition to those provided for ap- proved or assigned work units. However, since they are primarily to augment and exploit techni- cal competence, they shall not be used to make up deficits in directed parts of the regular approved program, nor take the place of a previously re- ______ research proposal, or normally to sponsor contract research. They shall ______ work which clearly has Navy relev- _______. (3) Controls. - Provided that administrative ______ elements herein indicated are ob- _______ BUMED approval is not required for studies undertaken with these funds. An in- _____ propose work on a task of an in- _______ re, to be established as a form of _____ object to approval by the command- _____should establish an advisory labo- tory committee on Independent Research for _______and recommended action. With the ________ the chairman of such a committee ________a technical director, the commanding ______laboratory will allocate funds to be _______ studies. These studies will normally _____ limitation, after which they will be ________completed or terminated. They may be ____ on recommendation of the comman- _______BUMED approval. Studies show- _____ shall be incorporated into the regu- _____or development program at any time _____on as a proposal in accordance with ______. (4) Reports. - In accordance with require- _____ning reports on all projects, whatever ___ source of funding, activities provided ______ laboratory Funds shall submit for each in- ______ work unit, immediately upon its incep- itial informative report ("new") on ____-498. Subsequently, a progress report, _________1498, shall be made to reach _______ Code ____ no later than 30 July each year. The reporting period shall be for the imme- diate past fiscal year for which funds were re- ceived, as its contents shall be the same required for all such report forms. 20.8. Use of Volunteers in Medical or Other Hazardous Experiments (1) Authority. - SECNAVINST 3900.39 (se- ries) prescribes Navy policies and procedures governing the use of volunteer subjects in RDT&E projects. The instruction shall be fol- lowed when it is necessary to utilize volunteers in hazardous experiments. (2) Definition. - The SECNAVINST 3900.39 states that hazardous conditions or materials are those which present risk of privation discomfort, distress, pain, physical or mental injury, or death greater than the hazards inherent in training or work within accepted occupational parameters. (3) Investigational Drugs. - The SECNAV- inst 3900.39 applies to the use of investigational drugs under an approved RDT&E project or task in a volunteer population of patients in which the experimental drug testing has no relationship to the cause of their being on the sicklist. BUMED- INST 6710.49 (series) must also be followed `n the utilization of Investigational drugs in RDT&E projects. (4) Record. - For each instance a statement shall be entered in the individual's medical record indicating the work-unit number and title, and a notation of the physical and/or psychological effect, or lack of same, resulting from the investi- gation. 20-9. Experimental Animals (1) DoD Instruction 3216.0 of 7 August 1967 establishes the policy governing the procurement, transportation, use, and care of laboratory ani- mals involved in the research, development, test, and evaluation programs of DoD Components, and certain public information aspects pertaining thereto. Pertinent portions are quoted below for compliance: IV. BACKGROUND AND POLICY A. Pursuant to PL 89-544 (reference (e)), the De- partment of Agriculture has published Regulations and Standards on Laboratory Animal Welfare (reference (d)). These regulations and standards require licensing of dealers, registration or of research facilities , maintenance of records, identification of dogs and cats, and com- pliance by dealers and research facilities, including laboratory animal facilities of the United States, with the minimum standards for the humane handling, care, treatment, and transportation of various categories of animals. B. It is the fundamental policy of the Department of Defense that animals intended for use in research are provided humane care and treatment. C. The following DoD policies on the procurement, transportation, use, and care of laboratory animals are consistent with the references (c), (d) and/or (e): 20-5 Change 61 CHAPTER 20. RESEARCH AND DEVELOPMENT 20-9 20-7. Navy Laboratory Funds (Independent Re- search) (1) Ojectives. - The principal objectives of ____ programs are to enable laboratories to en- hance their competience; to permit their growth in scientific stature; to attract highly competent in- vestigators; to initiate challenging work; and ult- timately to make new ideas and fresh approaches pay off in terms of their regular programs. (2) Funds. - Subject to the current availability of funds, BUMED will provide major research and development command activities with funds to conduct independent research. The funds will be furnished to provide flexibility for the investi- gation of new ideas generated during the year for which there is no provision for funding in the formal program. The Navy Laboratory Funds will be in addition to those provided for ap- proved or assigned work units. However, since they are primarily to augment and exploit techni- cal competence, they shall not be used to make up deficits in directed parts of the regular approved program nor to take the place of a previously re- ___ research proposal, or normally to ___ or sponsor contract research. They shall be used for work which clearly has Navy relev- _____. (3) Controls. - Provided that administrative ____ requirements herein indicated are ob- _____ , prior BUMED approval is not required for studies undertaken with these funds. An in- vestigator may propose work on a task of an in- vestigative nature to be established as a form of ____study, subject to approval by the command- ing officer who should establish an advisory labo- ratory committee on Independent Research for ___ review and recommended action. With the ___ of the chairman of such a committee and/or of the technical director, the commanding officer of the laboratory will allocate funds to be used for such studies. These studies will normally have a 2 year limitation, after which they will be rendered completed or terminated. They may be ___ upon recommendation of the command- ing officer and BUMED approval. Studies showing promise shall be incorporated into the regular research or development program at any time _____submission as a proposal in accordance with _____ 20 6(4). (4) Reports. - In accordance with require- ments governing reports on all projects, whatever ____ the source of funding, activities provided ____laboratory funds shall submit for each in- __ work unit, immediately upon its incep- _____ initial informative report ("New") pm Form 1498. Subsequently, a progress report, DoD Form 1498, shall be made to reach BUMED (Code 71) no later than 30 July each year. The reporting period shall be for the imme- diate past fiscal year for which funds were re- ceived, and its contents shall be the same required for all such report forms. 20-8. Use of Volunteers in Medical or Other Hazardous Experiments (1) Authority. - SECNAVINST 3900.39 (se- ries) prescribes Navy policies and procedures governing the use of volunteer subjects in RDT&E projects. The instruction shall be fol- lowed when it is necessary to utilize volunteers in hazardous experiments. (2) Definition.- The SECNAVINST 3900.39 states that hazardous conditions or materials are those which present risk of privation, discomfort, distress, pain, physical or mental injury, or death greater than the hazards inherent in training or work within accepted occupational parameters. (3) Investigational Drugs. - SECNAVINST 3900.39 series applies to the use of investigational drugs under an approved RDT&E or Clinical In- vestigation Program (CIP) project or task in a volunteer population in which the experimental drug testing has no relationship to any condition for which a volunteer may be receiving medical treatment. BUMEDINST 6710.49 series must also be followed in the utilization of investigational drugs in both RDT&E and CIP projects when the drug is related in any way to a condition for which a volunteer may be receiving medical treatment. (4) Record. - For each instance a statement shall be entered in the individuals medical record indicating the work-unit number and title, and a notation of the physical and/or psychological effect, or lack of same, resulting from the investi- gation. 20.9. Experimental Animals (1) DoD Instruction 3216.1 of 31 August 1967 establishes the policy governing the procurement, transportation, use, and care of laboratory ani- mals involved in the research, development, test, and evaluation programs of DoD Components, and certain public information aspects pertaining thereto. Pertinent portions are quoted below for compliance: IV. BACKGROUND AND POLICY a. Pursuant to PL 89-544 (reference (e)), the De- partment of Agriculture has published Regulations and Standards on Laboratory Animal Welfare (reference (d)). These regulations and standards require licensing of dealers, registration of research facilities, maintenance of records, identifications of dogs and cats, and com- pliance by dealers and research facilities, including laboratory animal facilities of the United States with 20-5 Change 80 CHAPTER 20. RESEARCH AND DEVELOPMENT ___he selection and approval of medical __posals will be based on program objec- __operational requirements, immediacy of __ ional impact, experience and competence __ tigators, scientific merit, availability of __funds, probability of success, level of __ the Navy, and the special opportunities __offered by the location and environment __ facilities. Programs are reviewed system- in-house scientific advisory committees C program managers, and on an ad hoc variety of mechanisms, including but not external peer review groups, technical program and resource sponsor reviews, Medical Research Conferences and Topi- __ Triservice RDT&E Coordinating Com- __National Research Council/National __Sciences Committees. ___orting Requirements. __Management Reports - NMRDC requires progress reports on work units under its __ responsibility. Interim progress reports __annually on all active work units. Final ___required at the earliest practicable time on __ or termination of work units. Technical/Scientific Reports - (1) In accordance with SECNAVINST series, a DD Form 1473, Document Control _____ be completed and included as the ____ of ___ copy of all technical/scientific ___including those submitted in reprint form. ___ sheet that is attached to DD Form ___be consulted for information about ___ of the form. (2) Twelve copies of technical/scientific __ be submitted to the Defense Technical ____ Center (DTIC), subject to the provisions ___ Instructions 3900.24 and 3900.29 series, accompanied by a DTIC Form 40. All copies of ___submitted shall include an appropriate distri- __ in accordance with NAVMATINST __ series. Three copies of all technical/scientific shall also be submitted to NMRDC. Repro __ of published articles will conform to existing copyright laws and regulations. (3) Technical/scientific reports shall be __ in accordance with OPNAVINST 5510.1 ___Department of the Navy Information Security ___A recommended distribution list for each __ report shall be submitted to NMRDC for __ approval prior to distribution. (4) To ensure uniform compliance with __ Navy policy and security regulations, ____ R&D technical/scientific reports, ___ and any other material planned for ____dissemination, shall be cleared by the com- ___ officer of the performing activity and be consistent with current guidance pro- _____ NMRDC Commanding officers will consult _____ NAVREGS and OPNAVINST 55 10.1 series in reviewing material for public disclosure. If a clearance determination cannot be made at the command level, the material may be submitted to NMRDC for review and decision. 20-6. Independent Research Program (1) Objective - The principal objective of this program is to enable laboratories to expand basic research capabilities. Through this program, highly competent investigators are encouraged to initiate new and challenging work that may ultimately enhance regular laboratory programs or lead to innovative long-term efforts. (2) Funds. Subject to the current availability of funds, NMRDC will provide Navy medical RDT&E laboratories with funds to conduct independent research. These funds, being allocated in addition to those used to support other approved or assigned work units, will provide flexibility for the investiga- tion of new ideas generated during the year. Pri- marily, independent research funds are to augment technical competence and be used for work that has clear Navy relevance. These funds shall not be used to compensate for other approved programs' deficits or as a substitute for previously rejected research pro- posals. (3) Controls. - NMRDC approval is not required for research undertaken with these funds. Such research, however, must conform to the policy guidance provided in the above paragraph. An investi- gator may propose innovative work in the form of a preliminary investigation to be submitted to the commanding officer for final approval. Commanding officers may, at their discretion, establish an advisory committee to review and recommend action on such proposals. This research will normally have a 2-year limitation, after which the research will be considered completed, terminated, or appropriate for funding in other research programs. The research may be ex- tended, however, on recommendation of the com- manding officer and with NMRDC approval. (4) Management Reports. - Annual progress re- ports on work sponsored under the Independent Research Program shall be submitted in accordance with NAVMATINST 3920.3 series and specific guid- ance issued annually by NMRDC. On approval of the research proposal by the commanding officer, a DD 1498 ("NEW") will be forwarded to NMRDC for assignment of a work unit number and submittal to the Defense Technical Information Center. 20.7. Use of Human Volunteers in Medical Research (1) Authority. - SECNAVINST 3900.39 series and implementing BUMED instructions prescribe Navy policies and procedures governing the use of human volunteers in RDT&E projects. These instructions shall be followed for any medical research and development efforts involving use of human volun- teers. 20-3 Change 95 MANUAL OF THE MEDICAL DEPARTMENT, U.S. (2) Records. - Medical research documentation and records must be filed and retained in accordance with the provisions of SECNAVINST 3900.39 series. 20-8. Use of Animals in Medical Research (1) Authority. DOD Instruction 3216.1 and im- plementing SECNAV and BUMED instructions estab- lish policies and procedures governing the utilization and humane care of animals in RDT&E programs. These instructions shall be followed for any medical research and development efforts involving the use of experimental animals. (2) Personnel and Technical Assistance. - BUMED Instruction 6401.1 series delineates the policies governing military veterinary medical support for naval activities. SECNAVINST 3900.38 series assigns BUMED the responsibilities of coordinating the use of laboratory animals by the Naval Establishment, and the Special Assistant for Veterinary Medicine (Code 98) NMRDC, will provide specialized assistance upon request. 20-9. Use of Investigational Items Under Federal Food and Drug Administration Control (1) Authority for Navy Medical Department activ- ities or contractors supported by the Navy Medical Department to conduct clinical, laboratory, or field trials of drugs or biologicals covered by the Federal Food, Drug, and Cosmetic Act must be obtained from BUMED in accordance with the provisions of NMCI 6710.4 series. (2) Compliance with SECNAVINST 3900.39 series is also required when human volunteers partic- ipate in Navy Medi____ investigations using _____ 20.10. Postdocto____ (1) NMRDC_____ Research Council, _______ the National Acad ______ ous _____ opportunities _______ fled civilian blome ______ areas of major _____ logical community ________ submarine, diving ______ and the behavioral ______ to define potential ________ naval systems, and _________ to counteract the _______ tiveness in under _____ vironments. (2) Postdoctors ____ may be offered _______ ments. Competition ________ National Research ________ orization from the _________ Award applications__________ Research Council ________ on a competitive _______ scientists and engin _________ for formulating a _______ related to NMRDC ________ which program the _____ individuals having _______ more of the oppor ________ are advised to con_________ for further informa_________ 20-4 Chapter 95 Research projects will have a 3-year limitation, after which the research will be considered completed, terminated, or appropriate for funding in other research programs. (4) Management Reports. - Annual progress reports on work sponsored under the Independent Research Program shall be submitted in accordance with NAVMATINST 3920.3 series and specific guidance issued annually by NMRDC. A DD 1498 ("New") will be forwarded to NMRDC for assignment of a work unit number and submittal to the Defense Technical Information Center. 20.7. Use of Human Volunteers in Medical Research (1) Authority. - SECNAVINST 3900.39 series prescribe Navy policies and procedures governing the use of human volunteers in ADT&E projects. These instructions shall be followed for any medical research and development efforts involving use of human volunteers. (2) Records. - Medical research documenta- tion and records must be filed and retained in accordance with the provisions of SECNAVINST 3900.39 series. 20.8. Use of Animals in Medical Research (1) Authority. DOD Directive 3216.1 series and implementing SECNAVINST 3900.38 series establish policies and procedures governing the responsible use, humane care, and review of the use of animals in RDT&E programs. These instructions shall be followed for any biomedical research and development efforts involving the use of animals. (2) Personnel and Technical Assistance.- BUMEDINST 6401.1 series delineates the policies governing military veterinary medical support for Naval activities. SECNAVINST 3900.38 series assigns NAVYMEDCOM the responsibilities of coordinating and overseeing the use of animals by the Naval Establishment, and the Assistant for Veterinary Medicine (Code 02E) NAVMEDCOM, will provide specialized assistance as needed. 20-9. Use of Investigations Items Under Federal Food and Drug Administration Control (1) Authority for Navy Medical Department activities or contractors supported by the Navy Medical Department to conduct clinical, laboratory, or field trials of drugs or biologicals covered by the Federal Food, Drug, and Cosmetic Act must be obtained from NAVMEDCOM in accordance with the provision of NAVMEDCOMINST 6710.4 series. (2) Compliance with SECNAVINST 3900.39 series is also required when human volunteers participate in Navy Medical Department - sponsored RDT&E investigations using FDA-controlled materials. 20-10. Resident Associateships (1) NMRDC, in cooperation with the National Research Council, National Academy of Sciences, and the National Academy of Engineering, offers numerous opportunities for postdoctoral research to qualified civilian biomedical scientists and bioengineers in areas of major concern to the scientific and technological community. Within the fields of aerospace, submarine, diving, preventive medicine, oral health and the behavioral sciences, NMRDC scientists seek to define potential medical hazards facing man in naval systems, and to devise methods and procedures to counteract them; thus ensuring maximum effectiveness in underwater, surface, and aerospace environments. (2) Resident Research Associateship awardees may be offered appointments by the National Research Council (NRC). Award applications will be received by the NRC Associateship Office and evaluated on a competitive basis by special NRC panels of scientists and engineers. Each applicant is responsible for formulating a specific research plan on a problem related to NMRDC current program interest, and which program the applicant wishes to investigate. Individuals having research interests relating to one or more of the opportunities described in this chapter are advised to communicate directly with NMRDC for further information. 20-4 Change 100