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4. Administrative Review and Special Clearances

IV. ADMINISTRATIVE REVIEW AND SPECIAL CLEARANCES
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A. CLEARANCES TO BE OBTAINED BEFORE ORA REVIEW

1. Project Participants  

2. Conflict of Interest

3. Human Subjects:

a. Exempt Research:

b. Research Project Notification (RPNs):

c. Definite Plans:

d. Applications and Proposals Lacking Definite Plans for Involvement of Human Subjects:

e. Requirements for Indemnification of Clinical Research Protocols:

f. Avoidance of Economic Risks to Patients:

g. Inclusion of Women and Minorities as Subjects in Clinical Research

4. Health, Safety and Environment

a. Radioactive materials:

b. Recombinant DNA:

c. Etiologic Agents Infectious, Pathogenic, Oncogenic Agents/Materials:

d. Hazardous and Toxic Chemicals:

5. Animals JHMI Animal Care and Use Committee

6. Core Facilities

7. Pharmaceutical Services at The Johns Hopkins Hospital

8. Development Office (The Fund for Johns Hopkins Medicine)

9. Space Changes (Use, Additional Need, Alterations)

10. Clearances Through The Johns Hopkins Hospital

11. Other Affiliated Institutions

12. Applied Physics Laboratory


 


A. CLEARANCES TO BE OBTAINED BEFORE ORA REVIEW

1. Project Participants

Be certain that each participant in the project can devote the effort indicated, that each has personally agreed to participate, that each has disclosed any potential conflicts of interest, and that adequate salaries have been requested (see "Salaries" Section, III.C.2.). Effort greater than 5% from an investigator with a primary appointment in another division of JHU requires approval from the investigator's primary department and divisional Research Administration office. In order to keep faculty effort and "Other Support" updated, a copy of the project budget should be sent to each participating investigator's department administrator.

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2. Conflict of Interest

As cited in the Faculty Policies Handbook of The Johns Hopkins University, School of Medicine, the following arrangements must be reviewed at the proposal stage by the Committee on Conflict of Interest, which will make recommendations to the Dean for final action:

a. Royalty
Proposals for external research support when the research will be performed by a faculty member who receives or will receive royalty from the sale of products which are the subject of the research.
b. Equity
-Proposals for licensing a faculty invention when the faculty member, on his own or through the University, holds equity or will hold equity in the licensee; and
-Proposals for external research support involving a faculty member who, on his own or through the University, holds equity or will hold equity in a company supporting the research or in a company whose technology is the subject of the research.
c. Other
-Proposals by a faculty member to have a management position, board of directors seat, or other fiduciary role in any organization (non-profit or for-profit); 
-Proposals for external research support involving a faculty member whose supervisor, spouse, or minor children hold a royalty, equity, or other financial interest in the sponsor; and 
-Proposals for external research support involving non-faculty employees and students if they are to receive royalty or hold equity under the circumstances described in Sections A and B above.

The following situations require written disclosure and review by the department and School of Medicine:

A. Whenever the aggregate time for all outside commitments exceeds 26 days per year.
The maximum amount of time spent on outside commitments which is compatible with fulfilling the primary responsibility to the University needs to be determined by the department director after discussion with the faculty member (or by the Dean, for department directors). The 26- day level is considered to be a threshold for reporting and not necessarily a limit on outside activities. Intermittent activities such as visiting lectureships are desirable and bring honor and credit to the faculty member and to the University, but excessive time devoted to these activities can compromise the faculty member's ability to meet his or her obligations to Johns Hopkins. In addition, faculty members at ranks below full professor must consider the impact of secondary commitments on their ability to fulfill the criteria for promotion.

Individual lectureships, conferences and scientific or professional meetings need not be included in the 26- day threshold unless those activities otherwise constitute or include activities described elsewhere in this policy. On the other hand, activities that must be reported include ongoing or repetitive arrangements with an outside organization for activities such as consultation, research, laboratory testing, teaching, writing or membership on advisory groups and councils.

B. Whenever outside activities require a written agreement.
With the exception of agreements for faculty to provide occasional guest lectures or for the publication of faculty writings, all written agreements relating to outside activities must be reviewed to insure that they do not conflict with institutional policy. Review is required regardless of duration of the activity.

C. In special circumstances.
A complete written report of all outside activities may be requested by the department director or Dean in special circumstances such as in connection with appointments, promotions or administrative assignments.

The Dean or his designees may also request a written report from faculty members in connection with requests for institutional clearance or certification of research (e.g. for research on animals or humans), application for support of academic endeavors or purchases of equipment, or similar requests.

D. Whenever the name of The Johns Hopkins University or the School of Medicine might be used by another party.
Since an academic relationship can be of great value to a non- university organization, opportunities for outside activities may be offered to faculty in part because of their association with The Johns Hopkins University School of Medicine. It must be remembered that there is no way to divorce the faculty member completely from association with Johns Hopkins. Reporting prior to undertaking a secondary commitment serves to protect the faculty member, the University, or both from possible discredit or embarrassment. Thus, faculty members must be discriminating in the selection of secondary commitments, regardless of whether they are professional or non- professional in character, and regardless of whether the obligation is to be discharged in "off hours" or during vacation. If a non- university organization wishes to use the University's name, symbols or logos, written approval must be obtained prior to such use. To obtain a copy of the University's statement on the use of its name, symbols or logos or to request approval, contact the Director of Corporate Communications, JHMI.

E. Whenever a proposed agreement involves the use of facilities or resources belonging to or utilized by The Johns Hopkins University.
A report must be made if the University will be investing its resources and sharing in the risks of a venture or in any other way subsidizing the activity, whether or not sharing in any revenues generated by the activity. The Johns Hopkins University School of Medicine Intellectual Property Guidelines govern a faculty member's participation in any agreement under which an outside entity will profit from the resources, including information, of the University itself as well as from the faculty member's personal involvement. On the other hand, because consulting arrangements and publication of books involve a faculty member's personal effort, contracts for publications and payment of related royalties, or limited consulting arrangements are not subject to sharing of income with the University, although they still must be reported.

F. Whenever an outside commitment provides for intellectual or tangible property rights in the way of patent ownership or licensing to an organization other than the University.
Faculty must report any relationship they are considering or are engaged in with another organization when the organization anticipates providing financial or other support for the faculty member's work or when the organization anticipates utilization of intellectual property (e.g., inventions, know- how, or tangible property (e.g., research materials) or original works of authorship (e.g., computer software but not textbooks) of that faculty member's academic work or the work of a subordinate faculty or staff member. (See The Johns Hopkins University School of Medicine Intellectual Property Guidelines for a full description of these matters.)

G. Whenever an agreement is being considered that restricts the faculty member's public reporting of the existence of the agreement or information developed by the faculty member under the agreement.
Occasionally it may be difficult to distinguish between academic research goals and commercial research goals. In the case of a relationship with a commercial organization, the faculty member must ascertain whether there are requirements for confidentiality that might compromise his or her fundamental rights of academic freedom or those of other faculty members or of students or of the University. Academic freedom means, in part, unhindered discussion and publication of results of research.

H. Whenever a faculty member's relationship to an outside party might appear to influence either the conduct of the University's business with the outside party or the conduct of research within the University.
A report must be made of a relationship to an organization when the organization proposes to conduct business with the University (or an affiliated organization) wherein the faculty member may influence or may appear to influence the decision- making process on behalf of either party.

Consideration must be given to whether there is a perception of outside financial incentives being used to direct research activity away from avenues that might lead to more substantial scientific discoveries or to the accomplishment of academic goals. Conflicts of interest may arise when a faculty member has a relationship (e.g., as a consultant, advisor, owner, or shareholder) to an outside organization that is conducting business with the University on behalf or either that faculty member or a subordinate faculty member.

Consulting arrangements between faculty members and outside institutions are distinct from research projects. Research projects require a contract with the University. In the latter case, payment for the faculty member's effort is part of the University budget (see E) and is used as a source of an appropriate proportion of the faculty member's University salary support. The Office of Research Administration must be made aware of compensation provided under a consulting agreement which will co-exist with a research grant or contract from the same industrial sponsor.

I. Whenever any remuneration for clinical practice is proposed in addition to the faculty member's salary support through the University.
All earnings from the practice of medicine by full- time faculty members are collected and distributed in accordance with the Medical Service Plan of The Johns Hopkins University School of Medicine.

Any faculty clinical practice occurring outside of a Johns Hopkins Medical Facility must be reported and approved prior to initiating the activity. Verification of professional liability insurance to non- Hopkins organizations will be provided only after a report is made to, and approved by, the department director and the Associate Dean for Clinical Practice. The existence of malpractice coverage with a carrier other than through The Johns Hopkins University does not preclude the requirement that the faculty member disclose plans for outside clinical practice and obtain permission for such activities in the manner prescribed above.

A written explanation on the conflict of interest should also be noted on Questions 12a and 12b of the JHU electronic Information Sheet which accompanies all grant and contract proposals submitted to the Office of Research Administration. The full written disclosure should be submitted to the department director, through the division director (if applicable). The department director will then forward approved disclosures to the CCOI staff for review. (See III.14.K, p. 35, for PHS and NSF disclosure requirements.)

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3. Human Subjects:

Federal law (53 FR 45660, 45 CFR 46 and 21 CFR 50) and institutional policy require assurance that the rights and welfare of human subjects of research are protected. The Institutional Review Boards which provide such assurance on behalf of the School of Medicine, School of Nursing, The Johns Hopkins Hospital and The Johns Hopkins Hospital System, The Kennedy Krieger Institute, Johns Hopkins Bayview Medical Center, Howard County General Hospital, Johns Hopkins Community Physicians and the Applied Physics Laboratory (for biomedical research) are the Johns Hopkins Medicine Institutional Review Boards (JHM IRB). A detailed explanation of JHM IRB procedures can be found at http://irb.jhmi.edu/.

New and Renewal grant applications (PHS-398 packets) that include activities involving human subjects must complete question 4 on the face sheet (Human Subjects). Continuation applications (PHS-2590) must complete question 7 on the form 2590 face page and Assurance 1.a. on the "Checklist" page.


a. Exempt Research:

The only exception to the requirement for IRB review and approval is for projects that fall into the exempt research categories. Exemptions are defined in the federal regulations that can be found on the IRB website at the following location: http://irb.jhmi.edu/Guidelines/exemptresearch.html

If an exemption category is appropriate for the human subjects portion of your application submit an Exempt Research application for JHMIRB review. Only the IRB may determine an exemption applies. The face sheet of the grant application should be marked with the exemption number provided by the IRB. Question 4.a should be marked “Yes.”  The information submitted with the grant should include an explanation to verify the decision on declaring the project to be exempt.

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b. Research Project Notification (RPNs):

If your research will involve human subjects in any manner and is not in the exempt category, you must complete and submit an application to the JHM IRB for review and approval. The application should describe the project and the methods you will use to minimize the risk to the subjects and to obtain informed consent.
The Research Plan described in the Grant application must include a Human Subjects section, describing six points regarding protection of human subjects (page 17 of the PHS 398 application kit).

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c. Just in Time Definite Plans:

 Applications with definite plans for involvement of human subjects for which you are applying to DHHS or any other federal agency, must be certified in one of two ways.

One specific instance for which Just in Time procedures do not apply is for new submissions of investigator-initiated grant applications for all mechanisms of support for AIDS research submitted to NIH for "expedited" funding review. Such applications must be submitted with an IRB approval date. Failure to provide human subjects approval on the grant face page could result in deferral or rejection of this type of application.

The certification form 596 has been replaced by OPTIONAL FORM 310, "Protection of Human Subjects Assurance Identification/Certification/Declaration." This certification form may be obtained from the IRB website (http://irb.jhmi.edu/). When follow-up certification is required for a grant application submitted with a pending human subjects designation, provision of the follow-up certification is the responsibility of the Principal Investigator.

The Institutions have approved Federal Wide Assurances (FWAs) effective October 2003. The FWA identification numbers to be used on the grant or 310 form are:
· The Johns Hopkins University School of Medicine, FWA00005752-expires 10/23/06
· The Johns Hopkins University School of Nursing, FWA00006088-expires 10/23/06
· The Johns Hopkins Hospital and Johns Hopkins Health Systems, FWA00006087-expires 10/23/06
· Johns Hopkins Bayview Medical Center, FWA00006089-expires 10/23/06
·  Howard County General Hospital, FWA00005743-expires 10/23/06
· The Kennedy Krieger Institute, FWA00005719-expires 10/23/06
· Johns Hopkins Community Physicians, 00002257-expires 10/1/06

It must be emphasized that regardless of sponsorship, no research involving human subjects may be performed by School of Medicine faculty without JHM  IRB approval, regardless of the source of subjects or site of performance. If you are in doubt as to whether your research qualifies for an exemption or IRB approval is required, call the JHM IRB office (Ext. 5- 3008). The office staff can provide general information concerning the review of human subjects research.

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d. Applications and Proposals Lacking Definite Plans for Involvement of Human Subjects:

Section 46.118 of D.H.H.S. Regulations on Human Subjects Research states:
"Certain types of applications for grants, cooperative agreements or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of funding, but definite plans would not normally be set forth in the application or proposal. These include activities such as...research training grants where the activities involving subjects remain to be selected; and projects in which human subjects involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an award may be made."
If your application is one in which definite plans for human subjects research are not set forth, state this in Section E. Human Subjects of the Research Plan as follows: "This is a grant application for which human subjects plans are not definite. A certification of IRB review and approval of research involving human subjects will be provided before the activity begins if certification has not already been filed. This is in accord with 45 CFR 46.118."

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e. Requirements for Indemnification of Clinical Research Protocols:

Agreements with commercial sponsors of clinical investigation protocols designed to evaluate investigational new drugs, biologics, or devices must include a written provision for indemnification. The purpose of an indemnification agreement is twofold: First is to protect the research subject from the risks of financial harm due to an unexpected adverse effect. Agreements include provisions for coverage of medical care costs to cover such a possibility. Second, an agreement is designed to protect the investigator and the Institutions from possible product liability suits caused by adverse effects. Federally supported studies are usually excluded from this requirement.
The University and Health System Counsels have drafted a statement to incorporate suggested language for such indemnification agreements with sponsors, stipulating the conditions and coverage provided for the human subjects, University, Hospital, Johns Hopkins Bayview Medical Center and members of the investigative team. This coverage is not intended to replace malpractice insurance, but is to address possible liability directly caused by an investigational agent. The current policy requirements must be met before subjects are recruited into a study. JHM IRB staff  cannot release consent forms for approved protocols until an acceptable indemnification agreement is on file. Checks for such projects will be deposited in a holding account by the Business Office until the indemnification discussions are completed. Although investigators may obtain a copy of draft indemnification language from either the JHM IRB staff, requests to sponsors should be initiated by the Office of Research Administration, as there are several master and individual agreements on file for reference. If a sponsor wishes to discuss specific language changes in the suggested standard indemnification language, he or she should consult the Associate Dean for Research Administration or one of the Assistant Directors of the Office of Research Administration at Ext. 5-3061. In some cases, final resolution of indemnification negotiations may require consultation with the General Counsel.
Because procurement of an acceptable agreement can be time-consuming, you are urged to provide the name of the sponsor representative to whom a request may be directed at the earliest possible date of negotiation with the sponsor.

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f. Avoidance of Economic Risks to Patients:
In recent years, there has been an increasing problem with financial burden due to patient participation in research protocols. Specifically, third party payors have been denying payment for activities they believe are "experimental" in nature. Denial of payment for an investigational product, a procedure mandated by a research protocol or for hospitalization required by study participation would place both the subject/patient and the Institutions at economic risk.
Therefore, clinical investigation protocols submitted to the JHM IRB which indicate that funding is not available from a sponsor or a department must include an explanation of what plans are available if denial of payment should occur. To avoid problems in this area, you are encouraged to obtain departmental review of possible payment problems before submitting an RPN application to the JHM  IRB. You are encouraged to also contact the Hospital's Director of Quality Assurance and Utilization at Ext. 5-2940 (103 Hurd Hall, The Johns Hopkins Hospital) to obtain information on how to address this problem.

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g. Inclusion of Women and Minorities as Subjects in Clinical Research

The National Institutes of Health (NIH) has established guidelines on the inclusion of women and minorities and their subpopulations in research involving human subjects, including clinical trials, supported by the NIH, as required in the NIH Revitalization Act of 1993.

"The new policy requires that, in addition to the continuing inclusion of women and members of minority groups in all NIH-supported biomedical and behavioral research involving human subjects, the NIH must:

· ensure that women and members of minorities and their subpopulations are included in all human subject research;
· For Phase III clinical trials, ensure that all women and minorities and their subpopulations must be included such that valid analyses of differences in intervention effect can be accomplished;
· not allow cost as an acceptable reason for excluding these groups; and,
initiate programs and support for outreach efforts to recruit these groups into clinical studies."

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 4.  Health, Safety and Environment

Health, Safety and Environment (HSE), located at 2024 East Monument Street, is responsible for providing information and advising research investigators concerning the approved methods for the handling and disposal of radioactive materials, recombinant DNA, infectious agents and toxic chemicals. Certain hazardous agents and materials require approval prior to use at these institutions. The HSE maintains a certification list of those university Principal Investigators who have registered their recombinant DNA and potentially pathogenic/oncogenic agents or materials. A copy of this registration list is on file in the Office of Research Administration.

If a project will involve organisms pathogenic to humans requiring safety practices, equipment, and facilities at Biosafety Level II and above (e.g., HIV, HVB, TB, legionella, CMV, shigella, etc.), or hazardous or highly toxic chemicals, the Health, Safety and Environment (HSE) must be notified and HSE approval obtained well in advance of submitting the application to the Office of Research Administration. If the number and/or date of approval is not provided on the back of the JHU electronic Information Sheet, or if the approval is listed as "pending," signature of the sponsored project application will be delayed until we get HSE confirmation that the project will not pose unacceptable risks or requirements.

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a. Radioactive materials:
The Radiation Control Unit (RCU) administers the radiation control program at The Johns Hopkins Medical Institutions, procures radioactive materials, and provides for radioactive waste disposal. The Radiation Control Committee is the review body which certifies the responsible investigator and facilities to be used for each radioactive nuclide. Application for an authorization to use radioactive material is made through the RCU, Ext. 5-3710. The JHMI Radiation Safety Manual contains a copy of the form which must be completed and the current institutional policies regarding radioactive materials.  Forms for projects that involve radiation exposure to human subjects are available at http://irb.jhmi.edu/Forms/index.html. The manual may be obtained at //www.hopkinsmedicine.org/hse/forms/forms.html.

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b. Recombinant DNA:
The Biosafety Officer of HSE provides advice and information concerning the current status of regulations which pertain to the use of recombinant DNA molecules in The Johns Hopkins Institutions. The Institutional Biosafety Committee,  reviews research registrations involving recombinant DNA. New investigators and those whose research is subject to NIH recombinant DNA guidelines are to complete a Registration of Research with Recombinant DNA Form  prior to the initiation of such research. The form and a copy of the latest NIH Guidelines for Research Involving Recombinant DNA Molecules may be obtained from the Biosafety Officer, Ext. 5-5918 or downloaded from the HSE Web Site, www.hopkinsmedicine.org/hse. A letter confirming the approval of this registration will be sent to each investigator for use by grant funding agencies. An annual survey of recombinant activity is performed to keep registrations up to date and to allow for rapid response to requests for letters to funding agencies.

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c. Etiologic Agents Infectious, Pathogenic, Oncogenic Agents/Materials:
The Biosafety Officer of HSE provides advice and information concerning the guidelines for research with agents which can cause disease in man, plants or animals. The Institutional Biosafety Committee, reviews and approves research with agents or materials identified as moderate to high risk. The Biosafety Officer provides review and containment guidelines for low risk agents. A Research of Registration with Human Tissue, Infectious Agents, Pathogens, Oncogenes or Toxins Form, is to be submitted to the Biosafety Officer at 2024 East Monument Street when any of the following are to be used:

(1) Etiologic agents (bacteria, viruses, fungi and other ecto or endoparasites) requiring biosafety level 2, 3 or higher as recommended by the Centers for Disease Control (CDC), the National Institutes of Health (NIH), or institutional policy.

(2) Tissue cultures, tissues, body fluids, specimens and samples presumed to contain such etiologic agents.

(3)  Tissue cultures, tissues, body fluids or human origin.

(4) Agents classified by the National Cancer Institute (NCI) as low, moderate or high risk oncogenic agents.

(5) Special registration procedures have been established for those working with sheep and goats, due to the risk of Q fever, and for those working with materials which are known or suspected to contain HIV, the virus which causes AIDS.

Investigators may be requested to submit further information for committee review to determine compliance with biohazard safety guidelines regarding the safe handling, storage and disposal of hazardous agents and to provide information for emergency planning. Work with agents requiring Biosafety Level 3 (CDC) precautions and those classified as high risk by the NCI must be approved prior to use at The Johns Hopkins Institutions. A written description of the proposed project is to include:
(1) Identification of the agent (genus, species, strains) or material.
(2) Pathogenicity of the agent and host range if known.
(3) Description of the experiment, including details of the techniques to be used.
(4) Quantities of organisms or hazardous materials to be used.
(5) Techniques, facilities, equipment and methods to be used to assure containment: autoclaves, biological safety cabinets, etc.
(6) Method used for terminal inactivation of the biological agent or material.
(7) Special requirements for handling experimentally infected animals.


d. Hazardous and Toxic Chemicals:

Researchers who use toxic chemical agents or materials in quantities and procedures which may lead to environmental perturbation or which may have acute or chronic toxicity to workers by inhalation, skin absorption or ingestion exposure should notify the Environmental Health Officer (EHO) of the Health, Safety and Environment, 2024 East Monument Street, Ext. 5-5918. The EHO will review protocols, engineering controls, personal protective equipment and disposal practices.  Forms for registration of Hazardous and Toxic Chemicals and the criteria for chemicals meeting HSE requirements for registration are available at www.hopkinsmedicine.org/hse/.

The HSE will provide a letter to verify institutional awareness and/or approval of registered projects involving hazardous agents or materials which can be included with grant/contract applications. Such letters are often required by funding agencies. Where appropriate, the HSE will provide justification for equipment and facilities necessary for compliance with JHU requirements for research involving hazardous agents and materials. The HSE requires at least 10 working days' notification for any documentation beyond a letter indicating institutional awareness that the proposal involves hazardous agents or materials.

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5. Animals JHMI Animal Care and Use Committee
Federal law and Institutional policy require humane care and use of all vertebrate animals (see P.H.S. Policy on Humane Care and Use of Laboratory Animals, revised September, 1986). The Johns Hopkins Medical Institutions (JHMI: School of Medicine and School of Hygiene and Public Health) and Kennedy Krieger Research Institute, have filed the required Assurance document with NIH (#A3272-01), documenting that review and approval by a JHMI Animal Care and Use Committee (ACUC) is required of all activities involving live vertebrate animals: (1) within the facilities supervised by JHMI; and/or (2) by faculty, staff, and students supported by funds under control of JHMI.

The animal care and use programs at the Johns Hopkins Medical Institutions are fully accredited by the American Association for the Accreditation of Laboratory Animal Care (AAALAC) and are routinely inspected by the U.S. Department of Agriculture under the provisions of the Animal Welfare Act as amended in 1986.

Protocol Form:
School of Medicine activities which use live vertebrate animals require prior Protocol review and approval by the School of Medicine Animal Care and Use Committee (ACUC) which also serves The Kennedy Krieger Institute. No animals may be purchased or maintained without protocol review by the Animal Care and Use Committee. Animal protocols must be reviewed annually. A detailed protocol review form (Appendix K) must be reviewed by the ACUC every three years. In the interim period between full reviews, this protocol may be renewed twice by submitting an annual protocol renewal request (Appendix L) to update the information originally submitted and to provide a brief progress report.
Committee Reviewed Protocols:

Protocol forms submitted by the first Friday of each month will, following review by the committee members, be considered at the ACUC meeting on the third Thursday of the same month.

Grant/Contract Applications:
Description of Animal Care and Use Activities
PHS regulations require Animal Care and Use Committee approval of all applications which involve the use of vertebrate animals. The JHMI have designed the review mechanism around "Protocols" for the use of animals to avoid repetitive review of the same protocol on multiple grant applications. However, the relevant/required animal care and use portions of any grant or contract application must be included in application material submitted to the Office of Research Administration. For PHS New and Renewal grants, the relevant animal portion is addressed as Section f in the Research Plan of the 398 application. PHS requires the information specified in the 398 New and Renewal application instructions (p. 18 - Points "1" and "5") to be included within the relevant vertebrate animal section, regardless if the same information may already be presented elsewhere in the application. New animal use proposed by non-competitive continuation application requires the same information ("1" through "5") to be evaluated in the 2590 application.

Certification of Animal Use Approval and Animal Welfare Assurance:
All PHS and NSF and most private foundation grant and contract applications involving the use of vertebrate animals require certification of (a) an Institutional Assurance having been filed with NIH and (b) review and approval of all proposed animal use. Such review includes three actions: (1) approval of the protocol by the Animal Care and Use Committee; (2) review by veterinary staff of the vertebrate animal section (Section f of the Research Plan) (or its equivalent for other than PHS applications) for correlation with the approved protocol; and 3) certification of (1) and (2) by the institutional official signing the application.

Grant applications processed without submission and approval of both the protocol and the vertebrate animal section f (or equivalent for other than PHS New and Renewal grants) will receive a "pending" Institutional Certification.

PHS has amended its application/proposal kits to incorporate certification. Most private sponsors have adopted similar procedures. Until sponsors provide certification forms within their application kits, the Office of Research Administration will provide letters of certification when returning signed grant or contract applications to you.

While PHS and NSF will allow application submission with "pending" certification of animal use, they require receipt of a follow up certification of approval within 60 days of the application due date. The 60-day grace period is not allowed for non-competing continuation applications or for applications for AIDS expedited review. Some sponsors, such as The American Heart Association (effective 7/1/86), require certification of approval of animal use at the time of application submission. Accordingly, the School of Medicine recommends submission of Protocol Forms to Comparative Medicine two months prior to the application due date to allow time for resolution of any Committee concerns.

Please Note:

If animal use proposed in an application is not approved by the ACUC, or if the protocol application is approved with modification after submission of the grant or contract application, the sponsor must be notified of the action taken/modification required and the application may need to be revised or withdrawn.

Animal Services:
The Comparative Medicine Division is responsible for Animal Services, including procurement of animals, housing and other animal facilities, medical care and husbandry. The handbook "Use of Experimental Animals at Johns Hopkins Medical Institutions," summarizes current federal regulations governing research utilizing animals and the Institutional procedures developed in response to the regulations. The handbook also includes instructions for animal purchase and care which must be coordinated through Comparative Medicine. A copy of the handbook may be obtained by calling Ext. 5-3273. The Division staff can provide additional information and advice regarding protocol forms, the review process, regulations, veterinary consultation, animal purchase, daily care costs, etc. (See Appendix I, Core Resources, for shared animal facilities, relating to animal surgery and x-ray, as well as SCID and transgenic mice.)

Training and Instruction Available to Scientists, Animal Technicians, and Other Personnel Involved in Animal Care and Treatment:
Qualification of investigators and the students and staff working with them are assessed by the ACUC in their review of protocols and grant applications. Training of individuals in appropriate research animal techniques is provided by the Division of Comparative Medicine in several ways.

Individual Training:
The veterinary and technical staff of the Division of Comparative Medicine can provide specialized training in procedures employing animals in the laboratory setting. This is often done on an informal basis. Investigators should contact the Division of Comparative Medicine at Ext. 5-3273 for further information.

Library Support:
A wide range of resource materials on laboratory animal medicine and veterinary medicine is housed in the Division of Comparative Medicine library. This library serves as a resource for individuals throughout the University.

Audiovisual Training Methods:
Audiovisual materials can assist in training individuals in the proper handling and use of laboratory animals. The Division of Comparative Medicine has prepared four slide sets for training staff in techniques using rats, mice, hamsters and rabbits. A taped narrative and syllabus accompany these slide sets.

Courses:
The use of laboratory animals is contained in several courses attended by faculty, students and staff. The School of Medicine seminar on responsible conduct of research also contains a segment on animal research. More concentrated training is provided in courses on surgical skills, and several elective courses are offered by the Division of Comparative Medicine for staff and students. Investigators should contact the Division of Comparative Medicine (Ext. 5-3273) for relevant animal courses in biomedical research.

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6. Core Facilities
There are a number of core facilities available to qualified investigators, such as the Clinical Research Centers, Peptide Synthesis and Protein Sequencing Facility, etc. Click here for a list of these facilities. A brief summary has been included for each facility to provide investigators with a contact person, facility director, facility function and access requirements.

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7. Pharmaceutical Services at The Johns Hopkins Hospital
The costs of assuring the establishment of a records and accounting system for investigational drugs sufficient to meet FDA requirements is borne by the School of Medicine, and will be initiated following submission of an IND protocol to the J.C.C.I..

A wide variety of pharmaceutical services are available for specific direct cost fees from The Johns Hopkins Hospital Department of Pharmacy, including: inventory management, randomization, blinding and dispensing of doses, and manufacturing of special dosages. These services must be provided either by the Pharmacy, commercial manufacturer, or Principal Investigator's staff.

Requests for pharmacy cost estimates and delivery of such services should be made well in advance of the anticipated start date of the project. This will allow time for the Pharmacy to determine a preparation and dispensing procedure, obtain supplies, and schedule personnel if necessary.

Cost estimates may be obtained from the Investigational Drug Service of the Department of Pharmacy at Ext. 5-6337 or beeper 119-1361.

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8. Development Office (The Fund for Johns Hopkins Medicine)
Project applications to certain foundations require clearance through The Fund for Johns Hopkins Medicine, which is the Development Office for the School of Medicine. See Foundations, Section III.A.4, for additional information regarding when such clearance is necessary and how far in advance of application preparation it should be obtained.

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9. Space Changes (Use, Additional Need, Alterations)
Requests for space changes should be forwarded through your Department Director to the Associate Dean, Finance and Administration, with a copy to the Executive Vice Dean. Resolution of such space requests must be accomplished well in advance of submitting the application to ORA for institutional signature. Failure to do so may result in refusal to process the application or conditional signature pending approval of the space request.

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10. Clearances Through The Johns Hopkins Hospital
Projects involving The Johns Hopkins Hospital which would require the Hospital to change its space or services, or which require resources not normally utilized in the care of the patient, must obtain several special clearances.

  • Contact your hospital functional unit administrator to verify which clearances are necessary.
  • Patient Care/Physicians' Fees (see Section III.C.8. of this manual).

Once the above steps have been taken, it may be necessary to obtain State Health Planning Agency approval if your application is for construction of clinical facilities or for grants/contracts involving delivery of health care services rather than research. For instance, State clearinghouse approval is required when applicants are seeking: (1) project grant support under most PHS planning, service, and construction grant programs, or (2) subgrant support from certain PHS formula grant programs where application is made to the State on a project- by- project basis. For assistance in obtaining such approval(s), contact the Vice President for Planning and Development of The Johns Hopkins Hospital (Ext. 5-3893).

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11. Other Affiliated Institutions
If your project involves personnel or facilities of other affiliated institutions, clear the project through your Departmental Administration and with the appropriate administrative officials of the affiliated institution and the School of Medicine. As an example, housestaff training requires the approval of the Department Director, Assistant Dean for Postdoctoral Programs, and the cognizant official of the affiliated institution.

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12. Applied Physics Laboratory
Since 1965, the Applied Physics Laboratory and the School of Medicine have encouraged joint multidisciplinary programs in which physical scientists and engineers of the APL collaborate with biomedical scientists and physicians from the School of Medicine in research of mutual interest. At the School of Medicine, responsibility for the collaborative biomedical research program lies with the Biomedical Engineering Department and at The Applied Physics Laboratory with the Office of the Assistant Director for Research and Exploratory Development. It is advisable to contact the Assistant Director for Research and Exploratory Development, APL (792- 5100), early in the proposal planning stage to discuss APL requirements and research priorities. Once the collaborative effort has been defined, the final budget and workscope must be reviewed by the Assistant Director of Biomedical Programs, who will also initial the electronic Information Sheet prior to submission of the application to the ORA.

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