USE OF HUMAN SUBJECTS IN RESEARCH
The IRRF recognizes the importance of the use of human subjects in some areas of vision research, but remains steadfast in its commitment to the ethical considerations that must influence the design and conduct of such research. Therefore, this policy statement encompasses requirements and recommendations that are based on expert opinion, published data, and methods and practices that promote ethical conduct on the part of the research investigators, while safeguarding the personal rights and physical and mental integrity of the human subject.
- It is our strict policy to require review and written approval by an Institutional Review Board (IRB) of all research protocols involving human subjects. This review ensures that risks are minimized and judged to be reasonable in relation to anticipated benefits; there is informed consent; and the rights and welfare of the subjects are maintained.
- Although a funding request can be submitted and approved without prior IRB human use protocol approval, documentation of the approval must be received by the IRRF before funds can be released. The approval must list the principal investigator, the title of the project, and the International Retinal Research Foundation as the funding agency or sponsor. Approval of similar projects will not be accepted.
- All human subject protocols must be reviewed yearly with a copy of the current approval submitted to the IRRF.
- It is the Principal Investigator’s obligation to discontinue the research if in his/her expert opinion, to proceed would be harmful to the individual.
- The interest of science and society should never take precedence over considerations related to the well-being of the subject.
USE OF ANIMALS IN RESEARCH
The International Retinal Research Foundation supports scientific research on the diseases of the human eye with the clearly delineated objective of discovering the causes, preventions, and cures of macular degeneration and diabetic retinopathy. While our trustees recognize that studies involving living animals play a vital role in vision research, they remain sensitive to public concerns and are committed to the humane care and treatment of laboratory animals. Therefore, this policy statement encompasses requirements and recommendations that are based on expert opinion, published data, and methods and practices that have proven to be consistent with ethical and humane animal care and use.
- Animals must not be subjected to unnecessary distress or discomfort, and whenever possible, animal use should be avoided. Therefore, an investigator must make the fundamental decision of whether the use of animals is an integral component of the design of the experiment.
- Once it is established that animals must be used, the investigator is obligated to take any and all measures that will insure humane treatment.
- Research projects in the United States and Canada involving vertebrate animals must meet or exceed standards required for United States federal government funding, and those standards set forth in the U.S. Animal Welfare Act1, as amended, and its accompanying regulations.
- A copy of the Institutional Animal Care and Use Committee (IACUC) protocol approval or comparable institutional approval must be provided to the IRRF before funds can be released. The approval must list the principal investigator, the title of the project, and the International Retinal Research Foundation as the funding agency or sponsor.
- All research must be performed at an institution that has a current animal welfare assurance on file with the Public Health Service Office of Laboratory Animal Welfare (OLAW).
- It is recognized that guidelines established in the United States are not necessarily enforceable by law in a country outside U.S. jurisdiction. However, in order for any funding request involving animal use to be considered by the IRRF, written assurance must be provided from the grantee institution stating that the vision science experiment involving animals will conform to the guidelines outlined in the U.S. Animal Welfare Act1, as amended, and the Guide to the Care and Use of Laboratory Animals2.
- Experiments should be designed to minimize the number of animals used and to avoid depletion of endangered species.
- The IRRF agrees with the guidelines produced by the Association of Research in Vision and Ophthalmology (ARVO) in its Statement for the Use of Animals in Ophthalmic and Visual Research3, and strongly recommends adherence to the recommendation encouraging vision investigators to distribute unrelated tissues to investigators in other research areas and, where practical, to obtain suitable ocular tissues from investigators working on other organs. This recommendation applies to all species.
- U.S. Animal Welfare Act. The U.S. Department of Agriculture, 10301 Baltimore Ave., Beltsville, MD 20705-2351. www.nal.usda.gov
- Guide to the Care and Use of Laboratory Animals. Institute of Laboratory Animal Resources, National Academy Press, 2101 Constitution Avenue, NW., Washington, DC 20418. oacu.od.nih.gov
- Statement for the Use of Animals in Ophthalmic and Visual Research. The Association for Research in Vision and Ophthalmology, 9650 Rockville Pike, Bethesda, MD 20814-3998. www.arvo.org/aboutarvo/animalst.asp
PATENT AND INTELLECTUAL PROPERTY
While the IRRF is committed to discovering the cause and cure of blinding eye diseases by mobilizing financial resources to support and sustain a unified effort through vision research, it is recognized that inventions having public health, scientific, or commercial application or value may be made during the course of these studies. Many such inventions involve equities beyond those of the inventor since the use of grantee institution facilities, the assignment of duties as a condition of employment, and the use of research funds with contractual obligations regarding patent rights give rise to questions concerning the rights and equities of all concerned.
It is in keeping with the goals and responsibilities of the IRRF that such inventions be made available for public benefit at the earliest possible time after it has been determined by all the appropriate regulatory agencies that such inventions are deemed safe for use. The most effective vehicle for accomplishing this goal is through patenting, copyrighting, and/or licensing of such inventions.
For the purpose of this policy, “invention” is defined as any discovery, material, method, process, product, program, software or use, whether or not patented or patentable or copyrighted or copyrightable, that has an application of value such that its use, licensing, lease or sale can generate revenue.
For the purpose of this policy, “patent” is a grant made by the government to an inventor, conveying and securing to the inventor the exclusive right to make, use, and sell the invention for a term of years.
For the purpose of this policy, “license” is an agreement giving the right to make, use, and/or sell a certain product, design or process.
For the purpose of this policy, “royalty” is the amount of the net sales paid to the owner of a patent.
- All inventions discovered or resulting from research or training grants supported in whole or in part by the IRRF must be reported at the earliest possible time to the IRRF. The grantee institution agrees to notify IRRF immediately of the decision to apply for a letter of patent or other legal protection for intellectual property. The grantee further agrees to seriously consider, in good faith, any comments, suggestions, or objections that the IRRF may have concerning such applications. All patenting expenses or intellectual property application expenses shall be borne solely by the grantee institution.
- If the grantee institution has an established and applicable patent, intellectual property, or technology transfer policy and procedure for administering inventions, the IRRF will defer to that policy.
- Title to all inventions will reside in the grantee institution to the extent such title is claimed by the institution under its Patent Policies and Procedures. If the grantee institution has no established and applicable patent, intellectual property, or technology transfer policy and procedure for administering inventions, the IRRF shall have the right to determine, with advice from its legal counsel, the disposition of the invention rights.
- If any invention is made with the joint support of the IRRF and an agency or department of the United States government, the IRRF may defer to the patent, intellectual property, or technology transfer policy of that agency or department upon receipt of a written statement by the appropriate agency or department notifying the IRRF of its policy and procedure and identifying the rights and interests of the IRRF in the invention in question.
- If any invention is made with the joint support of the IRRF and any other funding organization, not an agency or department of the United States government, the other funding organization, the inventor(s), the inventor’s institution, and the IRRF shall negotiate a mutually satisfactory disposition of the invention rights.
- Distribution of income derived from any inventions, which might include equity disposition, shall be made in accordance with the policies of the grantee institution. Otherwise, such distribution shall be guided by the principle that the IRRF’s proportion of income shall be commensurate with the IRRF’s proportion of support for the research leading to any inventions.
- No patent, patent application, or other type of protection for the inventions shall be abandoned without prior written notification to the IRRF. At such time, the grantee institution shall give the IRRF reasonable opportunity to take title to the invention.
- The International Retinal Research Foundation reserves the right to public acknowledgement for the inventions resulting from research that has received IRRF support. However, the IRRF’s name and logo may not be used in association with any invention without prior written approval of the IRRF.
- The IRRF may have use of the inventions without payment of royalties or license fees solely for the use by IRRF for public education purposes, but not for any of its grantee institutions.
- Before a funding request from any entity outside the United States can be considered for approval, a copy of the current prevailing patent policy of the grantee institution must be supplied to the IRRF for review.
- In cases where IRRF-supported research results in patentable discoveries or inventions, funds received from the IRRF must not be co-mingled with funds received from other funding agencies whose patent policies and guidelines are in conflict with those of the IRRF.
Postdoctoral scholars are an integral component of all leading research teams, and it is accepted that this training is a standard area in the preparation of performing research in the sciences. Realizing that the Visual Science Training Grant (NEI/NIH) provides financial support for pre-doctoral students, but not for postdoctoral scholars, the IRRF recognizes the need for this type support as an educational vehicle for these individuals. Therefore, funding for postdoctoral training is available for scholars who have received a terminal degree (Ph.D., M.D., O.D., D.D.S., D.V.M., etc.) and who have opted to pursue training in the area of vision research.
IRRF funding support for postdoctoral scholars should not be considered a “fellowship” as defined by the IRS, but as salary for services provided by the postdoctoral scholar to the grantee institution while training for a research career.
- Postdoctoral funding will only be granted for individuals who have been awarded a terminal degree. Although a request can be considered without written confirmation of degree status, a letter from the sponsoring Principal Investigator confirming that the terminal degree is forthcoming must accompany the application. No IRRF funds will be released without written documentation that the degree has been awarded.
- All postdoctoral scholars must be assigned to a Principal Investigator who will accept the role of mentor for the duration of the training period. Because this is a crucial time in the development of strong scientific methods and skills for the postdoc, periodic verbal and written evaluation of progress is strongly encouraged.
- Salary funding levels are determined by using current guidelines set by NIH, based on years of post-graduate experience. This annual amount should be increased by an additional percentage amount, determined by the institutional requirements for fringe benefits.
- Funding can be approved for one year, with actual funds being released at the beginning of the 12-month period. A written progress report and recommendation for continuation of funding must be submitted to the IRRF, not less than 60 days before the end of the 12-month period.
- All postdoctoral scholars receiving IRRF funding must abide by the rules and regulations mandated by the grantee institution’s Office of Postdoctoral Affairs, or if no formal office is designated, the department under which responsibility for overseeing postdoctoral training falls.
- The postdoctoral scholar will participate in a substantially full-time regimen of advanced training and research.
- All postdoctoral scholars receiving IRRF support are expected to participate in collaborative and independent research.
- All postdoctoral scholars are encouraged to produce publications of findings as determined by mutual agreement between the postdoctoral scholar and the mentor. Any publications resulting from research sponsored by the IRRF, including the support of a postdoctoral scholar, must include credit for such funding.
- NIH Guidelines for Stipend Levels – National Institutes of Health, Center Drive, Bethesda, MD 20892. grants2.nih.gov/grants/guide/notice-files/NOT-OD-02-028
- NIH Research Training Opportunities: Career Resources. Postdoctoral Scholar’s Associations. National Institutes of Health, Center Drive, Bethesda, MD 20892. grants.nih.gov/training/resources