Investigator Initiated Research
Policies, Procedures, Intellectual Property Policy
The ALS Association Mission:
Leading the fight to treat and cure ALS through global research and national advocacy while also empowering people with Lou Gehrig’s disease and their families to live fuller lives providing them with compassionate care and support.
Directing, encouraging, identifying, funding and monitoring relevant and cutting-edge research into the cause, treatment, prevention and cure for ALS.
Use of Animals in Biomedical Research Statement
– Animals shall be used in biomedical research only when no other means of obtaining scientifically sound, valid and useful results are available.
– The minimum number of appropriate animals required to obtain and validate results shall be used.
– The acquisition, care and use of animals must be in accordance with all applicable federal, state and local laws and regulations.
– Certifications must be received from research facilities prior to being approved for a research grant that the facility(ies), its researchers and employees adhere to the Animal Welfare Act, National Research Council Guide for the Care and Use of Laboratory Animals, and any appropriate U.S. Department of Agriculture or National Institutes of Health regulations and standards.
– In cases requiring the death of an animal, only the most appropriate and humane form of euthanasia shall be used consistent with the purpose of the research.
If Grantee is conducting Clinical Research Grantee shall comply with applicable federal, state, and local laws, regulations, guidance, standards, policies and requirements relating to the conduct clinical Research, such as but not limited to Health Insurance Portability and Accountability Act (HIPAA) of the USA, the Common Rule, the E.U. Data Protection Directive (Directive 95/46/EC), the U.S. Food, Drug and Cosmetic Act and its implementing regulations and guidance, standards, policies, and requirements issued by the FDA, and applicable industry standards and guidelines. Grantee shall conduct the Research described in the Research Plan under the oversight of and consistent with any requirements or directives imposed by the overseeing IRB(s), consistent with all applicable protocols as approved by such IRB(s), and obtain all informed consents, authorizations, and other permissions required under Applicable Law and as approved by the overseeing IRB(s). Grantee shall ensure that all informed consents, authorizations, and other permissions obtained from Subjects will allow all uses and disclosures of their PHI and other individually identifiable information as required under this Agreement and the Research Plan. Grantee shall provide documentation of IRB approval of the Research under the Research Plan and of any investigational new drug (“IND”) application required to conduct Research under the Research Plan upon request by the Association.
Contacting ALS Association Research
In all instances contact ALS Association Research at email@example.com
Patents on Discoveries Made Under Grants
This applies to all rights related to developments made by Grantees (Institutions) and Principal Scientists during research funded by The ALS Association. Arrangements or Contracts with Other Organizations: The ALS Association requires that the Principal Scientist and Grantee disclose any collaboration or arrangements with consultant(s) and/or with private companies, and membership on the boards of directors or advisory councils of such companies relevant to the project. For further information contact ALS Association at: firstname.lastname@example.org
Receiving a Call for Abstracts
Send an e-mail request with your full contact information to email@example.com
All nationalities are welcome to apply and awards are made to non U.S.A. based investigators.
Voluntary Accreditation of Human Research Protection
The ALS Association supports the concept of voluntary accreditation with the Association for The Accreditation of Human Research Protection [AAHRPP]. Please consult your research institute and answer the following questions clearly if applicable to your project.
– Is your institute human research protection program accredited?
– If yes, by which accrediting body?
– If no, does your institute plan to seek accreditation?
Terms of Your Proposal
By the act of submitting an application for a grant, it is agreed by the applicant and his/her institution that:
- Funds granted as a result of this request are to be expended for the purpose set forth herein and in accordance with the Research Grant Program Policies and Procedures set forth by The ALS Association for the award of grants;
- The grant may be revoked in whole or in part at any time by the Board of Trustees of The ALS Association, provided that a revocation shall not include any amount obliged previous to the effective date of revocation if such obligations were made solely for the purposes set forth in this application;
- All reports of investigations supported by any grant made as a result of this request shall acknowledge such support;
If any patentable discoveries or inventions are made in the course of the work aided by the Grant received as a result of this Application, the provisions of The ALS Association Intellectual Property Policy in force on the date of the Grant request shall govern the rights, title and interest to such discoveries or inventions and the disposition of revenues derived therefrom.
Types of Grants Offered
One-year awards for New Investigators entering the field of ALS proposing innovative and novel projects likely to provide important results relevant to ALS research. Alternatively, they can be pilot studies by established ALS investigators. These applications do not require strong preliminary data but must emphasize novelty, feasibility, innovation and relevance to ALS. A maximum budget of US$50,000. Applications from junior postdoctoral fellows for starter grants are not invited.
Research that is projected for periods of up to three years with a maximum budget of US$100,000 a year. Funding for multi-year grants is committed for one year only, with noncompetitive renewals conditioned upon receipt of satisfactory interim progress reports. Applications from junior post-doctoral fellows for multi-year grants are not invited.
The Milton Safenowitz Post-Doctoral Fellowship for ALS Research
Awards are for two years at a maximum of US$50,000 per year. Letters of support from the supervising Principal Scientist and the applicant’s graduate advisor must accompany the application. Preliminary data is required and can be data generated in the Principal Scientist’s laboratory not necessarily generated by the applicant. It is important to clearly state any preliminary data that has been done by the applicant. The Principal Scientist should already be involved in ALS research even though the post-doctoral fellow may be new to the field. Curriculum vitae for the Principal Scientist as well as the post-doctoral fellow must be included in the application. The Principal Scientist must sign the application. Postdoctoral fellows applying for the fellowship should not have been in the PI’s laboratory longer than 18 months when applying. If a post-doctoral fellow leaves the laboratory for any reason, the fellowship is automatically terminated and any unobligated funds must be returned to The ALS Association. Under no circumstances can a post-doctoral fellowship be transferred.
All applications are peer reviewed by The ALS Association Scientific Review Committee to ensure their scientific merit and relevance to ALS. The Scientific Review Committee's priority scores are forwarded only to The ALS Association Board of Trustees, which has the sole authority for awarding and funding research grants.
The ALS Association’s financial officer makes grant payments to the Principal Investigator’s institution for disbursement. Payments are made on a specified schedule and are contingent upon the receipt by ALS Association of satisfactory progress reports and documentation of research funds expended as requested in the award letter. Grant payments are made in US dollars only. The Principle Scientist must designate the institution (grantee) as the official recipient of the grant made for the support of research of the Principal Scientist.
It is expected that the person shown as the Principal Scientist in the application is the one who is personally and actively responsible for the conduct of the research. The Principal Scientist may not request salary support for him/herself.
Senior Postdoctoral Fellow as Principal Scientist
Starter applications from senior post-doctoral fellows with sufficient scientific independence to direct research supported by a grant are invited. Applications from junior postdoctoral fellows for multi-year or starter awards are not invited. These applications can only be submitted in The Milton Safenowitz Post-Doctoral Fellowship for ALS Research.
Graduate Students and Pre Doctoral Fellows
Graduate students are not eligible to apply for any of the awards as a Principal Scientist. The dissertation research of a graduate student will not ordinarily be supported through a salary stipend. Salary support for graduate students heavily involved in the project and/or with exceptional expertise in the procedures will sometimes be provide. In such cases, the grant proposal should include extensive information relating to the student's educational background. Assurances must be made that the requested stipend is in line with that received by pre-doctoral fellows at the institution. Under no circumstances will tuition costs be paid as part of the grant.
If successful, the Principal Scientist and the grantee will receive the same Award Letter informing them of the details and conditions of the award. This letter forms a contract between the Principal Scientist and the grantee.
Renewal or Supplemental Support
All ALS Association grants are designated terminal. Renewal or supplemental support depends upon submission and approval of an application for a new grant, which must include a full and detailed report on the research and a detailed itemized report of all funds expended during the term of any preceding grant.
No Cost Extension of the Term of the Grant
An extension of the term of the grant without additional funds may be approved when requested and justified. The request for a no cost extension must include a full and detailed report on the research and a detailed itemized report of all funds expended prior to the request. Requests for extensions of the terms of grants will not be honored when such extension would allow creation of reserves for contingencies.
Since research project budgets as detailed in the application are viewed as realistic estimates of the funds required to perform the research indicated, it is expected that for most grants some unexpended funds will remain at the termination of the grant. Such funds must be reimbursed to The ALS Association in the form of a U.S. Dollar cheque together with a detailed itemized report of all funds expended within thirty days of the end date of the award.
The ALS Association is not responsible for over-expenditures of grants, and The Association requires a refund of all non-allowable expenditures before payments will be made on continuation or supplemental grants.
Transfer of a Grant
A grant may not be transferred without prior written approval from The ALS Association. Under no circumstances can a post-doctoral fellowship be transferred. A Principal Scientist may request that his/her grant be transferred to another institute that the Principal Scientist and the funded research project are relocating to. Approval for this transfer must be received by the Grantee (Principal Scientist’s Institution) Transfer of a Grant within the institution to a new Principal Scientist may be requested when the original Principal Scientist leaves or becomes unable to continue supervision of the research. To request a transfer provide a written explanation of the reasons and circumstances of the transfer together with a full and detailed report on the research and a detailed itemized report of all funds expended prior to the request. Both of these reports must be approved by the grantee and the Principal Scientist. When a grant is transferred from one institute to another all unexpended funds must be reimbursed to The ALS Association before a transfer can be approved or made. To avoid interruption of financial support, the request for transfer should be made at least ninety days prior to the anticipated date of transfer. Requests for transfer of a grant from one scientist to another should take place within thirty days) of the change and are considered and interim step until the grant can be terminated appropriately or until the new Principal Scientist can submit a new and complete application. All transfers must have prior written approval from The ALS Association.
Re-budgeting of Funds
Transfers into personnel and consumable supplies categories may be made at the discretion of the Principal Scientist with knowledge of his/her Institution. Transfer of funds into equipment, travel, other expenses not specifically identified in the budget, or indirect expenses, may not be made without prior written approval of The ALS Association.
Funds remaining unobligated at the end of a grant period may not be carried over to the succeeding period to create an increase in funds for the succeeding period. Rather, unobligated funds will be applied against the succeeding grant payment. Where the grant in force has been terminated, all unobligated funds must be returned to The ALS Association within thirty days of the termination of the grant.
Accounting Procedures and Forms
Accounting of all expenditures made under each grant must be made to The ALS Association within thirty days of the termination of the grant.
Bonded Financial Officer
The Association prefers, but does not necessarily require, that the financial officer administering grant funds be bonded. Unless otherwise indicated in the application for a grant, it is understood that such officials are in fact bonded. Under circumstances satisfactory to The ALS Association, it may forego the need of the financial officer to be bonded.
The Association will not ordinarily fund renewal grants. In as much as all grants are terminal, they must be renewed by way of an application for continuation of funds.
All projects, unless specifically notified in the Award Letter, are subject to detailed reports on research every six months. It is the Principal Scientists responsibility to ensure that all reports are received by The ALS Association on time. All research reports are considered privileged communications and their distribution is limited to the reviewing consultants and staff of The ALS Association. The Principal Scientist will be notified in writing of the results of the review. Failure to provide a requested research report will result in a stop on payment of the grant and a written warning that the grant will be considered for early termination without further payments if the requested report is not received within two more weeks. At thirty days overdue a written early termination notice will be sent to the Principal Scientist and the grantee and a further two weeks will be given to provide the requested report. At 45 days overdue the grant will be terminated and no further payments will be made except with the discretion of The ALS Association even if reports are brought up to date.
Publication and reprints
The ALS Association expects that the results of the research shall be appropriately published. The responsibility for publication lies with the Principal Scientist. The results of any work supported by an ALS Association grant may be published without review by ALS Association. Therefore, responsibility for direction of the work is not to be ascribed to ALS Association. One copy of each manuscript accepted for publication must be submitted to The ALS Association, accompanied by information as to probable date of publication and the journal accepting the manuscript. These manuscripts will be regarded as restricted and privileged communication. For the sake of uniformity, it is requested that the following acknowledgement be used with all publications and, where appropriate and ethical, with scientific exhibits, “This investigation was supported wholly (or in part) by (a) grant(s) from The ALS Association”. Early notification of publications is essential to be included in the Research ALS Today Journal News and widely distributed by The ALS Association.
Non Allowable Expenditures
– The ALS Association ordinarily will not fund the purchase of permanent equipment.
– The cost of installing and maintaining equipment is not allowed unless such funds were requested and approved as part of the grant.
– Non economy travel and incidental expenses are not permitted and the maximum travel allowable is $2,000 per year.
– Duplication of funding is not allowable.
– No premiums are allowed for insurance of equipment and supplies.
– Dues to organizations such as federations or societies: purchasing of books, journals or office equipment; and registration fees for scientific meetings are not allowable expenses. No funds shall be budgeted as "Contingency funds.
– Any recurring annual increase is limited to 5% - applied only to personnel and consumable supplies.
– The ALS Association is not responsible for over-expenditures of grants, and The Association requires a refund of all non-allowable expenditures before payments will be made on continuation or supplemental grants.
A maximum of 10% of the award [for example Award = US$100,000 therefore Indirect Costs = US$10,000 maximum and must be part of the award].
Intellectual Property Policy of ALS Association
The primary purpose of The ALS Association ("The ALS Association") Intellectual Property Policy is to promote the development and implementation of discovery of the cause and effective treatment for ALS. This Policy applies to all rights related to developments made by Primary Scientist or employees of the Institution during research funded by The ALS Association, including rights to make and use such developments and rights in potentially patentable inventions, patent applications and issued patents ("Research Rights").
2. Ownership of Research Rights.
Grantee (Principal Scientist’s Institution) will own all right, title and interest in all Research Rights.
3. Reporting of Research Rights.
3.1 Grantee Institution will prepare and provide an annual report regarding Research Rights to The ALS Association within one month of the anniversary date of The ALS Association funding grant. All such reports will include the following:
3.1.1 A description of all Research Rights developed by Grantee during the preceding annual period.
3.1.2 A notification of whether Grantee intends to file or has filed a patent application on all potentially patentable inventions developed by Grantee Institution during the preceding year under The ALS Association funding and if Grantee Institution does not intend to file, an offer to assign all rights in any such invention to The ALS Association, subject to overriding obligations to the Federal Government and/or other sponsors of research. Grantee will not knowingly put The ALS Association in a less favorable position regarding ownership of rights in an invention than other non-governmental sponsors of research. If there are no overriding obligations to Federal Government sponsors and if a conflict in ownership rights occurs, Grantee will confer with all non-governmental sponsors in an effort to come to a resolution of the conflict.
3.2 Grantee Institution agrees to notify The ALS Association of the issuance of any patents on inventions developed by Grantee under The ALS Association funding, even after funding has terminated.
3.3 Grantee Institution agrees to notify The ALS Association of (a) any intent of Grantee to abandon any patent application on an invention developed by Grantee under The ALS Association funding or (b) any intent of Grantee to allow a patent on an invention developed by Grantee under The ALS Association funding to expire due to non-payment of maintenance fees, and prior to abandonment or expiration of any application or patent, to offer to assign all rights therein to The ALS Association.
3.4 The ALS Association agrees that all Research Rights disclosed in reports and notifications under this paragraph will be maintained by The ALS Association as confidential and will not be used for any purpose other than as recognized under this Policy.
4. License to The ALS Association
The ALS Association is hereby granted a non-exclusive, royalty free, worldwide license to practice all Research Rights including access to and the right to use biological materials, with the right to grant sublicenses to others, solely for non-commercial research and development purposes. The ALS Association's rights, and those of any sublicensee, under this Paragraph are subject to the obligations of confidentiality under Paragraph 3.4.
Any net income derived from licensing, sale, transfer or direct utilization of any inventions covered by Research Rights shall be distributed in accordance with this paragraph. Such net income shall be distributed to The ALS Association in proportion to its contributions to the direct activity leading to the development of the Research Rights. If, however, the parties disagree as to this allocation, the Grantee and The ALS Association will confer to arrive at a mutually acceptable disposition of this issue. Net Income is defined as gross income less expenses and administrative costs, and less mandatory distributions to State authorities and inventors if required by statue or regulation.
6. Disposition of Research Rights
Grantee agrees that the rights and obligations of Grantee Institution hereunder will be binding upon and insure to the benefit of any recipient of Research Rights by license, sale or otherwise and that such recipient will be made aware of the rights of The ALS Association hereunder.
7.1 Grantee agrees to indemnify and hold harmless The ALS Association, its partners, employees, or agents from and against all complaints, causes of actions, claims, losses, costs, damages, liabilities, or expenses by reason of any liability sought to be imposed upon The ALS Association resulting from injuries to persons or damages to property, provided such injuries to persons or damages to property are due and claimed to be due as a result of acts or omission of acts of Grantee Institution, its employees, or agents.
7.2 If Grantee is a duly authorized state governmental entity acting under limited waiver of sovereign immunity, the indemnity under this Policy shall be subject to any applicable statutory limitations.
8.1 Grantee agrees that, if Research Rights are not licensed or optioned three years after the issuance of a United States patent on Research Rights, or such longer time period as The ALS Association considers reasonable, and if Grantee has not made reasonable progress in bringing such Research Rights to practical application, Grantee Institution, upon The ALS Association's request, shall assign all such Research Rights to The ALS Association.
8.2 Grantee agrees that when it licenses any invention or intellectual property to a third party for commercialization that it will include provisions in the license to obligate the licensee to commercialize the technology in a diligent manner, and to include specific diligence requirements and milestones. Grantee will be responsible for monitoring such diligence provisions, and in the event that the licensee has failed to commercialize the technology in accordance with such diligence provisions, Grantee shall either re-negotiate revised diligence provisions with the licensee, as appropriate; terminate the license and seek other licensees; or convert the exclusive license to a non-exclusive license and seek other licensees. In the event Grantee terminates a license or converts the exclusive license in accordance with this provision and does not seek another licensee within a reasonable period of time upon termination or conversion, Grantee will assign its right in the technology to The ALS Association, to the extent it is legally able to do so. Grantee retains the right to use such technology for educational and research purposes under such circumstances.
9. Government's Rights.
Grantee Institution’s obligations hereunder are subject to the requirements of U.S. law under 35 USC § 202 for inventions made in the performance of federally-sponsored research.