NIH Guide - Vol. 2, No. 4 - July 2, 1973

MH GUIDE GUIDELINES FOR ESTABLISHINGND A for GRANTS and CONTRACTS U.S. DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE Vol. 2 , No. 4 , J u l y 2 , 1973 POLICY 1. PURPOSE The purpose o f t h i s issuance i s to provide g u i d e l i n e s f o r t h e develop­ m e n t d f o n s o r t i u m g r a n t when t h e i n s t i t u t i o n s i n v o l v e d b e l i e v e such an arrange­ ment t o be necessary o r p r e f e r r e d o v e r a t r a d i t i o n a l p r o j e c t g r a n t made t o a s i n g l e i n s t i t u t i o n . These g u i d e l i n e s are intended t o a i d i n the establishment o f a consor­ tium g r a n t w i t h a sound a d m i n i s t r a t i v e base among t h e p a r t i c i p a t i n g i n s t i t u t i o n s and between t h e N I H awarding u n i t and the grantee i n s t i t u t i o n . W 2 . BACKGROUND I n t h e e a r l y 1970's, N I H began t o r e c e i v e a small number o f research g r a n t a p p l i c a t i o n s i n which-support was sought f o r a s i n g l e p r o j e c t which i n v o l v e d two o r more i n s t i t u t i o n s through various cooperative arrangements. These guidel i n e s have evolved from experience w i t h t h e f i r s t consortium grants awarded and have been developed through cooperative e f f o r t s .of t h e grantee i n s t i t u t i o n s and t h e N I H i n r e c o g n i t i o n of problems p e c u l i a r t o these p a r t i c u l a r grants. 3. APPLIC~BILITY This p o l i c y i s a p p l i c a b l e t o any N I H grant-supported research p r o j e c t which embodies t h e c h a r a c t e r i s t i c s o f t h e consortium g r a n t as defined below. A consortium g r a n t i s d e f i n e d as: A g r a n t t o one i n s t i t u t i o n i n support o f a research p r o j e c t i n which t h e program i s being c a r r i e d o u t through a cooperative arrangement between o r among t h e grantee i n s t i t u t i o n and one o r more o t h e r i n s t i t u t i o n s ( p r o f i t o r n o n - p r o f i t ) which a r e a d m i n i s t r a t i v e l y independent of the grantee. The involvement o f t h e o t h e r i n s t i t u t i o n s may be i n the substance of t h e s c i e n t i f i c p r o j e c t , o r may be t h a t o f p r o v i d i n g a s p e c i f i e d s e r v i c e under a fee-for-service o r c o n t r a c t u a l arrangement, o r both. Examples o f such p r o j e c t s are: a. S i n g l e grantee p r o j e c t i n which i n v e s t i g a t o r s a t two o r more independent organizations c a r r y on various phases o f t h e p r i n c i p a l a c t i v i t y o f t h e project. b. S i n g l e grantee p r o j e c t i n which cooperating i n s t i t u t i o n s provide e s s e n t i a l services o r common data i n f o r m a t i o n f o r t h e p r o j e c t . 4. DEFINITION i * - The GUIDE i s published a t irregukzr intervals t o provide policy, program, and achinistrative information t o i n d i v i d u a h and organizations who need t o be kept informed of requirements and changes i n grants and contracts programs adninistkred by the National I n s t i t u t e s o f Health. Page Two POLICY The NIH may make an award f o r the support o f a p r o j e c t t o a grantee i n s t i t u t i o n on b e h a l f o f a named p r i n c i p a l i n v e s t i g a t o r even though one o r more i n s t i t u t i o n s o t h e r than t h e grantee a r e cooperating i n t h e p r o j e c t by c a r r y i n g on various p a r t s o f t h e planned a c t i v i t y . A c e r t i f i c a t i o n must accompany such a p p l i ­ cations i n d i c a t i n g t h a t a p p r o p r i a t e o f f i c i a l s i n each cooperating i n s t i t u t i o n i n t h e consortium arrangement, as w e l l as t h e formal a p p l i c a n t i n s t i t u t i o n o f f i c i a l , have reviewed the a p p l i c a t i o n o r a t l e a s t appropriate p a r t s o f t h e a p p l i c a t i o n s , and endorse i t s submission. 5. 4 8 6. CONDITIONS OF APPLICATION AND AWARD a. Agreement p r i o r t o a p p l i c a t i o n submission P r i o r t o submission o f an a p p l i c a t i o n f o r a consortium g r a n t t h e a p p l i c a n t i n s t i t u t i o n and a l l cooperating i n s t i t u t i o n s should thoroughly e x p l o r e and reach a t l e a s t t e n t a t i v e agreement regarding s c i e n t i f i c , a d m i n i s t r a t i v e , f i nanci a1 , and r e p o r t i n g requirements f o r such grants. b. A p p l i c a t i o n p r e p a r a t i o n The same a p p l i c a t i o n forms w i l l be used as f o r o t h e r types o f research proposals. However, f o r such consortium arrangements the a p p l i c a t i o n must i n c l u d e a d d i t i o n a l i n f o r m a t i o n , such as: (1) (2) A l i s t o f a l l proposed performance s i t e s both a t t h e a p p l i c a n t grantee i n s t i t u t i o n and a t t h e p a r t i c i p a t i n g i n s t i t u t i o n s . A separate d e t a i l e d budget f o r the i n i t i a l and f u t u r e years f o r each i n s t i t u t i o n and, where appropriate, f o r each p r o j e c t u n i t w i t h i n each i n s t i t u t i o n . (3) (4) A composite budget f o r a l l program u n i t s i n a l l i n s t i t u t i o n s , f o r each year, as shown under (2) above. A d e t a i l e d explanation o f t h e arrangements between the p r i n c i p a l i n v e s t i g a t o r and the responsible persons a t the cooperating i n s t i t u t i o n s t o d i r e c t and monitor t h e research e f f o r t . c. W r i t t e n agreement p r i o r t o i n i t i a t i o n o f t h e p r o j e c t The grantee i n s t i t u t i o n should f o r m a l i z e i n w r i t i n q w i t h each cooperating i n s t i t u t i o n t h e t e n t a t i v e agreement n e g o t i a t e d p r i o r t o r e c e i p t o f t h e award: The agreement w-i 1-1 Specify the o p e r a t i o n a l gui del ines f o r c o n t r o l and d i r e c t i o n o f t h e research e f f o r t t o ensure compliance w i t h a l l p e r t i n e n t Federal r e g u l a t i o n s and p o l i c i e s and t o f a c i l i t a t e a smoothly f u n c t i o n i n g coopera­ t i v e venture. A copy o f a l l such w r i t t e n agreements w i l l be provided t o the NIH awarding u n i t f o r i t s records. ( 1 ) S c i e t l t i f i c Considerations The agreement should i d e n t i f y t h e p r i n c i p a l i n v e s t i g a t o r and the responsible persons a t each cooperating i n s t i t u ­ t i o n and describe t h e i r r e s p o n s i b i l i t i e s i n the p r o j e c t . S p e c i f i c procedures f o r m o n i t o r i n g and d i r e c t i n g the research e f f o r t should a1so be del ineated. (2) F i s c a l Considerations The agreement should c i t e s p e c i f i c procedures t o be followed i n reimbursjng p a r t i c i p a n t s f o r t h e i r e f f o r t and should i n c l ude dol 1a r c e i 1ing , t h e time schedule and method o f reimbursement, t h e type o f supporting documents r e q u i r e d f o r reimbursement, and procedures f o r review and approval o f expenditure o f g r a n t funds a t each i n s t i t u t i o n . NIH Guide f o r Grants and Contracts, Vol. 2, No. 4 , J u l y 2, 1973 Page Three (3) A d m i n i s t r a t i v e Cdnsiderations I n instances where p o l i c i e s o f coopera­ t i n g i n s t i t u t i o n s d i f f e r from those o f t h e grantee i n s t i t u t i o n , p a r t i c u l a r l y i n such areas as t r a v e l , t r a v e l reimbursement, s a l a r i e s , and f r i n g e b e n e f i t s , a determination should be made and entered i n t o t h e agreement as t o which p o l i c i e s w i l l p r e v a i l . Any such p o l i c i e s must n o t be i n c o n f l i c t w i t h those o f DHEW-NIH. d. Assurances Required by DHEW-NIH The grantee i n s t i t u t i s n has t h e s p e c i f i c responsibi i i ty t o r a i I r e q u i r e d assurances. To make sure o f responsiveness on the p a r t of t h e cooperating i n s t i t u t i o n s , t h e grantee i n s t i t u t i o n should i n c o r p o r a t e an understanding concerning t h e assurances 1 i s t e d below as a p a r t o f t h e formal w r i t t e n agreement. (1) Care and Treatment o f Laboratory Animals Each cooperating i n s t i t u t i o n u s i n g warm-blooded animals i n t h e grant-supported p r o j e c t w i 11 comply w i t h ap l i c a b l e p o r t i o n s o f t h e Animal Welfare A c t (PL 89-544 as amended! and w i l l f o l l o w t h e g u i d e l i n e s prescribed i n DHEW P u b l i c a t i o n No. 72-23 (NIH), "Guide f o r t h e Care and Use o f Laboratory Animals." (2) C i v i l Rights and Equal Employment Opportunity Each cooperating i n s t i t u t i o n must comply w i t h T i t l e V I o f t h e C i v i l Rights Act o f 1964, and Executive Order 11246. The grantee must ensure t h a t a l l coopera­ t i n g i n s t i t u t i o n s have a v a l i d Assurance o f Compliance w i t h t h e C i v i l Rights A c t o f 1964 on f i l e w i t h t h e DHEW (Form HEW 441) and, i f a c o n t r a c t i s entered i n t o , t h e c o n t r a c t w i l l i n c l u d e paragraphs (1) through (7), P a r t 11, Subpart B y Section 202, Executive Order 11246. bd (3) P r o t e c t i o n o f Human Subjects The grantee i n s t i t u t i o n and the coopera­ t i n g i n s t i t u t i o n s should r e f e r t o DHEW P u b l i c a t i o n No. (NIH) 72-102, "The I n s t i t u t i o n a l Guide t o DHEW P o l i c y on P r o t e c t i o n o f Human Subjects," and s p e c i f i c a l l y Section B y "Special Assurances," p. 13 e t seq. I n a d d i t i o n t o assuring t h a t i n i t i a l requirements f o r p r o t e c t i o n o f human s u b j e c t s are met i n agreements between the grantee i n s t i t u t i o n and t h e cooperating i n s t i t u t i o n s , procedures a l s o must be e s t a b l i s h e d t o assure continued m o n i t o r i n g and compliance w i t h these requirements d u r i n g t h e course o f t h e p r o j e c t . (4) Patents and Inventions The f a c t t h a t two o r more i n s t i t u t i o n s share i n the grant-supported p r o j e c t does n o t a l t e r t h e grantee i n s t i t u t i o n ' s r e s p o n s i b i l i t i e s concerning patents and inventions. The grantee i n s t i t u t i o n should o b t a i n a p p r o p r i a t e p a t e n t agreements t o f u l f i l l t h e requirements from a l l persons who perform any p a r t o f t h e work under t h e grant and may be reasonably expected t o make inventions. The grantee should i n s e r t i n t o each such w r i t t e n agreement a clause making the p a t e n t and i n v e n t i o n s p o l i c y a p p l i c a b l e t o each cooperating i n s t i t u t i o n and i t s employees. Agreements should a l s o be obtained by t h e grantee t o govern d i s p o s i t i o n o f r i g h t s t o i n v e n t i o n s r e s u l t i n g from screening compounds synthesized under t h e grant. (5) Student Unrest Provisions Each cooperating i n s t i t u t i o n w i l l be responsible f o r c a r r y i n g o u t the p r o v i s i o n s r e l a t i n g t o remuneration from g r a n t funds t o any i n d i v i d u a l who has been engaged o r i n v o l v e d i n a c t i v i t i e s described as "student unrest." (Section 407 o f t h e DHEW Appropriations Act each y e a r s i n c e FY 1970.) (6) Any o t h e r assurance normally r e q u i r e d of t h e grantee i n s t i t u t i o n f o r t h e program i n question i s a l s o r e q u i r e d o f t h e cooperating i n s t i t u t i o n s . W Page Four 7. ELIGIBLE COSTS a. Direct costs The costs discussed below are those which are most frequently the subject of inquiry and do n o t represent a complete l i s t of allowable costs. Any cost category that under NIti policy i s an allowable direct cost category f o r the grantee i n s t i t u t i o n may also be requested on behalf of the cooperating institution. The policies related t o grant expenditures for research projects generally apply t o consortium grants w ithout exception. ( 1 ) Alterations and renovations Total A & R costs f o r the roject ‘(including the grantee and the cooperating institutionsi may n o t exceed the amount approved and awarded by the NIH or the lesser of $75,000 o r 25% of the total direct costs (exclusive of patient care costs) reasonably expected t o be awarded f o r the entire project period. Rebudgeting by cooperating institutions f o r A & R costs i n excess of the amount approved and awarded f o r t h a t purpose will require prior approval from the grantee institution. ( 2 ) Patient care costs The agreement qmong the participating institutions should include clauses pertaining t o the following: (a) Recognition that (1) the NIH i s n o t obligated t o award additional f u n d s f o r patient care costs over the original authorized level; ( 2 ) the amount of patient care costs awarded f o r each institution is t o be viewed as a ceiling amount for that instituion; ( 3 ) a l l rebudgeting i n or o u t of the patient care cost category 9 cooperating institution must be approved i n advance by the grantee institution; and ( 4 ) the use of funds for patient care costs when patient care a t t h a t institution on this project has n o t previously been approved by the NIH requires prior approval by the NIH award­ ing u n i t . ( b ) Requirement that charges t o the g r a n t be made according t o the cooperating institution’s negotiated rate agreement w i t h DHEW, o r i f no agreement e x i s t s , be consistent w i t h charges f o r a l l fu other patients. (c) Statement that recovery o f patient costs from a third party, e.g., health insurance, be attempted (whenever appropriate) f o r routine patient care; and ( d ) Designation of a specific individual(s) t o determine when a subject o r patient shall enter the protocols of the project and therefore o f f i c i a l l y become a ”research subject o r patient.” (3) Sal aries , wages , and fringe benefits The pol i ci es governing sal ari es , wages, and fringe benefits a t each cooperating institution will apply t o invividuals employed by t h a t institution. Any after-the f a c t adjust­ ments f o r insti tution-wide salary increases or merit promotions will , however, depend upon the availab’lity o f funds i n the awarded budget. b. Indirect Costs If indirect costs are requested from the grant, the indirect cost rate which has been negotiated w i t h the DHEW by each institution under the consortium grant i s the basis on wnich indirect costs are determined and paid under one of the followins p’irins: NH Guide f o r Grants and Contracts, Vol. 2 , No. 4, July 2 , 1973 I Plan A Page Five (1) Indirect costs f o r the grantee institution are handled as f o r any other research grant t o that institution. ( 2 ) Indirect costs f o r other institutions i n the consortium will be computed on individual institution budgets and reques'ted as part of the direct costs under the "Other" category in the com o s i t e application budget f o r the i n i t i a l and all future year* Application preparation, 6b) In such cases, the amount requested by cooperating institutions will be a fixed maximum amount f o r each year based on estimated direct costs and indirect costs calculated by using indirect cost rates existing a t the time of application. Reimbursement up t o b u t n o t i n excess o f this amount will be made by the grantee institution t o the cooperating institution through an acceptable b i 11i ng process. Where feasible, Plan A is preferred because of i t s simplicity and ease of management f o r a l l concerned. However, i f t h i s appears n o t to be an equitable arrangement, alternative P l a n B may be proposed as the method o f choice f o r reimbursement of i ndi rect costs. Plan B Each member o f the consortium may request and claim the full indirect costs t o which i t i s entitled based on the negotiated provisional rate, with final settlement when a final indirect cost rate i s established for all institu­ t i o n s involved. If Plan B i s proposed by the applicant and approved by the NH awarding u n i t , the following procedures will obtain: I (1) Indirect cost allowance a t time of award Prior t o an award f o r a consortium grant, the NIH awarding u n i t i n consultation w i t h the Indirect Cost Management System, Office of Financial Management, NIH, will calculate a "special" indirect cost rate for the consortium grant. This rate will be based entirely upon the rate currently being used by the DHEW for each component institution and will be used solely t o determine the allowance a t the time o f award. An example of the calculation i s provided: Institution A (grantee) HEW Rate Salary and Wage base $50,000 Indirect cost $25,000 5,000 5,000 50% B (cooperating) C (cooperating) 25% 10% 20,000 50,000 $120,000 Total $35,000 W -. . I c Page S i x "Special" award allowance rate f o r consortium = (The calculation can be adjusted t o accomnodate those situations where institutions may have other than an S and W base.) ( 2 ) Indirect cost claim on r e p o r t of expenditure When the report of expenditures i s submitted, the srantee i n s t i t u t i o n will recalculate the appropriate indirect cost f o r each i n s t i t u t i o n on any renegotiated indirect cost rates and/or any change i n the base against which the new rate is t o be applied. [In accordance w i t h NH policy, when the direct cost base upon I which indirect costs are calculated i s increased by any rebudgeting of direct cost funds, no additional funds f o r indirect costs resulting from such action will be provided by the NIH.] The indirect cost claim reflected i n the report of expenditures should represent the combined need of a l l institutions involved i n the consortium based on the pertinent information available a t the time the report of expenditures i s submitted. Information necessary t o justify the total indirect cost claim should be provided and should include the base, rate, and amount f o r each separate institution i n the consortium. The sum of the individual indirect cost 'claims i s the total t o be claimed on the report of expenditures. (3) ' Final settlement of indirect costs The amount of indirect costs a t the time of award and a t the time a claim i s made on the report of expenditures i s often based on a provisional rate. Final settlement is based on the establishment o f a final rate. Indirect cost final settlement f o r a particular consortium grant cannot be submitted, under Plan B y until all institutions concerned have negotiated final rates w i t h the DHEW. When the l a s t final rate has been negotiated for the various institutions i n the consortium, the grantee must assume responsibility f o r compiling the fiscal information necessary t o establish the base t o which the various indirect costs will be applied, n o t only f o r the grantee i n s t i t u t i o n b u t also f o r each cooperating i n s t i t u t i o n . These data will be submitted t o the Indirect Cost Management System, OFM, NIH, f o r settlement outside the automated routine used for other types o f grants. 8. OTHER ADMINISTRATIVE CONSIDERATIONS a. Rebudgeting authority of cooperating institutions Rebudgeting between budget categories on the part of non-grantee cooperating institutions must have the prior approval of the grantee institution. However, the grantee institution may wish t o establish i n the written agreement moderate levels of rebudgeti ng authority w i t h i n NIH pol icy 1 imitations w i t h each of the cooperating institutions. 1y- NIH Guide f o r Grants and Contracts, Vol. 2, No. 4 , J u l y 2 , 1973 b. A u d i t guide1 ines : Page Seven (1) A l l costs i n c u r r e d i n t h e consortium g r a n t w i l l be s u b j e c t t o a u d i t by t h e cognizant Federal a u d i t agency. ( 2 ) The w r i t t e n agreement w i t h cooperating i n s t i t u t i o n s should i n c o r p o r a t e as a minimum a l l t h e requirements t h a t would be c a l l e d f o r i n t h e agreement between NIH and t h e grantee, i n c l u d i n g a clause g i v i n g cognizant government a u d i t o r s access t o records where necessary t o support costs o f t h e cooperating i n s t i t u t i o n r e l a t i n g t o t h e grant. The grantee should e s t a b l i s h c o n t r o l s t o see t h a t t h e cooperating i n s t i t u t i o n ' s performance, i n terms o f c o s t e f f e c t i v e n e s s , i s monitored. c. Cost sharing guidelines: (1) A p r o v i s i o n w i l l be i n c l u d e d i n t h e w r i t t e n agreement covering c o s t sharing when i t i s a research g r a n t r e q u i r i n g such c o s t sharing. The grantee i n s t i t u t i o n i s responsible t o t h e N I H awarding u n i t f o r t h e e n t i r e c o n t r i b u t i o n t o t h e t o t a l c o s t o f t h e research p r o j e c t , e i t h e r under an i n d i v i d u a l o r an i n s t i t u t i o n a l c o s t s h a r i n g agreement w i t h t h e DHEW. However,the grantee should r e q u i r e cooperating i n s t i t u t i o n s , where appropriate, t o c o n t r i b u t e i n proporticm t o t h e i r p a r t i c i p a t i o n i n t h e t o t a l p r o j e c t . Any n e g o t i a t e d arrangement f o r cost-sharing p a r t i c i p a t i o n should be a p a r t o f t h e w r i t t e n agreement between t h e i n s t i t u t i o n s i n the consortium. -4 d. Equipment a c c o u n t a b i l i t y and d i s p o s i t i o n The grantee i n s t i t u t i o n s h a l l have t h e responsi b i 1it y f o r the purchase, i n v e n t o r y , accountabi 1ity and d i s p o s i t i o n o f equipment i n accordance w i t h N I H p o l i c y . T i t l e t o equipment w i l l r e s i d e w i t h t h e grantee i n s t i t u t i o n . e. Grant-related income The w r i t t e n agreement between t h e grantee i n s t i t u t i o n and t h e cooperating i n s t i t u t i o n s w i l l i n c l u d e a clause p r o v i d i n g f o r t h e coverage o f g r a n t - r e l a t e d income i n accordance w i t h t h e p o l i c y which r e q u i r e s the grantee t o be accountable f o r t h e NIH's share o f any such income. The grantee i s responsible f o r the records on t h e r e c e i p t and d i s p o s i t i o n o f such income. The cooperating i n s t i t u t i o n w i l l maintain such records as are necessary f o r t h e grantee i n s t i t u t i o n t o f u l f i l l i t s r e s p o n s i b i l i t y . Expenditure o f t h e Federal share o f g r a n t - r e l a t e d income w i l l n o t be allowed t o meet cost-sharing agreements except f o r grants under those programs where i t i s c l e a r t h a t l e g i s l a t i v e i n t e n t was t o p e r m i t such income t o be used f o r t h a t purpose. f. P u b l i c a t i o n s The cooperating i n s t i t u t i o n s must decide i n advance whether t h e p r i n c i p a l i n v e s t i g a t o r a t t h e grantee i n s t i t u t i o n alone receives c r e d i t on r e s e a r t h r e p o r t s and o t h e r p u b l i c a t i o n s o r whether the actual i n v e s t i g a t o r a t one o f t h e cooperating i n s t i t u t i o n s w i l l r e c e i v e such c r e d i t . Regardless o f t h e l arrangement general agreements regarding authorships should be e s t a b l i s h e d i n i t i a l l y . Page E i g h t 9. R E P O ~ I N G REQUIRE~NTS In the written agreement i t should be spelled o u t that the cooperating institutions are responsible f o r making full and complete reports on anything requiring reporting t o the grantee institution which will i n t u r n make the required reports t o the NIH. The progress report should be patterned a f t e r the format generally used f o r program projects and center grants t o show specific parts o f the project separately and to report progress separately by the investigators responsible f o r the various portions of the project. 10. EFFECTIVE DATE This policy i s effective f o r a l l new and competing renewal grants w i t h beginning dates on or a f t e r July 1 , 1973. Grantee institutions which now have consortium grants are encouraged t o adopt the principles contained i n t h s policy as soon as practicable.