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Sponsored Research Contracts: Management and Issues Contracts and Industry Agreements Office of Sponsored Programs

Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

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Page 1: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Sponsored  Research  Contracts:Management  and  Issues  

Contracts  and  Industry  Agreements    Office  of  Sponsored  Programs

Page 2: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Contract  Management

§ OSP  comprises  two  separate  Units:

• Contracts  Unit

• Grants  Unit

Page 3: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Contract  Types  by  OSP Unit  (Grants  and  Contracts)

§ Industry  sponsored   Clinical  trial  and  clinical  research  contracts  

§ Confidentiality  Agreements   related  to  Clinical  Trials

§ Clinical  Material  Transfer  Agreements  § SBIR/STTR subawards§ Incoming  and  outgoing   subcontracts  

under   federal  contracts§ Non-­‐FDP incoming  subs§ State  contracts  (including   county  and  

city  contracts)§ Purchased  service  agreements§ Federal  Request  for  Proposals  (RFPs)

§ Federal  Grants  with  terms  and  conditions

§ Foundation   grants  with  terms  and  conditions  

§ Outgoing   subawards under   federal  grants  (both   FDP and  non-­‐FDP)

§ FDP incoming  subs

CONTRACTS  UNIT GRANTS  UNIT

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Contracts  Generally  NOT  Reviewed  by  OSP  Contracts  Unit§ Personal  Consulting  Agreements  (Faculty/staff  not  performing  or  serving  

in  capacity  of  university  employee)

§ Agreements  to  establish  Academic  Programs/Accreditation  

§ Teaching/Training  Agreements  where  faculty  are  paid  directly

§ Agreements  to  purchase  equipment  to  be  used  for  Patient  Care  (Emory  Healthcare  generally  handles  these  agreements)

§ Vendor  Agreements  for  the  purchase  of  goods  and  services  (University  Procurement  generally  reviews  these  agreements)  

§ Licensing  Agreements  (OTT  generally  reviews  these  agreements)

Page 5: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Management  Statistics

How  many  contracts  did  the  OSP Contracts  Unit  receive  for  review/negotiation  during  calendar  

year  2013?

Page 6: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Guesses?

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Total  Number  of  Contracts  received  for  review/negotiation  in  2013  (Jan  1  – Dec.  31)

Contract  Type Number  of  Contracts  Received  by  Contracts  Unit

Clinical  Trials     326

Research  Agreements 238

Confidential/Non-­‐DisclosureAgreements   (CDAs)

285

Amendments 388

Data  Use  Agreements 10

Material Transfer   Agreements  (MTAs)

6

Other  (Research Services,  StateAgreements,   etc.)  

218

Research  Service  Agreements 22

Master  Clinical  Trial  Agreements 4

Total  Contracts 1497

Page 8: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Master  and  Template  Agreements

§ Purpose:  Reduce/eliminate  lengthy  negotiations

§ Function:  Predetermined  terms  and  conditions  already  agreed  upon  by  parties  for  

§ Benefit:  Allows  award  set-­‐up  (NOA issuance)  faster  assuming  all  other  requirements  are  met  

Page 9: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Drawbacks  to  Master  Agreements?

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One  Notable  Drawback

Terms  agreed  by  the  parties  will  be  “locked”  for  a  few  years  which  may  present  some  challenges  if/when  Emory  policies/positions  changes,  or  new  laws/regulations  are  enacted  during  the  course  of  existing  master  agreement  period,  etc.  

Examples:• Subject  Injury  Policy• University  Accreditation  Requirements  (AAHRPP)• FDA  or  other  federal  regulations/law,  etc.

Page 11: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

End  Result  

***May  have  to  go  back  and  negotiate  to  amend  existing  master  agreement  w/  

sponsor  

Page 12: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Master  and  Template  Agreements  to  Date

Page 13: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Master  Agreements

By  Sponsor  • Abbott  Laboratories• Abbott Vascular  • American  Foundation  for  Aids  Research  • Amgen• Bayer• Biogen• Calypso  Medical  Tech• Celgene• Cerus• Children’s  Hospital  and  Regional  Medical  

Center• Cytodome• DuPont• Eli  Lilly• Evalve,  Inc.  (division  of  Abbott)• Emmes• General  Electric• Genzyme• Georgia  Core• Guidant

• Hoffman-­LaRoche• ImClone• IND 2  Results,  LLC• Medarex• Medtronic• Merck• Millennium• Moffitt  Research  Institute• Myriad  Pharmaceuticals• Novartis• Novo  Nordisk• Purdue  Pharmaceutical• Schering  Plough• Sekisui  • St.  Jude  Medical• Siemens• SMO-­USA,  Inc.

Page 14: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Master  Confidentiality  Agreements

§ Abbott  Laboratories

§ AstraZeneca

§ Celgene

§ Oak  Ridge  

§ Array  Biopharma

Page 15: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Template  Agreements

§ Georgia  Department  of  Community  Health  (formerly  Georgia  Department  of  Human  Resources)

§ Children’s  Healthcare  of  Atlanta  Subcontract  (outgoing)

§ Oak  Ridge  MOU  &  Teaming  Agreement  

Page 16: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Template  Agreements  (OSP  Website)

§ Clinical  Trial  Agreement  (CTA)

§ Sponsored  Research  Agreement

§ Research  Services  Agreement

§ Non-­‐Disclosure  Agreement  (NDA  or  CDA)

§ SBIR  Subcontract  Template  

§ STTR  Subcontract  Template

Page 17: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

How  Contracts  are  Routed  to  OSP

Page 18: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Emory  Proposal  Express  EPEX§ What  is  Emory  Proposal  Express  (EPEX)?

• The  Purpose  of  EPEX is  to  assist   in  budget  development,  electronic  routing,  and  institution  approval  related  to  extramural  funding  at  Emory.  EPEX replaces  the  SPAF (Sponsored  Programs  Approval  Form)  and  is  a  necessary  accompaniment  to  any  Grant  or  Contract  requiring  Institutional  endorsement.

§ When  to  Route  through  EPEX• All  extramurally  sponsored  projects  requiring  Institutional   review/approval  

(i.e.  Dept,  School,  OSP,  etc.),  including    industry  and  cooperative  group  funded  clinical  trials to  be  conducted  at  Emory  or  Emory  affiliate  sites  must  be  routed  through  EPEX.    

• This  includes:  new  projects/studies  and  Budget  Amendments that  increase or  decrease per  patient  costs  (to  be  covered  later)    

• This  does  not  include  Budget  Amendments  to  increase  the  number  of  patients  with  no  change  in  the  amount  per  patient (to  be  covered  later)

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Clinical  Trial  Model

Clinical  Trial  Agreements  represent  the  majority  of  agreement  types  reviewed/negotiated  by  OSP  

Contracts  Unit

Page 20: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)
Page 21: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)
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EPEX Needed

School Approval OSP Approval OCR Review

IRB Approval

Sponsor Approval Staff

Type of Amendment: Yes No Yes No Yes No Yes No Yes No Yes No

Change of PI ü ü

Requires OSP Prior Approval

Form

ü

Requires OSP Prior Approval

Form

ü ü

Copy of new IRB Approval with new PI

ü TG

Change in contract provision, not involving the project length or any monetary aspect of the Agreement (i.e. contract terms, Protocol Amendments)

ü ü ü ü ü

Current IRB Approval Required

ü Analyst

Budget Amendment that increase or decrease the awarded budget (including pass-through items).

*Exceptions: Budget Amendment to increase number of patients to be enrolled

ü ü ü ü if coverage review is required

ü

Current IRB Approval Required

ü Analyst

Budget Amendment that changes payment schedule.

ü ü ü ü ü

ü Analyst

Extension of budget/project end dates œ specified end date in the contract.

Extension of budget/project end dates œ no specified end date in the contract.

ü ü ü

Requires OSP Prior Approval Form or Email

ü ü

Current IRB Approval Required

ü Analyst

TG

Extension of budget/project end dates œ no specified end date in the contract.

ü ü ü

Requires OSP Prior Approval

Form

ü ü

Current IRB Approval Required

ü TG

Change in Sponsor/Sponsor Address Changes

ü ü ü ü ü ü TG

Page 23: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Contract  Tracking

Contracts  Database§ Purpose:  To  track  the  status  of  contract  negotiation  from  receipt  to  

completion  

§ Function:  Stores    data  elements.  Interface  w/EPEX (some  data).  At-­‐a-­‐glance  view  of  status    

§ Benefit:  Reporting,  follow-­‐up,  management  tool  to  measure  performance  and  campus  access  (coming  soon  to  faculty/designated  staff)

Page 24: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Contract  Tracking  (con’t)

§ Web  based  application  coming  soon  for  faculty/staff,  IRB,  and  Controller’s  Office  access  to  retrieve  needed  information:

• Status  of  Contract  • Subject  Injury  Option  per  Emory  Policy    • Private  Use/UBTI  for  IRS  compliance

Page 25: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

OSP  Contracts  Dept.  Assignments

To  be  Distributed

Page 26: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

DirectorNikki C. Simmons

Associate DirectorJanette Hannam

Sr. Assoc. AnalystShannon Walker

OSP Contracts  Unit  

Sr. Assoc. AnalystRaeTreal McCrory

Lead AnalystShirley Vanier

Assistant DirectorIruka Ndubuizu

Sr. Assoc. AnalystAmelia Myers

Sr. Assoc. AnalystMichelle Nwaogu

Sr. Assoc. AnalystTina Stovall-Goolsby

Sr. Assoc. AnalystJoanna West

Sponsored AnalystTeresa Graves

Assoc. AnalystSubcontractsMekia Hardy

Page 27: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Additional  Resources

EPEX§ Training

• Training   is  available  24/7  via  PeopleSoft  UPK on  the  Compass  Training  Page:  Compass>  Training>  Grants:    http://compass.emory.edu/training/index.html

• Instructor-­‐led  is  available  bi-­‐monthly.    Dates  and  Times   for  the  instructor-­‐led  EPEX course  can  be  found  on  the  Training  page  of  the  OSP website:  http://www.osp.emory.edu/communication/training/index.cfm

§ EPEX and  OCR§ Information  regarding  OCR  and  EPEX can  be  found  on  the  EPEX page  of  the  OSP

Website:  http://www.osp.emory.edu/forms/epex.cfm and  includes:• Required  Attachments• Clinical  Trials  Procedures  and  Workflow

§ Other  Available  Information• EPEX FAQs:    http://www.osp.emory.edu/OSP_other/EPEXFAQs.cfm• Compass  Grants  Help: [email protected]

Page 28: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Contract  Issues(some)

Page 29: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Some  Issues  Requiring  Negotiation  

• Publication  

• Confidentiality  

• Intellectual  Property

• Subject  Injury/adverse  effects

• Indemnification/hold  harmless

Page 30: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Publication

Rights  and  Restrictions    Do  the  terms  of  the  contract  allow  the  University/PI  to  use  theresearch  results  (data,  etc.)  for  teaching,  training,  or  patient  care?    

• Why  is  this  important?• Impacts  on  University  tax-­‐exempt  status• Multi-­‐site  considerations• Confidentiality  Considerations?• Acknowledgment  of  sponsorship  

Page 31: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Questions?

Page 32: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Issue  or  non-­‐issue

A  term  in  a  contract  requires  the  University/PI  to  submit  a  copy  of  any  proposed  publication  of  the  research  results/data  no  less  than  30  days  prior  to  the  date  of  publication  for  review  and  approval  by  the  sponsor.

This  is  an  issue.  True  or  False?

Page 33: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Answer

Page 34: Management and Issues PPT Updated NCS 1-13-14 · Total)Number)of)Contracts)received)for) review/negotiation)in)2013)(Jan)1) –Dec.)31) ContractType Number)of)Contracts)Received)

Discussion

…for  “approval”  is  an  issue

“….for  review  and  comment is  acceptable”

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Confidentiality

Non  disclosure,  duration,  exclusions,  etc.Do  the  terms  of  the  contract  contain  a  non-­‐disclosure  provision?Generally  acceptable  if:

• to  protect  sponsor’s  confidential/proprietary  info.  Research  results/data  should  be  excluded  to  reserve  publication  rights  

• duration  for  non-­‐disclosure  period  is  “reasonable”• does  obligation  of  non-­‐disclosure  do  not  include  any  of  the  generally  

acceptable  exclusions:  

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General  Exclusions  to  Confidentiality/non-­‐disclosure§ Information  which,  at  the  time  of  disclosure,   is  in  the  public  knowledge;§ Information  which,  after  disclosure,  becomes  part  of  the  public  knowledge  by  

publication  or  otherwise,  except  by  breach  of  this  Agreement;§ Information  which  was  in  the  possession  of  recipient  at  the  time  of  disclosure  and  

which  was  not  acquired  directly  or  indirectly  by  recipient  from  the  disclosing  party,  and  which  prior  possession  can  be  proven  by  documentary  evidence;

§ Information   received  from  third  parties,  provided  such  information  was  not  obtained,  to  their  knowledge,  by  said  third  parties,  directly  or  indirectly,  on  a  confidential  basis;

§ Information  which  is  independently  developed  by  University  personnel  not  privy  to  Sponsor’s  Confidential   Information  disclosed  under  this  Agreement;

§ Information  which  is  required  to  be  disclosed  by  applicable   law,  rule,  regulation,  judicial  order  or  subpoena;  or

§ Information  which  is  necessary  to  provide  patient  care  for  any  Study  subject  participating   in  the  Study  under  this  Agreement.

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Issue  or  non-­‐issue?

A  term  in  a  contract  states,  “University/Principal   Investigator  shall  not  disclose   any  confidential  or  proprietary  information  identified  as  such  and  provided  by  the  sponsor   pursuant  to  this  Agreement.  Any  Confidential   Information  furnished   by  the  Sponsor  must  be  submitted  to  the  Principal  Investigator  and  clearly  marked  as  Confidential.  

The  obligation   for  confidentiality  shall   not  apply   to:§ Information  which,  at  the  time  of  disclosure,   is  in  the  public   knowledge;§ Information  which,  after  disclosure,   becomes  part  of  the  public  knowledge  by  publication  or  otherwise,  

except  by  breach  of  this  Agreement;§ Information  which  was  in  the  possession   of  recipient  at  the  time  of  disclosure  and  which  was  not  acquired  

directly  or  indirectly  by  recipient  from  the  disclosing   party,  and  which  prior  possession   can  be  proven  by  documentary  evidence;

§ Information  received  from  third  parties,  provided  such  information  was  not  obtained,  to  their  knowledge,  by  said  third  parties,  directly  or  indirectly,   on  a  confidential  basis;

§ Information  which  is  independently  developed  by  University  personnel  not  privy  to  Sponsor’s   Confidential  Information  disclosed  under  this  Agreement;

§ Information  which  is  required  to  be  disclosed   by  applicable   law,  rule,  regulation,  judicial   order  or  subpoena;  or

§ Information  which  is  necessary  to  provide  patient  care  for  any  Study  subject  participating   in  the  Study  under  this  Agreement.

§ The  obligations   of  this  paragraph  shall   not  restrict  the  ability  of  the  University  to  use  Research  results  and  to  publish   as  described  in  Article  ___  of  this  contract.

This  clause  is  an  Issue.  True  or  False?

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Answer

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Discussion

The  obligation  of  non-­‐disclosure  in  the  proposed  clause  does  not  contain  a  “reasonable”  non-­‐disclosure  period.  In  fact,  it  does  not  contain  a  period  at  all.

Thus,  it  could  be  interpreted  that  the  University/PI’s  obligation  is  perpetual.  

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Intellectual  Property  

Inventions,  ownership,  etc.Does  the  contract  limit  the  University’s  ownership  of  intellectual  property/inventions  created  as  a  result  of  the  research  performed  or  services  provided?  

As  a  general  position,  the  University  will  not  require  ownership  of  inventions  resulting  from  a  Clinical  Trial.          Ownership  to  inventions  are  looked  at  more  fully  when  the  Protocol  or  statement  of  work  is  written  by  an  Emory  PI.  

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Intellectual  Property  (con’t)

The  use  of  data  and  work  products  (deliverables)  relating  to  the  University’s/PI’s performance  under  the  contract  should  be  retained  for  teaching,  research,  clinical  and  publication  purposes,  as  well  as  to  comply  with  federal,  state  or  local  laws  or  regulations.

§ Work-­‐for-­‐Hire  obligations  are  generally  not  acceptable.  Impact  on  University’s  tax-­‐exempt  status.  UBTI/Private  Use

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Intellectual  Property  (con’t)

License:  Sponsor  will  generally  grant  University  a  non-­‐exclusive  license  to  use  a  Sponsor’s  Invention  (  subject  to  confidentiality  provisions)  for  internal,  non-­‐commercial  research  and  educational  purposes.    

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Issue  or  non-­‐issue

A  term  in  a  proposed  contract  requires  University  to  grant  ownership  of  inventions  created  by  University  or  PI  prior  to  and  during  the  period  of  performance  of  the  contract.

This  is  an  Issue.  True  of  False?      

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Answer

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Discussion  

As  a  general  rule,  ownership  of  inventions  existing  prior  to  the  Effective  Date  of  the  contract,  are  the  separate  property  of  University/PI,  and  should  not  be  affected  by  current  contract.  Thus,  sponsor  shall  not  have  any  claims  to  or  rights  in  such  intellectual  property.  (background  IP)

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Subject  Injury  

Payment,    Adverse  Affects,  and  reportingDoes  the  contract  require  the  Sponsor  to  pay  for  medical  costs  in  the  event  of  patient  injury?Language  in  the  contract  must  be  consistent  with  one  of  three  options  per  University’s  Subject  Injury  Policy.

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Subject  Injury  Policy

§ OPTION  1:  The  sponsor  may  choose  not  to  pay  for  Subject  Injury  Costs  for  any  subject,  no  matter  if  the  subject  is  insured,  or  how  he/she  is  insured.  

§ OPTION  2:  The  sponsor  may  choose  to  pay  for  Subject  Injury  Costs  for  all  subjects,  no  matter  if  the  subject  is  insured,  or  how  he/she  is  insured.  

§ OPTION  3:  The  sponsor  may  choose  to  pay  for  Subject  Injury  Costs  for  uninsured  subjects  or  subjects  with  Medicare/Medicaid  and  to  pay  any  part  of  Subject  Injury  Costs  for  privately  insured  subjects  that  are  not  covered  and/or  paid  by  their  private  insurance.  

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Subject  Injury  (con’t)

Does  the  contract  require  the  sponsor  to  notify  all  study  sites  of  issues  that  may  potentially  negatively  affect  research  subjects?

AAHRPP: Association  for  the  Accreditation  of  Human  Research  Protection  Programs

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Subject  Injury  (con’t)

§ Sponsor  will  promptly  report  to  the  Principal  Investigator  and  to  University,  at  the  notice  address  indicated  in  the  notice  section  of  this  Agreement,  any  findings  that  could,  (i)   affect  the  safety  of  research  Subjects  during  and  after  the      

Research  (ii) their  medical  care  or  their  willingness  to  continue  participation,  (iii)  

influence  the  conduct  of  the  Research,  or  (iv) alter  the  IRB’s approval  to  continue  the  Research.    

§ Sponsor  shall  monitor  the  data  to  ensure  the  safety  of  research  subjects  and  timely  provide  University  and  Principal  Investigator  with  a  copy  of  all  medical  monitor  or  safety  monitoring  committee  reports  generated  for  the  Research

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Indemnification/hold  harmless

General  definition:  means  to  allocate  risk  of  claims  by  third-­‐parties  (i.e.  research  subjects)  to  shift  liability    to  a  specific  contractual  Party.  

Clinical  Trial  Contracts:With  the  exception  of  University/PI  negligent  actions,  we  generally  require  sponsors  to  indemnify  the  University/PI  from  liability  with  respect  to  the  use  of  study  drug/device  or  protocol  procedures.  

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Indemnification  (con’t)

Sponsored  Research  Contracts:With  the  exception  of  University/PI  negligent  actions,  we  generally  require  sponsors  to  indemnify  the  University/PI  from  liability  with  respect  to  their  use  of  data,  research  results,    and  deliverables  (subject  to  governing  law)    

Mutual  Indemnity  is  also  generally  acceptable.  

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