David B. Resnik, JD, PhDNIEHS/NIH/DHHSNIEHS/NIH/DHHS

This research was supported by the intramural program of the NIEHS/NIH. It does not represent the views of the NIEHS, NIH, or U.S. government.

• I have learned about and helped to mediate disputes involving collaborations with NIEHS

h d h f hresearchers and researchers from other institutes.

• These typically involve disputes about yp y pauthorship, publication, data management, or intellectual property.

• Researchers have different understandings about• Researchers have different understandings about these issues.

• One way to minimize these disagreements is to d l itt ll b ti t idevelop a written collaboration agreement in which these issues are worked out up-front.

• The collaboration agreement can be revised as gcircumstances warrant.

• Collaboration agreements can be especially f l d i t t i i t ti luseful and important in international

research, because of various factors that can give rise to misunderstandings and disputes, g g p ,such as:

• Different ethical standardsDiff t d ti l b k d• Different educational backgrounds

• Cultural and linguistic differences• Geographic distance• Geographic distance• Political, social, or legal concerns, problems

or issues

Authorship. On what basis will authorship be determined? Who will be an author? Who willdetermined? Who will be an author? Who will receive an acknowledgment? What will be the authorship order?Publication. Where will publication(s) be submitted? How many publications? On what topics? When will the work be ready to publish?p y pData management. Who will have access to data? How will records be kept, stored, secured, analyzed? How will data be shared? Will any dataanalyzed? How will data be shared? Will any data be confidential? Will any data be placed on public websites?

Materials. Who will have access to research t i l ? H ill th b t d dmaterials? How will these be stored and

shared? Intellectual property. Will a patentIntellectual property. Will a patent application be submitted? Who will have patent rights? Copyrights?F di Wh ill l f f di ? WhFunding. Who will apply for funding? Who will pay for the project? For different parts? Conflict of interest: Are there any COIs thatConflict of interest: Are there any COIs that need to be addressed? How will these be addressed or managed?

Roles and responsibilities. What is the role of each collaborator? Who is responsible for different parts/aspects of the project?Timelines When will the project start? End?Timelines. When will the project start? End? When will different phases take place? What are the deadlines for funding, journalare the deadlines for funding, journal submission, IRB submission, etc.? Regulation. What regulations and guidelines (national and international) apply to the project? Do they harmonize? Conflict?

• The NIH Ombudsman’s office has developed a similar set of questions for collaborations: http://sourcebook.od.nih.gov/ResEthicsCases/collaborationagreement htm/collaborationagreement.htm

One of the challenges of developing or implementing any agreement is that you mayimplementing any agreement is that you may not know (and trust) the people you are working with. How do you know that your collaborators will collect data, store, and analyze data properly? Treat human or animal research subjectsTreat human or animal research subjects properly? Disclose actual or potential conflicts of interest?conflicts of interest?

Agreements work best when they help to clarify understandings among people who already have mutual trust/expectations.You need to determine whether yourYou need to determine whether your collaborators are likely to be trustworthy. This is often difficult to determine in advanceThis is often difficult to determine in advance but can often be ascertained as you begin working together and learn more about each other.

How often do investigators develop these collaboration agreements? My guess is not g y goften. Very few investigators at my institute have. As far as I know, there has been no

i i l h thi t iempirical research on this topic.Why not? Ignorance People don’t know they can doIgnorance. People don t know they can do this.Inconvenience. These agreements take timeInconvenience. These agreements take time and effort; many things must be worked out.Legal-phobia: These agreements are legalistic. Many people prefer a more informal approach.

Investigators have told me that they wish they had developed a collaboration agreement after something went wrong. These agreements should be used moreThese agreements should be used more often, especially in international research, where the potential for misunderstanding iswhere the potential for misunderstanding is great.

M t i l t f t (MTA )Material transfer agreements (MTAs)Data use agreementsConfidentiality agreementsConfidentiality agreementsCooperative research and development agreements (CRADAs)agreements (CRADAs)These may all be necessary and relevant too. Sometimes many important issues will be y pspelled out in these, but they often don’t go far enough.