Access to Data Stewardship Responsibilities Although institutions are responsible to sponsors, good management practice and practical considerations

necessitate that the stewardship of various kinds of data be distributed. Institutions should be clear in dening stewardship accountability and responsibility. Unless the distribution of responsibility is clear, misunderstandings can result and compliance jeopardized. The stewardship of research data properly falls within the purview of the principal investigator and other researchers. Depending on the nature of the project, certain responsibilities can be delegated from the principal investigator to other members of the research project (e.g. other faculty, post-docs, and graduate students). At the same time, no matter how such responsibilities are delegated, the ow of accountability runs from the principal investigator being responsible to the institution for the stewardship of research data, just as the institution is ultimately responsible to the sponsor. The stewardship of nancial and administrative data is allocated according to the function, expertise, and responsibilities of various administrative ofces. Institutions will allocate stewardship responsibilities according to their organizational structure. For instance, it is likely that decentralized organizations will allocate responsibilities to departments, while centralized organization maintain the data a less dispersed fashion. Some institutions, for example, will maintain cost-sharing data centrally, while others will allocate responsibility to departments. In such case, the departments periodically provide cost-sharing data to the central administration to enable the latter to complete nancial reports to sponsors. The auditable records, however, may very well be maintained at the department level. Other types of administrative data are maintained by administrative and compliance ofces both within departments and the central administration. Again, whether these ofces are centralized or decentralized depends upon the general institutional structure. For instance, larger institutions may have more than one Institutional Review Board that exist within large departments or schools. Smaller institutions are more likely to have one central IRB that has responsibility for reviewing human participant research protocols for projects in all departments. Below are some examples of how stewardship of administrative data may be distributed. This list is representative only and is by no means exhaustive: Institutional Review Board human participant research protocols and approvals; Institutional Animal Care and Use Committee animal research protocols and approvals; Institutional Biosafety Committee protocols involving rDNA or hazardous biological materials and approvals; Ofce for Sponsored Programs data and information related to subawards, project and budget approvals, and data related to effort reporting; Intellectual Property Ofce data and information related to patents, licensing and compliance with sponsor requirements. Who May Access Research Data? No matter whether data are research, nancial, or administrative data, there are reasonable levels

of controls that can and should be placed regarding access. Research data will include preliminary and raw data that are the building blocks of scholarly publications. Such data are also the foundation of intellectual property and its protection. Financial data may contain information that neither an institution nor individuals may wish to be generally known. This might include salary information as well as data that is used to create cost and pricing analyses, facilities and administrative cost rate calculations and negotiations, and the like. Similarly, administrative data may contain information, such as the content of subcontract negotiation notes and reports related to conicts of interest or research misconduct that is really of valid use to a restricted group. Normal access to data is set as follows: Research Data: Funding Sponsor Sponsor access may be limited by the terms of the award document. In some cases, sponsors will want access to all research data. Sometimes, sponsors may agree or even propose in their terms and conditions that their access be limited to copies of intended publications or copyrightable materials. Much will depend upon the nature of the work being done and whether the sponsor intends to further develop the research. Intellectual Property Licensees Companies that license inventions will need access to the data upon which the intellectual property is based. Frequently companies will license inventions resulting from basic research that are not fully developed and ready to market as a product. In order to engage in the development of such licensed technology, the company will need access to the research data. This will be addressed in the license and specically covered by the terms of a Condential Disclosure Agreement. The latter will give the company access to the data but also prohibits the company from further sharing the data with other parties. Institution The institution will need access to the data for several reasons. First, as noted previously in the section on Ownership, the institution is responsible to sponsors to provide the data or access to it should the sponsor make a valid request. Second, there could be lawsuits pertaining to the data and the institution will be regarded as the owner. Third, there may be administrative actions that require institutional access to research data. These actions could include cases of research misconduct, conicts of interest, or possibly disputes between or among researchers that require institutional intervention. Others If federal funding is involved in sponsoring the research, members of the public may seek access to research data by using the Freedom of Information Act (FOIA). This was discussed previously in the Ownership section. While such use of the FOIA may be attempted, there are clear rules promulgated by the Ofce of Management and Budget that conne fullling such FOIA requests to that data that is used by federal agencies in their formulation of federal policy. The FOIA can also be used to gain access to funded proposals, but the background data that was used in creating the proposal is not similarly accessible. Financial Data: Sponsor Generally, projects sponsors have broad access to all nancial data related to the project. This access may be exercised through the sponsors grants or contracts ofce or through the use of an audit. Federal funding is also subject to audits performed by private audits rms under the auspices of OMB Circular A-133.

Institution Within an institution, access to nancial data is generally limited to those having a need for access. Institutions, for instance, place controls in their accounting systems over who may access budgets and salary information. Cost-sharing and effort reporting data are similarly controlled due to salary information. Administrative Data: Sponsor Sponsors have broad access to administrative data, but given the fact that administrative data can take many forms, generally sponsors will have specic ofces having those rights of access. For instance, the Ofce of Human Research Protections will have sole access to administrative data pertaining to NIH-funded projects involving human participants. Similarly, misconduct cases that arise in NIH funded projects are handled by the DHHS Ofce of Research Integrity. Other types of administrative data, such as information related to invention disclosure and patent applications, will fall under the cognizance of the sponsors intellectual property ofce or legal counsel. Institution As is the case with nancial data, institutions place controls on administrative data that limit access to those having a need for access.