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Access to Data

Stewardship Responsibilities

Although institutions are responsible to sponsors, good management practice and practicalconsiderations necessitate that the stewardship of various kinds of data be distributed.Institutions should be clear in defining stewardship accountability and responsibility. Unless thedistribution of responsibility is clear, misunderstandings can result and compliance jeopardized.

The stewardship of research data properly falls within the purview of the principal investigatorand other researchers. Depending on the nature of the project, certain responsibilities can bedelegated from the principal investigator to other members of the research project (e.g. otherfaculty, post-docs, and graduate students). At the same time, no matter how such responsibilitiesare delegated, the flow of accountability runs from the principal investigator being responsible tothe institution for the stewardship of research data, just as the institution is ultimately responsibleto the sponsor.

The stewardship of financial and administrative data is allocated according to the function,expertise, and responsibilities of various administrative offices. Institutions will allocate

stewardship responsibilities according to their organizational structure. For instance, it is likelythat decentralized organizations will allocate responsibilities to departments, while centralizedorganization maintain the data a less dispersed fashion. Some institutions, for example, willmaintain cost-sharing data centrally, while others will allocate responsibility to departments. Insuch case, the departments periodically provide cost-sharing data to the central administration toenable the latter to complete financial reports to sponsors. The auditable records, however, mayvery well be maintained at the department level.

Other types of administrative data are maintained by administrative and compliance offices bothwithin departments and the central administration. Again, whether these offices are centralized o

decentralized depends upon the general institutional structure. For instance, larger institutionsmay have more than one Institutional Review Board that exist within large departments orschools. Smaller institutions are more likely to have one central IRB that has responsibility forreviewing human participant research protocols for projects in all departments.

Below are some examples of how stewardship of administrative data may be distributed. This lisis 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 maand approvals;Office for Sponsored Programs data and information related to subawards, project and buapprovals, and data related to effort reporting;Intellectual Property Office data and information related to patents, licensing and compliwith sponsor requirements.

Who May Access Research Data?

No matter whether data are research, financial, or administrative data, there are reasonable levels

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of controls that can and should be placed regarding access. Research data will includepreliminary and raw data that are the building blocks of scholarly publications. Such data arealso the foundation of intellectual property and its protection. Financial data may containinformation that neither an institution nor individuals may wish to be generally known. Thismight 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 noteand reports related to conflicts of interest or research misconduct that is really of valid use to arestricted 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 mayagree or even propose in their terms and conditions that their access be limited to copies ointended publications or copyrightable materials. Much will depend upon the nature of thework being done and whether the sponsor intends to further develop the research.

Intellectual Property Licensees Companies that license inventions will need access to tdata upon which the intellectual property is based. Frequently companies will license inveresulting from basic research that are not fully developed and ready to market as a productorder to engage in the development of such licensed technology, the company will need acthe research data. This will be addressed in the license and specifically covered by the termConfidential Disclosure Agreement.The latter will give the company access to the data buprohibits the company from further sharing the data with other parties.

Institution The institution will need access to the data for several reasons. First, as notedpreviously in the section on Ownership, the institution is responsible to sponsors to provid

data or access to it should the sponsor make a valid request. Second, there could be lawsuipertaining to the data and the institution will be regarded as the owner. Third, there may beadministrative actions that require institutional access to research data. These actions couldinclude cases of research misconduct, conflicts of interest, or possibly disputes between oramong researchers that require institutional intervention.

Others If federal funding is involved in sponsoring the research, members of the public seek access to research data by using the Freedom of Information Act (FOIA). This wasdiscussed previously in the Ownership section. While such use of the FOIA may be attempthere are clear rules promulgated by the Office of Management and Budget that confine fu

such FOIA requests to that data that is used by federal agencies in their formulation of fedpolicy. The FOIA can also be used to gain access to funded proposals, but the background that was used in creating the proposal is not similarly accessible.

Financial Data:

Sponsor Generally, projects sponsors have broad access to all financial data related tothe project. This access may be exercised through the sponsors grants or contracts officeor through the use of an audit. Federal funding is also subject to audits performed byprivate audits firms under the auspices of OMB Circular A-133.

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Institution Within an institution, access to financial data is generally limited to those haneed for access. Institutions, for instance, place controls in their accounting systems over wmay access budgets and salary information. Cost-sharing and effort reporting data are simicontrolled due to salary information.

Administrative Data:

Sponsor Sponsors have broad access to administrative data, but given the fact thatadministrative data can take many forms, generally sponsors will have specific offices

having those rights of access. For instance, the Office of Human Research Protections willhave sole access to administrative data pertaining to NIH-funded projects involving humanparticipants. Similarly, misconduct cases that arise in NIH funded projects are handled bythe DHHS Office of Research Integrity. Other types of administrative data, such asinformation related to invention disclosure and patent applications, will fall under thecognizance of the sponsors intellectual property office or legal counsel.

Institution As is the case with financial data, institutions place controls on administrativthat limit access to those having a need for access.