03 · What You Need to Know
Responsibility Can Overlap Without Becoming Indistinguishable
Start with roles rather than asking which institution is “the responsible one”
Institutional responsibility follows what an organization actually does, controls, authorizes, or has formally agreed to undertake.
A university employing the principal investigator may have responsibilities for research governance, researcher conduct, training, integrity, and institutional systems. A hospital hosting participants may have responsibilities for local authorization, facilities, staff involvement, records, and participant care. A sponsor may have project-level oversight responsibilities. A funder may have responsibilities attached to scientific assessment and funding. A collaborating institution performing laboratory work may be responsible for the quality and integrity of that work.
Calling one organization the "lead institution" may be useful administratively, but it does not automatically extinguish the responsibilities of everyone else.
This follows the broader principle that research accountability is distributed according to roles.
Collaborative research needs explicit governance arrangements
The Australian Code for the Responsible Conduct of Research recognizes collaborative research as an area requiring particular attention. Its supporting guidance on collaborative research emphasizes that institutions and researchers should establish agreements for collaborative projects and address responsibilities relevant to the collaboration. The Code also assigns institutions responsibility for maintaining governance arrangements that support responsible research conduct.
Collaboration agreements can address matters such as governance, data management, intellectual property, authorship, publication, confidentiality, financial arrangements, ethics and other approvals, management of conflicts, research records, and responses to potential breaches.
Not every collaboration needs a fifty-page contract. The level of documentation should be proportionate to the project. But the more institutions, sensitive resources, money, participants, intellectual property, or regulatory requirements involved, the more dangerous informal assumptions become.
The researcher's home institution and host institution may both be responsible
Consider a university researcher conducting interviews at a hospital.
The university may remain responsible for its researcher's employment, training, research-integrity environment, institutional governance, and perhaps sponsorship. The hospital may be responsible for deciding whether the study may occur on its premises, controlling access to its staff or patients, protecting records, managing local resources, and fulfilling responsibilities associated with being a research site.
The researcher crossing the hospital entrance does not cause the university's responsibilities to disappear. Nor does university ethics approval automatically absorb the hospital's responsibilities.
The division becomes especially important when determining responsibility for research conducted outside the researcher's own institution.
One institution can hold several roles at once
Research governance becomes easier to understand when institutional names and institutional roles are separated.
| Institution |
Possible Role |
Possible Responsibility |
| University A |
Employer and sponsor |
Researcher support and accountability, institutional governance, plus sponsor-level oversight |
| Hospital B |
Research site |
Local authorization, site suitability, local resources, and responsibilities for activities under its control |
| University C |
Collaborating laboratory |
Appropriate conduct, quality, records, and governance of laboratory activities assigned to it |
| Research Council D |
Funder |
Responsibilities associated with funding assessment, conditions, and reporting |
| Repository E |
Data or material repository |
Responsibilities established by its custodial role, applicable requirements, and agreements |
This is illustrative rather than a universal allocation. The actual responsibilities depend on the applicable framework and agreements.
Shared sponsorship is one formal example of shared institutional responsibility
Some governance frameworks explicitly allow several organizations to share the sponsor role.
Current Health Research Authority guidance states that two or more organizations can act as co-sponsors or joint sponsors. Co-sponsors allocate specific sponsor responsibilities between them, while joint sponsors each accept liability for all sponsor responsibilities. Any co-sponsorship, joint sponsorship, or delegation should be formally agreed and documented.
This demonstrates an important distinction. "Shared responsibility" can describe very different arrangements. Two institutions might divide responsibilities, both accept the same responsibility, or hold entirely separate responsibilities that happen to concern the same project.
Several institutions may have responsibilities for research integrity
Research-integrity problems can become particularly difficult in collaborations.
Suppose a researcher employed by University A is accused of fabricating data generated in a laboratory at University B for a jointly authored project. Which institution investigates?
The answer depends on applicable institutional policies, employment relationships, collaboration agreements, where the conduct occurred, and relevant research-integrity frameworks. More than one institution may have legitimate interests or responsibilities.
Collaborative-research guidance under the Australian Code is designed partly to prevent such questions from being improvised after a problem arises. Institutions should establish how concerns and potential breaches involving collaborators will be managed.
A lead institution may coordinate the process, but coordination is not necessarily the same as exclusive authority.
Data responsibility can also cross institutional boundaries
Research data rarely respect organizational charts.
Data may be collected at one site, transferred to another institution for analysis, stored on infrastructure provided by a third organization, and later deposited in a repository.
Each transfer can create questions about custody, control, lawful use, security, access, retention, destruction, breach reporting, and responsibility for responding to participant requests where applicable.
Researchers should therefore establish who controls or holds which data at each stage and what agreements govern those transfers. Simply saying "the consortium owns the data" may not answer the legal or governance questions that matter.
Ethics approval from one institution does not automatically make it responsible for all sites
Central or single ethics review can be extremely useful because it reduces unnecessary duplication. But ethical review and institutional responsibility should not be conflated.
A reviewing ethics committee can provide an ethical decision that several organizations recognize under an appropriate framework. Participating institutions may nevertheless retain responsibilities for local authorization, feasibility, resources, data, staff, contracts, or other matters.
Researchers therefore need to distinguish ethics reliance arrangements from institutional responsibility and determine which approvals participating institutions actually require.
Being the lead institution does not necessarily make every other institution a subcontractor
Research collaborations take many forms.
One institution may genuinely commission another to perform a defined service. In another project, two universities may be intellectual partners with independent responsibilities. In a third, a hospital may host research without participating in the analysis or publication.
Labels such as lead institution, partner, collaborator, site, contractor, and service provider should therefore correspond to the actual arrangement.
This matters because authority, liability, intellectual property, data rights, publication responsibilities, and research-integrity processes can differ considerably among those relationships.
Delegating work does not necessarily transfer institutional accountability
An institution may arrange for another organization to perform particular functions. A sponsor may delegate monitoring to a contract research organization. A university may use an external laboratory. A consortium may designate one partner to manage a shared database.
Whether the underlying responsibility also transfers depends on the applicable framework and agreement.
For example, the UK Policy Framework permits sponsors to delegate sponsor activities to a contract research organization but states that ultimate sponsor responsibility for matters such as research quality and data integrity remains with the sponsor.
Researchers should therefore distinguish who performs an activity from who remains accountable for ensuring that the activity is appropriately performed.
Shared responsibility becomes dangerous when it is merely assumed
The phrase "we are all responsible" sounds collaborative but provides remarkably little governance information.
If participant data are breached, who reports the incident? If an ethics amendment is required, who submits it? If a researcher leaves, who replaces them? If a publication dispute arises, which policy applies? If a participant complains, which institution responds? If serious misconduct is alleged, who coordinates the investigation?
These questions should be answered before the project tests them.
Watch Out
Shared responsibility should not mean undefined responsibility. When several institutions participate, document which organization is responsible for each major function, where responsibilities overlap, and how disagreements or incidents will be managed.
