Manuel B. Garcia

Manuel B. Garcia serves as the Senior Director for Educational Technology and Digital Learning at FEU Institute of Technology, Manila, Philippines. Read More

Contact Info

1607, FEU Tech Building,
P. Paredes St, Sampaloc,
Manila, Philippines
mbgarcia@feutech.edu.ph

Follow Me

Part 5 · Guide 17 of 398

Who Is Responsible for Research Ethics: the Researcher, Supervisor, Institution, Sponsor, or Ethics Committee?

Research ethics is a shared responsibility, but not an interchangeable one. Researchers, supervisors, institutions, sponsors, and ethics committees each control different parts of the research process and therefore carry different ethical responsibilities.

By Manuel B. Garcia
17
Who Is Responsible for Research Ethics? Guide 17 of 398
01 · The Question

When Something Goes Ethically Wrong, Whose Responsibility Is It?

A research project may involve a principal investigator, students, supervisors, co-investigators, an institution, a sponsor, funders, data custodians, research staff, and an ethics committee.

Who, then, is responsible for making sure the research is ethical?

The tempting answer is “everyone,” but that becomes unhelpful if it suggests that everyone has the same responsibility. Research ethics is better understood as shared but differentiated responsibility: several actors contribute to ethical research because each controls different decisions, resources, safeguards, or forms of oversight.

02 · The Short Answer

Responsibility Is Shared, but It Cannot Simply Be Passed Around

In Brief

Responsibility for research ethics is distributed among researchers, supervisors, institutions, sponsors, ethics committees, and sometimes other actors, but their responsibilities are distinct: researchers remain responsible for how they conduct the study, while oversight bodies and organizations carry responsibilities associated with review, supervision, resources, governance, monitoring, and the decisions they control.

The exact allocation depends on the research type, jurisdiction, institution, funding arrangement, and applicable regulatory framework. Shared responsibility does not mean that one actor's approval or oversight automatically removes another actor's obligations.

03 · What You Need to Know

How Ethical Responsibility Is Distributed Across Research

The Researcher Has Direct Responsibility for Conducting the Study Ethically

The people actually conducting research make ethical decisions every day.

They approach participants, explain studies, obtain consent where required, collect information, perform procedures, protect data, respond to unexpected disclosures, manage withdrawal, document events, analyze information, and report findings.

Under OHRP's human-research protection framework, investigators have primary responsibility for protecting the rights and welfare of human research participants. Investigators are responsible for conducting research according to the IRB-approved protocol, complying with IRB determinations, obtaining and documenting consent unless appropriately waived, and ensuring that prospective participants understand the nature of the research and participation.

Ethics approval therefore does not convert the researcher into a passive implementer. The researcher remains the person making many of the decisions through which the approved protocol becomes real.

The Principal Investigator Cannot Delegate Away Overall Responsibility Simply by Assigning Tasks

Research teams necessarily divide work. A coordinator may obtain consent. A statistician may analyze data. A research assistant may conduct interviews. A laboratory technician may process samples.

Delegation is necessary, but assigning a task does not mean ethical responsibility disappears.

In clinical trials, ICH E6(R3) defines the investigator as responsible for trial conduct and describes sub-investigators as team members operating under the investigator's oversight.

The broader principle travels well beyond clinical trials: people given research responsibilities should be appropriately qualified, trained, and supervised, while leaders remain accountable for the responsibilities assigned to them under the applicable system.

Supervisors Have Responsibilities That Differ From Those of Student Researchers

Supervision creates its own ethical responsibilities.

A supervisor may not personally recruit participants or hold the raw data, but they influence the student's research question, methodology, ethical reasoning, preparation for review, response to problems, and understanding of institutional requirements.

Supervisors should not treat ethics as paperwork the student must somehow “get approved.” Appropriate supervision may include checking whether the student understands risks, ensuring that methods are suitable for the researcher's level of competence, reviewing recruitment and consent plans, discussing unexpected situations, and knowing when institutional advice is needed.

The precise duties of supervisors vary by institution and discipline. A doctoral adviser is not automatically legally responsible for every act of a student researcher merely by virtue of being an adviser. Institutional policies should therefore be consulted rather than inventing a universal supervisory liability rule.

Institutions Have Responsibilities That Individual Researchers Cannot Fulfill Alone

Ethical research requires infrastructure.

An individual researcher cannot independently create a credible ethics-review system, institution-wide data-security environment, reporting process, training structure, conflict-management system, or culture of accountability.

OHRP explicitly states that responsibility for protecting human research participants does not rest solely with the IRB. It describes shared responsibilities among institutional officials, IRBs, and investigators. Institutions operating under an OHRP assurance are responsible for policies and procedures, appropriate oversight mechanisms, communication, resources, and other elements of the human research protection program.

CIOMS has similarly developed international guidance specifically addressing good governance by research institutions, emphasizing that ethical and good-quality research depends not only on individual researchers but also on institutions providing the structures and resources necessary to support it.

An Institution Cannot Simply Say “The Researcher Should Have Known Better”

Individual accountability matters, but organizations shape the conditions under which research occurs.

If an institution provides inadequate training, understaffs oversight systems, rewards speed and publication while ignoring responsible practice, provides insecure research infrastructure, or creates unclear reporting channels, ethical failures cannot always be understood solely as individual mistakes.

This does not excuse researcher misconduct. It recognizes that research ethics has a governance dimension.

A mature ethical system asks both what the researcher did and what organizational conditions made responsible conduct more or less likely.

The Ethics Committee Has an Independent Review Responsibility

Research ethics committees or IRBs provide independent scrutiny that researchers cannot provide for themselves.

OHRP describes IRB review as a cornerstone of institutional human-research protection and states that IRBs are responsible for ensuring that participant rights and welfare are adequately protected.

The 2024 Declaration of Helsinki requires research ethics committees reviewing medical research to be transparent, sufficiently resourced, independent of undue influence, appropriately qualified, and familiar with local context.

In clinical trials, ICH E6(R3) likewise describes the IRB or independent ethics committee as an independent body responsible for protecting participant rights, safety, and well-being through review of matters including the protocol, investigators, facilities, and consent process.

The Ethics Committee Is Not the Researcher's Ethical Substitute

An ethics committee can review what researchers propose. It cannot stand beside every interviewer, monitor every conversation, watch every file transfer, or anticipate every unexpected situation.

The committee also depends on researchers providing accurate and sufficiently complete information. Review quality can be undermined when important details are omitted or described inaccurately.

This is why favorable ethics review does not make every later research action ethical. Independent review and researcher responsibility are complementary safeguards.

Sponsors Have Responsibilities Because They Shape the Research System

In sponsored research, the sponsor may control or influence study initiation, financing, protocol development, monitoring systems, site selection, data systems, safety processes, and other structural features.

ICH E6(R3) defines a clinical-trial sponsor as an individual, company, institution, or organization taking responsibility for trial initiation, management, and financing arrangements. The guideline assigns sponsors extensive responsibilities for trial quality, oversight, participant safety, information, monitoring, and management.

Sponsor responsibility is therefore not exhausted by paying the bills.

Outside regulated clinical trials, the word sponsor may have different meanings, so researchers should not automatically import clinical-trial responsibilities into every funded project. The relevant contract, policy, funder requirements, and regulatory framework should be checked.

Funding Does Not Entitle a Sponsor to Control Ethical Decisions Improperly

A sponsor's financial investment can create influence, but ethical review and scientific reporting should not simply bend to sponsor preference.

The Declaration of Helsinki requires ethics committees to have the independence and authority to resist undue influence from researchers, sponsors, and others.

Researchers should also manage conflicts of interest and preserve appropriate scientific and ethical independence according to applicable standards.

A sponsor's desire for faster recruitment, favorable results, or restricted publication does not remove the researcher's responsibilities toward participants and the research record.

A Sponsor-Investigator Carries Both Sets of Responsibilities

Sometimes the person conducting a clinical trial also initiates and sponsors it.

ICH E6(R3) calls this a sponsor-investigator and explicitly states that the individual carries both sponsor and investigator obligations.

This is a useful reminder that responsibilities attach to functions, not merely job titles. Combining roles does not make one set of obligations disappear.

Shared Responsibility Does Not Mean Equal Responsibility

The phrase “everyone is responsible” can obscure who actually had control over a decision.

Actor Typical area of responsibility What that responsibility does not automatically mean
Researcher or investigator Ethical conduct of research, participant interactions, protocol compliance, data handling, recognition and reporting of problems That the researcher alone must create the institution's entire protection system
Supervisor Appropriate guidance, oversight, competence development, review of student or trainee research according to institutional expectations That the trainee has no personal responsibility for their own conduct
Institution Governance, infrastructure, policies, resources, oversight systems, training environment, organizational accountability That institutional approval excuses individual misconduct
Sponsor Responsibilities associated with initiation, management, financing, oversight, safety, and quality as defined by the applicable research framework That funding gives the sponsor unrestricted authority over participant protection or scientific reporting
Ethics committee Independent ethical review, participant protection, review of relevant protocol changes and information within its remit That approval transfers day-to-day ethical responsibility away from researchers

These are broad categories rather than universal legal assignments. Exact responsibilities should always be verified in the framework governing the particular research.

Responsibility Should Follow Control, Knowledge, and Role

A useful way to think about responsibility is to ask three questions.

Who controlled the decision? Who knew or reasonably should have known about the ethical issue? What responsibility did that person's or organization's role create?

A research assistant cannot normally change an institution's data-security infrastructure. An institution cannot personally obtain consent from every participant. An ethics committee cannot correct a protocol problem it was never told about. A supervisor cannot respond to a serious event that a student deliberately conceals.

Responsibility therefore needs to be connected to actual authority, information, and duty rather than assigned symbolically.

Collaboration Makes Responsibilities More Important to Clarify, Not Less

Multi-institution and international projects can create dangerous assumptions: each team believes another institution is monitoring safety, managing consent, securing data, or reporting problems.

OHRP guidance on collaborative research emphasizes documented oversight arrangements in relevant human-subject research.

ICH E6(R3) similarly recognizes that clinical trials can involve multiple sponsors and provides for documented allocation of responsibilities. Where responsibilities are not specified, the guideline may assign them to all sponsors under the applicable arrangement.

The practical lesson is straightforward: shared responsibility works better when responsibilities are actually written down.

Researchers Remain Responsible for Raising Problems They Notice

A researcher who recognizes an ethical problem should not ignore it merely because another actor technically “owns” the relevant process.

If a student discovers that confidential data are exposed, the immediate responsibility is not satisfied by thinking that cybersecurity belongs to IT. If a sponsor pressures investigators to deviate from an approved protocol, investigators cannot defend the deviation simply by saying the sponsor requested it.

People may not control the final institutional response, but they can still have a responsibility to identify, report, escalate, or avoid contributing to a problem.

No Approval Transfers the Researcher's Ethical Responsibility Away

The most consequential misconception is that responsibility moves upward once someone else approves the research.

A supervisor signs the proposal. An institution authorizes it. A sponsor funds it. An ethics committee approves it.

None of those actions makes an unethical decision by the researcher automatically ethical.

This is why the question of whether ethics approval transfers ethical responsibility away from the researcher has a particularly clear answer: oversight adds responsibility elsewhere; it does not subtract the researcher's own.

04 · A Practical Example

One Ethical Problem Can Trigger Several Different Responsibilities

Hypothetical Example

A Student Researcher Discovers That Interview Files Are Publicly Accessible

A doctoral student is conducting approved interviews about sensitive workplace experiences. Recordings are stored in an institutionally provided research system. The student discovers that a configuration error has made several files accessible through a public link.

Student researcher The student should stop further inappropriate exposure where they can do so safely, preserve relevant information about the incident, inform the appropriate supervisor or institutional authority promptly, and follow the approved incident-reporting process.
Supervisor The supervisor helps assess the research implications, ensures the student follows applicable reporting requirements, and provides appropriate oversight rather than leaving the trainee to manage a serious confidentiality problem alone.
Institution Relevant institutional units investigate and secure the system, determine the scope of exposure, apply data-security and breach procedures, and provide the governance infrastructure required for an appropriate response.
Ethics committee Where the event falls within its reporting remit, the committee evaluates the implications for participant welfare and whether protocol, consent, data handling, or continuation of the study requires modification.
Sponsor or funder If applicable requirements or agreements require notification, the sponsor or funder may have responsibilities concerning oversight, resources, reporting, or corrective action.
Shared does not mean interchangeable Each actor contributes something different. The student cannot repair institutional cybersecurity alone, while the institution cannot retroactively make the student's participant communications for them.

The most effective response comes from recognizing the chain of responsibilities rather than spending the first crucial hours deciding who can be blamed for owning the problem.

05 · What Researchers Often Get Wrong

Common Misunderstandings About Responsibility for Research Ethics

Misconception

The Ethics Committee Is Responsible Once It Approves the Study

Ethics committees have responsibility for independent review and oversight within their remit, but researchers remain responsible for actual study conduct. Approval adds an external safeguard; it does not transfer day-to-day ethical responsibility.

Misconception

The Principal Investigator Is the Only Person Responsible

Investigators carry substantial responsibility, but institutions, supervisors, sponsors, ethics committees, and other actors may have independent duties. Ethical research depends on both individual conduct and functioning systems of governance.

Misconception

A Student Researcher Is Not Responsible Because the Supervisor Approved the Work

Students and trainees remain responsible for their own research conduct within their competence and role. Supervisors have additional responsibilities for guidance and oversight, but supervision does not erase the researcher's obligations.

Misconception

The Sponsor Is Responsible for Anything It Funds

Sponsor responsibilities depend on the applicable research framework and agreement. In regulated clinical trials they can be extensive, but funding alone should not be used to invent a universal responsibility for every decision made by every funded researcher.

Misconception

Delegating a Task Delegates All Responsibility for It

Research necessarily involves delegation, but investigators and other responsible actors may retain oversight obligations. Tasks should be assigned to appropriately qualified people, and the allocation of responsibilities should be clear.

Misconception

If Everyone Is Responsible, Nobody Is Individually Accountable

Shared responsibility means several actors can hold distinct responsibilities at the same time. Accountability should be examined according to each actor's role, authority, knowledge, decisions, and applicable obligations.

06 · What This Means for You

Know Which Responsibilities Are Yours Before the Study Starts

Ethical governance works poorly when roles are discovered only after something goes wrong. Researchers should clarify responsibilities during study planning, especially in collaborative, supervised, sponsored, or multi-institution projects.

A practical responsibility framework

If you are the researcher or principal investigator
Know the approved protocol, participant protections, reporting requirements, data responsibilities, and limits of what you may delegate.
If you supervise a student or junior researcher
Clarify how closely the project will be reviewed, which decisions require consultation, and how unexpected ethical problems should be escalated.
If your institution provides the research environment
Ensure that appropriate policies, infrastructure, oversight, expertise, training, and reporting pathways exist for the research being authorized.
If a sponsor or funder is involved
Identify its actual responsibilities from the governing framework and agreements rather than assuming either complete control or no responsibility beyond funding.
If several organizations collaborate
Document who handles ethics review, consent, safety monitoring, data security, reporting, protocol changes, and other important responsibilities.
If an ethical problem falls partly outside your authority
Do what your role permits to protect participants and raise the problem promptly with the person or body that has authority to act.

The practical question is not simply “Who is responsible?” It is “Who is responsible for this decision, this safeguard, and this response?” Research ethics becomes much easier to govern once responsibility is attached to specific functions.

07 · A Quick Checklist

Before Research Begins, Make Responsibility Explicit

For each project, check:
Who has primary responsibility for day-to-day conduct of the research and participant protection?
Which tasks are delegated, to whom, and what oversight remains with the investigator or research leader?
What ethical oversight responsibilities does the supervisor have under the institution's actual policies?
Which institutional offices are responsible for ethics review, data governance, security, legal issues, conflicts of interest, and incident response?
What responsibilities does the sponsor or funder actually have under the relevant agreement, regulation, or research standard?
What falls within the ethics committee's remit, and what remains the responsibility of researchers or other institutional bodies?
Who must be notified if a participant problem, protocol deviation, data breach, or new risk occurs?
For collaborative research, are responsibilities documented clearly enough that important safeguards cannot fall between organizations?
Does everyone know how to raise an ethical concern that exceeds their own authority to resolve?
08 · Frequently Asked Questions

Frequently Asked Questions About Responsibility for Research Ethics

Who has the main responsibility for protecting research participants?

Researchers or investigators have direct responsibility for conducting research ethically and protecting participants within their role. However, institutions, ethics committees, sponsors, supervisors, and other actors can have distinct responsibilities for oversight, resources, review, governance, or particular research functions. OHRP explicitly describes human-participant protection as a shared responsibility.

Is a supervisor responsible for a student's research ethics?

Supervisors ordinarily have responsibilities for appropriate guidance and oversight, but the precise scope depends on institutional and disciplinary requirements. Students remain responsible for their own conduct; supervision does not transfer all responsibility from the researcher to the supervisor.

Is the ethics committee responsible if an approved study harms someone?

Not automatically. Responsibility depends on what occurred, what information was available, each actor's obligations, and how the research was conducted. Ethics committees have review and oversight responsibilities within their remit, while researchers and institutions retain their own responsibilities.

Can a principal investigator delegate responsibility to research assistants?

Tasks can and must be delegated in team research, but delegation should be appropriate to competence and accompanied by the oversight required by the applicable framework. Assigning a task does not necessarily remove the investigator's responsibility for supervising how that task is performed.

What is the sponsor responsible for?

It depends on the research framework. In clinical trials governed by ICH E6(R3), sponsors have extensive responsibilities associated with initiation, management, financing arrangements, quality, safety, and oversight. Other types of funded research may allocate responsibilities differently through law, policy, or agreements.

Who is responsible when several institutions conduct the same study?

Responsibilities should be established through the applicable regulatory, ethics-review, institutional, and contractual arrangements. Collaborative research benefits from explicit documentation of who handles review, participant protection, reporting, data governance, and other important functions rather than relying on assumptions.

Can an institution be ethically responsible for failures caused by its research culture?

Institutions have responsibilities for governance, oversight, resources, policies, and research environments. CIOMS guidance on research-institution governance specifically recognizes that responsible research depends on institutional structures as well as individual researchers. Individual responsibility nevertheless remains relevant when researchers themselves act improperly.

09 · The Bottom Line

Research Ethics Is Shared Responsibility Without Shared Excuses

The Bottom Line

Researchers, supervisors, institutions, sponsors, and ethics committees can all carry responsibility for ethical research, but their responsibilities differ according to the decisions, resources, oversight, and authority each controls.

Independent review, supervision, sponsorship, and institutional governance add safeguards; they do not erase the researcher's own responsibilities. Ethical research works best when roles are explicit enough that everyone knows what they must do and no important responsibility disappears into the reassuring phrase “someone else approved it.”

10 · Sources and Further Reading

Sources and Further Reading

11 · Cite this Guide

How to Cite This Guide

This guide is intended to be read, shared, and used in research, teaching, and academic work. If you draw on its ideas, explanations, or other content, please acknowledge the source by citing the guide. Doing so gives appropriate credit and helps your readers locate the original resource.

Has the Field Guide helped your research?

If a guide helped clarify a question, inform a research decision, or move your work forward, I would love to hear about your experience. Your story may also help other researchers discover the Field Guide.

Share Your Experience
Takes only a few minutes