Are electronic signatures legally valid?

Yes. Electronic signatures are generally enforceable under the federal ESIGN Act (15 U.S.C. ch. 96) and state UETA statutes where adopted, provided the signature demonstrates intent, consent to transact electronically, attribution to the signer, and that the record can be retained and reproduced.

Do I need a Business Associate Agreement?

If the agreement permits exchange of protected health information (PHI), a signed BAA is required to comply with HIPAA; include detailed security and breach-notification obligations in the contract.

When is notarization or RON required?

Most research agreements do not require notarization, but certain institutional policies or attached affidavits may. Remote Online Notarization (RON) is permitted in most states but check state rules and the governing law clause before relying on RON.

How do I amend an executed agreement?

Use a written amendment signed by authorized representatives of all parties; document the amendment's effective date, and ensure it references the original agreement to avoid ambiguity.

Who must sign on behalf of an institution?

Authorized institutional signatories, typically research administration or officials with delegated authority; always verify delegated signature authority and document the signer’s title and authority.

How do I revoke consent or cancel the agreement?

Follow termination or cancellation provisions in the agreement. For participant consent, follow IRB-approved withdrawal procedures. Contract cancellation may require notice and wind-down obligations as specified in the agreement.

Electronic Signature
Templates
Miscellaneous
Research Studies Agreement

Research Studies Agreement

This template is fully customizable. Edit the text, fill out the fields, and send it for signature. Give it a try!

RESEARCH STUDIES AGREEMENT

This Research Studies Agreement (the "Agreement") is entered into as of , by and between:

Principal Investigator / Sponsor Name: Address: Principal Investigator / Sponsor Contact Person: Research Institution / Contractor Name: Address: Institution Contact Person:

RECITALS

WHEREAS, Sponsor desires to retain Institution to conduct the research study described herein and to produce deliverables and reports in accordance with the terms and conditions of this Agreement; and

WHEREAS, Institution represents that it has the personnel, facilities, and expertise necessary to perform the research activities described in this Agreement in compliance with applicable laws, regulations, and ethical standards; and

WHEREAS, the parties desire to set forth their respective rights and obligations with respect to the conduct of the research and the disposition of results and confidential information.

SCOPE OF WORK

Institution shall perform the research activities, tasks, and deliverables described below in accordance with the timeline and standards of care set forth in this Agreement.

Description of Research Activities and Deliverables: Key Milestones / Delivery Schedule:

PAYMENT TERMS

In consideration for the services and deliverables, Sponsor shall pay Institution the fees and reimburse expenses as set forth below.

Total Fee (USD): Payment Schedule and Terms: Late Payment Fee:

Payments not received within days of the due date shall accrue interest at a rate of per month, or the maximum rate permitted by law, whichever is less.

Invoicing Address and Instructions:

TERM AND TERMINATION

The term of this Agreement shall commence on , and shall continue until , unless earlier terminated in accordance with this Agreement.

Either party may terminate this Agreement for convenience upon prior written notice to the other party of days. Either party may terminate for material breach if such breach is not cured within days after written notice specifying the breach.

Upon termination, Sponsor shall pay Institution for work performed and allowable costs incurred through the effective date of termination, subject to the parties' agreed acceptance criteria for deliverables.

CONFIDENTIALITY

Each party (a "Receiving Party") shall treat as confidential all non-public information disclosed by the other party (a "Disclosing Party") that is designated as confidential or that reasonably should be understood to be confidential given the nature of the information and the circumstances of disclosure ("Confidential Information"). The Receiving Party shall not disclose or use Confidential Information except to perform its obligations under this Agreement and shall protect such information with at least the same degree of care it uses to protect its own confidential information, but in no event less than reasonable care.

Confidentiality obligations shall survive termination of this Agreement for a period of years, except that trade secrets shall be protected for as long as they remain trade secrets under applicable law.

INTELLECTUAL PROPERTY AND DATA

Background Intellectual Property owned by a party prior to this Agreement remains that party's sole property. Subject inventions and intellectual property arising directly from the performance of the Study ("Study IP") shall be owned as follows:

Ownership of Study Results and Inventions:

Institution will maintain research data in accordance with accepted scientific practice and applicable law. Sponsor shall have the rights to use data and results as set forth in this Agreement, subject to Confidentiality and applicable human subjects protections.

Human Subjects or Regulated Materials Involved:

Check if the Study involves human subjects, protected health information, or other regulated materials. If checked, Institution shall obtain all required approvals (IRB, IACUC or equivalent) prior to initiation and comply with applicable laws.

PUBLICATION; ACKNOWLEDGMENT

Institution shall have the right to publish or present results from the Study. Sponsor may request a confidential review period of days prior to submission to review for patentable subject matter or Sponsor Confidential Information. Such review shall not unreasonably delay publication.

INDEMNIFICATION AND LIABILITY

Each party shall indemnify, defend, and hold harmless the other party from claims arising out of the indemnifying party's gross negligence or willful misconduct in performing its obligations under this Agreement. Except for liability arising from gross negligence, willful misconduct, or indemnification obligations, neither party shall be liable to the other for consequential, incidental, or punitive damages. The parties' aggregate liability for direct damages under this Agreement shall not exceed the total fees paid to Institution under this Agreement.

COMPLIANCE WITH LAWS

Each party shall comply with all applicable federal, state, and local laws and regulations applicable to its performance under this Agreement, including laws governing research, human subjects protection, export controls, health and safety, and data protection.

GOVERNING LAW

This Agreement shall be governed by and construed in accordance with the laws of the State of without regard to its conflicts of law principles.

ENTIRE AGREEMENT

This Agreement, including any exhibits or attachments executed by the parties, constitutes the entire agreement between the parties with respect to the Study and supersedes all prior and contemporaneous agreements, proposals, and communications, whether oral or written. Any modification to this Agreement must be in writing and signed by authorized representatives of both parties.

MISCELLANEOUS

Notices shall be given in writing and delivered to the contact persons identified in this Agreement. If any provision is held invalid, the remaining provisions shall remain in full force and effect. Neither party may assign this Agreement without the other party's prior written consent, except to an affiliate or successor in interest.

Principal Investigator / Sponsor:

By:

Title:

Date:

Research Institution / Contractor:

By:

Title:

Date:

What a Research Studies Agreement Covers

A Research Studies Agreement is a written contract that sets out the legal and operational terms between parties involved in human-subject or other research activities. It typically defines the study scope, responsibilities of the sponsor and investigator, data ownership and use, confidentiality and privacy protections, payment or funding terms, intellectual property rights, indemnification, insurance, publication rights, and termination conditions. For studies involving protected health information, the agreement must address HIPAA compliance and specify any required business associate arrangements. Properly executed agreements reduce regulatory risk and clarify obligations for all parties.

Why a Clear Agreement Matters for Research

A well-drafted Research Studies Agreement allocates liability, documents data use and security expectations, and clarifies who controls study results and intellectual property. It also ensures compliance with relevant laws and institutional policies, reducing disputes and delays.

Who typically prepares and signs this agreement

Institutions, sponsors, and investigators each play distinct roles in creating and approving research agreements.

Clinical research organizations and sponsors who fund or oversee the study.
Academic institutions, IRBs, and principal investigators responsible for conduct and compliance.
Legal, contracts, and research administration professionals who review risk, IP, and funding terms.

Each signer should confirm authority to bind their organization and that required approvals (IRB, institutional signoff, funding) are in place before execution.

Core provisions to expect in the agreement

A professional Research Studies Agreement groups standard clauses so reviewers can quickly identify obligations, risk allocation, and regulatory controls relevant to study conduct and data handling.

Scope of Work

Describes study objectives, endpoints, tasks, deliverables, timelines, and locations where research activities will occur; anchors performance obligations.

Payment Terms

Specifies compensation, invoicing schedule, allowable costs, milestones, and procedures for expense reimbursement or budget changes.

Data Ownership

Defines ownership, licensing, and permitted uses of study data, including de-identified datasets, data transfer protocols, and publication rights.

Privacy & Security

Details HIPAA protections for PHI, required safeguards, breach notification procedures, and whether a Business Associate Agreement (BAA) is needed.

Intellectual Property

Allocates rights to inventions and publications, identifies investigator rights, and sets processes for patent filing and commercialization.

Liability & Insurance

Allocates indemnity responsibilities, limits on liability, and required insurance coverage for study activities and participant claims.

Step-by-step: completing the agreement

Follow this sequence to prepare, review, and execute a Research Studies Agreement with minimal rework.

01

Draft: Populate core fields and attach protocol and budget.
02

Internal review: Legal and compliance review for IP, indemnity, and HIPAA implications.
03

IRB confirmation: Confirm IRB approval or submission status before final signature.
04

Execution: Obtain authorized signatures and circulate fully executed copies to stakeholders.

Typical routing and sign-off flow

Understand the common routing order so you can plan approvals and secure required signatures efficiently.

Sponsor review: Sponsor legal reviews draft and negotiates key commercial terms.
Institutional signoff: Research administration checks budgets, indemnity, and insurance.
IRB verification: IRB confirms approval or conditional approval for the finalized protocol.
Final execution: Authorized signatories sign; executed copies distributed to archive and investigators.

Digital workflow settings to configure

Configure these fields when preparing an electronic routing and signature workflow to reflect required approvals and authentication.

Field	Configuration
Signing Order	Sequential or parallel routing based on required approvals
Authentication	Email link, SMS code, or knowledge-based authentication
Attachment Handling	Allow attachments for protocol, budget, and consent form
Audit Trail	Capture IP, timestamp, and action logs for compliance

Technical considerations for e-submission and signatures

Choose a platform that supports required authentication, PDF/A export, and audit trails for compliance.

Document formats: PDF, DOCX supported
Integrations: Works with Google Workspace, NetSuite, Salesforce
Security: TLS in transit, AES-256 at rest

Ensure the selected vendor can supply a BAA for HIPAA-covered data and produce a reproducible audit trail that meets ESIGN/UETA evidentiary tests.

Common pitfalls to avoid when preparing the agreement

Using inconsistent legal entity names across exhibits and signature blocks, which can invalidate authority to sign and delay execution.
Omitting IRB approval or leaving approval status unspecified; execution before IRB clearance can breach institutional policy.
Neglecting to define data ownership and reuse rights, leading to disputes over secondary analyses or publication rights.
Failing to include a BAA and specific PHI safeguards where HIPAA applies, which increases regulatory and liability exposure.

Legal and compliance risks associated with errors

Regulatory noncompliance: Civil penalties and corrective action

HIPAA exposure: Breach fines and notification requirements

Contract disputes: Delay in funding or litigation risk

Data misuse: Reputational harm and sanctions

Invalid signatures: Enforceability challenges under ESIGN/UETA

Audit failures: Sponsor or agency audit findings

Key timing and renewal events to track

Track approval and reporting deadlines to meet sponsor, IRB, and regulatory obligations and avoid interruptions in study activity.

IRB approval date:

Document IRB approval date before participant enrollment

Study start date:

Align effective date with site readiness and approvals

Reporting deadlines:

Sponsor and regulatory reports per contract schedule

Renewals:

IRB continuing review or renewal intervals

Final closeout:

Complete final reports and disposition of data

Sequential milestones during contract lifecycle

Use a milestone sequence to coordinate contracting, approvals, and execution across teams and departments.

01

Negotiation

Parties exchange drafts and redlines prior to sign-off

02

Internal Approvals

Legal, finance, and compliance reviews are completed

03

IRB Confirmation

IRB issues approval or conditional approval

04

Execution & Handover

Fully executed agreement issued and archived

eSignature pricing and capability snapshot

Basic plan pricing and common features across vendors to inform platform selection for research contracting and signature workflows.

	signNow	DocuSign	Adobe Sign	PandaDoc	HelloSign
Starting Price	$8/user/mo	$15/user/mo	$14/user/mo	$19/user/mo	$15/user/mo
Free Trial	7-day free trial	Trial available	Trial available	Trial available	Trial available
Bulk Send	Yes (Business Premium)	Yes	Yes	Yes	No
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes (BAA required)	Yes (BAA available)	Yes (BAA available)	No	No
Envelope Cap	No cap	100 env./user/yr	Varies	Varies	Varies

Real-world scenarios showing how agreements are used

These brief case notes illustrate common ways organizations apply Research Studies Agreements in practice.

Academic Clinical Trial

A university signs with a pharmaceutical sponsor to run a Phase II study.

Sponsor funds site start-up and monitoring.
The agreement clarifies data ownership, publication rights, and indemnity, enabling timely enrollment and clear responsibilities for adverse event reporting and data transfer.

Industry-Sponsored Observational Study

A medical device company engages multiple clinics for post-market surveillance.

Sites collect de-identified data and transmit to sponsor.
Contracts standardize data security clauses and BAA terms, reducing individual site negotiations and ensuring HIPAA-compliant transfers.

Practical tips for accurate, efficient completion

Adopt consistent templates and an approval checklist to reduce iteration and accelerate execution.

Use a master template

Maintain a vetted institutional template with pre-approved insurance, indemnity, and IP language to limit legal review to negotiated commercial items.

Confirm signatory authority

Verify each signer has organizational authority and include documentation of delegated signing power to prevent later challenges to enforceability.

Attach essential exhibits

Include protocol, consent forms, and budget as numbered exhibits with cross-references to avoid ambiguity about scope or deliverables.

Recordkeeping procedures

Store executed agreements and related approvals in a centralized, access-controlled repository and retain audit logs for compliance and audits.

FAQs and troubleshooting for Research Studies Agreements

Answers to frequent questions about execution, electronic signatures, privacy, and changes to signed agreements.

Need help? Contact support

Are electronic signatures legally valid?
Yes. Electronic signatures are generally enforceable under the federal ESIGN Act (15 U.S.C. ch. 96) and state UETA statutes where adopted, provided the signature demonstrates intent, consent to transact electronically, attribution to the signer, and that the record can be retained and reproduced.
Do I need a Business Associate Agreement?
If the agreement permits exchange of protected health information (PHI), a signed BAA is required to comply with HIPAA; include detailed security and breach-notification obligations in the contract.
When is notarization or RON required?
Most research agreements do not require notarization, but certain institutional policies or attached affidavits may. Remote Online Notarization (RON) is permitted in most states but check state rules and the governing law clause before relying on RON.
How do I amend an executed agreement?
Use a written amendment signed by authorized representatives of all parties; document the amendment's effective date, and ensure it references the original agreement to avoid ambiguity.
Who must sign on behalf of an institution?
Authorized institutional signatories, typically research administration or officials with delegated authority; always verify delegated signature authority and document the signer’s title and authority.
How do I revoke consent or cancel the agreement?
Follow termination or cancellation provisions in the agreement. For participant consent, follow IRB-approved withdrawal procedures. Contract cancellation may require notice and wind-down obligations as specified in the agreement.

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