Can IRB Agreements be signed electronically?

Yes. Electronic signatures are legally recognized under the ESIGN Act (15 U.S.C. §7001) and UETA in most states; ensure the chosen method captures intent, consent, attribution, and retention to meet legal validity tests.

Do IRB Agreements need notarization or witnesses?

Generally no; notarization or witnesses are not standard requirements for IRB reliance agreements. If a state statute or institutional policy requires notarization for particular contract types, follow that rule and document the reason.

What authentication level is recommended for signers?

Use role-appropriate authentication: email link for routine institutional signers, SSO or multifactor for authorized institutional signatories, and stronger identity proofing where required by institutional policy or state law.

How should HIPAA-covered data be addressed?

If PHI will be shared, explicitly state HIPAA applicability, include required safeguards, and attach or reference a Business Associate Agreement to ensure obligations and liability are documented.

What happens if parties disagree post-execution?

Refer to the agreement's dispute resolution and termination provisions; preserve records, notify the IRB of record, and follow the communication and escalation process set forth in the agreement.

How long must executed agreements be retained?

Retain executed IRB Agreements for the active term plus applicable regulatory periods; follow HIPAA six-year retention when PHI is involved (45 CFR §164.530(j)) and consult institutional retention schedules for any longer state-specific requirements.

Electronic Signature
Templates
Legal
Institutional Review Board Agreement

Institutional Review Board Agreement

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INSTITUTIONAL REVIEW BOARD AGREEMENT

This Institutional Review Board Agreement (the Agreement) is entered into as of by and between IRB Name: with principal address: and Sponsor/Institution: with principal address: (each a Party and collectively the Parties).

RECITALS

WHEREAS, Sponsor is conducting clinical research identified as Protocol Title: , Protocol Number: , under the direction of Principal Investigator: at Institution: .

WHEREAS, IRB has the authority, experience and resources to provide independent ethical review of human subjects research in accordance with applicable law, regulations, and recognized standards of research ethics; and

WHEREAS, the Parties desire to set forth their respective rights and obligations with respect to IRB review, ongoing oversight, reporting, confidentiality, record retention, fees and other matters relating to the Protocol.

NOW, THEREFORE

In consideration of the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are acknowledged, the Parties agree as follows:

1. DEFINITIONS

1.1 "Agreement" means this Institutional Review Board Agreement and all exhibits and schedules hereto. 1.2 "Protocol" means the clinical investigation described in the Protocol Title and Protocol Number fields above and all amendments. 1.3 "Investigator" means the Principal Investigator identified above and any designated sub-investigators. 1.4 "Adverse Event" and "Unanticipated Problem" shall have the meanings set forth under applicable regulations and guidance and include any event that places subjects at greater risk than previously known.

2. SCOPE OF REVIEW

2.1 Engagement. Sponsor retains IRB to perform independent ethical review of the Protocol, associated informed consent documents, recruitment materials, and related study documents as required by law and recognized ethical standards. IRB's review shall include initial review, continuing review (where required), review of amendments, and review of reports of adverse events or unanticipated problems.

2.2 Regulatory Compliance. IRB's determinations shall be made in accordance with applicable federal, state and local law, institutional policy and established ethical standards. Sponsor acknowledges that IRB's determinations relate only to the ethical review of the Protocol and do not constitute a warranty as to regulatory approval for conduct of the research.

3. IRB RESPONSIBILITIES

3.1 Review and Determination. IRB shall evaluate the Protocol and make written determinations regarding approval, conditional approval with required modifications, or disapproval. IRB shall establish and document the basis for each determination and provide written notice to Sponsor and Investigator.

3.2 Continuing Review. IRB shall conduct continuing review as required by applicable law and will notify Sponsor of the schedule and requirements for such review. Failure to secure continuing approval may require suspension of subject enrollment.

3.3 Recordkeeping and Reporting. IRB shall maintain minutes, records of votes, membership rosters and copies of submitted materials in accordance with record retention obligations set forth in Section 7. IRB shall report to Sponsor and Investigator any determinations that materially affect the conduct of the Protocol, including suspension or termination of IRB approval.

4. SPONSOR AND INVESTIGATOR RESPONSIBILITIES

4.1 Provision of Materials. Sponsor shall provide IRB with all documents necessary for review, including but not limited to the Protocol, informed consent documents, investigator brochure, recruitment materials, and any sponsor communications to investigators.

4.2 Reporting. Sponsor and Investigator shall timely report all adverse events, unanticipated problems, protocol deviations affecting subject safety, and other events specified by IRB, in the manner and timeframe required by IRB and applicable law. Sponsor shall also notify IRB of any regulatory actions affecting the Protocol.

5. FEES AND PAYMENT

Review Fees and Payment Terms

5.1 Payment. Sponsor shall pay IRB fees for initial review, continuing review, amendment review, and any expedited reviews in accordance with IRB's fee schedule. Unless otherwise agreed in writing, fees are due within 30 days of invoice. Late payments shall accrue interest at the lesser of 1.5% per month or the maximum lawful rate.

5.2 Non-Refundable. Fees paid for completed reviews are non-refundable. If Sponsor terminates the Protocol prior to completion of a review, IRB may retain fees to cover costs reasonably incurred.

6. CONFIDENTIALITY

6.1 Confidential Information. Each Party shall maintain in confidence all non-public proprietary information disclosed by the other Party in connection with this Agreement, including unredacted Protocol materials and safety reports (Confidential Information). Confidential Information shall not include information that is publicly known through no fault of the recipient or that is required to be disclosed by law.

6.2 Limited Use. IRB shall use Confidential Information solely for the purpose of carrying out IRB review and approvals. IRB may disclose Confidential Information to its members, staff, consultants and legal counsel on a need-to-know basis provided such persons are bound to obligations of confidentiality at least as protective as those herein.

7. RECORDS, ACCESS AND RETENTION

Retention Period (years)

7.1 Retention. IRB shall retain records of reviews, minutes, approvals and correspondence for the retention period specified above or as required by law, whichever is longer. Sponsor and regulatory authorities shall have the right to inspect IRB records relevant to the Protocol upon reasonable notice and during normal business hours, subject to redaction of unrelated confidential information.

8. REPORTING OF UNANTICIPATED PROBLEMS AND ADVERSE EVENTS

IRB Reporting Contact Sponsor Reporting Contact

8.1 Timeframes. Sponsor and Investigator shall notify IRB of events constituting unanticipated problems or serious adverse events consistent with applicable law and within the timeframes specified by IRB. Where immediate action is required to protect subjects, Sponsor shall notify IRB within 48 hours and submit a full report within the time required by IRB.

9. INDEMNIFICATION AND INSURANCE

9.1 Indemnity. Sponsor shall indemnify, defend and hold harmless IRB, its members, officers, employees and agents from and against any and all claims, liabilities, losses, costs and expenses (including reasonable attorneys' fees) arising out of Sponsor's breach of this Agreement, Sponsor's negligence or willful misconduct, or claims related to the conduct of the Protocol, except to the extent caused by IRB's gross negligence or willful misconduct.

9.2 Insurance. Sponsor shall maintain insurance coverage or other financial responsibility sufficient to satisfy its indemnification obligations and to cover liabilities reasonably anticipated in connection with the Protocol.

10. TERM AND TERMINATION

10.1 Term. This Agreement shall commence on the Effective Date set forth above and shall continue until completion of IRB obligations for the Protocol unless earlier terminated in accordance with this Section.

10.2 Termination for Cause. Either Party may terminate this Agreement for material breach by the other Party if the breaching Party fails to cure such breach within 30 days following receipt of written notice specifying the breach. Termination shall not relieve Sponsor of obligations to pay fees incurred prior to termination.

10.3 Effect of Termination. Upon termination, IRB shall maintain records in accordance with Section 7 and shall provide Sponsor any required closing documentation. Sponsor shall remain responsible for payment of fees and for fulfilling any post-termination obligations relating to subject safety and reporting.

11. NOTICES

IRB Notice Address Sponsor Notice Address

11.1 Methods. All notices required or permitted under this Agreement shall be in writing and delivered by hand, nationally recognized overnight courier, or certified mail, return receipt requested, to the addresses set forth above or to such other address as a Party designates in writing. Notices shall be effective upon receipt.

12. AMENDMENT; WAIVER; COUNTERPARTS

12.1 Amendment. This Agreement may be amended only by a written instrument executed by authorized representatives of both Parties. 12.2 Waiver. No waiver of any provision shall be effective unless in writing and signed by the waiving Party. A waiver of any breach shall not constitute a waiver of any subsequent breach. 12.3 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one instrument.

13. GOVERNING LAW; ENTIRE AGREEMENT; SEVERABILITY

Governing Law State

13.1 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the state specified above, without regard to conflict of laws principles. 13.2 Entire Agreement. This Agreement constitutes the entire agreement between the Parties with respect to its subject matter and supersedes all prior negotiations, understandings and agreements, whether written or oral. 13.3 Severability. If any provision of this Agreement is held invalid or unenforceable, the remaining provisions shall remain in full force and effect to the maximum extent permitted by law.

14. MISCELLANEOUS PROVISIONS

14.1 Assignment. Neither Party may assign this Agreement without the prior written consent of the other Party, except that Sponsor may assign to an affiliate or in connection with a merger or sale of substantially all of its assets provided the assignee assumes Sponsor's obligations. 14.2 Independent Parties. The Parties are independent contractors and nothing in this Agreement shall be construed to create a partnership, joint venture or agency relationship.

IRB Name:

By:

Title:

Date:

Sponsor/Institution:

By:

Title:

Date:

What the Institutional Review Board Agreement Is and who it governs

An Institutional Review Board Agreement (IRB Agreement) is a written contract between research institutions that assigns IRB review responsibilities, reporting duties, and oversight for human subjects research. It defines which institution acts as the IRB of record, clarifies roles for investigators and sponsors, describes data handling and privacy obligations, and records communications and review timelines. The agreement supports regulatory compliance with federal human subjects protections (Common Rule), clarifies HIPAA-protected data handling where applicable, and establishes liability allocation for multisite studies.

Why a clear IRB Agreement matters for multisite research

A properly drafted IRB Agreement reduces regulatory uncertainty, documents which party performs ethics review, aligns reporting requirements, and protects subject welfare. It streamlines multisite approvals, clarifies data-protection responsibilities under HIPAA when health data are involved, and creates an auditable record that supports institutional compliance and oversight.

Who typically prepares, reviews, and signs an IRB Agreement

Multiple institutional roles participate in IRB Agreements; responsibilities vary by institution and study complexity.

Research administration teams that coordinate multisite study reliance and documentation management.
Institutional legal or contracts offices that review indemnity, liability, and data-use clauses.
Principal investigators and study directors who must comply with the agreed oversight and reporting schedule.

Assigning clear internal owners for review, legal approval, and signature reduces delays and improves audit readiness.

Stepwise process to complete an Institutional Review Board Agreement

Follow these sequential steps to prepare, review, and finalize an IRB Agreement with minimal rework.

01

Assemble team: Gather research, legal, and compliance stakeholders for initial review.
02

Draft terms: Populate scope, responsibilities, data clauses, and effective date.
03

Internal review: Route to contracts and privacy officers for redlines and approval.
04

Sign and record: Obtain authorized signatures and store the executed agreement in records.

How to configure an online review and signature workflow

Use a consistent online workflow to assign reviewers, collect signatures, and capture an audit trail for each executed IRB Agreement.

Field	Configuration
Document upload	Upload final PDF or DOCX version for signing.
Signer order	Set role-based order: legal → compliance → authorized signatory.
Authentication	Require email plus optional SMS code or SSO for key signers.
Audit trail	Enable timestamps, IP logging, and certificate download.

Where to send and file the completed agreement

Determine distribution and recordkeeping destinations before signatures to ensure consistent filing and access for audits.

Institutional Records: Store final executed PDF in each institution's contracts repository.
IRB Office: Provide a copy to the IRB of record and local IRBs as required.
Principal Investigator: Send a signed copy to the PI for study files and regulatory binders.
Sponsor or Funder: Deliver a copy to sponsors if the agreement requires sponsor notice.

Technical considerations for electronic signing and secure storage

Choose a signing platform that supports required authentication, audit trails, and privacy controls for human subjects research.

Authentication: Email, SMS, SSO
File formats: PDF, DOCX, PDF/A
Integrations: SSO, Box, Google Drive

Core clauses and sections to include in a professional IRB Agreement

A robust IRB Agreement contains defined sections that allocate responsibilities, protect subject data, and provide dispute and termination procedures.

Scope and Covered Studies

Define expressly which protocols, amendments, and ancillary activities are covered; include identifiers or a mechanism to add new studies without reopening the entire agreement to avoid ambiguity during multisite operations.

IRB Roles and Responsibilities

Describe which party is the IRB of record, responsibilities for initial review, continuing review, reporting of unanticipated problems, and who notifies regulatory bodies to ensure compliance with the Common Rule.

Data Privacy and Security

Specify whether HIPAA applies, required safeguards, data-sharing limits, de-identification standards, and whether a Business Associate Agreement or data-use addendum is required to protect PHI.

Reporting and Communications

Set timelines and formats for safety reports, adverse events, and protocol deviations; designate points of contact and escalation paths to minimize delays in regulatory reporting.

Liability and Indemnification

Allocate responsibility for breaches, noncompliance, and participant harm; include insurance expectations and indemnity language that aligns institutional risk policies without conflicting with public obligations.

Amendments and Termination

Set the process for amendments, effective dates for changes, notice periods, and conditions for termination while addressing study continuity and participant protections after termination.

Required data elements and metadata to include

Institution Names: Full legal name

Signatory Details: Name, title, date

Study Identifiers: Protocol ID

Effective Date: MM/DD/YYYY

HIPAA Status: Applies / Not applies

Retention Location: Repository path

Potential risks and legal exposures from an incorrect agreement

Regulatory Noncompliance: Common Rule violations

HIPAA Breach: 45 CFR §164.530 risk

Data Misuse: Unauthorized sharing

Liability Disputes: Indemnity disagreements

Delays in Research: Approval hold-ups

Contractual Penalties: Sponsor remedies

Common drafting and execution errors to avoid

Using informal institution names or acronyms that do not match legal registrations, which can create enforceability problems and require a corrected amendment.
Failing to specify whether HIPAA applies or omitting required Business Associate Agreement language when protected health information will be shared across sites.
Leaving the scope unclear by saying 'related studies' without identifying protocols or a process to add new protocols, leading to disagreement about coverage.
Not confirming an authorized signatory with contracting authority, which can result in seemingly executed documents that lack binding effect and require re-signing.

Typical timing and deadlines associated with IRB Agreements

Establish clear dates for effective execution, reporting windows, and review cycles to align institutional processes and maintain regulatory timeliness.

Effective Date Entry:

Set as MM/DD/YYYY and use consistently across all copies.

Continuing Review Cycle:

Follow the IRB-approved interval; document next review date.

Adverse Event Reporting:

Follow IRB-established internal timelines for prompt reporting.

Amendment Notices:

Specify notice period for amendments and required approvals.

Record Retention Start:

Begin retention from effective date or last action date, whichever is later.

Key milestones from negotiation to archived record

Track major milestones so each party meets review, signature, and retention obligations without gaps in oversight.

01

Negotiation Complete

Final terms agreed by research, legal, and compliance.

02

Institutional Approvals

Internal sign-off from authorized offices completed.

03

Execution

All parties sign and exchange the executed agreement.

04

Filing and Retention

Store final copy in contracts repository and study file.

Common eSignature vendor pricing and capability snapshot for IRB Agreements

Select an eSignature vendor that supports required authentication, audit trails, and HIPAA compliance if protected health information is involved.

	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, no credit card	Varies by vendor	Varies by vendor	Varies by vendor	Varies by vendor
Bulk Send	Yes	Yes	Yes	Yes	No
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes	Yes	Yes	No	No
Envelope Cap	No cap	100 envelopes/user/year	Varies by plan	Varies by plan	Varies by plan

Real-world examples of Institutional Review Board Agreement use

Two brief examples show how institutions use IRB Agreements to coordinate multisite human subjects oversight and maintain compliance.

Optica Ventures LLC — Brian Fitzgibbons

Optica used an IRB Agreement to centralize review for a multi-center study

The arrangement assigned one IRB of record to avoid duplicate reviews
The executed agreement reduced administrative rework, clarified reporting pathways, and provided a single point of contact for sponsors and investigators.

Fertility Centers of Illinois — John Butler

A clinical practice coordinated oversight across affiliate sites using a reliance agreement

Central IRB responsibilities were delegated to one qualified review board
The agreement documented PHI safeguards, required BAA considerations, and ensured uniform consent language across sites to protect participants.

Frequently asked questions about Institutional Review Board Agreements

Answers to common questions about electronic execution, enforceability, signatures, and retention for IRB Agreements in the United States.

Need help? Contact support

Can IRB Agreements be signed electronically?
Yes. Electronic signatures are legally recognized under the ESIGN Act (15 U.S.C. §7001) and UETA in most states; ensure the chosen method captures intent, consent, attribution, and retention to meet legal validity tests.
Do IRB Agreements need notarization or witnesses?
Generally no; notarization or witnesses are not standard requirements for IRB reliance agreements. If a state statute or institutional policy requires notarization for particular contract types, follow that rule and document the reason.
What authentication level is recommended for signers?
Use role-appropriate authentication: email link for routine institutional signers, SSO or multifactor for authorized institutional signatories, and stronger identity proofing where required by institutional policy or state law.
How should HIPAA-covered data be addressed?
If PHI will be shared, explicitly state HIPAA applicability, include required safeguards, and attach or reference a Business Associate Agreement to ensure obligations and liability are documented.
What happens if parties disagree post-execution?
Refer to the agreement's dispute resolution and termination provisions; preserve records, notify the IRB of record, and follow the communication and escalation process set forth in the agreement.
How long must executed agreements be retained?
Retain executed IRB Agreements for the active term plus applicable regulatory periods; follow HIPAA six-year retention when PHI is involved (45 CFR §164.530(j)) and consult institutional retention schedules for any longer state-specific requirements.

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