Can this form be e-signed?

Yes. Electronic signatures are generally valid under the ESIGN Act (15 U.S.C. §7001) and UETA where adopted; however, exceptions may apply for documents requiring wet ink or notarization. Ensure consent to electronic records and retain reproducible records per applicable law.

What privacy rules apply to my study?

It depends on data. HIPAA applies to protected health information in covered entities; FERPA applies to student education records. The IRB must document authorizations or waivers and reviewers should consult institutional privacy and compliance officers before approving data collection.

Who must sign the form?

Primary signers typically include the principal investigator and authorized study personnel; institutional sign-off may require department chairs or research compliance officers. IRB chairs sign determinations. Ensure signatures are by individuals with authority to commit institutional resources.

Are notarization or witnesses required?

Generally the Research Ethics Review Form does not require notarization or witness signatures; however, state laws or sponsor agreements may impose witness or notarization requirements for specific consents or legal authorizations. Verify local rules and incorporate notarized documents when required.

How long should records be kept?

Retention varies: follow institutional policy, but federal baselines apply — IRS-related records three years (IRC §6501(a)); HIPAA-regulated records six years from creation or last effective date (45 CFR §164.530(j)). Sponsor or state law may require longer retention.

Can e-signature platforms meet HIPAA?

When used with a HIPAA-compliant vendor under a signed Business Associate Agreement, e-signature platforms can meet HIPAA requirements. Verify encryption standards (TLS 1.2/1.3 in transit, AES-256 at rest), access controls, audit trails, and breach notification capabilities.

Electronic Signature
Templates
Miscellaneous
Research Ethics Review Form

Research Ethics Review Form

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

RESEARCH ETHICS REVIEW FORM

Principal Investigator Name: Institution / Department:

Project Title:

WHEREAS

WHEREAS, Principal Investigator: seeks review and approval of the research project identified above for the protection of human subjects and the ethical conduct of research; and

WHEREAS, the Institutional Research Ethics Committee (referred to herein as the Committee) has authority to review, condition, approve, or disapprove research involving human participants and to require safeguards to protect participant rights and welfare; and

WHEREAS, the Principal Investigator requests that the Committee perform an ethics review under the Committee's established procedures and the parties wish to record the terms governing review, confidentiality, and oversight.

PROJECT INFORMATION

Contact Email Contact Phone Mailing Address Funding Source(s)

SCOPE OF WORK

Scope of Work (description of activities requiring ethics review)

STUDY SUMMARY

Brief Summary of Study Purpose and Design

METHODOLOGY, PARTICIPANTS, AND CONSENT

Type of Review Requested: Full Review Expedited Review Exemption Determination

Target Participant Population Consent Process (attach consent forms and describe process below)

RISKS, BENEFITS, AND SAFEGUARDS

Anticipated Risks and Proposed Safeguards Potential Benefits

DATA MANAGEMENT AND CONFIDENTIALITY

Does study collect identifiable or sensitive data? Identifiable Sensitive (health, sexual, criminal, financial)

Data De-identification and Storage Measures Proposed Data Retention Period

PAYMENT TERMS

Review Fee Amount: $ Payment Schedule:

Late Payment: A late fee of per month will be assessed on overdue amounts. All fees due to the Committee must be paid within the schedule above and are non-refundable except as expressly provided by the Committee's written determination.

TERM AND TERMINATION

Review Term Commencement Date: Anticipated Review Completion Date:

Either party may terminate the review request for cause upon written notice to the other party. Notice of termination shall be provided not less than days prior to the effective termination date, except termination for material noncompliance by the Principal Investigator may be immediate and without prior notice where required to protect participant welfare.

CONFIDENTIALITY

The Committee and Principal Investigator acknowledge and agree that information submitted for review, including study materials, participant data, and Committee deliberations, constitute confidential information. Each party shall use reasonable administrative, technical, and physical safeguards to protect confidential information from unauthorized access or disclosure. Confidential information shall not be disclosed except (i) as required by law or regulation, (ii) with prior written consent of the disclosing party, or (iii) as necessary to comply with Committee reporting obligations regarding participant safety or regulatory authorities.

GOVERNING LAW

This agreement and any disputes arising out of the ethics review process shall be governed by and construed in accordance with the laws of the jurisdiction in which the Committee is established, without regard to conflict of law principles.

ENTIRE AGREEMENT

This document, together with any written attachments or determinations issued by the Committee, constitutes the entire agreement between the Principal Investigator and the Committee with respect to the subject matter hereof and supersedes all prior understandings, representations, and agreements, whether written or oral, concerning the same.

CERTIFICATIONS AND REPRESENTATIONS

By signing below, the Principal Investigator certifies that the information submitted is accurate and complete to the best of their knowledge; that all research personnel will comply with Committee determinations and applicable ethical standards; and that required training for human subjects protection has been completed for listed personnel.

Conflict of Interest Disclosure: No conflicts to disclose Conflicts disclosed in attachment

Additional Attachments Included (select all that apply)

Protocol document Consent forms Survey instruments Investigator CVs

Principal Investigator:

Printed Name:

By:

Date:

Ethics Committee Representative:

Printed Name:

By:

Date:

What the Research Ethics Review Form Records

Research Ethics Review Form documents the institutional review board (IRB) assessment for human-subjects research, capturing protocol details, consent processes, risk mitigation, and data handling plans. It standardizes information reviewers need to determine compliance with federal regulations, institutional policies, and applicable privacy laws such as the Common Rule and HIPAA. Completed forms record determinations, required modifications, and monitoring conditions, and they create an auditable record of approvals or denials for sponsors, investigators, and regulators. They also document consent form versions, recruitment materials, and investigator training records used during review.

Why a Structured Review Form Matters

A Research Ethics Review Form clarifies participant protections, documents regulatory compliance, and provides a consistent record for IRB decisions. It reduces review ambiguity, supports audit readiness under 45 CFR part 46 and HIPAA, and helps investigators demonstrate adherence to approved protocols.

People Involved in Completing and Reviewing the Form

Investigators, IRB members, research coordinators, and institutional compliance officers complete or review the Research Ethics Review Form during protocol submission and continuing review.

Principal investigators and co-investigators preparing protocol materials and consent documents for board review.
IRB chairs and reviewers assessing risk, benefit, recruitment, and informed consent adequacy.
Clinical research staff submitting updates, adverse event reports, and continuing review information.

Use roles-mapped workflows to ensure the right parties sign and attest to ethics requirements at each review stage.

Essential Fields to Include

Project Title: Full protocol title as submitted

Principal Investigator: Name, credentials, contact email

Study Population: Eligibility criteria, age ranges

Consent Process: Method, form version, assent details

Risks and Benefits: Known risks, mitigation, anticipated benefits

Data Handling: Storage, access controls, PHI handling

Step-by-Step: Complete and Submit the Form

Follow these steps to complete and submit a Research Ethics Review Form accurately and track review status.

01

Prepare Materials: Compile protocol, consent, recruitment, and questionnaires
02

Complete Form: Enter required fields, attach documents, date entries
03

Submit to IRB: Upload form, assign reviewers, select review type
04

Respond & Archive: Address contingencies, upload revisions, maintain records

Where to File and Who Receives It

Typical routing for Research Ethics Review Forms depends on institutional systems — IRB portal, compliance office, and any sponsor submission channels.

IRB Portal: Primary submission channel for initial and continuing review
Compliance Office: Institutional routing for HIPAA/FERPA and conflict checks
Sponsor Upload: If funded, submit required copies to sponsor portal
External Agencies: Report approvals to regulatory bodies when required

Configuring an Online Review Workflow

Configure an online review workflow to automate field validation, routing, notifications, and document attachments for consistent submissions.

Field	Configuration
Form Template	Pre-filled sections, conditional fields, validation rules
Routing	Sequential reviewer assignment with escalation timers
Notifications	Email and in-app alerts for pending actions
Attachments	PDF, DOCX, and consent artifacts allowed

Distribution Channels and Technical Requirements

Set platform requirements for secure distribution, signer authentication, and audit logging before accepting electronic submissions.

File Formats: Accept PDF, DOCX, and scanned files
Authentication: Email, SMS code, or stronger KBA
Audit Trail: Timestamps, IP, and action history captured

Key Deadlines and Reporting Timelines

Key deadlines for submission, continuing review, and reporting vary by institution; follow IRB policies and federal reporting timelines when applicable.

Initial Submission Due:

Submit before study start; allow IRB processing time

Continuing Review:

Annual or as-specified intervals per IRB approval

Amendment Reporting:

Report proposed changes prior to implementation when required

Adverse Event Reporting:

Report serious events within IRB-specified timeframe

Record Retention:

Retain approved forms per institutional policy and law

Common Preparation Mistakes to Avoid

Incomplete or inconsistent protocol details delay review; failing to attach consent versions, recruitment materials, or data security plans commonly triggers administrative hold and requests for revision.
Using ambiguous or nonstandard language about participant risks and benefits undermines reviewer assessment and can result in conditional approval or additional safeguards being required.
Omitting HIPAA or FERPA considerations when data includes identifiable health or education records can create compliance gaps and delay institutional sign-off.
Submitting forms close to project start without allowing standard IRB turnaround times increases risk of unauthorized participant contact or protocol deviations.

Consequences of Incomplete or Noncompliant Submissions

Regulatory Noncompliance: Corrective action or suspension

Funding Loss: Sponsor withdrawal or audit

Legal Liability: Civil penalties or litigation

Data Breach Risk: HIPAA fines and remediation

Study Delays: Approval holds and recruitment pause

Reputational Harm: Institutional trust impaired

Practical Examples of Form Use

Sample instances show how Research Ethics Review Forms appear in student studies and multicenter clinical trials.

University Student Project

An undergraduate sociology project submitted an IRB form describing interviews with adult volunteers, requiring expedited review due to minimal risk.

IRB requested consent template revisions and data storage details.
After revisions the board approved the study; the record included documented consent version, recruitment scripts, and a monitoring plan, enabling the student to proceed while meeting institutional and federal documentation standards.

Multicenter Clinical Trial

A multicenter clinical trial submitted harmonized ethics forms across sites, coordinating consent language, data transfer agreements, and sponsor reporting requirements.

IRBs required local approvals and data use agreements.
Central project management tracked approvals, amendments, and continuing review schedules; consolidated records and version control simplified audits and sponsor inspections while preserving site-specific approvals and local consent variations and documentation.

eSignature Pricing and Feature Snapshot

Comparative pricing and feature snapshot for common eSignature needs relevant to Research Ethics Review Form processing.

	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 trial	No	No	Yes, limited	Yes, limited
Bulk Send	Yes	Yes	Yes	Yes	No
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes	Yes	Yes	No	No
Envelope Cap	No envelope cap	100 envelopes/user/year	Varies	Varies	Varies

Frequently Asked Questions and Troubleshooting

Answers to frequent questions about completing, signing, and submitting a Research Ethics Review Form, including digital signature and retention concerns.

Need help? Contact support

Can this form be e-signed?
Yes. Electronic signatures are generally valid under the ESIGN Act (15 U.S.C. §7001) and UETA where adopted; however, exceptions may apply for documents requiring wet ink or notarization. Ensure consent to electronic records and retain reproducible records per applicable law.
What privacy rules apply to my study?
It depends on data. HIPAA applies to protected health information in covered entities; FERPA applies to student education records. The IRB must document authorizations or waivers and reviewers should consult institutional privacy and compliance officers before approving data collection.
Who must sign the form?
Primary signers typically include the principal investigator and authorized study personnel; institutional sign-off may require department chairs or research compliance officers. IRB chairs sign determinations. Ensure signatures are by individuals with authority to commit institutional resources.
Are notarization or witnesses required?
Generally the Research Ethics Review Form does not require notarization or witness signatures; however, state laws or sponsor agreements may impose witness or notarization requirements for specific consents or legal authorizations. Verify local rules and incorporate notarized documents when required.
How long should records be kept?
Retention varies: follow institutional policy, but federal baselines apply — IRS-related records three years (IRC §6501(a)); HIPAA-regulated records six years from creation or last effective date (45 CFR §164.530(j)). Sponsor or state law may require longer retention.
Can e-signature platforms meet HIPAA?
When used with a HIPAA-compliant vendor under a signed Business Associate Agreement, e-signature platforms can meet HIPAA requirements. Verify encryption standards (TLS 1.2/1.3 in transit, AES-256 at rest), access controls, audit trails, and breach notification capabilities.

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