Can this form be signed electronically?

Yes. Electronic signatures are generally valid under the ESIGN Act (15 U.S.C. §7001) and UETA where adopted. Institutional policy may require specific authentication or audit-trail features for research records.

Who must sign the form?

The principal investigator typically signs and dates the form; departmental or sponsor approvals may require additional signatures. The IRB or compliance office will specify required signatories in institutional policy.

Are notarization or witnesses required?

Most IRB evaluation forms do not need notarization or witnesses. Where a state or institutional rule requires notarization, follow that rule. Refer to state notary and RON guidance if applicable.

How do I correct an error after submission?

Submit an amendment or corrected form per IRB procedures. Do not implement substantive changes before approval; administrative corrections may be accepted at the IRB's discretion.

How long must records be kept?

Retain forms and supporting records per the longest applicable requirement: HIPAA 6 years (45 C.F.R. §164.530(j)) or institutional policy, commonly 7 years post-study.

What if a signer cannot use eSign?

Provide an alternative such as printed signature, scanned signed page, or institution-approved paper workflow. Ensure the alternative produces an auditable record consistent with institutional policy.

Electronic Signature
Templates
Project Management
Human Subjects Research Proposal Evaluation Form

Human Subjects Research Proposal Evaluation Form

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

What the Human Subjects Research Proposal Evaluation Form Is

The Human Subjects Research Proposal Evaluation Form is a structured instrument used by institutional review boards (IRBs), ethics committees, or research offices to assess proposed studies involving human participants. It summarizes study objectives, methodology, recruitment, consent processes, risk/benefit analysis, data handling and protections, and investigator qualifications. The completed form documents compliance with the Common Rule (45 C.F.R. part 46), institutional policies, and any applicable federal requirements such as HIPAA for research using protected health information. The form creates a consistent record for reviewers and for institutional recordkeeping.

Why this Evaluation Form Matters for Compliance and Oversight

A standardized evaluation form ensures consistent IRB review, documents risk assessments and consent adequacy, and records determinations required under the Common Rule and institutional policies. It helps track required approvals, conditions, and monitoring steps so researchers and administrators maintain regulatory and ethical accountability.

Who Completes or Reviews the Form

Typical users include research investigators, IRB reviewers, compliance officers, and departmental administrators who support oversight.

Principal Investigators preparing submissions and responses for IRB review.
IRB members and protocol reviewers assessing risks, consent, and protections.
Research compliance officers verifying HIPAA, data security, and training completion.

Use the form to centralize reviewer comments, record board decisions, and produce an auditable compliance trail.

Core Sections to Include in a Professional Evaluation Form

A thorough form covers study identification, participant selection, consent processes, privacy and data security, risk mitigation, and reviewer recommendations to support reproducible ethical decisions.

Study ID

Unique protocol identifier, sponsor/funder details, IRB protocol number, and version history to track submissions and amendments over time.

Objectives

Clear, measurable primary and secondary objectives and hypotheses so reviewers can judge scientific validity and participant risk relative to anticipated benefit.

Population

Inclusion and exclusion criteria, vulnerable population flags, estimated sample size, and recruitment sources to assess fair selection and protection needs.

Consent Process

Planned consent procedures, language summary, assent for minors, and documentation method including translations and readability considerations.

Data Protection

Data collection, storage, de-identification, retention, and access controls including HIPAA protections and data sharing plans.

Risks & Benefits

Identified physical, psychological, privacy, and social risks; mitigation strategies; and the risk/benefit rationale presented for board determination.

Step-by-Step: Submitting and Completing the Form

Follow this sequence to prepare, submit, and respond to IRB review efficiently.

01

Prepare Materials: Collect protocol, consent, data plans, and training certificates before starting the form.
02

Complete Form: Fill fields accurately, attach documents, and confirm PI signature block is correct.
03

Submit to IRB: Upload the form and attachments via the institutional submission portal per instructions.
04

Respond to Queries: Timely address reviewer questions or requested revisions to avoid review delays.

Typical Review Flow After Submission

A consistent review workflow helps applicants know what to expect and when decisions will be recorded.

Triage: Administrative check for completeness and jurisdictional applicability.
Primary Review: Assigned reviewer evaluates risks, consent and scientific validity.
Committee Decision: Full board or expedited committee issues approval, conditional approval, or disapproval.
Post-Decision: Final documents are archived and investigators receive the determination and required conditions.

Recommended Digital Workflow Settings for eSubmission

Configure your submission workflow to reduce errors and produce an auditable trail for IRB records.

Field	Configuration
Required Fields	Make investigator, title, protocol number mandatory to prevent incomplete submissions.
Attachments	Require PDF consent and protocol attachments; enforce filename convention for traceability.
Versioning	Enable automatic version numbering for amended submissions and reviewer notes.
Notifications	Set email alerts for reviewer assignments and investigator query deadlines.

Technical Considerations for eSubmission and Signatures

Ensure the platform supports secure uploads, audit trails, and required signer authentication for institutional compliance.

File Formats: Accept PDF/A and DOCX to preserve formatting and metadata.
Authentication: Support email links, SMS codes, or stronger methods for high-risk studies.
Audit Trail: Capture timestamps, signer IP, and action history for review records.

Choose tools that preserve records reliably, support HIPAA where needed, and integrate with institutional record systems.

Timing and Typical Deadlines to Expect

Timelines vary by institution; use the board's published schedule and submission cutoffs to plan your submission.

Submit Before Study Start:

Obtain IRB approval prior to initiating recruitment or data collection.

Initial Review Windows:

Expedited or full-board reviews follow institutional cycles and may range across weeks.

Continuing Review:

Submit annual reports when required by the IRB or sponsor conditions.

Reportable Events:

Report unanticipated problems per institution policy and IRB timelines.

Amendments:

Submit protocol changes for approval before implementing substantive modifications.

Key Milestones from Submission to Record Closure

A sequential view of major stages helps teams track progress and responsibilities during review.

01

Submission Received

Administrative completeness check and assignment to reviewer.

02

Primary Reviewer Report

Reviewer documents findings and recommended board action.

03

Committee Determination

Board issues approval, conditional approval, or disapproval with conditions.

04

Final Archival

Approved materials and correspondence are archived in institutional systems.

Common Errors That Slow Review

Incomplete attachments such as missing consent form versions or incomplete training certificates delay administrative acceptance and assignment.
Mismatched names between investigator records and signature blocks trigger identity verification and require corrected resubmission.
Vague recruitment descriptions or unclear inclusion criteria prompt reviewer requests for clarification or restriction.
Insufficient data protection detail, including missing de-identification or storage plans, leads to conditional approvals or required revisions.

Essential Security and Compliance Fields to Address

HIPAA Considerations: Include BAA status and PHI handling.

Data Storage: Specify encryption and access controls.

De-identification: Describe methods and re-identification risk.

Access Controls: List roles with data access privileges.

Retention Plan: State retention period and archival location.

Breach Response: Outline incident reporting and remediation steps.

Consequences of Incomplete or Noncompliant Submissions

Enrollment Halt: Study activities may be suspended.

Funding Risk: Sponsor funding or approvals can be withdrawn.

Regulatory Action: Noncompliance can trigger audits or sanctions.

Data Inadmissibility: Collected data may be unusable for publication.

Privacy Violations: HIPAA breaches can result in penalties.

Institutional Sanctions: Disciplinary measures for investigators.

eSignature Pricing and Basic Feature Comparison

Basic vendor pricing and plan-related differences for electronic signature solutions. Confirm vendor sites for plan specifics and enterprise options.

	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	Vendor-specific	Vendor-specific	Vendor-specific	Vendor-specific
Bulk Send	Yes	Yes	Yes	Yes	Vendor-defined
Audit Trail	Yes	Yes	Yes	Yes	Yes
Envelope Cap	No cap	100 envelopes/user/year	Vendor-defined	Vendor-defined	Vendor-defined

Frequently Asked Questions About the Evaluation Form

Answers to common questions about electronic completion, signatory authority, corrections, and recordkeeping for IRB evaluation forms.

Need help? Contact support

Can this form be signed electronically?
Yes. Electronic signatures are generally valid under the ESIGN Act (15 U.S.C. §7001) and UETA where adopted. Institutional policy may require specific authentication or audit-trail features for research records.
Who must sign the form?
The principal investigator typically signs and dates the form; departmental or sponsor approvals may require additional signatures. The IRB or compliance office will specify required signatories in institutional policy.
Are notarization or witnesses required?
Most IRB evaluation forms do not need notarization or witnesses. Where a state or institutional rule requires notarization, follow that rule. Refer to state notary and RON guidance if applicable.
How do I correct an error after submission?
Submit an amendment or corrected form per IRB procedures. Do not implement substantive changes before approval; administrative corrections may be accepted at the IRB's discretion.
How long must records be kept?
Retain forms and supporting records per the longest applicable requirement: HIPAA 6 years (45 C.F.R. §164.530(j)) or institutional policy, commonly 7 years post-study.
What if a signer cannot use eSign?
Provide an alternative such as printed signature, scanned signed page, or institution-approved paper workflow. Ensure the alternative produces an auditable record consistent with institutional policy.

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