Is an electronic signature legally valid?

Yes. Under the federal ESIGN Act and state UETA laws, electronic signatures are legally valid for most research consents unless a specific exception applies.

Do I need IRB approval before eSigning?

Yes. The IRB must review and approve the consent form language and the method of electronic signature and storage before enrolling participants.

When is HIPAA authorization required?

If the study collects or discloses protected health information, include a standalone HIPAA authorization that explains uses, recipients, and revocation procedures.

How do I update a signed consent form?

Use an IRB‑approved amendment and reconsent existing participants when changes materially affect risk or participation; retain prior versions for the record.

What authentication level is adequate?

Follow institutional policy; email link with access code often suffices for low‑risk studies, stronger identity proofing may be required for higher‑risk research.

How long must I keep signed consents?

Retain consents per institutional retention policy and applicable federal standards, commonly at least three to seven years depending on study type.

Research Wings Study

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

RESEARCH WINGS STUDY AGREEMENT

Client Name: Research Provider Name:

Effective Date:

RECITALS

WHEREAS, Client engages Research Provider to perform a scientific and analytical study entitled "Research Wings Study" (the Study) to evaluate specified hypotheses, methodologies, and deliverables described below; and

WHEREAS, Research Provider represents that it possesses the professional expertise, facilities, personnel, and resources necessary to perform the Study in accordance with applicable industry standards and regulatory requirements; and

WHEREAS, the parties wish to set forth the terms and conditions under which the Study will be conducted, including scope, payment, confidentiality, and ownership of results.

SCOPE OF WORK

Research Provider shall perform the Study as specified in this Agreement and any attached schedules. The Study shall include experimental design, data collection, analysis, interim reporting, and final reporting as set forth below. Specific tasks, milestones, and acceptance criteria are to be described by the parties in the Scope of Work field.

Detailed Scope of Work and Milestones: Deliverables (list and format):

PAYMENT TERMS

Client shall pay Research Provider the fees described below in consideration for performance of the Study. All amounts are exclusive of any applicable taxes unless otherwise provided.

Total Fee: Payment Schedule and Milestones: Invoicing Address / Billing Contact: Late Payment Fee:

Payments are due within the invoiced payment terms specified. Overdue amounts shall accrue interest at the rate specified above from the due date until paid. Client shall be responsible for reasonable collection costs for delinquent payments.

TERM AND TERMINATION

This Agreement shall commence on the Effective Date and continue until completion of the Study or until the End Date specified below, unless earlier terminated in accordance with this Agreement.

Commencement Date: End Date:

Either party may terminate this Agreement for material breach not cured within days after written notice specifying the breach. Either party may terminate for convenience upon days' written notice; in such event Client shall pay for all work performed to the termination effective date and for reasonable wind-down costs.

CONFIDENTIALITY

"Confidential Information" means non-public business, technical, financial, and personal information disclosed by one party to the other in connection with the Study. Each party shall: (a) use Confidential Information solely to perform its obligations under this Agreement; (b) protect Confidential Information with at least the same degree of care it uses to protect its own confidential information, but no less than reasonable care; and (c) not disclose Confidential Information to any third party except as required for performance or as required by law.

Confidentiality obligations do not apply to information that: (i) is or becomes generally available to the public other than by breach of this Agreement; (ii) was rightfully in the receiving party's possession prior to disclosure; (iii) is received from a third party without breach of an obligation of confidentiality; or (iv) is independently developed by the receiving party without use of the disclosing party's Confidential Information. Confidentiality obligations shall survive termination for a period of except that trade secrets shall remain protected for as long as such information qualifies as a trade secret under applicable law.

DATA OWNERSHIP AND INTELLECTUAL PROPERTY

Subject to payment in full of fees due under this Agreement, Research Provider grants Client a worldwide, royalty-free, nonexclusive license to use, reproduce, and distribute the final Study deliverables for Client's internal business purposes. Research Provider retains ownership of pre-existing intellectual property and methodologies not developed specifically for Client under this Agreement. To the extent the Study produces new intellectual property jointly developed by the parties, the parties shall negotiate in good faith ownership and licensing terms prior to commercialization.

WARRANTIES, INDEMNITY, AND LIMITATION OF LIABILITY

Each party represents that it has the authority to enter into this Agreement. Research Provider warrants that services will be performed in a professional manner consistent with industry standards. EXCEPT AS EXPRESSLY SET FORTH HEREIN, ALL WARRANTIES ARE DISCLAIMED. Each party agrees to indemnify, defend, and hold harmless the other from third-party claims arising from the indemnifying party's breach, negligence, or willful misconduct. TO THE MAXIMUM EXTENT PERMITTED BY LAW, NEITHER PARTY SHALL BE LIABLE FOR INDIRECT, CONSEQUENTIAL, OR PUNITIVE DAMAGES, AND THE AGGREGATE LIABILITY FOR DIRECT DAMAGES SHALL NOT EXCEED THE TOTAL AMOUNTS PAID UNDER THIS AGREEMENT IN THE TWELVE MONTHS PRECEDING THE CLAIM.

COMPLIANCE WITH LAW

Each party shall comply with all applicable laws, regulations, and ethical requirements in performing its obligations under this Agreement, including data protection, human subject research rules where applicable, and export control requirements. Research Provider shall obtain any necessary approvals, consents, or permits required to perform the Study.

GOVERNING LAW

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

ENTIRE AGREEMENT

This Agreement, together with any attachments and schedules executed by the parties, constitutes the entire agreement between the parties regarding the Study and supersedes all prior and contemporaneous agreements, understandings, and communications, whether written or oral. Any amendment must be in writing and signed by authorized representatives of both parties.

NOTICES

All notices required or permitted under this Agreement shall be in writing and delivered to the addresses below or to such other address as a party may designate in writing.

Client Notice Address: Research Provider Notice Address:

Client:

By:

Date:

Research Provider:

By:

Date:

What the Research Wings Study is and what it covers

The Research Wings Study is a structured participant consent and data-collection protocol used by institutions conducting human-subject research. It documents study objectives, procedures, participant eligibility, risks and benefits, data handling practices, and required authorizations such as HIPAA authorizations when health information is collected. The Study form serves as both a protocol appendage and a participant-facing consent document, and it supports electronic completion and signature where allowed by federal and state law. Proper completion ensures ethical oversight, IRB compliance, and defensible records for audits or regulatory review.

Why a consistent Research Wings Study matters for compliance

Using a standardized Research Wings Study clarifies participant consent, documents data protections, and supports institutional review board (IRB) determinations. It helps ensure legal compliance under ESIGN and UETA for electronic signatures and aligns recordkeeping with HIPAA when health data is involved.

Who prepares and signs the Research Wings Study

Academic investigators, clinical coordinators, institutional review boards, sponsor monitors, and data managers commonly use or complete the Research Wings Study.

Academic investigators and co-investigators responsible for protocol and consent accuracy.
Clinical research coordinators who enroll participants, collect consents, and maintain source documents.
Sponsor or CRO representatives managing multi-site compliance and monitoring documentation.

Responsibilities vary by role; delegation logs and IRB-approved signatory lists should define who may complete or sign each section.

Key signers and their responsibilities

Principal Investigator

The Principal Investigator leads the study, ensures informed consent is obtained per IRB approval, maintains oversight of study staff, and is legally responsible for study conduct, data integrity, and timely reporting of adverse events and protocol deviations to the IRB and sponsor.

Authorized Official

The Authorized Institutional Official (e.g., IRB chair or designee) signs on behalf of the institution, verifies regulatory and ethical compliance, and confirms that institutional resources, insurance, and oversight are appropriate for conducting the Research Wings Study.

Essential components included in a professional Research Wings Study

A complete Research Wings Study bundles the consent text, protocol references, signature blocks, and administrative metadata so reviewers and auditors can verify compliance at a glance.

Consent Text

Clear plain-language description of procedures, risks, benefits, voluntary participation, and withdrawal procedures; must match IRB-approved language exactly and include alternatives where relevant.

Eligibility Criteria

Explicit inclusion and exclusion criteria with screening instructions and fields to record the source of eligibility documentation and any pre-enrollment assessments or lab results.

Data Use

Details on what data are collected, how data will be used, who will access them, retention periods, and whether data will be de-identified or shared with third parties or sponsors.

HIPAA Authorization

Separate HIPAA authorization text when protected health information is collected; must state purpose, recipients, and an expiration or revocation mechanism consistent with institutional policy.

Signature Blocks

Distinct signer blocks for participant, legally authorized representative (if applicable), witness or notary fields where required, and a dated investigator signature area for confirmation.

Study Contacts

Investigator and IRB contact information for questions, reporting adverse events, and withdrawal instructions; include phone numbers and email addresses for 24/7 safety reporting if applicable.

Step-by-step: complete the Research Wings Study

Follow these sequential steps to satisfy IRB, consent, and privacy requirements and to create an auditable record.

01

Prepare Materials: Gather protocol, consent text, and HIPAA authorization drafts.
02

IRB Submission: Submit protocol and consent for institutional review board approval.
03

Collect Consent: Provide consent, verify identity, and obtain signature.
04

Archive Records: Store signed records with retention policy and audit trail.

Configure the online Research Wings Study workflow

Set up electronic routing and authentication to mirror the IRB-approved workflow, minimizing manual steps and preserving an audit trail.

Field	Configuration
Authentication Method	Email link, SMS code, or institution SSO based on required assurance.
Signature Fields	Place participant, witness, and investigator signature fields with required date stamps.
Conditional Fields	Show HIPAA text only when health data collection is selected.
Notifications	Email confirmations to participant, PI, and study coordinator upon completion.

Typical eSubmission and signing flow

A concise flow helps staff and participants understand each interaction from upload to archival.

Upload Document: Sender uploads IRB-approved consent and supporting files.
Assign Fields: Place signature, date, and data fields for each signer.
Send to Participant: Participant receives secure link or email to review and sign.
Capture Audit Trail: System records timestamps, IP, and actions for compliance.

Technical considerations for eSigning and storage

Verify integrations, file formats, and authentication options before deploying an electronic Research Wings Study.

Integrations: Salesforce, NetSuite, Microsoft 365, Google Workspace supported.
File Formats: PDF, DOCX, and HTML accepted for upload and signing.
Authentication: Email, SMS code, SSO, or advanced verification available.

Security and compliance features to confirm

Encryption: AES-256 at rest; TLS 1.2/1.3 in transit

Audit Trail: Detailed event log and timestamps

HIPAA BAA: Business associate agreement required

Access Controls: Role-based permissions and SSO options

21 CFR 11: Support for FDA records where required

ISO & SOC: ISO 27001 and SOC 2 Type II

Common preparation errors to avoid

Using non‑IRB‑approved consent language or last‑minute edits that invalidate prior approvals and require reconsent.
Mismatched signer names or dates that break identity verification and complicate audit trails during sponsor or regulatory review.
Failing to include a standalone HIPAA authorization when health data will be shared, risking noncompliance with privacy rules.
Relying on unsecured email for PHI transmission or using weak authentication that increases re-signing and identity-dispute incidents.

Principal risks and potential consequences

Regulatory Sanctions: IRB actions and corrective measures

HIPAA Enforcement: Civil penalties and remediation

Data Loss: Operational disruption and reconsent

Invalid Consent: Risk to study validity and publications

Signature Disputes: Potential legal challenges

Delayed Start: Sponsor and timeline penalties

Real-world examples of electronic consent use

Institutions across healthcare and research use electronic consents to streamline enrollment while preserving auditability and privacy controls.

Fertility Centers of Illinois

Fertility Centers of Illinois implemented electronic consent to speed patient intake while preserving compliance with privacy requirements.

Integration cut turnaround time by weeks.
Signatures and audit trails are stored centrally, enabling rapid retrieval for audits and IRB queries while reducing manual processing, minimizing missing consents, and maintaining encrypted storage with controlled access for authorized personnel.

Optica Ventures LLC

Optica Ventures used the Research Wings Study form to collect participant agreements for remote usability testing across multiple sites and time zones.

A centralized form reduced administrative follow-up.
Centralized records simplified sponsor reporting and allowed role-based access controls for sensitive data, reducing duplication across spreadsheets and improving the traceability of consent events for audit and internal compliance reviews.

Best practices for accurate and efficient completion

Adopt these operational practices to reduce errors, speed approval, and preserve legal validity for the Research Wings Study.

Match IRB language exactly

Always use the IRB‑approved version of consent text and track version numbers; even small wording differences can require re‑submission and reconsent, delaying enrollment and complicating sponsor deliverables.

Verify signer identity consistently

Use the authentication strength required by institutional policy—SSO, two‑factor authentication, or ID credential review—document the method used, and record the outcome in the audit trail to prevent later disputes.

Segment PHI and limit exposure

Design forms to collect only necessary protected health information, apply encryption in transit and at rest, and grant access on a need‑to‑know basis to reduce breach risk and simplify compliance obligations.

Maintain delegation and training logs

Keep up-to-date delegation of authority records and training certificates for staff completing consent activities; auditors often request evidence that individuals were qualified and authorized to obtain consent.

Typical timelines and submission expectations

Timelines vary by institution and IRB; use these target milestones to plan review and enrollment phases.

Protocol Finalization:

Complete all protocol and consent drafts before IRB submission to avoid iterative reviews.

IRB Review Window:

Initial review commonly requires several weeks depending on IRB workload and study risk.

Participant Enrollment Start:

Begin enrollment only after receiving documented IRB approval and any required institutional sign-offs.

Adverse Event Reporting:

Report adverse events per IRB and sponsor timelines; serious events typically require prompt notification.

Annual Continuing Review:

Submit renewals as required by IRB policy to maintain approval and enrollment eligibility.

Key milestones from planning to closeout

Track these sequential milestones so no stage is overlooked during the study lifecycle.

01

Protocol Finalization

Document objectives, endpoints, and consent language before submission.

02

IRB Approval

Obtain written approval and retain approval notice in the study file.

03

Participant Enrollment

Collect consents, verify eligibility, and enter participants into study records.

04

Study Closeout

Complete data lock, archive records, and file final IRB reports.

How the Research Wings Study differs from a standard consent form

Compare core criteria to choose the right template or to adapt a standard consent into the Research Wings Study format.

Criteria	Research Wings Study	Standard Consent
Editable Fields	extensive	limited
eSignature Ready		sometimes
IRB Metadata	embedded	separate
Retention Guidance	included	not included

Typical vendor pricing and feature snapshot for eSignature solutions

Pricing and basic feature availability used here are representative; verify plan details directly with each vendor prior to purchase.

	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	Varies	Varies	Varies	Varies
Bulk Send	Yes	Yes	Yes	Yes	Yes
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes	Yes	Yes	No	No

FAQs and troubleshooting for the Research Wings Study

Answers to common questions about validity, eSign usage, IRB interaction, and recordkeeping for the Research Wings Study.

Need help? Contact support

Is an electronic signature legally valid?
Yes. Under the federal ESIGN Act and state UETA laws, electronic signatures are legally valid for most research consents unless a specific exception applies.
Do I need IRB approval before eSigning?
Yes. The IRB must review and approve the consent form language and the method of electronic signature and storage before enrolling participants.
When is HIPAA authorization required?
If the study collects or discloses protected health information, include a standalone HIPAA authorization that explains uses, recipients, and revocation procedures.
How do I update a signed consent form?
Use an IRB‑approved amendment and reconsent existing participants when changes materially affect risk or participation; retain prior versions for the record.
What authentication level is adequate?
Follow institutional policy; email link with access code often suffices for low‑risk studies, stronger identity proofing may be required for higher‑risk research.
How long must I keep signed consents?
Retain consents per institutional retention policy and applicable federal standards, commonly at least three to seven years depending on study type.

be ready to get more

Join over 28 million airSlate SignNow users

Sign Now