Human Subjects Research Proposal

Use a Human Subjects Research Proposal 2016 template to make your document workflow more streamlined.

What a human subjects research proposal does

A Human Subjects Research Proposal explains how a study will involve people, including its purpose, procedures, participant population, consent process, privacy safeguards, and risk controls. Researchers submit it for institutional review before beginning covered activities; the reviewing body determines whether revisions, approval, or additional protections are required. The proposal is not itself a universal federal form, so required sections and deadlines depend on the institution, sponsor, and applicable rules. When signatures are permitted electronically, signNow can route the proposal, capture approval events, and retain the completed record with an audit trail.

Research teams

Research teams can complete protocol approvals, participant-facing consent forms, investigator attestations, and amendment acknowledgments when institutional policy permits electronic signatures.

Healthcare and education

Healthcare and academic organizations can route privacy-sensitive study records while limiting access, preserving signer identity, and retaining the approved document version.

How the proposal workflow works

Prepare the institution-approved version first, then use signNow to route signatures without changing the research substance.

Upload the proposal: Upload the approved proposal and let signNow detect fillable fields for names, dates, initials, and signatures.
Assign fields: Review detected fields, assign each reviewer or investigator, and add required consent or approval fields.
Route for signatures: Send the proposal through signNow so each participant or approver completes the fields in sequence.
Store the record: Download the completed proposal and audit trail after every required signer finishes the assigned actions.

Setting	Recommendation
Authentication method	Email verification with SMS OTP
Signature type	Electronic signature with signer intent
Audit trail	Export with completed proposal
Document retention	Six years for HIPAA records
Encryption	TLS 1.2/1.3 and AES-256

be ready to get more

Get legally-binding signatures now!

Start free trial

Request a call

Best ROI. Our customers achieve an average 7x ROI within the first six months.
Scales with your use cases. From SMBs to mid-market, airSlate SignNow delivers results for businesses of all sizes.
Intuitive UI and API. Sign and send documents from your apps in minutes.

Field detection

Upload the institution-approved proposal and let signNow identify fields for investigator names, dates, initials, and signatures, reducing manual placement before routing.

Role assignment

Assign each signature or approval field to the correct investigator, reviewer, or administrator so responsibilities remain visible throughout the proposal workflow.

Controlled routing

Route the proposal electronically to authorized reviewers, preserving the sequence required by the institution’s approval process without changing the protocol text.

Audit trail

Capture signer actions, timestamps, and document history in an audit trail that can accompany the completed Human Subjects Research Proposal.

Reusable templates

Use templates for recurring proposal structures while updating study-specific risks, participant information, consent language, and approval dates before each distribution.

Mobile access

Access assigned documents through signNow mobile apps when authorized reviewers need to review or sign away from a desktop workstation.

Platform requirements for signing

Use an up-to-date Chrome, Firefox, Safari, or Edge browser on Windows or macOS. signNow also provides mobile apps for iOS and Android, allowing authorized reviewers to access and sign assigned research documents from supported phones or tablets.

Browsers Chrome, Firefox, Safari, and Edge
Desktop systems Windows and macOS computers
Mobile access iOS and Android mobile apps

Organizations handling participant information should manage devices through established security policies, limit downloads, and apply role-based access. Teams can connect signNow to approved systems through available integrations or API options, while regulated deployments should confirm whether a business associate agreement, stronger signer authentication, or additional institutional controls is required.

Find and fill out the correct human subjects research proposal

airSlate SignNow helps you fill in and sign documents in minutes, error-free. Choose the correct version of the editable PDF form from the list and get started filling it out.

Versions	Form popularity	Fillable & printable
DYC Human Subjects Research Proposal 2016	4.8 Satisfied (9579 Votes)
DYC Human Subjects Research Proposal 2010	4.8 Satisfied (265 Votes)

Integrations for research documentation

Connect proposal routing with the systems that hold study, participant, project, and approval information.

Record-keeping practices for research proposals

A defensible research record connects the approved protocol, consent materials, amendments, signatures, and audit evidence.

Set retention from applicable requirements

Set the retention period from the study sponsor, institutional policy, and applicable privacy requirements rather than assuming one universal period. For HIPAA-covered documentation, retain required policies and procedures for six years from creation or last effective date under 45 CFR §164.530(j).

Preserve the approval record together

Export the completed proposal and signNow audit trail together. The audit trail records signing activity, timestamps, and related events, helping reviewers connect the approved version with the people and actions associated with it.

Archive approved versions securely

Archive the final proposal in a restricted repository with version naming, access controls, and documented ownership. Keep superseded drafts separate so staff can identify the approved protocol without accidentally treating an earlier version as authoritative.

Control amendments and identifiers

Review participant-facing content before circulation. Remove unnecessary identifiers, confirm the consent language matches the approved protocol, and document any amendment so the retained record shows which version governed the study.

Retention periods for related records

A proposal has no single universal retention period; apply the rule that matches the data, institution, sponsor, and record category.

Six years for HIPAA records

HIPAA-covered records require retention for six years from creation or last effective date under 45 CFR §164.530(j).

Three years for tax records

Federal tax records generally require three years from filing under IRC §6501(a), unless a longer rule applies.

Three years for payroll records

Payroll records under the FLSA require three years under 29 CFR §516.5 when applicable to the study organization.

Five years for injury records

OSHA injury records require five years following the covered year under 29 CFR §1904.33.

Thirty years for exposure records

OSHA exposure records require thirty years under 29 CFR §1910.1020 when the research record qualifies.

Privacy and disclosure risks to check

Participant names, health information, and contact details can appear in proposals; restrict access and remove unnecessary identifiers before circulation.
Electronic consent records should identify the signer, document the consent event, and preserve the version reviewed by each participant.
Sharing a proposal through unrestricted links can expose research protocols and participant information to unauthorized recipients.
Role changes can leave former coordinators with access to signed proposals; review permissions and revoke access promptly.

Security controls for research documents

Transport encryption:

TLS 1.2/1.3 in transit

Storage encryption:

AES-256 at rest

Security reporting:

SOC 2 Type II certified

Information security:

ISO 27001 certified

Health data controls:

HIPAA compliance with BAA

Electronic signatures:

ESIGN and UETA compliant

Human Subjects Research Proposal troubleshooting

These answers address approval, consent, privacy, routing, and plan questions that arise when preparing this research document.

Can signNow replace institutional review board approval? No. signNow routes and records signatures, but the institution or reviewing board must decide whether the Human Subjects Research Proposal is approved and whether study conditions are satisfied.

How should a consent version mismatch be handled? Stop routing, compare the proposal with the approved consent language, correct the document, and resend it. Preserve the superseded version and audit trail so the amendment history remains understandable.

Does electronic signing satisfy ESIGN and UETA requirements? signNow supports ESIGN and UETA workflows, but enforceability still depends on intent, consent, signer attribution, and retention of a reproducible record under 15 U.S.C. chapter 96 and applicable state law.

Is HIPAA coverage automatic for every research proposal? No. HIPAA applies when protected health information and a covered entity or business associate are involved. signNow states that HIPAA compliance requires a business associate agreement, along with appropriate organizational safeguards.

Why did a reviewer fail to receive the proposal? Check the assigned email address, resend the invitation, and verify access permissions. signNow templates and audit trails can help identify the routed document and recorded delivery or signing activity.

Which signNow plan includes bulk sending? Business Premium includes bulk send at $15 per user per month when billed annually. The Business plan is $8 per user per month annually, while plan limits and overage terms should be reviewed before repeated study distribution.

28M+Documents signed

13+Years in business

4.6/5Average G2 rating

BE READY TO GET MORE

Get this form now!

If you believe that this page should be taken down, please follow our DMCA take-down process.