Accelerated Ethical Review Application: Low-Risk Research Protocol

Principal Investigator Full Name

Principal Investigator Academic Title

Department or Division

Institution or University Name

Principal Investigator Email Address

Principal Investigator Phone Number

Principal Investigator Credentials and Qualifications

Co-Investigators and Research Team Members

Study Protocol Title

Protocol Version Number

Protocol Date

Anticipated Study Start Date

Anticipated Study Completion Date

Study Type Classification

Please specify the study type and justify its classification:

Research Design Methodology

Describe the research design methodology:

Primary Research Objective

Secondary Research Objectives

Study Hypotheses

Funding Source

Funding Agency Name

Funding Agency Name

Commercial Sponsor Name

Funding Source Description

Grant or Award Number

Is this a multi-site study involving more than one institution or location?

Multi-site Study Details

Has this protocol been previously reviewed or approved by any IRB or ethics committee?

Previous IRB Approvals

Regulatory Classification

Describe the medical device and regulatory pathway:

Describe the drug/biologic and regulatory requirements:

Describe the clinical investigation and oversight requirements:

Describe the regulatory classification and requirements:

Target Sample Size

Sample Size Justification and Statistical Rationale

Recruitment Strategies and Methods

Describe the alternative recruitment method:

Recruitment Locations and Settings

Inclusion Criteria

Exclusion Criteria

Age Range of Target Participants

Specify the minor age range (e.g., 13-17 years)

Specify the age range for minors in the study

Specify the full age range (e.g., 8-75 years)

Will your study involve any vulnerable or special population groups requiring additional protections?

Select all vulnerable populations that apply:

Describe specific protections for minor participants (parental permission, assent procedures, child advocate):

Describe protections for pregnant participants (fetal risk assessment, obstetric consultation):

Describe protections for prisoner participants (prison advocate, non-coercive environment, institutional permissions):

Describe protections for cognitively impaired participants (legally authorized representative, capacity assessment):

Describe protections for economically disadvantaged (non-coercive compensation, resource provision):

Describe how power differential will be managed (voluntary nature emphasized, independent recruitment):

Describe language accommodations (translated materials, interpreter services, cultural adaptation):

Describe protections for terminally ill participants (palliative care coordination, emotional support):

Describe the vulnerable population and specific protections:

Will participants be recruited from the same institution where the Principal Investigator is employed or holds authority?

Describe the relationship and measures to prevent undue influence or coercion:

Will participants receive compensation, reimbursement, or incentives?

Compensation Details

Do you believe the compensation could be considered coercive or undue inducement?

Explain your assessment and any steps taken to minimize coercion risk:

Have all recruitment materials (flyers, emails, scripts) been reviewed for accuracy and non-coercive language?

Upload all recruitment materials for IRB review:

Describe the Informed Consent Process

Consent Form Language

List all languages and confirm translation verification process:

Describe the language and translation verification:

Describe the language arrangement:

Will written informed consent be obtained from all participants?

Justify the waiver or alteration of informed consent. Explain why the research could not practicably be carried out without the waiver and how participants' rights are protected:

If minors are involved, will assent be obtained from the minor participants?

At what age will assent be sought?

Justify why assent is not appropriate or feasible:

Will parental permission be obtained for minor participants?

Parental permission requirement:

Will any audio, video, or photographic recordings be made of participants?

Describe specific consent for recording, storage, use, and future dissemination:

Data Collection Methods

Specify the online platform and data security features:

Specify interview location and privacy measures:

Specify group size and confidentiality protocols:

Specify measurements and safety protocols:

Specify sample type, collection procedure, and storage:

Specify data source and permission status:

Specify recording type and consent details:

Specify tracking technology and privacy safeguards:

Describe the data collection method:

Will data be anonymized such that individual participants cannot be identified, directly or through identifiers linked to them?

Anonymization Technique

Describe the anonymization technique:

Justify why data cannot be anonymized and describe confidentiality protections:

Data Storage Location and Infrastructure

Describe the storage arrangement:

Data Security and Protection Measures

Describe the security measure:

Data Retention Period

Data Destruction or Disposition Method

Describe the disposition method:

Confidentiality Level of Collected Data

Re-identification Risk Assessment

Have you obtained or will you obtain a Certificate of Confidentiality or equivalent legal protective instrument?

Provide details of the certificate and protected data:

Will data be shared with other researchers or deposited in a repository?

Describe data sharing plan, repository name, access controls, and any data use agreements:

Overall Risk Level Classification

Are there any physical risks or discomforts to participants?

Select all physical risks that apply:

Describe blood draw volume, frequency, trained personnel, and infection control:

Describe activity intensity, screening, and emergency preparedness:

Describe substance, dosage, and toxicity monitoring:

Describe radiation dose and justification:

Describe device and safety monitoring:

Describe pain management and minimization:

Describe the physical risk and mitigation:

Are there any psychological, emotional, or social risks to participants?

Select all psychological/social risks that apply:

Describe distress screening and support resources:

Describe trauma-informed approach and crisis protocol:

Describe group facilitation and voluntary participation:

Describe confidentiality protections and breach response:

Describe stigma mitigation and social risk management:

Describe relationship safeguards and participant control:

Describe sensitive measurement and support:

Describe the risk and mitigation strategy:

Are there any digital, technological, or cybersecurity risks?

Select all digital risks that apply:

Describe breach prevention, detection, and notification plan:

Describe cybersecurity measures and incident response:

Describe backup systems and data recovery:

Describe software vetting and privacy controls:

Describe tracking limitations and opt-out:

Describe third-party agreements and data protections:

Describe the digital risk and mitigation:

Risk-Benefit Analysis and Justification

Adverse Event Reporting Plan

Data Breach Response and Notification Plan

Study Monitoring and Quality Assurance Plan

Emergency Contact Information and Procedures

Will a Data Safety Monitoring Board (DSMB) or independent monitor be used?

Describe DSMB composition, charter, and monitoring frequency:

Are there clear procedures for participant withdrawal or study termination?

Describe withdrawal procedures, data handling for withdrawn participants, and circumstances for study termination:

Will participants receive individual or aggregate study results?

Describe how and when results will be shared, and any counseling or interpretation support:

IRB Review Category Requested

If requesting Exempt status, select applicable category:

Describe the exempt category and justification:

If requesting Expedited status, select applicable category:

Describe the expedited category and justification:

Do you or any research team member have any potential conflict of interest related to this study?

Describe the nature of the conflict and management plan:

Are there any financial conflicts of interest (e.g., equity, patents, consulting fees)?

Disclose all financial interests and how they will be managed to protect research integrity:

Institutional Approvals Required Beyond IRB

Describe the approval required:

Have all required institutional approvals been obtained?

List pending approvals and expected timeline:

Additional Documentation Submitted with this Application

I attest that all information provided in this application is truthful, accurate, and complete to the best of my knowledge. I understand that any misrepresentation may result in protocol suspension or revocation of IRB approval.

I confirm that I will conduct this study in accordance with all applicable ethical principles, institutional policies, and international guidelines for research involving human participants.

I agree to submit continuing review reports as required, report any adverse events or protocol deviations promptly, and obtain IRB approval for any modifications before implementation.

Principal Investigator Signature

Date of Submission

Additional Comments for IRB Chair or Reviewers