Institutional Review Board (IRB)

Forms

Find below the forms and suggested language for components of your IRB study. If you have any questions regarding the forms or trouble accessing them, please contact the IRB: BSPH.irboffice@jhu.edu. 

Please note, when uploading study documents to the PHIRST system, a standard file-naming convention should be used for study documents to help us with document control, such as: 

[type of form]_[population]_[activity]_[language if translating documents]_[version#]_[date of the document]_[clean or tracked] 

Examples: 

  • Adult Consent Form_Women 15-49_IDI_Spanish_V1_01Jan2025_Clean
  • Recruitment Script_Men_IDI_English_V1_01Jan2025_TrackedNote that the file name should also appear on the document itself to assist reviewers. 
Research Plan Templates
Consent Form Templates
  • Informed Consent Elements Worksheet
  • Adult Informed Consent/HIPAA Authorization for Signature
    • Use for any study when a signature is required.
    • Use for emancipated children, and under circumstances when a child is receiving medical treatment where parental permission is not required.
    • Use for any study that requires HIPAA authorization.
    • Template includes language for data collection on genes, cell lines, and genomes, certificates of confidentiality, clinicaltrials.gov, repository storage, etc; select and customize sections that apply.
  • Adult Oral Consent Script
    • Use for minimal risk studies with no local signature requirements (e.g. surveys, interviews, focus groups, and behavioral interventions).
    • Use for children considered emancipated who can consent for themselves, and a signed consent is not required.
    • Each of the elements must be addressed in the oral consent: Purpose, Procedures, Risks, Benefits, Voluntary Participation.
    • Templates can be used for virtual consent and for electronic surveys with no in-person contact with participants.
  • Parental Permission Form for Signature
    • Use for the parent or guardian to grant permission for their child to participate in a specific activity, program, or study.
    • Use for greater-than-minimal-risk studies.
    • Use language such as “your child,” “your daughter,” etc.
    • Includes HIPAA language to grant legal permission for accessing and using a child’s protected health information in your research, protecting the child’s privacy and informing parents/guardians about the purpose and scope of the data usage.
  • Parental Permission Form – Oral
    • ````Used when obtaining signed permission is impractical or in minimal risk research activities.
  • Assent Form – Signed and Oral
    • Assent required for children 7 years of age or older.
    • Signed assent: Signed assent is typically required for greater-than-minimal-risk activities or when dealing with sensitive information, and when the minor is able to comprehend the form and provide a signature. It is obtained only from minors who are old enough to read and understand the assent text. The IRB determines when a signature should be used.
    • Oral assent is used for minimal-risk activities or when signed assent is impractical.
    • Oral assent scripts should not include HIPAA language.
  • Media Permission Form
    • To be used when recordings or images will be disseminated beyond the research, such as publishing pictures in newsletters.
  • Certificate of Translation Template
    • Use this form when documents are translated from English to another language by a study team member, a translation company, or anyone who is fluent in English and the local language(s). Only the consent and recruitment documents are required to be translated unless the translated instruments need to be listed in the approval memo. The PI must sign off on the completed form. 
Informed Consent GuidelinesGlossaries of Lay Terms and Other Resources

Code of Federal Regulations (CFR) 
The U.S. Department of Health and Human Services (HHS) codified its regulations for the protection of human subjects research in the Code of Federal Regulations (CFR), which includes five subparts (A through E) and contains the legal framework for informed consent requirements under U.S. law. 

Title 45: Public Welfare 
Code of Federal Regulations: Title 45 Public Welfare 
This is the main landing page for all parts of Title 45 of the Code of Federal Regulations (CFR), including regulations related to research protections like Part 46, which outlines the ethical and regulatory requirements for research involving human subjects. 

Department of Health and Human Services (HHS) Part 46: Protection of Human Subjects 
Code of Federal Regulations - 45 CFR Part 46 - Protection of Human Subjects 
This federal regulation outlines the U.S. Department of Health and Human Services (HHS) policy for the protection of human subjects in research. It sets requirements for IRB review, informed consent, and additional protections for vulnerable groups. 

Section 46.116 – General Requirements for Informed Consent 
Read 45 CFR 46.116 
This section explains what must be included in the informed consent process, including essential information participants need to understand the research, their rights, and the voluntary nature of participation. 

Section 46.117 – Documentation of Informed Consent 
Read 45 CFR 46.117 
This section describes how informed consent must be documented, including when a signed consent form is required and when an IRB may approve a waiver of documentation. 

These resources help researchers translate complex scientific and medical terms into plain language so that participants can better understand: 

OHRP FAQ and Guidance for Informed Consent 
Resources from the Office for Human Research Protections (OHRP), part of the U.S. Department of Health and Human Services (HHS), offer detailed guidance, FAQs, and compliance tips related to informed consent. 

HHS Informed Consent Guidance 
Comprehensive OHRP guidance on the informed consent process, including tips for writing clear, understandable forms and ensuring ethical consent processes. 

HHS Informed Consent FAQ 
Frequently Asked Questions on informed consent requirements, waivers, and documentation standards. 

HHS Informed Consent Posting Guidance 
Instructions for posting consent forms for clinical trials (as required by the revised Common Rule), including timelines and locations for posting. 

 

HIPAA Forms
  • Application for Disclosure of Protected Health Information from Johns Hopkins Medicine (JHM) for Research Purposes
    • Use this form for disclosure of PHI from Johns Hopkins Medicine (JHM) for research purposes and to request one or more of the five mechanisms that you need to use the PHI for in your study: Authorization, Preparatory to Research, Waiver, Limited Dataset, or Decedents.
  • HIPAA Authorization for Signature
    • The HIPAA Authorization Form has been incorporated into the Adult Signed Consent Form Template. There is no longer a need for a separate HIPAA Authorization Form unless otherwise instructed due to special circumstances, such as relying on an external IRB.
    • This form includes a HIPAA statement for International Research to be included in the consent document if the participant’s personal information may be sent to a U.S. covered entity for analysis or storage. 

  • Parent Permission Form (with HIPAA language)
    • Use this form to obtain legal permission for accessing and using a child’s protected health information in your research, protecting the child’s privacy and informing parents/guardians about the purpose and scope of the data usage.
  • Medical Record Release Form
    • This generic form authorizes the release of protected health information (PHI) for research from health care providers. May be used in conjunction with a HIPAA Authorization and/or a consent form without a HIPAA Authorization. 

Anticipated Problems Reporting Form
  • Anticipated Problem/Event Summary Form
    • Use to report any anticipated problems/events that have been described in the research plan, consent form, and/or the investigator’s brochure.
    • Submit as an attachment to your Progress Report in PHIRST.
    • Must be used to submit sponsor-required adverse events that do not meet the BSPH requirements for Unanticipated Problem/Event reporting. Not to be used to submit Sponsor Generated IND Safety Reports.
    • Note: this form is only to be used to log and report anticipated problems that are documented by the research team during normal study operations. Unanticipated problems should be reported promptly (within 10 working days) after discovery through PHIRST. 
Ancillary Review Forms