Human Stem Cell and Related Research
Human Stem Cell and Related Research Guidance
There are several resources and processes for faculty conducting Human Stem Cell and related research at The Johns Hopkins University.
Committees and Related Entities
Due to the nature of human stem cell and related research, a Principal Investigator (PI) may need to submit more than one application. In addition, related committees may need to review research proposals to confirm they meet current safety, ethical, and administrative requirements.
Below are links to charts that briefly describe the function of committees/entities with oversight responsibilities for some human stem cell and research, which types of research they oversee, and related links. In addition, there are some examples of potential proposed research and how the application may flow through the approval process.
Be aware that the following guides were formulated relevant to the JHU SOM. Researchers from other JHU faculties may also find this guide helpful, but know that certain processes or points of contact may differ.
Committee and Entity Chart
Committees and entities are categorized into Primary Oversight Committees, Ancillary Committees, and Institutional Agreement Entities.
- Primary Oversight Committees are PI-facing and require direct submission of materials from the PI.
- Ancillary Committees are generally triggered as applicable through the eIRB or eISCRO application and evaluate relevant parts of the research proposal internally. In some cases, submission of materials to an ancillary committee may be required.
- A PI might interact with an Institutional Agreement Entity for matters pertaining to contracts, grants, agreements, and procurement of commercial materials.
Example Scenarios
The example scenarios may be used to understand how certain reviews may be triggered and which applications should be submitted. Proposed actions or items that may trigger a review are underlined and color coded, which corresponds to the color of the respective committee or entity on the chart. Included are also explanations of why such an item may trigger a review and which entity or committee such a review’s jurisdiction falls under. Note that the examples are hypothetical and should be used for reference only.
Relevant Policies, Documents, and Resources
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- Biospecimen Testing Language - Download the Biospecimen Testing Language Word document under “Forms, Tools, and Templates Related to the Revised Common Rule.”
- Consent Template for Human Pluripotent Stem Cell Research - Download the appropriate consent forms under “Consent Forms.”
- JHM IRB Forms - All forms, tools, and templates related to the IRB application, including Application Forms, Consent Forms, High Risk Review Forms, HIPAA Forms, IND/IDE Forms, NCI CIRB Forms, Problem/Event Report Forms, Reliance Documents, and Additional Forms available to download in Word or PDF format.
- JHM IRB Resources - Resources provided by the IRB including Databases, Libraries, JHM Offices, Popular Resources, and Policies.
- JHM Policy Governing Use of Human Biospecimens to Derive Immortalized or Pluripotent Stem Cell Lines - See this document for policies on Human Biospecimen collection and Incoming/Outgoing Material Transfer Agreements.
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- International Society for Stem Cell Research: Guidelines for Stem Cell Research and Clinical Translation - The International Society for Stem Cell Research (ISSCR)’s revised Guidelines for Stem Cell Research and Clinical Translation (2021) “address the international diversity of cultural, political, legal, and ethical issues associated with stem cell research and its translation to medicine.” This document informs some of JHM’s policy on Human Stem Cell and Related research.
- Maryland Stem Cell Research Fund - The Maryland Stem Cell Research Fund promotes state-funded stem cell research and cures through grants and loans to public and private entities in the state.
- National Academies' Guidelines for Human Embryonic Stem Cell Research - Download or read online the Final Report of the National Academies’ Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academie’s Guidelines for Human Embryonic Stem Cell Research.
- NIH Human Embryonic Stem Cell Registry - Lists federally approved lines eligible for use in NIH funded research.
- NIH Stem Cell Information - NIH Stem Cell Research Policy and FAQs.
- Training Module: Ethical Oversight of Human Stem Cell Research 2010 - This online training course provides an introduction to both ethical guidelines for human pluripotent stem cell research and to the Policies and Procedures of the Johns Hopkins University Institutional Stem Cell Research Oversight (JHU ISCRO) Committee.
- U.S. Department of Health and Human Services Regulations and Policy - Materials from the Office for Human Research Protections (OHRP)’s Regulations, Policy, & Guidance to assist in conducting ethical research in compliance with U.S. Department of Health and Human Services (HHS) regulations.