What is the IRB?

IRB stands for “Institutional Review Board”.  The IRB is a committee established to review and approve applications for research projects involving human subjects.  The primary purpose of the IRB is to protect the rights and welfare of the human subjects.

What is a human subject?

Under the DHHS regulations “human subject” means a living individual about whom an investigator (whether professional or student) conducting research:

1. obtains information or biospecimens through intervention or interaction with living individuals and uses, studies or analyzes the information or biospecimens; or
2. obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Who can be the Principal Investigator (PI) of a study?

JHM IRB policy requires the principal investigator of a study to be a Hopkins faculty member or designated senior staff of one of the non-JHU entities covered under the Federal Wide Assurance.  The reason for this requirement is that faculty is required to know the policies of the SOM/SON/Institutions and, thus, have the ultimate responsibility for conduct of human subjects research approved by the JHM IRBs. For more information see " Investigator Responsibilities - Principal Investigators, Co-Investigators and Consent Designees, Post-Doctoral Fellows, and Ph.D.s.

What are the training requirements for the Principal Investigator (PI) and/or study team members?

As of August 1, 2010, the JHM IRB moved to CITI (Collaborative Institutional Training Initiative) for Basics Human Subjects Research (BHSR) and Conflict of Interest (COI) training. Registration for these courses, along with HIPAA & Research and other JHM IRB courses, is available through the Hopkins myLearning website at http://training.jhu.edu/ComplianceTraining. Be sure to save and print your certificates at the time you complete each course. 

For more information on Compliance Training see "Human Subjects Research Training Requirements" .

How can participants be recruited?

It is the job of the IRB to make sure that the selection of subjects for a study is equitable. Each protocol submitted to the JHM IRB for review must explain how subjects will be identified and recruited for the study. Once the pool of potential subjects is identified, the IRB considers how the investigator proposes to approach those individuals. Any approach to subjects must be non-coercive and the potential subjects must voluntarily participate in the recruitment process. The IRB and the investigator must respect and protect subject privacy, the subject’s right to control access to him/herself. In order to assure that these principles are met, the IRB reviews the study recruitment plan and all recruitment materials to determine how the materials will be used, whether the plan will reach the target audience, and how communication between the investigator and the potential subjects will occur. Guidelines for participant recruitment include: "Patient Recruitment and Referral", "Recruiting Study Subjects" , "Reasonable Payment", "Recruiting Students and Employees", "Self-experimentation", and providing information about "Departmental Communications to Patients about Ongoing Research".

Are there requirements for recruitment ads?

All proposed printed advertisements or brochures, web postings, or audio/video advertising, and all communications with primary care physicians, other investigators, or potential subjects informing them about a study must be submitted for IRB review and approval prior to use. These tools are considered to be part of the subject selection and the informed consent process for the study.  This includes any recruitment plans, tools, or campaigns that will be undertaken by the sponsor or any contract research organization involved in the research.  Any proposed changes (including where the tool will be used) to previously approved recruiting tools must be submitted to the JHM IRB for review and approval before they may be used to recruit subjects for a study.  Guidelines for participant recruitment include: "Patient Recruitment and Referral", "Recruiting Study Subjects" , "Reasonable Payment", "Recruiting Students and Employees", "Self-experimentation", and providing information about "Departmental Communications to Patients about Ongoing Research".

What does the IRB consider research?

Research means a systematic investigation (including research development, testing, and evaluation) designed to contribute to generalizable knowledge.

Do I need IRB approval to send study data to an outside site?

Yes, you do need IRB approval to send study data to an outside site. For more information about coordinating center functions and multi-site studies see "Coordinating Center Functions and Multi-Site Studies" and "Policy 114.2 Organization Policy on Cooperative Research and Multi-Center Studies".

What kinds of IRB review are there?

Types of IRB review include convened, expedited, and exempt review. All applications are submitted through eIRB, the on-line electronic application submission system.

Convened IRB Review (full committee review): Any study involving greater than minimal risk, including studies with vulnerable populations and/or sensitive questions, as well as studies with the possibility of physical risk.

Expedited IRB Review (individual committee member review): Only research involving no more than minimal risk to subjects, including blood sampling in minimal amounts, review of records collected for non-research purposes (such as chart reviews), and survey research.

Exempt from Continuing IRB Review: Research with very minimal risk to human subjects as determined by regulatory guidelines may be exempted from continuing review at the discretion of the IRB.  An exemption is granted by the IRB upon review of the application.

What is exempt research?

Exempt research are projects that meet specific criteria as defined in the Revised Common Rule. Exempt research must initially be reviewed by the IRB to make a determination the project meets the criteria. Exempt research does not require continuing review by the IRB. Examples of exempt research may include educational tests, surveys, or interviews or the use of existing data, documents, or other records. Note that the IRB, rather than the researcher, determines when research is exempt.  Researchers proposing exempt research should review the full list of the categories for exempt research, which can be found here.

What is expedited research?

Expedited research involves research that presents no more than minimal risk to the participants, and does not require full IRB Committee review. Examples of expedited research includes blood draw within certain allowable volumes or non-invasive collection of biological specimens, such as a saliva swab. The Revised Common Rule identifies specific categories of research that qualify for expedited review, available here.

How do I submit a new application to eIRB?

All new applications must be submitted in eIRB online at https://e-irb.jhmi.edu . eIRB is the JHM IRB electronic submission system.  Information, instructions and tutorials are located in the "eIRB" section of the IRB website at https://www.hopkinsmedicine.org/institutional_review_board/about/eIRB/eirb_training.html.

What do I need to know about submitting a new application to the IRB?

Any faculty member under the JHSOM auspices whose research involves human subjects must submit an application to the JHMIRB. All Principal Investigators must hold a faculty level appointment, senior staff may act as PI by submitting a letter of support from the Department Chair with the new application. Applications should be as complete as possible using the most recently approved templates as applicable. The IRB must approve the application before research can begin.  All study team members must complete the required compliance training before the application can be approved. All new applications are reviewed for regulatory and administrative issues prior to being scheduled for IRB review. Time to approval for new applications usually depends on the type of research conducted and timely submission of responses to IRB issues.

What should I do if I have a problem with research training requirements?

For assistance with compliance training requirements see the guidance on "Training Requirements for Human Subjects Research".

How often does the IRB meet?

There are seven JHM IRBs. Six IRB Committees (IRB 1, 2, 3, 5,6, & X) meet weekly. The JH-ACH IRB meets monthly.

Can non-Hopkins researchers be on the study team?

Only Hopkins faculty members can be the Principal Investigator of a study. Only Hopkins affiliated investigators may be study team members. Any exception to these requirements must be approved by the JHM Reliance Team. For more information see the guidance on "Investigator Responsibilities Principal Investigators, Co-Investigators and Consent Designees, Post-Doctoral Fellows, and Ph.D.s".

Does the IRB require a complete copy of the grant application with a new application?

Yes.

Where can I go for help in preparing an application?

The IRB website provides links to IRB guidelines, policies, and general information.  eIRB information, including tutorials is available in the “eIRB” section. Contact the eIRB Help Desk at [email protected] for technical assistance.  Call the Office of Human Subjects Research at 410-955-3008 for non-technical assistance. eIRB training is offered monthly on the Johns Hopkins Medical Campus. Registration is required to attend an eIRB technical training class. Classes are listed on the registration site as long as seats are still available.  

What should my application say about risk?

Research subjects may be exposed to physical, psychological, social, and economic risks.  Very few studies involve no risk.  In minimal risk studies, the risks to participants should be no more than those encountered in everyday life (or during routine physical or psychological tests).  The PI must evaluate whether the degree of risk is safe enough for the specific subject population by considering: 1) Who are the research subjects and what kinds of risks do they routinely encounter? 2) Are some subjects more vulnerable than others, and is the risk/benefit ratio worth the exposure? 3) What are possible adverse effects, and can the harm be fixed or prevented? 4) Having taken the obvious steps to reduce or circumvent harm, what, if any, are the remaining levels of risk, possible consequences to certain classes of subjects, consequences to the entire research population, and is the research now “safe enough”?

What is Informed Consent?

Consent is a continuing process that starts before any forms are signed and continues until the individual’s participation is complete.  It involves meeting with a potential participant, determining whether s/he is capable of giving consent, discussing the purpose, risks, and benefits of participation, etc.  Its goal is to assure that prospective participants can knowledgeably and voluntarily, without coercion, decide whether to participate.  Consent is required for every participant unless the consent or one of its elements has been waived by the IRB or the IRB has determined that the research is exempt.  Information on informed consent and assent may be found in the Guidelines section of the IRB website.

 

When can I request a waiver of documentation of consent?

In certain cases, the IRB may waive the requirement that an investigator obtain a participant’s signature as part of the consent process.   The circumstances under which a waiver of documentation of consent may be granted by the IRB can be found in the IRB’s Guidance on Waiver of Documentation of Consent.

When requesting to waive the consent signature requirement, you should consider which of the circumstances may apply to your study and describe the process for obtaining consent without a signature in Section 16 of the eIRB application. Please note:

• in all cases, the IRB requires a document that will be used for consent purposes. This could be in the form of short text, a cover letter, or a script [e.g. when consent will be presented orally]
• even when waiving the signature requirement, all other required consent elements must still be included in the consent script/text.

What is Informed Assent?

Informed Assent is the consent form for children and must be accompanied by a parent/guardian consent form.  Information on informed consent and assent may be found on the Guidelinespage.

Where can I find information on Informed Consent?

Information on informed consent may be found here and here.

Please click here for information about the new JHM IRB Combined Informed Consent/HIPAA Authorization Template, required for studies approved on or after January 21, 2019. 

Does the consent form given to research participants have to be the IRB approved/stamped consent?

Yes.  Download the IRB approved consent template from within the eIRB application.  Click the “?” icon beside the consent application question, and right click the green consent template link.  Save it to your local drive before completing.  eIRB information and instructions are provided in the “eIRB” section of the website. Contact the eIRB Help Desk at [email protected] for further assistance.

Can deception be used in my research?

Deception may be used if the benefits outweigh the risks to the participants and if there is compelling justification.  The subjects must be informed at the end of their participation, either in person or via email, that the experiment involved some deception and the reason for the deception.  They must have the opportunity to ask questions during the debriefing.  A debriefing script must be submitted as part of the application.

What do I need to know about data?

Maintaining confidentiality is essential to any research in order to protect the privacy and well-being of participants.  Whenever possible, research should use data prepared from personal information from which the participant cannot be identified by the recipient of the information.  If this is not possible, the amount of personal data stored by researchers should be kept to the minimum necessary to achieve the purpose of the research.

What does it mean to be “de-identified”?

Data that does not include any direct identifiers of the individual or of the individual’s relatives, employers, or household members is considered to be de-identified.

What about HIPAA?

HIPAA stands for the Health Insurance Portability and Accountability Act of 1996.  HIPAA regulations focus on privacy and security protections for individuals’ health care information, protected health information (PHI).  PHI includes individually identifiable health and health care payment information (including the demographic data that is a potential identifier of the individual) maintained in the records of health care providers.  If a research study either uses or creates PHI, documentation of the subject’s authorization to use such information is required. Learn more about HIPAA and research.

Can HIPAA Authorization be waived?

HIPAA Authorization may be waved when strict confidentiality measures are in place, or when the research could not practicably be conducted without the waiver or without access to the PHI.  A limited waiver or authorization for recruitment purposes may be requested as part of your application.

What happens after submission?

Your study will be assigned to an IRB Committee.  The Research Subjects Specialist (RSS) for that committee will review your application and uploaded documents.  If the application is determined “incomplete” by the RSS, it will be returned to you to make revisions.  Once you submit the completed application, the RSS will assign your application to the next available meeting.  A Consent Form Specialist (CFS) will review your consent form and make necessary changes.  Upon review by the IRB Committee additional changes may be requested.  You will have the opportunity to accept or reject these changes.

How long does IRB review take?

An expedited or exempt review may take about two weeks.  Studies requiring convened review may take three or more weeks.  The PI has a significant influence on the length of time between submission and approval.  Well prepared applications result in fewer requests for changes raised as issues by the IRB.  Rapid response by the PI to the IRB issues speeds the approval process.

What criteria do reviewers apply when looking at my project?

Reviewers look at purpose, methodology, adequate handling of informed consent, whether the research deals with high risk or sensitive issues and, if so, whether the benefits outweigh the risks, and the degree to which confidentiality is both assured and protected.

What delays approval of my IRB application?

Some things that may delay approval of your IRB application include submitting an incomplete application by failing to: complete compliance training, cross-checking information on the consent form against information in the protocol, and proofreading the application and relevant documents.

What are the possible outcomes of IRB Review?

Approved: The PI is notified that the application is approved and does not require modification. This is a rare outcome.

Approved with Administrative Changes: If minor modifications are required by the IRB, the PI must complete the revisions and resubmit the application. In most cases, the modifications will be reviewed and administratively approved.

Tabled: If the proposal generates significant ethical questions, or appears to be scientifically unsound, the study will be tabled and further information will be requested. Studies may also be tabled if the protocol or consent documents are poorly written or do not provide sufficient information. If the application is tabled at a convened meeting it will be reviewed at a subsequent IRB meeting once the PI has submitted the revisions. If an expedited reviewer tables an application, the response will be reviewed using an expedited review process.

Disapproved: Applications will be disapproved if they are judged to be ethically or scientifically unsound. Investigators are not advised to resubmit disapproved studies without consulting the IRB. This is a rare – but possible – outcome.

What happens after I receive approval?

You may begin your research upon receipt of the written documentation of IRB approval.  This approval letter may be downloaded from the application workspace in eIRB.  Tutorials and instructions where to find and how to download IRB letters are available, or you may contact the eIRB Help Desk [email protected] for assistance.  eIRB training is offered monthly on the Johns Hopkins Medical Campus and the Bayview Medical Campus.  Registration is required to attend an eIRB technical training class. Classes are listed on the registration site as long as seats are still available.

How long is the approval period?

The approval period for any research is no more than one year, less if the proposed research needs more frequent monitoring.  Before the end of the approval period, the Principal Investigator must submit a request for continuing review.  Even if within the approval period a change in research (amendment) is submitted and approved, the original approval date will stand.

What if I encounter problems during research?

Researchers must promptly report to the IRB any serious or continuing noncompliance with federal regulations or university policies, any injuries to subjects, or unanticipated problems.  Information on reporting problems be found on the Guidelines page.  For assistance call the Office for Human Subjects Research at 410-955-3008 and ask to speak to a member of the compliance team.

If your protocol deviation is not a Serious Adverse Event (SAE) and has already occurred, or if it is a proposed deviation (has not yet occurred), you may wait and report it with the next continuing review or include it in a change in research.  If your protocol deviation is a SAE, the PI needs to submit a problem event report.

When do I need to submit a Problem/Event Report?

Prompt reporting of unanticipated problems/events should occur as soon as possible after the PI learns of the event, but in all cases within 10 working days with the exception of death of a JHM participant.  Prompt reporting requirements for death of a JHM participant are defined in the Organizational Policy on Prompt Reporting of Reportable Events.

When do I need to submit a report on unanticipated problems?

Prompt reporting of unanticipated problems/events should occur as soon as possible after the PI learns of the event, but in all cases within 10 working days with the exception of death of a JHM participant.  Prompt reporting requirements for death of a JHM participant are defined in the Organizational Policy on Prompt Reporting of Reportable Events.

What if I want to modify the study?

Once the application is submitted, the study team can read it but not make any changes unless the application is returned to the PI by the IRB Committee or the Research Subjects Specialist (RSS) assigned to the study.  To change a currently approved study, the PI must submit a Further Study Action - Change in Research through eIRB.  The Change in Research must be reviewed and approved by the IRB Committee before it can take effect.

What are the guidelines on keeping research data?

Researchers are required to keep IRB letters of approval and confidential research data, including informed consent/assent forms in a secure location as long as the data is scientifically valuable. For more information see "Record Retention".

Do I need to let the IRB know when my study is finished?

When the study is finished, the PI must submit a Termination Report through eIRB.  The report should include information about the total number of participants, changes since the last approval, problems and withdrawals, study results, sponsor/accounting information, and reasons for termination. For more information see "IRB Review of Research: Project Closed to Accrual, in Data Analysis Only, or Terminated".

If my study approval lapses, do I need to submit a termination report?

If you are no longer interested in continuing the study there is nothing that you need to do.  If you want to continue the study but your approval has lapsed, you will have to submit a new application in eIRB.  There is a place in your new application where you select that this is a resubmission of a previously approved study and enter the original study number. For more information see "IRB Review of Research: Project Closed to Accrual, in Data Analysis Only, or Terminated".

I have an application that expired before I was able to submit my continuing review.  I am getting an error message when I try to do it.  Do I have to reapply under a new number?  I don’t want to interrupt the project for too long.

The eIRB system will not allow us to extend expiration dates for continuing reviews.  As you may recall, one of the findings that the government used to shut down the IRB in 2001 was a practice of allowing investigators to extend research beyond the limit of the approval, even in situations that seemed beyond their control.  Ever since then, the policy has been in place to terminate any study that had not been submitted for a renewal prior to the expiration date.  There is a place in your new application where you select that this is a resubmission of a previously approved study and enter the original study number.

How do I end or close my study?

To end or close your study you should submit a Termination Report.

If I am only doing data analysis, do I have to keep my study open?

If the PI is not using identifiable data, the study can be terminated and no further IRB oversight is required.  Research that initially required a convened review may change to an expedited review for the continuing review if the PI is completing data analysis with identifiable data.  For more information see "IRB Review of Research: Project Closed to Accrual, in Data Analysis Only, or Terminated" and "Expedited Review Process".

Where and how do I find out billing information?

For more information see "Fees for JHM IRB Review ".

Where do I get more information?

The IRB website provides links to IRB guidelines, policies, and general information.  eIRB information, including tutorials is available in the “eIRB” section. Contact the eIRB Help Desk at [email protected] for technical assistance. Call the Office of Human Subjects Research at 410-955-3008 for non-technical assistance. eIRB training is offered monthly on the Johns Hopkins Medical Campus and the Bayview Medical Campus. Registration is required to attend an eIRB technical training class. Classes are listed on the registration site as long as seats are still available.