IRB News Archives - 2008
- The IRB has revised its Amendment Application form to clarify the requirements for changing study personnel. An “Investigator Agreement” has been posted as a tool for documenting each new study team member’s agreement to assume the responsibilities of being involved in a human subjects research project.
- The JHSPH IRB has posted a new policy (number 101.04) on “Public Health Practice and Public Health Research.” In addition, we have posted a new document called “Guidance: Determining Public Health Practice from Public Health Research” that explains how the IRB will make determinations as to whether a project is practice or research.
- The Institution Official has approved a set of JHSPH IRB Policies which govern the conduct of human subjects research at the Bloomberg School of Public Health. They are consistent with those posted by the School of Medicine IRB, with some variations to account for the differences between our institutions and the kind of work we do. The policies are posted under Policies and Guidance. We have provided a pdf version that can be searched by the policy number that is listed in the policy table, or by word or phrase.
- Investigators who submit VCN forms for the IRB and ORA to consider should review the new IRB “Verification of Confidential Nature (VCN) Forms Guidance and Process.” The IRB is also posting an Instructional VCN form, and a fill-in version, for investigators to use. Note that if investigators submit VCN forms without the grant number, budget number, correct project title number, and correct participant payment information, the IRB will return the form for correction.
- The Office of Human Subjects Research (OHRP) has posted the 2009 edition of its “International Compilation of Human Subjects Protections.” This listing contains information about 1,100 laws, regulations, and guidelines on human subjects’ protections from 92 countries. This year’s edition includes information on 7 new countries: Burma, Egypt, the Gambia, San Marino, South Korea, the Sudan, and Vietnam. Many of the listings include the web address, allowing the reader to link directly to the law, regulation, or guideline of interest.
- The IRB has posted a new guidance on “Informed Consent: Understanding the Process and Documentation Requirements” to help investigators understand what the human subjects research regulations require.
- IRB Holiday Schedule:The IRB is cancelling the IRB X and FC meetings for the weeks of December 22 and 29. If you have a study with an IRB approval lapse date in December or January, please submit your progress report in ample time for the IRB to review it.
- Investigators who create or maintain biorepositories for future research may use the new consent template called “Informed Consent Document for Storing Biospecimens for Future Research” as-is, or to guide the drafting of an appropriate consent document. This template has the same format as the other new consent templates and may be used as a stand-alone or may be incorporated into a parent study consent document.
- The JHSPH IRB has recently posted new templates, including a new research plan template, amendment application, and progress report. Starting November 1, 2008, all submissions to the JHSPH IRB office which include one of these three documents must use the appropriate new template. If you have the old templates saved on your computers, please replace them with the new ones. The consent form template submissions should follow the posted guidance.
- Investigators may search the IRB database by accessing this site: Click Here. You may search for information by investigator name, IRB number, or project title. For JHSPH employees, who use my.jhsph.edu, go to the “Resources” tab and click “Search Tools”; the IRB database is the third choice on that list.
- A new guidance explaining the new consent templates and the new process for consent form submission and approval is available.
- The IRB is changing how it processes consent documentation. New consent form templates (instructional and fill-in), oral script, and children’s research assent form and oral script have been posted for use in JHSPH studies. For all consent forms submitted using the new consent form templates after October 6, 2008, the IRB will provide an approval date and IRB version number, and no expiration date. The approval for the consent document will be “continuous”; it will last either for the life of the study, or until it is amended – whichever comes first. It is important that the PI identify the version of the document in the footer to assist in tracking versions submitted to the IRB. The IRB will use a new logo in the header, and will list an approval date and an IRB version number for the document. Only consents using the new templates will be treated as “continuous”; all consents using the old templates will be given an expiration date.
- New Applications: The IRB encourages all PIs to submit their consent documents on the new templates, but will accept documents based upon the old templates until November 1. After that date, all new or amended consent documents must be submitted on the new template.
- Currently Approved Studies: All PIs of existing approved studies must amend their consent documents by transitioning to the new templates by their next progress report due date, unless there is a compelling justification accepted by the IRB to keep the existing consent form as is. For example, it may be onerous for a PI to change the consent form that has already been approved by multiple IRBs or translated into another language. The PI may submit this justification with the progress report. If the justification is accepted, and the PI can provide an electronic version of the consent document, the IRB will approve it using the new process.
- The Associate Dean for Research has approved a new Policy on Student Investigators. This is the first new policy in a series that the IRB will post in the coming months. Please check this site periodically for new postings.
- The IRB Office has posted a new guidance called "Who Should be listed on a Research Application?" to help principal investigators understand which co-investigators, student investigators, and other study team members they should list in their PHIRST application and/or the research plan.
- In an effort to provide investigators with approval letters in a more timely fashion, late last year we adopted the use of approval notices, not letters, as the notification format. This distinction means that when your protocol is approved the notice you will receive will no longer contain a signature block or require the signature of an IRB committee chairperson. We are confident that this new practice meets the regulatory requirement for notification of approval. We can provide you with a letter outlining this policy if you believe your funding agency requires it. For investigators funded by the FDA, please refer to the “FDA 1998 Information Sheets Frequently Asked Questions” for additional information on FDA’s response to the question “Does FDA expect the IRB chair to sign the approval letters?” Please contact our office if you have concerns about this new policy.
- The IRB has posted a new Amendment Application.
- The IRB has posted a new Unanticipated Problem/Event Report Form.
- The IRB has posted several new forms for Continuing Review, including a new Progress Report Form, Anticipated Event Summary Form, and Protocol Deviation Summary Form.
- The new Amendment Application is designed to ask questions that will help the IRB assess the impact of the proposed change to the approved research plan, in particular, its effect on the risk to subjects and/or prospect of direct benefit to subjects and the balance of risk and benefit. In addition, it focuses on whether the participants already enrolled in a study need to be notified about the change. If you are adding new co-investigators or study team members, we require a signature on a letter, or email communication from that person's email box, as documentation of his/her agreement to assume the responsibilities as co-investigator or study team member.
- The IRB has posted a revised Unanticipated Problem/Event Report Form. This form should be used for any problem or event that: 1) poses harm or risk of harm to subjects or others; 2) is unanticipated (not described in research plan or consent form); and is 3) related to the study procedures. NOTE: “Prompt reporting” means submission within 10 working days of learning about the unanticipated problem.
- The new Progress Report Form is designed to improve the information that the PI provides to the IRB so that the IRB may be more efficient in its review. Some investigators report Anticipated Events promptly between approvals, though there is no requirement that they do so. The IRB has created a new “Anticipated Problem/Event Summary Form” which may be used to submit such events with the Progress Report. In addition, protocol deviations, which are administrative and minor departures from the approved research plan which have no effect on the safety or welfare of the participants, may be reported on the “Protocol Deviation Summary Form".
- The full review committee (IRB-FC) will commence weekly meetings on Wednesday mornings starting on July 9, 2008. The committee that reviews expedited protocols (IRB-X) already has weekly meetings, which take place on Thursday mornings.
- The JHSPH IRB has posted a new research plan template. Read more about it on the Announcements page.
- The full review committee (IRB-FC) will commence weekly meetings on Wednesday mornings starting on July 9, 2008.
- The Research Plan template has been revised to be more specific. Delays in turn-around time are often caused by IRB requests for additional information from the PI; the goal for this revision is to reduce the back-and-forth by being more transparent as to what information is needed at the outset. Most sections of the template do not apply to most JHSPH studies and can be deleted.
- We have recently expanded our accelerated review process for administrative and minor amendments, which currently accommodates changes to study team personnel and other minor changes. These changes are reviewed by an IRB member within a day or two of submission. The new feature for our “fast track” procedure permits investigators to email requests for modifications to previously approved materials (limited to study questionnaires, interview or focus group guides, other data collection or recruitment materials) that are consistent with the original aims of the protocol and do not increase risk to participants.
- An e-mail was circulated to faculty with a link to a new tool to help investigators distinguish whether a research project qualifies as Human Subjects Research or not. Please make sure to read all three pages for definitions and clarifying information.
- BCHD Research : Investigators who plan to conduct research at a Baltimore City Health Department (BCHD) site need JHSPH IRB approval prior to submitting the study to the BCHD for internal review. The JHSPH serves as the IRB of record for the BCHD for studies conducted by JHSPH investigators. For more information about the review process and the requirements for submitting studies to the BCHD, see Policies and Guidelines.
- Some sponsors require that IND Safety Reports from sites in a multi-center study be sent to all the IRBs involved in the research. The regulations do not require that the IRBs review these reports, so the JHSPH IRB will acknowledge receipt, but will not review these submissions.
- If a study is complete and ready for approval, but the IRB requires some specific administrative changes or there are outstanding issues like local IRB approval or acquisition of a Certificate of Confidentiality, the IRB may act to “Approve with Administrative Changes.” This means that the PI will have a letter of approval, and the approval period will begin from the date of the IRB action, but the IRB will not release final, stamped consent documents until the administrative changes are resolved. PIs may receive consent documentation marked, “DO NOT USE TO ENROLL SUBJECTS”; the PI may not begin enrollment until the final, stamped consent documents are released.
- In order to make the IRB review process more efficient, the primary reviewers for IRB X and IRB FC may contact the PIs of the studies they are reviewing to resolve questions prior to their meetings. Do not be surprised if you receive such communications, and please respond quickly so as to avoid delaying completion of the review.
- IRB X meets weekly, on Thursday mornings. All new applications which meet the criteria for an expedited review process, and are submitted through PHIRST by Friday at 5 pm, will be on the agenda for the following week’s meeting.