Things To Know
Below are some helpful links and resources to help investigators and research support staff to navigate the new INSPIR II:
- Important Change for WIRB Submissions
- Personnel Changes in INSPIR
- Research Misconduct
- When Continuing Review is no Longer Necessary
- New Research Funding Opportunities
Important Change for WIRB Submissions
If you wish to submit an industry-sponsored, multi-center protocol, you have two (2) options.
- You can submit it to the BUMC IRB for review in INSPIR as for any other protocol; OR
- You can submit it to the BUMC IRB to request that it be reviewed by the Western Institutional Review Board (WIRB) in Olympia, Washington. The BUMC IRB has an agreement with WIRB to review industry-sponsored, multi-center protocol submissions from BUMC Principal Investigators. However, effective 3/2/12, BUMC will only allow studies to be submitted to WIRB if the sponsor accepts the following language as written without changes for the compensation for research related injury section of the consent form. No other statements related to compensation for research related injury will be accepted for submission by BUMC to WIRB. If the sponsor requires alternate compensation for research related injury language, then the study must be submitted to the BUMC IRB to be reviewed by one of its internal IRB Panels rather than WIRB. Questions about alternate compensation for research related injury language should be directed to Attorney Anne Clark in the BU Office of Sponsored Programs (OSP) at aclark4@bu.edu; phone 617-638-5263.
- “BUMC Preferred Compensation for Research Related Injury Language for Industry Sponsored Studies” (Revised 02-28-12):
If you think you have been injured by being in this study, contact [insert PI name and contact information] right away. You can get treatment for the injury at Boston Medical Center. The reasonable costs of treatment for a research injury that are not covered by your insurance or a government program will be paid by [insert sponsor’s name]. A research injury is any physical injury or illness directly caused by your participation in the study. If you are injured by a medical treatment or procedure that you would have received even if you were not in the study, that is not a research injury. Payment for such things as lost wages, expenses other than medical care, or pain and suffering is not routinely available. To help avoid injury, it is very important to follow all study directions. You are not giving up any of your legal rights by signing this form.
If the sponsor accepts the 2/28/12 compensation for research related injury language as written without changes, then a WIRB submission should be submitted as described at the BUMC IRB WIRB website (to see the procedures for submitting to WIRB, click here.) Multi-centered, industry-sponsored protocols must meet the BUMC IRB eligibility criteria for WIRB review, in addition to the mandatory compensation for research injury language. The BUMC IRB will make the final determination as to whether a protocol is appropriate for WIRB review, or whether it must be submitted to the BUMC IRB via INSPIR.
Please be sure to check the BUMC IRB WIRB website for the most current submission forms. If you have any questions about a WIRB submission, contact IRB Coordinator Roz Schomer at roz@bu.edu; phone 617-414-1320.After a study has been approved, all subsequent changes to “Section 3.0 - Grant key study personnel (KSP) access to the study” of the INSPIR application can only be made by submitting “Internal Study Personnel Changes”; this would also apply to a PI change. “Change Request & Amendments” cannot be used to make changes to Section 3.0.
When changing the PI: If there is a need to update the application or the consent forms to reflect the PI change, then you also need to submit a “Change Request & Amendments” with these updates. The “Change Request & Amendment” and the “Internal Study Personnel Change” for the change in PI can be submitted simultaneously.
Exceptions: To add a Study Contact and/or an Administrative Assistant:
- Section 3.3 (Study Contacts) is only used to indicate those who need to receive email notifications about a protocol; however, “Study Contact” is not a study role. A Study Contact must also be listed in Sections 3.1, 3.2, or 3.6.
- “Study contacts” who are engaged in human subjects research must also be listed in Section 3.1 (Principal Investigator) or 3.2. (Protocol Staff), they must be in compliance with the BUMC requirements for human subjects training certification and recertification, and they must also comply with the institutional policies for submitting Project Specific Conflict of Interest Disclosure forms (COI-PSDs). An “Internal Study Personnel Change” does not need to be submitted to add a Study Contact who is already listed in Sections 3.1, 3.2, or 3.6.
- Section 3.6 (Administrative Assistant) is used to add anyone to the protocol simply for administrative purposes (not engaged in research and having no contact with subjects or identifiable data—certification/recertification and COI disclosure form are not required). An Administrative Assistant can also be a Study Contact. An “Internal Study Personnel Change” does not need to be submitted to the IRB to add an Administrative Assistant or an Administrative Assistant/Study contact.
“Research Misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
(a) Fabrication is making up data or results and recording or reporting them.
(b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
(c) Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
(d) Research misconduct does not include honest error or differences of opinion.” [42 CFR Part 93.103]
Recently, on February 2, 2012, a notice was posted by the Office of the Secretary at the Department of Health and Human Services about Research Misconduct. This notice by the Office of Research Integrity (ORI) describes a case of Research Misconduct involving Calleen S. Zach at Creighton University. Callen S. Zach “knowingly and intentionally provided falsified subject enrollment numbers in reports to the CU Institutional Review Board (IRB) in 2008 and 2009.” This notice also states that “…ORI found that Respondent's intentionally deceptive behavior, including false statements made to the CU institutional officials, forgery of petty cash receipts, and theft of NIH research grant funds establish a lack of trustworthiness and present responsibility to be a steward of Federal funds. 2 CFR 180.125, 180.800(d), 376.10.”
The above notice and other cases of Scientific Misconduct can be found on the Office of Research Integrity website.When Continuing Review is no Longer Necessary
The following information which Identifies the Point When Continuing Review is no Longer Necessary is taken directly from OHRP’s Guidance on IRB Continuing Review of Research:
“Continuing review and re-approval of a research project at least annually is required so long as the project continues to involve human subjects. OHRP considers a research project to continue to involve human subjects as long as the investigators conducting the research continue to obtain:
- Data about the subjects of the research through intervention or interaction with them; or
- Identifiable private information about the subjects of the research.
With respect to obtaining identifiable private information, OHRP considers this to include obtaining identifiable biological specimens originating from living individuals. Furthermore, OHRP considers obtaining identifiable private information to include:
- Collecting or receiving identifiable private information (including identifiable biological specimens) from any source (i.e., not already in the possession of the investigator);
- Collecting identifiable private information by observing or recording private behavior without interacting or intervening with the human subjects; and
- Using, studying, or analyzing identifiable private information (including identifiable biological specimens), even if the information was already in the possession of the investigator before the research begins. This includes using, studying, or analyzing any of the following:
- Identifiable private information obtained by interacting or intervening with the human subjects;
- Identifiable private information stored in documents, records, photographs, images, video recordings, or audio recordings provided to the investigators from any source;
- Identifiable private information stored in documents, records, photographs, images, video recordings, or audio recordings already in the possession of the investigator before the research begins;
- Identifiable private information obtained about an individual by interviewing other people (e.g., an individual’s healthcare provider or teacher);
- Identifiable biological specimens provided to the investigators from any source; or
- Identifiable biological specimens already in the possession of the investigator before the research begins.
A research project no longer involves human subjects once the investigators have finished obtaining data through interaction or intervention with subjects or obtaining identifiable private information about the subjects, which includes the using, studying, or analyzing identifiable private information.”
The BUMC IRB does require a final report. Please click on How to create and submit a Final/Closure Report to see what needs to be done in INSPIR II.New Research Funding Opportunities
Every month the Office of the Associate Provost for Research distributes to the research community by e-mail a compilation of funding opportunities available through various agencies and federal sources. If you missed the e-mail or were not on the distribution list, here’s a link to a copy of the email and the contact information of the Office if you have additional questions or want to be added to the list.