Indiana University Bar
Research Compliance Quarterly 12th Edition
October 6th, 2017
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:
 
 
Regulatory Updates: Human Subjects Research

NIH single IRB policy - Update

The NIH single IRB (sIRB) policy, which requires all sites participating in human subjects research funded by NIH to utilize a centralized sIRB, will be effective January 2018. The policy requires that new grant applications to NIH submitted on or after this date include a plan for use of a sIRB, including identification of the sIRB, relying site agreement to utilize the sIRB, and a plan for communication between the sIRB and the relying sites. The HSO is continuing to assess the impact of the policy and to draft procedures and processes for local implementation of sIRB review, both for studies impacted by the NIH policy and studies for which sponsors and funding agencies other than NIH are requesting sIRB review. If you are planning for an NIH proposal which will be submitted after January 25, 2018 or have questions about potential reliance on an external IRB, please contact Amy Waltz at acthurst@iu.edu.

HSO continues to receive questions about requesting the IU IRBs provide IRB review for external performance sites and serve as the central IRB for multi-site studies. It’s important to remember that the IU PI and study team would need to be responsible for collecting the required IRB information from external sites and investigators, compiling it for the IU IRB, making IRB submissions on behalf of sites and investigators, and communicating IRB decisions and approved documents back to the sites and investigators. Many study teams aren’t fully prepared to handle this level of coordination and communication, so HSO asks that you contact the HSO reliance team before offering to utilize the IU IRBs for multiple sites.

HSO update – Revised Common Rule

On January 19, 2017, the Department of Health and Human Services published revised regulations on the protection of human subjects in research, known as the Common Rule. Read the previous announcement, which includes an overview of the proposed changes and the HSO’s response. The revised regulations are effective January 19, 2018.

Over the past months, HSO has been taking positive steps to prepare for implementation of the revised Common Rule and has convened several working groups to obtain input from the research community during the process – see below. More specific information regarding implementation of the revised Common Rule will be available throughout the fall and winter of 2017.

Major Changes

The new Common Rule focuses largely on reducing administrative burdens, especially those that do not offer additional protection for human subjects, and tries to better align administrative requirements with the level of risk of the research. A few important changes to note:

  1. Several categories of research which previously required expedited IRB review will now be considered exempt from the regulations. Exempt research must be conducted in accordance with ethical guidelines but isn’t subject to the same, formal IRB review and informed consent requirements as expedited and full board research. Exempt research is submitted to HSO via a much shorter application and does not require ongoing review, with the exception of substantive changes to the research. The new Common Rule allows for exempt review of several areas of research which were previously subject to expedited IRB review, including: research with benign behavioral interventions which meet certain criteria; secondary research use of information/biospecimens protected by HIPAA, e.g. retrospective and prospective chart reviews; and use of identifiable information which meets certain criteria even when disclosure could place subjects at some additional risk.
  2. Annual or ongoing renewal will no longer be required for expedited research, or for research which is greater than minimal risk research but continuing only for long-term follow-up or data analysis. Investigators will still be required to request prospective IRB approval before making changes to expedited and full Board research; however, formal annual review will only be required for research which is FDA-regulated, greater than minimal risk and continuing to intervene with subjects, or expedited research which the IRB reviewer specifically requests renewal on a case-by-case basis. For research not requiring annual or ongoing renewal, IU investigators will receive an automatic annual notification for all research projects which are open with the IU IRB, reminding them of ongoing responsibilities to the IRB and requesting that the study be closed when completed.
  3. The informed consent process and template will include new requirements. Most importantly, informed consent must begin with a concise and focused presentation of key information which potential participants need in order to make a decision about whether to participate in the research. Generally, this information will include a statement that the project is research and that participation is voluntary, and a summary of the purpose, duration, procedures, risks, discomforts, benefits, appropriate alternatives, costs and payment. This information will be outlined in a short summary of the research which will be added to the informed consent template and made available to researchers in late October. Informed consent documents which are already concise will not need to utilize the specific template and there will be no requirement to reconsent previously-enrolled subjects.

    In addition to the concise and focused presentation, several new elements must be included in the informed consent template. Some of these elements are already commonly included in IU consent documents, and the revised informed consent template will include these new elements for consistency.

    The new regulations also revise the criteria to be met before the IRB can approve a waiver of the entire informed consent process. Many of the studies which currently require a waiver of consent will be considered exempt under the new regulations, so this change is unlikely to have a significant impact on the conduct of research.
  4. “Broad consent” is allowable under the new Rule but will be implemented at a later date. The revised Common Rule includes a new provision for obtaining informed consent for certain research. This provision, called broad consent, allows subjects to consent to the storage, maintenance, and use of their information and biospecimens for future research purposes on a shorter, more specific informed consent template. While the term “broad consent” implies a consent to future unspecified use, the regulations require that subjects be given a description of the research which would help them reasonably understand how their information and biospecimens will be used. Practically, this requirement means that the new consent provision is really consent to future, specific use. Declining broad consent has consequences for future use of subjects’ information and biospecimens for other research purposes. As such, use of this provision requires significant implementation and tracking mechanisms which are still being defined. The IU Human Research Protection Program will continue to address these challenges and implement the broad consent provisions sometime after the initial effective date, after IU and its affiliates have had a chance to consider the implications comprehensively. Consent to future use will continue to be allowable via the traditional informed consent mechanism.

Transition

The revised regulations are effective January 19, 2018. Any research approved after that date will be subject to the new regulations and requirements. HSO is still defining what impact, if any, the new regulations will have on previously-approved research and whether the investigators conducting those research studies will be able to take advantage of the reduced administrative requirements. More specific details will be available shortly.

What to Expect

HSO staff has spent the past few months analyzing the new rule and its impacts and making decisions about how to implement the changes, with feedback from the IRB Executive Committee, HRPP Advisory Committee, and consent working group. More specific information about the transition, including how the changes will affect previously-approved research and changes to KC IRB will be communicated beginning in November 2017. Training sessions on the revised Common Rule will be available throughout January and February 2018. Please feel free to contact the HSO at irb@iu.edu to schedule a department-specific training for your group today.

Changes to NIH Policy on Certificates of Confidentiality

The NIH recently issued a Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality. A Certificate of Confidentiality (CoC) helps researchers protect the confidentiality of human subjects enrolled in research by limiting disclosure of identifying information through otherwise-compulsory legal demands, such as court orders and subpoenas. Under the previous policy, investigators conducting potentially sensitive research could request a CoC from the NIH. Effective October 1, 2017, CoCs will automatically be issued for all applicable NIH-funded research.

Under the revised policy, CoCs will automatically be granted to all NIH-funded biomedical, behavioral, clinical or other research commenced on or after December 13, 2016, in which identifiable, sensitive information is being used or collected. This includes:

  1. Human subjects research unless information is recorded in a way that subjects cannot be identified; or
  2. Research involving the collection or use of identifiable information or biospecimens, or information or biospecimens for which there is a small risk that some combination of the biospecimens, a request for the biospecimens, and other identifiable data sources could be used to determine the identity of an individual; or
  3. Research involving the generation of individual level, human genomic data.

For investigators who are conducting non-federally funded research and wish to obtain a CoC, the NIH will continue to consider requests for specific projects in accordance with the current policy.

When Can Information Be Disclosed?

The new Policy allows disclosures when:

  1. Required by federal, state, or local laws (e.g., state laws requiring the reporting of communicable diseases to state and local health departments), EXCEPT instances of disclosure in any federal, state, or local civil, criminal, administrative, legislative, or other proceeding; or
  2. Made with the individual’s consent;
  3. Necessary for the individual’s medical treatment;
  4. Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

What Does This Mean for Study Teams?

It’s important for researchers subject to the new policy to carefully protect subjects’ identifiable information in accordance with the automatically-granted CoCs. In addition, the NIH policy requires that research subjects participating in studies protected by CoCs be provided with information about those protections. Research studies with previously-granted CoCs should already have the required language included in current consent forms. If you are conducting NIH-funded research which may be granted a CoC under the policy (e.g. almost all NIH-funded research begun after December 13, 2016), please contact HSO to determine appropriate steps for updating your IRB-approved documents.

More information on CoCs is available on the NIH CoC FAQs webpage. Specific information regarding CoCs for IU research is coming soon to the HSO website.

 
 
IRB Submission Information

Adverse Events – What to report and when?

  1. Promptly (within 5 business days of study team becoming aware of the event):
    1. Local or external adverse events assessed by the Principal Investigator as (1) unexpected, (2) related or possibly related to study participation, AND (3) suggests that the research places subject(s) or others at greater risk of harm than was previously known.
  1. At time of study Renewal:
    1. Local adverse events related or possibly related to study participation not previously reported to the IRB.

Electronic Approval Stamps

When viewing or downloading unsecured PDF documents from the Notes & Attachments tab of your KC Protocol in KC IRB, KC applies a watermark signifying the approval status of your protocol. Please keep some considerations in mind when uploading PDF documents into KC IRB:

  1. The watermark is only applied to unsecured PDF documents. Before uploading into KC, please secure any PDF documents that do not require an approval stamp.
  2. PDF documents that contain “mixed content,” i.e., fillable forms or attachments embedded into documents, should not be uploaded to KC unless they are secured. The watermarking functionality does not function properly when viewing/downloading these types of documents.

Read about Electronic Approval Stamps and what you should know.

Completing COI Disclosure

In August, 2017, the Office of Research Compliance, Conflict of Interest (COI) released a new Annual Research-Related Conflict of Interest Disclosure Form process. If you are notified by the Human Subjects Office, Sponsored Project Office, or the Conflict of Interest Office that you need to complete or update your COI disclosure, you must do so using your IU user account in the Kuali COI system accessed via One.IU. Paper disclosures will no longer be accepted for IU and IU affiliates with active IU computing accounts.

If you need assistance locating your username or need to obtain account information, please contact Sharon Moran at morans@iu.edu.

See How To Submit Your Annual Disclosure for more information.

Processing of dbGaP Requests

HSO has noted a sharp increase in submissions from investigators seeking to submit data to or receive data from dbGaP. The database of GenoTypes and Phenotypes (dbGaP) was developed to archive and distribute the data and results from studies that have investigated the interaction of genotype and phenotype in humans. dbGaP is administered by the National Center for Biotechnology Information and is a program of the National Institutes of Health (NIH).

Investigators submitting data to dbGaP are required to include an Institutional Certification with their data submission. This certification must be signed by John Baumann, the authorized Institutional Official for purposes of this certification. This form should be submitted for processing and signature via KC IRB as an Amendment submission. If you have any questions regarding the Institutional Certification for submission of data to dbGaP, contact the IRB office at irb@iu.edu or by phone at 317-274-8289.

Investigators requesting data from dbGaP may or may not require IRB approval specific to the data request. This determination is made by NIH as part of the data request process. Regardless of whether IRB approval is required, these requests must be routed through the Office of Research Administration. Contact ORA at srsinfo@iupui.edu or 317-278-3473 (Indianapolis) or resdev@indiana.edu or 812-855-0516 (Bloomington) with questions regarding the data request process.

Protocol Clarification Memos and Eligibility Waivers –
When to Submit an Amendment

Per the regulations, changes in approved (expedited and full board) research may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject. However, it is often unclear whether a sponsor communication constitutes an Amendment requiring IRB review and approval.

In the case of protocol clarification memos, notes to file, and similar sponsor communications related to the protocol, the PI is responsible for assessing whether the communication constitutes a change to the IRB approved protocol or a change in the conduct of the research. If so, IRB review and approval is required before the change can be implemented unless the change is being made due to an immediate safety concern. If you are unsure whether review is required, contact Human Subjects Office staff via phone or email for assistance.

If a protocol change or deviation is authorized in advance by the sponsor, for example, to extend a screening window or waive an eligibility criterion, this also requires IRB review and approval before you can proceed with enrollment of the subject. Even if the change will apply to only one subject and not to all subjects moving forward, an Amendment is required. However, the KC IRB questionnaire and study documents such as the consent and protocol typically will not require revision. The KC IRB Amendment questionnaire should be completed describing the exception or deviation and justification. Documentation of sponsor agreement or approval should also be submitted. If such an Amendment requires IRB review and approval urgently, please notify HSO upon submission so it can be prioritized for review.

 
 
Other HSO Updates...

IRB Fee Structure Revision

The Indiana University Institutional Review Boards (IRBs) currently assess review fees on projects that have industry or commercial sponsors in order to help support the functioning costs of the IRB. The fees help underwrite a portion of the office and administrative support needed to handle the IRB review and approval process. Not all sponsors allow this type of a fee (for instance, it is prohibited on federal agreements), but we must offset these administrative costs. The current IU IRB fee structure has been in place since 2010.

Based on rising administrative costs and benchmarking with similar academic medical centers, the IU IRBs are proposing increasing the IRB fees for contracts executed after January 1, 2018, as follows:

Type of Item Level of Review Description 2010 Fee Proposed Fee
New Study Full Board New study requiring review by the convened IRB $2500 $2500
New Study Expedited New study not requiring review by the convened IRB, but which meets applicability for expedited review $2000 $2500
New Study Exempt New study exempt from IRB review N/A $500
Continuing Review Full Board Annual review of research by the convened IRB $500 $1000
Continuing Review Expedited Annual review of research by expedited means N/A $1000
Amendment Full Board Change in research requiring review by the convened IRB $500 $500
Amendment Expedited Change in research reviewed by expedited means N/A $500
New Study, Reliance on External IRB Administrative Review New study requiring administrative review by IU IRB staff for protocols reviewed by an external IRB $500 $1000

Investigator-Initiated Trial Resource Forum

Do you work on Investigator-Initiated trials (IITs)? Do you have questions about requirements or best practices for the conduct and management of these studies? Do you have great processes already in place that might help newer research staff in this situation? A small group of study personnel have expressed an interest in creating a forum on campus where IIT study personnel can talk about, brainstorm, and share resources related to these types of studies. If you would be interested in potentially participating in a forum of this nature, please contact Neala Lane, lanen@iu.edu. If sufficient interest is generated, scheduling and format discussions may occur in early 2018.

HSO Staffing Updates

Please join us in welcoming two new Research Compliance Associates to the IU Human Subjects Office. Ryan Ballard and Christian Kautzman joined HSO on August 15th. Ryan previously worked for the State of Indiana in Family and Social Services Administration. Christian worked for the last two years as an extremities sales representative for a medical device company. We are excited to have both join our biomedical team as screeners.

 
 
A RIO Minute...

Research Integrity Office Announces New Policy

On April 18, 2017, the Research Integrity Office (RIO) received a New Policy on Research Misconduct. Shelley Bizila and the RIO staff are thankful to the faculty council and Vice President for Research Fred Cate, who dedicated their time and effort to streamline the policy and clarify some of the definitions and procedures.

Research Integrity Office Kicks Off RCR Educational Series

Last month, the first of a four-part series kicked off the RCR Educational series and focused on "Threats to Research Integrity: Research Misconduct and Conflicts of Interest". The next session, scheduled for November 9th, 2017 on the Bloomington campus, will focus on "Protection of Research Subjects/Participants: Human Subjects Research and Research with Animals".

This training is intended to meet the needs of NIH and NSF funded students and investigators, as well as any other interested researchers. Visit Canvas to learn more about this Bloomington RCR Educational Series. Visit the IU Center for Bioethics to learn more about Indianapolis RCR Opportunities.

If you have any questions about registration and/or available courses, contact the RIO office via email at rio@iu.edu.

Research Integrity Office Receives ORI grant award!

The Research Integrity Office, in collaboration with the IU Center for Bioethics, has been awarded a grant from the Office of Research Integrity (ORI) to provide a conference in 2018. The Research Integrity Office created a national steering committee which has begun developing a 2018 conference to enhance the understanding of plagiarism in research and identify a platform to share resources and practical tools in successfully handling research misconduct allegation of plagiarism.

The goal is to provide an interactive conference that will expand the understanding of cultural variables which may contribute to plagiarism in research, supply practical tools and resources in handling of plagiarism allegations for Research Integrity Officers and their staff; and offer responsible conduct of research educational tools that further promote the prevention of plagiarism.

 
 
October is National Biosafety Stewardship Month

Environmental Health and Safety is now requiring storage equipment including freezers, refrigerators and liquid nitrogen Dewars used to store biological material in shared/common spaces be labeled with the name and phone number for an emergency contact. The contact should be someone that is willing to assume responsibility for the material inside of the storage equipment in the event of an emergency and therefore has some knowledge about what type of agents are inside of the equipment.

 
 
New IBC Protocols for Teaching Labs Using rDNA/BSL2+

The Indiana University Institutional Biosafety Committees (IBC) on both the Bloomington and Indianapolis campuses have discussed the requirements for teaching protocols that involve recombinant DNA or biological materials. It has been determined by both committees that protocols should be put in place for any class or teaching lab that is using BSL-2 or higher materials or recombinant DNA at any biosafety level. This requirement is to ensure students in the class are receiving proper training and wearing the correct personal protective equipment.

A guidance document for PIs filling out new teaching protocols has been developed and is available. If you would like a copy of the guidance document or have any questions, please contact iubibc@indiana.edu or ibcbhc@iupui.edu.

 
 
Required Training Reminder for New Personnel and Annual Renewals on IBC Protocols

The Office of Research Compliance strongly encourages all required training for personnel be complete before submitting an amendment to add new research members or before submitting your Annual Continuing Review.

When adding personnel, please remember that all personnel should complete the required training before beginning work on the protocol. A personnel amendment cannot be approved until training is completed. Having training complete before you submit the amendment will allow for much faster processing so personnel may begin work in the lab sooner.

 
   
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