Updates from the Director
Michele Countryman, CIP
This month, my update is going to take a regulatory focus on two specific policies. The NIH final policy on the Use of a Single IRB and the pending NPRM (Notice of Proposed Rulemaking) of the Common Rule.
NIH Policy – Use of a Single IRB (sIRB)
The NIH final policy on the Use of a Single IRB was issued on June 21, 2016. It will be effective May 27, 2017. Here are links to the official policy and an FAQ on the policy. There is also a link to guidance on the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy. As it becomes available, additional information will be posted to the NIH Office of Science Policy website.
Below is a breakdown extracting what I feel are the most important elements in the policy and associated guidance:
- The policy only applies to research studies where the same protocol is being conducted at more than one site. It will not apply to studies that involve more than one site carrying out different research roles (Scope & Applicability)
- The policy will not apply to career development, research training, or fellowship awards issued by NIH. (Scope & Applicability)
- The policy will only apply to domestic grants and participating domestic sites. Foreign sites with NIH funded research will be exempt from this policy. (Scope & Applicability)
- The policy applies to all new, renewals, revisions, and resubmissions of NIH awards. (Effective Date)
- Those ongoing non competing awards will be required to comply with the new policy at the point a competing renewal is submitted.
- Costs are addressed in the policy (Roles & Responsibilities, subsection Applicant/Offeror and Awardees)
- Costs associated with sIRB review may be charged to grants or contracts as direct costs or can be applied as indirect costs only if:
- Costs are well justified and consistently applied
- Consistent with FAR 31.302 and FAR 31.203
- Costs associated with sIRB review may be charged to grants or contracts as direct costs or can be applied as indirect costs only if:
- Grant applicants (generally also the Principal Investigator) are expected to:
- Submit a sIRB (single IRB of record) plan identifying who will serve as the single IRB (Roles & Responsibilities, subsection Applicant/Offeror)
- NIH indicates it is the grant applicant’s responsibility to assure the sIRB is qualified to serve (Roles & Responsibilities, subsection Applicant/Offeror)
- The grant applicant will be responsible for ensuring communications between the sIRB and participating sites, but these responsibilities may be delegated. (Roles & Responsibilities, subsection Applic ant/Offeror and Awardees)
- University of Iowa HRPP (Human Research Protection Program) which is overseen by the Human Subjects Office (HSO) in conjunction with the Division of Sponsored Programs (DSP) will be responsible for:
- Management and oversight of the award which includes verifying implementation plans with the Grant applicant. (Roles & Responsibilities, subsection Funding Institute or Center (IC))
- The University of Iowa IRB and\or the HSO will retain responsibilities dependent on who serves as the IRB of record.
- When the University of Iowa would serve as the single IRB of record – the UI IRB would be responsible for ensuring studies meet regulatory requirements under 45 CFR 46 and may serve as a Privacy Board, as applicable, for all participating research sites to fulfill HIPAA requirements. (Roles & Responsibilities, subsection sIRB)
- When the University of Iowa would serve as a participating site with another IRB of record – the UI HRPP remains responsible for “other regulatory obligations” (i.e. informed consent, implementation of IRB approved protocol, UPIRTSO, study progress to the sIRB when we are a participating site. (Roles & Responsibilities, subsection Participating Site) In other words, we maintain institutional compliance responsibilities as outlined in the Federalwide Assurance (FWA).
- Exceptions may be granted by NIH for: (Roles & Responsibilities, subsection Exceptions)
- Use of sIRB if prohibited by federal, state, or tribal law or regulations
- If a compelling justification is provided for why a sIRB can’t be implemented
If you are submitting, or planning to submit, a multi-site NIH grant application I strongly encourage you to contact our office early and often. We are happy to help you navigate this new process. Current policies and procedures related to the use of a single IRB and ongoing updates to be compliant with the NIH final policy can be found on the HSO website by clicking on “Central & External IRBs” found here. Contact: firstname.lastname@example.org or call (319)335-6564 with questions.
The HSO is partnering with the ICTS to present in this topic in the fall on October 6th 2016 from Noon-1:00pm. We will outline this new policy and our expectations for implementation and adherence. Please stay tuned for further updates on this presentation.
NPRM (Notice of Proposed Rulemaking) of the Common Rule
The update is, there is no update. There has been a lot of buzz about the pending final rule for the NRPM of the Common Rule. According to the Office of Information and Regulatory Affairs a final action is still scheduled to occur sometime in September 2016. In order for this to occur the 18 departments and agencies which have agreed to follow the Common Rule would need to endorse the final rule. According to information presented in a recent OHRP (Office of Human Research Protections) conference in Nashville, TN those discussions are underway. A copy of the presentation on the NPRM can be found in the conference agenda. As a summary, the significant changes proposed in the NRPM fall under the following categories:
- Improvements to the Informed Consent process
- Expansion of definition of “human subject” for the collection and retention of any biospecimens
- Use of a single IRB for multi-site research
- Expanding the scope of the common rule to cover all clinical trials regardless of whether or the research has federal funding support.
- No Continuing Review required for specific types of research falling under the “expedited” (or no more than minimal risk) category of review
- Enhancement of privacy standards as “safeguards”
- A “excluded” category of research and expansion of exempt categories
The comment period allowing the public to comment on the NPRM proposed changes closed on 12/7/15. The public comments submitted during this time were almost double (2100+ vs 1100+) compared to when the proposed rule was initially released as an Advanced Notice of Proposed Rule Making in July 2011. These comments have been under analysis by OHRP and DHHS (Department of Health & Human Services.)
By and large the portion of the NRPM which obtained the greatest number of public comments was related to the proposed changes surrounding the use and collection of biospecimens. However, until the final guidance is issued, we are unclear as to what impact the comments will have on the final rule. The Human Subjects Office will continue to monitor all developments on a federal level. We will be communicating them to you, our research community, as they become available.
ClinicalTrials.gov Reporting: An Update to
Elizabeth Jach, MA
For studies with the UI as the IRB of Record, the IRB application asks for information about trial type in HawkIRB Section VII.B.1. Federal law (Section 801 of the Food and Drug Administration Amendments Act, or FDAAA 801) currently requires registration and results reporting of applicable clinical trials through ClinicalTrials.gov. In addition, the International Committee of Medical Journal Editors (ICMJE) also requires registration of clinical trials as a consideration for publication. As part of the University of Iowa’s Human Research Protections Program, HawkIRB Section VII.B.1.b currently captures ClinicalTrials.gov registration numbers (or NCT) for clinical trials reported as phase 2-phase 4. Due to draft National Institutes of Health (NIH) policy surrounding ClinicalTrials.gov registration and results reporting as well as relevant ICMJE’s proposal on sharing clinical trial data, the Human Subjects Office (HSO) is modifying the HawkIRB application to better meet the needs of researchers.
In order to meet the needs of researchers who have chosen to register and report to ClinicalTrials.gov, HawkIRB Section VII.B.1 will now allow the entry of a ClinicalTrials.gov registration number (NCT#) for study types that are indicated to be a “physiology intervention/study”, “behavioral intervention/study”, and or “other-describe”. In addition, if the response to VII.B.1 is “Clinical Trial” and the study is marked as “Phase 1”, Section VII.B.1.b will also open for the optional entry of a NCT# (even though registration is not currently required for Phase 1 trials).
By allowing the entry of NCT# into the HawkIRB application for more study types, the Human Research Protections Program will better be able to ascertain a match between ClinicalTrials.gov records and IRB records. The HSO will also be sending out a brief survey to all Principal Investigators utilizing Western IRB (WIRB) to verify ClinicalTrials.gov registration requirements.
Reminder: Institutional Policies Surrounding Research Subject Compensation
Elizabeth Jach, MA
The Human Subjects Office (HSO) reminds UI researchers that studies compensating research subjects must adhere to relevant institutional policies, including those housed by the Controller’s Office as well as the Grant Accounting Office. All UI faculty, staff, and student researchers are required to comply with the cash handling and research subject compensation policies, including studies that are overseen by another IRB. Specifically, the Research Subject Compensation Cash Handling Policy Statement establishes “internal controls for disbursement of cash and its equivalents”.
For all research studies regardless of the IRB of Record, research subject compensation must be described in HawkIRB Section VII.E.9-19. If cash or its equivalent is provided by the research team directly to research subjects, attach a copy of the cash handling plan approval memo from Accounting Services in the “Cash Handling Approval Memo” Attachment category as seen below.
It is not necessary to provide documentation of approval of the cash handling plan if subjects are compensated by check directly from Accounting Services via the e-Voucher system.
One of the most common misconceptions is that when gift cards under $75 are used as compensation in a research study there is no internal documentation requirement. This is not accurate. Per the Research Subject Compensation Policy & Procedures, for gift cards valued at $75 or less, a recipient list should be attached to the Procurement Card or e-Voucher used to purchase the gift cards and include the following information. This list should contain the following:
- Gift card #
- Gift card value
- Gift card issue date
- Recipient’s name
- Recipient’s address
Research subjects should be adequately informed in the consent document of what information will be collected for compensation purposes.
For additional policy related information, review the Grant Accounting Office’s Research Subject Compensation Policy & Procedures to ensure appropriate measures “for requirements regarding confidentiality and record keeping requirements of the State of Iowa, grantor agencies and the Internal Revenue Service” are met. If you have further questions, please contact the HSO at email@example.com or 319-335-6564.
Patricia F. Katopol, PhD
In a previous column, IRB Connection provided a broad overview of social media and human subjects research. This column drills down to examine selected issues faced by investigators when conducting research in a variety of online environments such as social media (e.g., Facebook, Twitter, and Flickr), web pages, online fora, and wikis and where research may be conducted with or without documentation of consent, or without any consent. It will also review what the IRB will consider when reviewing this research.
The first consideration in doing research in online environments is determining if subjects are who they say they are and whether they meet eligibility criteria for the study. These uncertainties may be reduced if the investigator uses a targeted approach to recruiting, such as contacting people in specific groups, such as Facebook pages for people with certain diseases, email lists provided by professional and special interest associations, or using sites that require registration by participants.
The Secretary’s Advisory Committee on Human Research Protections of the US Department of Health & Human Services (SACHRP) provides guidelines for determining the importance of identity confirmation. First, is eligibility criteria critical? Is there a likelihood of repeat or fraudulent participation? Second, what is the level of risk to subjects? High-risk studies transmitting sensitive information may require authentication via passwords delivered by mail or telephone, or via an identity verification software or vendor. Third, the site may have a third-party policy or terms of agreement in place that should be reviewed when considering identity confirmation.
Organizations and scholars addressing ethics in online research continue to examine authentication and validity in this environment, but these issues do not have easy answers, especially in light of continuing technological change.
Data security for this type of research poses unique concerns. The UI IT Security & Policy Office points to the Higher Education Information Security Council Information Security Guide, which researchers may find helpful. If storage in the cloud is planned, PIs are advised to review the UI ITS page on cloud storage and to be aware of recommendations and restrictions, including restrictions on vendor selection, that the University may have in place regarding using the cloud to store study data. If a third party venue or processing site is involved, the application should be specific as to how the vendor will access and store study data.
While there are risks in all human subjects research, PIs and the IRB should consider where they might differ in research in online environments. SACHRP suggests that hacking, phishing, and lack of appropriate security measures may be included among the risks found in everyday life when as applied to computer usage. These risks should be listed in addition to the risk of a loss of confidentiality.
Some aspects of research in online environments that remain problematic and usually require a case-by-case review by the IRB include:
- Determining a public vs. private site – Do users need to register and have a password to post? Do they need to be registered and have a password to even see the site?If the site is private, the IRB will look for procedures to make sure there is a mechanism for responding to the PI or require the PI to advertise the study and to ask members to contact him/her to grant permission to use their posts. Other sites may be public, but not permitted for research use – that is, even if the public can see posts without registering or using a password, it doesn’t mean that members agree to have their posts used for research. To assist in determining whether a site is public vs. private, SACHRP suggests that 1) intentionally posted or provided information on the Internet is considered public; 2) relevant law, site policies, and terms of service may indicate that posted information is considered private; 3) sites that require authorization for membership should be considered private; and 4) sites where participation does not require third party approval should be considered public.
Note that there can be observable public behaviors in what may otherwise be considered a private space. “If an activity (textual, visual, auditory) is legally available to any Internet user without specific permission or authorization from the individual being observed, or from the entity controlling access to the information, the activity should be considered ―public behavior.” (SACHRP, 2013). According to SACHRP, comments and posts on news sites, YouTube®, or Craigslist® are public, but so are posts available to any authorized user of sites such as Facebook® or LinkedIn®, even though access to the site is restricted to registered users.
Electronic signatures – There are two concerns here - one being whether the IRB can approve the use of an electronic signature and the other being what proofs the IRB may require for ascertaining the signing subject’s identity.
- Permission for online consent may be granted by the IRB for minimal risk studies via use of a waiver of documentation of consent. A consent letter or information sheet containing the elements of consent (see the template provided in the attachments section of a HawkIRB application) is used to provide all of the required elements of consent to participants. A web portal or screen may be used to present the consent information to the participant, with the individual indicating consent by selecting a button to proceed with participation.
Ascertaining who signed the consent can be difficult. In a study recently approved by the IRB, obtaining online parental consent involved using email to send the parent a code and a private link to access the consent. While not foolproof, requiring a code to access the research instrument can deter unauthorized persons from participating in the research.
- Obtaining consent signature in the online environment is one thing, but how can PIs and the IRB determine if the subject understood what s/he signed? Having subjects answer a quiz about the consent to show their understanding of the study is one way to do this. Other ways include online chats in designated chat rooms, emails, virtual worlds, or video to discuss the study and consent form with the subject.
Although techniques and processes for research in online environments may be new, assuring that subjects have volunteered for and understand the study, protecting subjects’ personally identifiable information, and reducing risks are still concerns for researchers and the IRB.
IRB Advisor: Reanimation Study a Step Toward Brain-death Breakthrough?
Research using “living cadavers” may sound like some fantastical sub-plot of that ever-present television show on the undead. In fact, it is not science fiction, and the implications to future research and medicine are very real. A researcher in Rudrapur, India, is recruiting twenty human subjects who have been declared brain dead as a result of diffuse axonal injury, a common cause of brain death. Enrolled subjects will be exposed to a variety of therapies, from stem cells to nerve stimulation, and studied for any signs of brain regeneration.
This is a new frontier and there are only scant regulations guiding research using brain dead patients. Additionally, philosophical and ethical questions about the boundary between the living and the dead have also been posed, which are likely to be questions with no easy answers.
Read the full article in the July issue of IRB Advisor. The July issue also includes articles about:
- Finding successors and mentorship in IRB Members
- Career advancement and office structure in IRB Offices
- New FDA guidance on using electronic health records in research
- The NIH’s new draft clinical trial template protocol
- How education may increase participation in clinical trials
- Minnesota ombudsman’s office may be granted oversight of U of MN psychiatric drug research
What is IRB Advisor?
IRB Advisor is a monthly newsletter that contains articles about regulatory issues, informed consent, current events in human subjects protections as well as articles about IRB administrative and management issues. The UI IRB subscribes to this publication as a resource for UI faculty, staff and student researchers as well as for IRB members and Human Subjects Office staff. Each month the IRB Connection Newsletter features an article from the current issue of IRB Advisor.
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