IRB Member Newsletter--Volume 9 (Summer 2015)

Updates for IRB Members

• Member Evaluations
• Member Surveys
• IRB Member Training Requirement
• Review Tips: Summarizing Initial Review Applications at a Meeting
• IRB Member Website Spotlight: "Children: Regulations" Fact Sheet
• HS IRBs Guidance Spotlight: DHS Variance Guidance
• Article Spotlight: "Biobanking Research and Human Subjects Protections: Perspectives of IRB Leaders" Summary
• 2015 Meeting Schedule
• Reminder: Point-of-Contacts (POC) for IRB Member Questions

Member Evaluations
As you may know, UW-Madison’s Human Research Protections Program (HRPP) is accredited by  the Association for Accreditation of Human Research Protection Programs (AAHRPP). Part of retaining accreditation is implementing mechanisms that help ensure the quality of IRB performance. One mechanism to help ensure a high level of IRB function is providing feedback on IRB member performance.

The Health Sciences (HS) IRBs Office designed a formal tool that is used to provide feedback on IRB member performance.  The evaluation focuses on IRB member knowledge of federal regulations and institutional policies governing human subjects research, attendance at IRB meetings, communication with IRB staff and responsiveness to IRB office requests. An evaluation schedule is created by the HS IRBs Office so that each member receives at least one formal evaluation during his or her term on the IRB. Evaluations are based on feedback from the IRB chair, vice-chair (if applicable), and the IRB staff.

Although the evaluations may identify instances in which IRB members are not performing at a level necessary for continued membership, the primary goal is to identify and acknowledge those members who demonstrate exemplary performance. 

Please contact Nichelle Cobb (262-1980), Gretchen Anding (263-4170), Yoram Shenker, M.D. (262-8605), or Peter Rahko, M.D. (263-8838) with questions.

Member Surveys
 In the fall, we plan on conducting a survey in Qualtrics of all IRB Members to provide the HS IRBs Office and Chair(s) with feedback.  The questions are meant to elicit your thoughts about the IRB Chairs (and their management of meetings), the HS IRBs Office Staff (and their communication with you, as well as the materials they prepare for meetings), educational materials and experiences, and feelings about being an IRB Member.  Please keep an eye out for an email asking you to take the survey.  If you have any additional questions about the survey, please contact Emily Jenner (262-3752) or Chelsea Dahmen (265-4389).

IRB Member Training Requirement
UW-Madison’s HRPP requires IRB Members to take the IRB Member Training course through the Collaborative Institutional Training Initiative (CITI) Program as part of ongoing education and training.  IRB Members are required to complete this course once to ensure compliance with the HRPP Education and Training Policy.  IRB Members are also required to complete the Human Subjects Protection for Biomedical Researchers course through CITI, which expires every three years.  To ensure compliance with this policy, the HS IRBs office will be sending out email reminders to IRB Members who have not completed one or both of these courses at the end of June.

Please contact Emily Jenner (262-3752) or Chelsea Dahmen (265-4389) with questions. 

Review Tips: Summarizing Initial Review Applications at a Meeting
The Health Sciences IRBs assign two primary reviewers to every submission discussed at IRB meetings. Two primary reviewers are assigned to ensure that at least two members conduct an in-depth review of a submission. When assigned as a primary reviewer for an initial review application, both reviewers should be prepared to briefly summarize the study; the second primary reviewer may need to present the study if the primary reviewer cannot attend the meeting.  The summary should include the following aspects:

1. purpose of the research
2. who will be invited to participate in the study
3. where the study will be performed (and if the study is multi-site, who the coordinating center is)
4. any risks to subjects, especially those that are unusual or significant
5. any funding for the study (especially if it is federally funded)
   

Reviewers should also discuss whether the study meets the “111 criteria” (i.e., the federal criteria that must be met for an IRB to approve a study), or what changes need to be made in order for the study to meet 111 criteria.  Specific areas that need to be mentioned (and documented) are:

• whether the study is minimal risk and, if not, whether the risks are adequately minimized and are reasonable in relation to the potential benefits
• whether the subject population is reasonable (i.e., equitable selection of subjects), and whether the enrollment of vulnerable populations, if proposed,  are approvable (and if any additional safeguards for this population are required)
• whether the consent process is approvable (including documents), and whether waivers of consent and/or documentation can be granted (if needed)
• whether the data monitoring plan is acceptable
• whether privacy and confidentiality plans meet institutional standards
  

Other aspects of the study may need to be discussed, as outlined in the reviewer checklist prepared by the assigned staff reviewer for a study.  If any questions arise while reviewing a study, please feel free to contact the assigned staff reviewer (staff contact information) or one of the IRB member points of contact.

For more information on summarizing initial review applications, please see the following additional guidance on our website:
Guidance for UW Madison Health Sciences IRB & Minimal Risk IRB Primary Reviewers for Summarizing Initial Review Applications
Making a Motion at IRB Meetings
Primary Reviewer Guidance for Initial Reviews

IRB Members Website Spotlight: "Childrens: Regulations" Fact Sheet
When the IRB is reviewing a study involving the enrollment of children, additional determinations need to be made based upon the federal regulations for protecting the welfare of children involved as subjects of research (45 CFR 46, Subpart D).  In order to approve the enrollment of children, a study must fall into one of the following categories:

• 46.404
• minimal risk
• obtain assent of child (when children able to provide assent)
• obtain permission of parent/guardian
• 46.405
• potential direct benefit to the child
• any associated risk is justified by the anticipated benefit to the child
• the risk/benefit ratio is at least as favorable as that presented by any available alternatives approached
• obtain assent of child (when children able to provide assent)
• obtain permission of parent/guardian
• 46.406
• only a minor increase over minimal risk
• any intervention or procedure presents experiences to subjects that are reasonably commensurate with those with those inherent in their actual or expected medical, dental, psychological, social, or educational situations
• likely to yield generalizable knowledge about a disorder or condition
• obtain assent of child (when children able to provide assent)
• obtain permission of both parents or guardian
  

The board may also determine that a waiver of parental or guardian permission is acceptable under 46.408(c) if the study otherwise meets the criteria for a waiver of consent.

For more information on research with children, please see the following additional guidance on our website:

• Children as research participants: Regulations
• [Link for document 29293 is unavailable at this time.]
• [Link for document 42482 is unavailable at this time.]
• Children as research participants: Assent and Consent 

HS IRBs Guidance Spotlight: DHS Variance Guidance
There is a Wisconsin Department of Health Services (DHS) regulation that applies to some human subjects research studies using x-ray.  IRB members may see this being addressed in staff reviews.  For more information about the DHS statute and the process UW-Madison researchers need to follow to request a variance, please see the following guidance: Guidance for X-Ray Radiation Use in Research Studies for Non-Healing Arts Purposes 

Article Spotlight: "Biobanking Research and Human Subjects Protections: Perspectives of IRB Leaders" Summary
The researchers for this article wanted to examine differences (and similarities) on IRB policies and procedures  for collecting, storing and sharing biospecimens.  IRBs at institutions that are members of the NIH’s Clinical and Translational Science Awards (CTSA) consortium were asked to be interviewed after completing a survey; the institutions with “divergent responses” on the survey (defined as extreme responses, such as “always” or “never” on policy options) were the institutions that were chosen to be interviewed.  Key study results outlined in the article are as follows:

• Process for Developing Guidance for Biobanking
• Most respondents indicate their institution prefers guidance for biobanking, as opposed to policy (for those institutions that distinguish between guidance and policy)
• While some institutions rely on working groups to develop guidance, most institutions rely on the guidance of:
• the Office of Human Research Protections (OHRP)
• the Association for the Accreditation of Human Research Protections Programs (AAHRP)
• institutional legal counsel
• Other resources for developing biorepository/biobanking guidance come from:
• National Cancer Institute’s Best Practices for Biospecimen Resources
• guidance and policies at other research institutions
• feedback from own investigators
• Biobanking versus Other Human Subjects Protection Policies
• Additional considerations not often involved in other human subjects protection policies may need to be considered
• There may be limitations on the IRB’s/institutions ability to monitor secondary use of archived specimens
• The need for IRB’s to trust researchers to conduct ethical research when the specimens are de-identified, and requests for their use may not need to be reported to the IRB, specifically when use of a specimen is not considered human subjects research
• Consent Forms and Participant Choice Regarding Future Research
• Most institutions use a consent approach that offers participants a choice about whether the biospecimen can be used in the future
• Two general approaches were identified when it came to how the consent forms describe how specimens are used in the future:
• broad consent to allow future, unspecified research
• participants given the option to decide specifically how specimens are used
• When approving secondary uses of biospecimens, most IRBs noted that they review the consent form for the collection of the sample to see if future uses are explicitly prohibited, such as certain types of research or sharing outside of an institution
• Challenges to Current and Retrospective Changes to Biobanking Guidance
• It can be difficult to develop guidance for biobanking, so many IRB decisions are made on a study-by-study basis
• Exceptions to existing guidance have sometimes been made (if it does not conflict with federal regulations) in cases where:
• there is an absence of the original consent form
• participants cannot be recontacted for a new consent
• when a study is outside the scope of the original study, but the study is minimal risk
  

In summary, the investigators found that researchers’ need for access to banked specimens and data remain.  However, institutions need to balance the need for samples with the need to protect the interests and welfare of the participants.  Most institutions supported broad consent to minimize the difficulties associated with tracking use of biospecimens when participants are given the option to decide specifically how specimens are used.  There also remains concerns about when the use of biospecimens constitutes human subjects research, largely due to the Department of Health and Human Services proposal to change the Common Rule so that biospecimens are inherently reidentifiable.  Due to variation across IRBs regarding guidance for biobank-related research, there remains difficulties with multi-site studies that either create or use banked specimens.

For further information regarding this study, please see the following article: BiobankingArticle.pdf
Rothwell E, Maschke KJ, Botkin JR, et al. Biobanking research and human subjects protections: Perspectives of IRB leaders, IRB: Ethics & Human Research 2015;37(2):8-13.