September 2017 IRB Connection Newsletter

Request a Presentation Now for Your Research-Oriented Class or Group

As the Fall 2017 semester begins, we want to promote a resource that may be especially useful to instructors of research methods courses, other research-related courses, journal clubs and orientation sessions or seminars for new faculty, graduate and professional students. The IRB Education and Outreach program is available upon request to give classroom and group presentations about the ethical conduct of research, the UI IRB review process and other human subjects research-related topics. We can tailor the length and content of the presentation to suit your needs, and we will present outside normal business hours, including evening and online classes. 

IRB Overview Presentation

We offer a general IRB overview presentation that provides a broad overview of topics that are relevant for students and others who plan to conduct research themselves, whether as a course requirement or as an honors, Master’s or doctoral dissertation. This presentation can cover some or all of the following:

  • The definition of human subjects research
  • How to ask if you need IRB approval
  • Ethical conduct of research (the Belmont Report)
  • The UI IRB review process
  • Informed consent
  • Research off campus or outside the United States
  • Course-related student projects
  • IRB Resources that are available for UI/VA researchers

This presentation provides a good orientation to the UI IRB and the IRB approval requirements for faculty, staff and student researchers.

Ethical Conduct of Research

We also offer a full presentation about the ethical conduct of research.   It includes an in-depth discussion of the ethical principles of human subjects research that are outlined in the Belmont Report and examples of unethical research conducted both historically and recently. This presentation is designed to help students apply basic ethical standards to real-world examples of human subjects research.  It would be an excellent supplemental lecture for any research methods course.

These presentations typically fill a 50-minute class period, but we can tailor the length and topic to suit the needs of the class or group.   Contact us today at irb-outreach@uiowa.edu to schedule a presentation for your class or group.

Summer Recap Article

By: Brent Collinsworth
Palm Trees

It’s been a busy summer for the IRB Connection! Here’s what readers missed when they were away:

May:

ClinicalTrials.gov Final Rule Update: This article is about the new final rule from the US Department of Health and Human Services. The new final rule (42 CFR 11) details the requirements for researchers to register and provide summary results in a public database for clinical trials, called ClinicalTrials.gov.

HawkIRB Update: Changes in the “Approval” Tab: This article discusses changes made to the Approval tab in the HawkIRB system. This tab now includes some basic study information like IRB number and study title on the page, to assist researchers when they are sharing information about IRB approval with sponsors. Next, there is a new section (Consent Updates) with the file name, approval, and expiration dates of all consent documents associated with the study. Lastly, researchers can now access a printer-friendly version of the Approval tab.

Who’s Steering The Boat? When PIs (and research team members) “jump ship”: When research Principal Investigators leave the study, they must either be replaced or the study must be closed. This article discusses these process, what to do when a researcher departs unexpectedly, and how to remove deactivated research team members.

July:

Enrolling Children in Research: They’re not just small adults!: Are you conducting research with children? If so, this article is for you. This article discusses the federal regulations for children in research, getting parent or guardian permission, and additional procedures if minor subjects are wards of the state.

Best Practices for Documentation of Informed Consent: This article outlines some helpful best practices for documenting informed consent in research. For instance, printing consent documents directly from the attachments page in HawkIRB ensures that the current consent document is being used. This is a helpful article for all team members that are involved in the consent process.

International Research: IRB Approval in Any Language: Research conducted in other countries still needs to be approved by the IRB if UI faculty, staff, or students are involved. This article outlines the three major differences between international research and research conducted at UI. This article is a helpful guide to anyone working on an international research study.

August:

FDA Draft Guidance for Electronic Records and Signatures: The FDA recently issued draft regulations on conducting research using electronic records and electronic signatures. This document covers many topics related to confidentiality, mobile technology, and consent validation, just to name a few.

Other Human Research Protection Program Committees & Units: Most people know about the nature and purpose of the IRB. Did you know there are multiple committees that may review research as a part of the overall human research protection program? This article is a helpful outline of the purpose and procedures of committees that the researcher may interact with when seeking IRB approval.

Risk Communication and Consent: A key component of ensuring that subjects are well-informed about research is ensuring that risks are properly communicated. But how do researchers ensure subjects are properly informed? This article discusses a variety of best practices for researchers to ensure that their participants are able to understand the risk of participation.

IRB Advisor:

IRB Advisor is a monthly newsletter from AHC media that contains articles on topics like regulatory issues in research, informed consent, and current events in human subjects protections. Each month, we spotlight an article from IRB Advisor. The featured IRB Advisor articles over the summer include:

There is a link to current and past issues of IRB Advisor on the Education and Training page of the Human Subjects Office web site. This link provides automatic access to the newsletter from all computers with a University of Iowa IP address. If researchers want to access IRB Advisor from a non-UI computer, they may contact the Human Subjects Office to request the username and password.  Contact us by e-mail at irb-outreach@uiowa.edu or call us at 319-335-6564.

The Good News about CITI Training (if already completed at another institution)

By Kelly O’Berry
CITI Logo

University of Iowa (UI) researchers are required to complete an online human subjects protections training through the Collaborative Institutional Training Initiative (CITI) before they can serve as a Principal Investigator (PI) or research team member. This training covers the history of research involving human subjects and ethical principles that apply to this type of research. The good news is that new faculty, staff, students and trainees who completed CITI training at another institution may have already completed some of the UI training requirements and do not need to repeat the entire training. (NOTE: VA researchers have separate CITI training requirements. For more information, contact Michelle MacDonald at michelle-macdonald2@va.gov or Nadine Miller at Nadine-miller@uiowa.edu.)

The UI is one of many institutions that require researchers to complete CITI training before they can conduct human subjects research. Each institution selects the modules that make up their training requirements. If there is overlap between the UI requirements and the modules required by your previous institution, it’s likely that ‘credit’ for these modules will transfer to the UI. There is one module that is unique to the University of Iowa, so even if you completed CITI training somewhere else you will need to complete at least that one module to satisfy the UI training requirements.

Follow these steps to complete the UI training requirements:

  1. On the Human Subjects Office (HSO) website, click on the blue CITI icon in the upper left corner.
  2. Click on Question #14 and follow the instructions to affiliate with the UI – log in to CITI with your previous username and password and select “Click here to affiliate with another institution” on the Main Menu screen and enter “University of Iowa.” You may need to update your demographic information.
  3. There are several different CITI training courses available for UI researchers. Be sure to complete the one that is required to conduct research. (HINT: You might think it would be the “Responsible Conduct of Research” course, but that is not the correct course!) On the UI ‘Select Curriculum’ page, select the option, “I am required to complete human subjects research training” to access the correct course.
  4. Select the appropriate group for your research. Group 1 is for Biomedical research and Group 2 is for Social/Behavioral research. These group numbers correspond to the UI IRB that will oversee your research, IRB-01 or IRB-02. The board that oversees your research depends on the department in which you conduct it.  Click here to see the lists of departments under each board.
  5. You will see the UI required modules that you did not already complete at your previous institution. The previously completed modules will be greyed out.

If you have questions about the CITI training requirements for UI researchers, please review the CITI page of the HSO website or contact Joanie Neyens (Joanie-wilson@uiowa.edu or 319-384-1176).

PRIM&R Webinar Series: Informed Consent and the Revised Common Rule

by Brent Collinsworth
PRIM&R Logo

In June, Public Responsibility in Medicine and Research (PRIM&R), the professional organization for the field of human subjects protections, hosted four webinars about the major changes in the revised Common Rule. In the June 1st webinar, Jeremy Corsmo and Dr. Paula McAllister talked about changes in the regulations regarding informed consent. This article provides the highlights from that webinar.

 

Concise presentation of key information to subjects during the consent process. This change establishes that the consent process and document must begin with a concise and focused presentation of the key information about the study. This must include the information most likely to assist subjects with deciding whether to participate in the study (e.g., the study’s risks, benefits, and time commitment). The information must be organized and presented in a way that facilitates comprehension of the material.

 

Changes in the required and additional elements of informed consent. There are four new elements of informed consent, one required and three optional, which focus on secondary use of samples and data and genomic research. 

 

  1. Required- Researchers working with identifiable private information or identifiable biospecimens must include one of the following statements in their consent document:

 

  • A statement indicating that collected samples/data may be de-identified in the future and used for future research without contacting the subject for further consent

OR

    • A statement indicating that samples/data will not be used in future research, even if is later de-identified.

 

  1. Optional- Researchers working with biospecimens, even if they are de-identified, should disclose to subjects if their specimens may be used for a commercial profit. If so, the researcher must disclose whether that profit will be shared with subjects.

 

  1. Optional- Researchers who may collect clinically relevant research results during the course of research would need to disclose whether these results will be given to the subject and under what conditions.

 

  1. Optional- Researchers studying biospecimens must disclose to subjects whether the research will include or might include whole genome or exome sequencing.

 

Broad Consent. Broad consent is an option when researchers plan to store subjects’ identifiable information and/or identifiable biospecimens for future use. Broad consent contains some of the usual elements of consent, such as benefits, risks, confidentiality protections, and emphasizing voluntariness. Broad consent also has its own elements of consent, such as disclosing data/specimen storage time. Broad consent can be used alongside the usual consent process or alone for specialized studies (i.e., repositories). Finally, if a subject declines to sign a broad consent, the IRB cannot grant a waiver of informed consent for future use their data/samples.

 

Revised definition of a legally authorized representative (LAR). A legally authorized representative is an individual that is legally able to grant permission for an adult subject who is unable to consent for themselves to participate in research. There is no federal law about who can serve as an LAR, but some states and jurisdictions have laws that apply. In jurisdictions where there are no specific laws addressing the matter, the new provision of the revised Common Rule would apply. In the absence of an applicable state law, the new Common Rule allows researchers to apply the institutional policy about who can serve as an LAR for providing consent in a non-research (i.e., clinical) context .

 

[NOTE: The state of Iowa has specific laws about guardianship of a minor (a child who is less than 18 years of age) that apply to who can serve as an LAR for research purposes. Another section of the Iowa Code addresses who can serve as the LAR for adults who cannot consent for themselves. University of Iowa IRB policy is based on these state laws.]

 

A new criterion for waiver of documentation of informed consent. When the IRB grants a waiver of documentation of consent, the researcher conducts the consent process but participants do not sign the consent document indicating their agreement to participate in the study. Under the current regulations, the IRB can grant this waiver under two scenarios:

  1. The research presents no more than minimal risk AND the study involves no procedures for which consent is normally required outside of a research context,

OR

  1. The main risk to subjects is the potential harm resulting from a breach of confidentiality and the only record linking the subject to the research would be the consent documentation.

 

The revised Common Rule adds a third category for waiving documentation of consent. Researchers may now request a waiver when it is not the cultural norm for subjects to sign informed consent documents in the location where the research is being conducted. In some countries, signing an official document may be associated with negative consequences. In other places, a higher importance is given to signatures, and people only sign important legal documents like wills. This new category will allow researchers to conduct research in a way that is sensitive to the cultural standards of the location. The IRB could only grant a waiver of documentation of consent under this new category if the research presents no more than minimal risk of harm to subjects and the researcher has an appropriate alternative method for documenting that informed consent was obtained.

 

A new requirement for any waiver or alteration of informed consent. The current regulations include a list of required elements of informed consent, the information that researchers must provide to subjects during the consent process (a statement that the study involves research, the purpose of the study, reasonably foreseeable risks, etc.).  With proper justification, the IRB can grant a waiver of one or more required elements of consent. That means a researcher could apply for a waiver of all elements of consent, essentially waiving the whole consent process. A full waiver of informed consent is only allowed in a specific set of circumstances, such as retrospective record review, use of existing specimens, and secondary data analysis. The revised Common Rule adds another acceptable justification for this type of waiver. Researchers may now apply for a full waiver of consent when they are using identifiable private information or identifiable biospecimens if the research could not practicably be carried out without using the information in an identifiable format. This means that the identifiable nature of the data must be crucial to the research study; otherwise, the study is ineligible for the waiver. This requirement is designed to protect subject confidentiality.

 

A summary of all changes in the revised Common Rule can be found in the Federal Register. The Human Subjects Office will continue to provide the UI research community with information about the revised Common Rule and the steps we are taking as an institution to comply with these revised regulations. At this time, the effective data for the new regulations is scheduled for January 19, 2018 but we have not yet heard whether the current administration will allow these regulations to go forward as approved by President Obama in January 2017.

 

Resources for New (and Not-So-New) Researchers

By Kelly O’Berry
Resources

Whether you’re just getting started as a researcher here at the University of Iowa (UI) or you’ve been conducting research here for many years, the Human Subjects Office (HSO) offers a variety of resources to support your human subjects research activities. Rather than providing hyperlinks to take you right to the page, this article tells you where to find these resources so you can find them yourself when/if you need them in the future.

IRB Policies and Procedures– The “UI Investigator’s Guide” link takes you to the University of Iowa IRB Standard Operating Procedures (SOP) and Researcher Guide. This is a comprehensive collection of institutional policies for the conduct of human subjects research. If you call the HSO to ask a question, we are going to check to see if the issue is addressed in our published policies. This is a good place to start to get an answer to your question or learn more about an IRB process or specific research methodology.

Human Subjects Research Overview for Researchers – There is a brief overview about:

  • UI Institutional Review Board (IRB)
  • What needs IRB approval
  • How to ask if you need IRB approval
  • IRB review types
  • Principal Investigator training requirements
  • Research off-campus or outside the U.S.

CITI Training and the Certified Investigator Database – Click on the blue “CITI Program” link to find background guidance for the UI human subjects protections training requirement. The page is set up in FAQ format. Here is some of what you will find on this page:

  • What is the human subjects protections training requirement and who is required to complete it (Questions 1 & 2)
  • What other trainings are available for UI researchers – Good Clinical Practice (Question #4) and Responsible Conduct of Research (Question #5)
  • How to access the Certified Investigator Database to see if someone completed the training (Question #8)How to complete the UI training requirements (Question #9)
  • How to affiliate with the UI if you completed training at another institution (Question #13 and #14)

HawkIRB Training – This is one of many resources available on the Education and Training page of the HSO web site. The UI Institutional Review Board uses an electronic application system, called HawkIRB. Researchers use this system to submit New Project, Modifications (Mods) and Continuing Review (CR) forms and Reportable Event Forms (REFs). HSO staff teach a two part series of trainings on how to use the HawkIRB system. You can probably figure out a lot of it on your own, but the trainings provide a very complete overview to help you prepare applications, understand the review process and get the most out of the HawkIRB system. Section-by-section recordings are available in the IRB ICON Course for Researchers (see below).

HawkIRB Help Messages – There are little blue Help messages (that look like this https://hawkirb.research.uiowa.edu/hawkirb/images/info2.gifhttps://hawkirb.research.uiowa.edu/hawkirb/images/info2.gif) associated with most of the questions in the HawkIRB application. The messages open in a separate window and provide additional instructions/guidance to help you respond to the question. As a general rule, the more detail you provide in the response – the better the staff reviewer and the IRB know your study procedures – the more smoothly your application will move through the review process.  We recommend using these Help messages as you prepare your HawkIRB application.

IRB Office Hours – During the spring and fall semesters, HSO staff are available three days a week, for two-hour blocks of time, to answer questions and assist researchers with ethical considerations and preparing HawkIRB applications. Beginning September 6, the Fall 2017 IRB Office Hours schedule will be:

Mondays from 10 am – 12 pm, S 108 Lindquist Center (LC)

Wednesdays from 2-4 pm, 101 Hardin Library for the Health Sciences (HLHS)

Thursdays from 10 am – 12 pm, 101 Hardin Library for the Health Sciences (HLHS)

The schedule is posted on the “Education & Training” page. Our staff is ready and willing to help. Stop by and ask your questions in person.

IRB Presentations – Each semester, the IRB Education & Outreach Group offer several presentations about topics related to human subjects research. See the “Education & Training” page for the schedule and a link to register to attend. We also welcome presentation topic suggestions. Send them to irb-outreach@uiowa.edu.

Class/Group Presentations – The Education & Outreach Group is available to give presentations to research methods courses, new faculty or trainees, research teams or any other group that needs an overview of the UI IRB review process and/or information about the ethical conduct of research. See the a list of potential topics and instructions for requesting a presentation on the section of the “Education & Training” page about Classroom Presentations.

IRB ICON Course for Researchers – This course is available to anyone with a UI HawkID and password. The “IRB Core Courses” is a set of recordings with basic information about human subjects research. Viewers can earn a certificate of completion for listening to all of these recordings. The “HawkIRB” section includes brief recordings about each section of the New Project application, an overview of the Inbox, and instructions for submitting Modification forms, Continuing Review forms, Reportable Event Forms (REFs) and Project Closure forms. There is also a recording about how to use HawkIRB workflow. The “Additional Topics” section includes several other recordings that might be of interest if you are conducting research off campus or outside the United States, if you want to know more about the regulations or waivers of informed consent.

IRB Connection Newsletter – The Human Subjects Office has a monthly newsletter with timely and relevant topics for UI faculty, staff, student and trainee researchers. We send this newsletter to Principal Investigators and everyone who is named on a research team of a study in HawkIRB. We also send it to people who recently completed CITI training but have not yet been added to a research team. If you’d like to subscribe to the newsletter, there are instructions on the Education & Training page about the newsletter.

Frequently Asked Questions (FAQ) – If you have a question, there’s a good chance the answer is addressed on our FAQ page. Some of the things you’ll find on this page include:

  • A general overview of the IRB and HSO
  • An explanation of the IRB review process
  • Requirements for trainings and certification
  • Information about HawkIRB applications and delegates
  • Information about VA and Department of Defense research
  • And much more!

There are many more resources available on the HSO website. Let us assist you with finding what you need to get started, or for the ongoing conduct of your research.

 

IRB Advisor September 2017

Pregnant Pause: Time to Push ‘Play’ on Trials With Expectant Mothers

Including pregnant women in clinical trials has always been a controversial topic, with many opinions on either side of the issue. Legal counsel for institutions and IRBs may be concerned about the liability if pregnant women are included in research. Many people bring up the thalidomide exposures in Europe in the ‘50s and ‘60s as an example of why pregnant women should not be included in research. Others are afraid of “long-tail” liability, where children of the pregnant subject could sue for damages. Since the regulations prevent exculpatory language in consent documents, researchers cannot ask subjects to sign away their right to sue the research team. However, there is also a significant risk to pregnant women if they are not included in clinical trials. Indeed, many bioethicists agree that the thalidomide crisis could have been prevented if pregnant women had been included in the clinical trials.

Some practical considerations discourage the inclusion of pregnant women in research. Some researchers claim that pregnancy creates “background noise” in the data, others state that there is no financial incentive to conduct research with pregnant women. But Anna C. Mastroianni, JD, bioethics expert and professor of law at University of Washington in Seattle, argues that including pregnant women in research is an ethical imperative. Read more to learn about the ethics and necessity of including pregnant women in research.

Other articles in the September issue of IRB Advisor include:

 

Current and Past Issues

There is a link to current and past issues of IRB Advisor on the Education and Training page of the Human Subjects Office web site. This link provides automatic access to the newsletter from all computers with a University of Iowa IP address.

 

The University of Iowa username and password cannot be posted on the Human Subjects Office web site.  UI researchers may contact the Human Subjects Office to request the username and password to access IRB Advisor from a personal computer.  Contact us by e-mail (irb-outreach@uiowa.edu) or call us at 319-335-6564.

 

Continuing Education Credits

Individual newsletter subscribers can receive 1.5 AMA PRA Category 1 Credits™ or 1.5 nursing contact hours for reading an issue and completing an online test.  However, since this is an institution-level subscription, UI researchers must purchase access to an individual issue for $40, or purchase a full subscription, to receive CME/CE credits.  Visit the AHC Media web site for information about subscription options.