IRB Connection HSO Newsletter August 2016

Ethical Principles in Research - Respect for Persons
Balancing the Belmont principles on a measuring scale

By Brent Collinsworth

When most people think of “ethics,” they think of general codes of conduct for life, governing what is acceptable and unacceptable behavior. Ethics allow people to have a clear standard for what should and should not be done in certain situations. The same is true for the ethical conduct of research. Ethical codes for the conduct of research put forth standards to promote truth, accountability, and the welfare of human research subjects. In the United States, the ethical standards in human subjects research are described in the Belmont Report.

Published in 1979, the Belmont Report specifies the difference between ‘research’ and ‘practice’ and also outlines the three primary ethical principles for activities that meet the definition of human subjects research.  In a series of three IRB Connection Newsletter articles we will explore these three principles:

  • Respect for persons (August 2016)
  • Beneficence (September 2016)
  • Justice (October 2016)

Part 1, Respect for Persons


The principle of respect for persons is primarily concerned with the autonomy of research participants; in other words, subjects have the right to decide whether they want to participate in research or have someone else authorized to make that decision, free from coercion. This means that there should never be any pressure to participate in a study, whether real or implied. Additionally, participants in a study have the right to make an informed choice about whether to participate in research. This means that researchers have a responsibility to fully inform potential subjects about the nature of the study, including the risks and benefits of participation. Lastly, participants have the right to withdraw from a study at any time, for any reason, and not have their data used in the research study as well. 

Application of this Principle

The concept of Respect for Persons can be most readily seen in the act of obtaining informed consent from study participants. In fact, the Belmont Report sets out three applications of the principle to be used in the consent process: Information, Comprehension, and Voluntariness.


The element of ‘Information’, as you might expect, is concerned with whether there is sufficient information given to the participant during the consent process. That means written Informed Consent Document as well as any verbal interaction during the recruitment and consent process.  But how does the average researcher know how much information is “sufficient?” The Belmont Report suggests that a standard of “the reasonable volunteer” be met. The information given to potential participants should be the amount and type of information about the study is enough that a reasonable person could decide whether or not to participate in the research. Participants should be informed of the research procedures and purpose, as well as the risks and potential benefits of participation.  Of course, there are also some instances in which researchers are unable to inform subjects of an element of the study. A common occurrence of this is in studies involving deception. In these instances, researchers would need to make sure that this is necessary to the project, all risks have been disclosed, and an adequate plan for debriefing subjects after participation has been devised.


The element of ‘Comprehension’ relates to how this information is received by the participant. The study information must be given to research participants in a language they can understand.   Comprehension can be enhanced if participants have time to ask questions and the researcher can clarify concepts that participants might not understand.  And there are even ways to provide study information at an appropriate level for people who have limited cognitive abilities or are not competent to provide informed consent for themselves (such as young children). In order to make sure that the documents are comprehensible, the researchers may need to go through a comprehensive reading of consent documents and information sheets given to the participants. Find where complex, “jargon-y” words are being used in the study and decide where it would be appropriate to substitute less complex words for the sake of clarity. Don’t underestimate how helpful keeping the document in active voice can be to aid in participant understanding as well. And finally, make sure that every consent process has time allotted for participant questions.

Voluntary Participation

 ‘Voluntariness’ refers to the freedom of individuals to choose whether or not to participate in a research study, free from coercion or undue influence. Coercion would include any threat of harm or loss of benefits to which the individual is entitled.  Coercion may be presented intentionally in order to make an individual participate in the study, although this approach us less common in research settings. Alternately, individuals could feel ‘unduly influenced to participate in the research, due to the relationship between the researcher and potential subject.  For example, student may feel compelled to participate if they are recruited by their course instructor.  Or a patient may feel obligated to participate if asked by their physician in order to receive good health care services.  Undue influence can even occur without the researchers’ knowledge or intention just as a result of the nature of the relationship.

Undue influence is defined in the Belmont Report as “an offer of excessive, unwarranted, inappropriate, or improper reward or other overture in order to obtain compliance.” In order to avoid undue influence, researchers should examine their study from the perspective of a participant. Is the offer in the study so excessive or improper that subjects might sign up for the study, even though they might have objections to it? Finally, the fact that participation in research is entirely voluntary cannot be said enough to potential subjects.

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Course-Related Student Project Updates

By Brent Collinsworth

An important part of research methods and ethics courses is to teach students how to conduct research in practical settings, and often this is taught by assigning projects to gather and analyze data. Since the majority of these course-related projects are not designed to create new knowledge or to be published, the University of Iowa IRB has a Course-Related Student Projects Policy and a related checklist to help instructors know when IRB approval is not required for projects that are conducted as a course requirement.  In time for the Fall semester, the Human Subjects Office updated this policy and revised the checklist to provide better guidance for course instructors and students.

All human subjects research conducted by University of Iowa faculty, staff or students must have approval from the Institutional Review Board (IRB) prior to initiation. A key component of the regulatory definition of research is the intent to “develop or contribute to generalizable knowledge.” Projects conducted for research methods courses are generally more limited in scope, and are intended to help students learn how to conduct research.  These projects are done to satisfy curriculum requirements rather than to further scientific knowledge in a particular field or discipline.  A course-related project is not considered human subjects research and does not require IRB approval unless it is part of an honors, masters or doctoral thesis project or intended for any other purpose, or if study design excludes it from qualifying for this exception.

Course-related research activities would not require IRB review if:

  • The purpose of the assignment is to teach research methodology (such as in a research methods course).
  • The results of the assignment will not “contribute to generalizable knowledge” because they are either being to satisfy a course requirement, or because of limits on who will have access to the results of the project. 
  • The procedures will be limited to surveys, questionnaires, interview procedures, observation of public behavior, or standard educational exercises. 
  • Data will be recorded without any identifying information (such as code numbers, birth dates, etc.).   Or the data being collected is not sensitive in nature to pose a risk of harm to the participants’ reputation, employment, financial standing or put them at risk for criminal or civil liability.
  • The participants will not include prisoners, children, or data about them. 
  • There is no monetary compensation or direct financial support for the project from an external company, organization or agency.
  • The project will not be conducted at the Veteran’s Administration Health Care System (VAHCS) or using any VA resources. 
  • The project is not conducted or supported by a federal department or agency that follows the federal regulations for the protection of human subjects (the ‘Common Rule’).

The Human Subjects Office provides a Course-Related Student Projects Checklist, a fillable pdf that students complete and instructors use to determine whether a project qualifies as a course-related student project. The form has pop-up messages and STOP buttons if the study design involves any aspect that might require IRB approval.  If that’s the case, the student should submit a Human Subjects Research Determination form in the HawkIRB system to ask whether IRB approval is necessary.

Please contact the Human Subjects office (319-335-6564 or if you have any questions about the Course Related Student Projects Policy or Checklist.

Herky Hints: What to Review for your Continuing Review
Herky the Hawkeye says \"Herky Hints\"

By Sarah Heady

The responsibility for communication with the IRB doesn't end after receiving IRB approval. One of the many post-IRB approval requirements is the ‘continuing review’ of your research application.  The IRB can only approve a study for up to one calendar year so it needs to be reviewed at least annually (unless your project is Exempt) as long as the research team continues to engage in research activity, such as data collection and/or analysis of identified data.  

Studies that involve prospective subject enrollment all report the cumulative number of subjects who have agreed to participate, but project design and funding source will affect what is reported in the CR— for example, VA projects are required to report race and ethnicity, where a project without funding may not be required to track these variables. Social/Behavioral research probably does not need a column for adverse events.  The table below is but one example of how research teams might organize and update this information throughout the research study.

Subject ID

Date Consent Obtained




Consent for future contact

Study Visit Status/Completion Date


Adverse Events


Concerns, Complaints, or Comments






Y    N

Complete 2/6/16








Y    N

Complete 3/2/16








Y    N

Visit 2








Y    N

Visit 1



Timing of Continuing Review Date

How do you know when to submit your continuing review for approval? The date the next approval is due by can be found on the Project Summary page under ‘review.’ (Find the Project Summary page by clicking on your project IRB ID number.)

Circled due date for Continuing Review

This is the date IRB approval expires at 12:01 am.  So by the time you wake up in the morning on this date, IRB approval will have lapsed unless you have submitted a Continuing Review (CR) form that has been approved by the IRB. You must submit your study CR form enough in advance of the meeting for addressing questions, making revisions to the form, and for the study to be reviewed at an IRB meeting, if necessary.  On the lapse date, IRB approval expires and all work on the project must stop until the IRB approves the CR form.

The CR Form

The CR form is concise—3 screens of questions: a short report on both the past year of research, and cumulative accounting of subjects, and various types of progress reports. It opens with a request to provide a general description of the progress of the study to date.  Researchers should report any problems, delays, or significant changes to the project design since the study was initially approved by the IRB.  This is also the place to provide any additional information the IRB would need to be able to approve the study to continue for another year.

Subject Enrollment

Researchers are asked to provide the total number of subjects consented or enrolled to date (NOTE: This is NOT just the number of participants enrolled in the past year) and the number enrolled by gender. The HawkIRB Continuing Review form requests the total number of subjects consented to equal the number of female and male participants reported in the form.  If you report 20 total subjects, females + males must = 20. A future IRB Connection article will address how to report enrollment for transgender subjects and those who do not identify with the binary gender options.

Subject Withdrawals and Complaints

Other pieces of information you should track while the project is open to enrollment:

  • Anyone who withdraws from participation, either by their own choice or a decision by the research team or Principal Investigator to remove a study participant
  • The reasons for withdrawal (i.e. study requires too much time, moving, etc.) if known
  • Any complaints or concerns from participants (distinct from any reason for withdrawal)

Provide as much detail as possible about the reason for withdrawal and about complaints and concerns.

Reportable Events

There are 5 categories of events that should be reported to the IRB at the time they occur; within 10 days of the event or within 10 days of the researcher finding out about the event.  The CR form has two separate questions about four of the five events.  CR III.1 asks about any reportable events (including Serious Adverse Events and Unanticipated Problems).  This would include serious adverse drug events and serious adverse device effects.  CR III.7 asks about another type of reportable event, new information that might affect someone’s willingness to enroll or continue participating in the study.  At the time of the CR, if there are any reportable events that were not previously reported to the IRB, they should be described in the appropriate section of the CR form and the Principal Investigator should submit a reportable event form (REF) in HawkIRB.  If there have been any incidents of noncompliance that have not yet been reported to the IRB,  the PI should submit a REF in HawkIRB within 10 days of the event or within 10 days of the PI or research team learning of the event.

Reports, Grants, Correspondence and Monitoring

There are questions at the end of Section III of the CR form that do not apply to all studies.  They ask about progress reports to a funding agency, competitive continuation grants, correspondence with a regulatory agency (such as the Food and Drug Administration or the Office of Human Research Protections) and monitoring by a sponsor, coordinating center, funding or regulatory agency, or Data Safety Monitoring Board.  “Yes” responses will open attachment categories on the CR form to attach any related documents. To state the obvious, if you don’t have any of these, you don't need to attach anything.

The last question of the CR form asks about monitoring events.  In this case we're talking about monitoring by someone outside the UI, NOT internal monitoring by a Compliance Monitor from the Human Subjects Office.  Internal monitoring is tracked in the HawkIRB system, under the “Monitoring” tab on the Project Summary page.  It is not necessary to report that type of monitoring in the CR form.

In short, the CR form asks for information that should be tracked throughout the study. It will be easier to complete the form if as much of this information as possible is captured in a study enrollment log.  Once a year, at the time of the CR, is also a good time to review your entire IRB application to make sure everything else is up to date. For additional discussion of the Continuing Review submission process, check out the HSO FAQ. And as always, if you have any questions feel free to contact the Human Subjects Office by phone or e-mail (319-335-6564 or

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A Measure of Our Performance: 2015 IRB Review Metrics
Metrics measuring stick

By Kelly O'Berry

The research community is invited to review updated metrics for the University of Iowa Institutional Review Board (IRB) and the Human Research Protection Program (HRPP).  The posting on the Human Subjects Office (HSO) web site now includes comparison data for the past four years (2012-2015) for New Project form submissions, active protocols, application processing times and research funding. 

Originally used in the field of finance, the practice of tracking and reporting ‘performance metrics’ is now common in a variety of fields to measure the activities, or performance, of an organization.  Like any business that examines its processes to improve its’ “bottom line,” the HSO analyzes metrics for the IRB review process to drill down to specific points in the process to identify delays or waste and create opportunities for improvement. Our primary focus is to reduce the application turn-around time while still ensuring the protection of human subjects and compliance with federal regulations, state and local laws as well as institutional policies.

As the administrative office that supports the Institutional Review Board (IRB), the HSO plays a large role in compliance oversight for the broader UI HRPP.  UI HRPP metrics cover everything from total numbers of submissions and open studies to the length of time it takes to receive IRB approval for different IRB review types (full board, expedited review and exempt determinations).  This analysis definitely has internal uses, and there are many more reports that we run and use internally.  But the purpose of posting IRB metrics on the HSO website is to provide transparency and to further support the needs of our customers, the UI research community. 

Why track this information?

It is no secret that UI researchers want and need to have HawkIRB applications reviewed and approved as quickly as possible.  HSO staff and IRB members want that too!  The goals for tracking and reporting metrics include (1) improving the quality of service we provide to the research community, (2) decreasing application review times, (3) making sure the institution is competitive in the central and external IRB application review model, and (4) satisfying AAHRPP accreditation standards and (5) make process improvement recommendations to the various Human Research Protection Program (HRPP) entities.

According to the Association for the Accreditation of Human Research Protection Programs (AAHRPP), “Effective and efficient systems of oversight within organizations provide better protections for research participants and produce higher quality research.”  Ultimately, the accreditation of the UI HRPP demonstrates that the institution is committed to:

  • Improving the systems that protect the rights and welfare of individuals who participate in research.
  • Communicating to the public the strength of the University of Iowa’s commitment to the protection of human research participants.

The application review time metrics are presented separately for each IRB and separate out the following components of the review process:

  • Principal Investigator (PI)
  • Institutional Review Board (IRB)
  • Human Research Protection Program (HRPP)

Highlights from the 2015 metrics

Forms and Active Projects - It might surprise most researchers to learn that the number of active protocols under the UI IRBs purview in 2015 is 3,511.  That was an increase of over 90 protocols since 2014 and up 122 since 2013.  And for each active protocol, the Principal Investigator can submit multiple Modification forms and, for non-Exempt research, one Continuing Review form every year.  The total number of forms that the IRB reviewed also grew steadily over the past four years.  In 2015, the UI IRBs reviewed 8,601 forms, an increase of 339 just in the past year.  New Project forms alone were up 85 from 2014. 

IRB Meetings - The UI has separate boards that review biomedical, social/behavioral and VA research (IRB-01, IRB-02 and IRB-03) and there will be a new board forming soon to review research funded by the Department of Defense (IRB-04).  The three existing IRBs meet on different schedules.  IRB-01 meets 6-7 times per month.  IRB-02 meet once a month, as needed and IRB-03 meets monthly to correspond to the meeting schedule of the VA Research and Development Committee.  There was an average of 91 board meetings per year over the last four years, with an average of 613 agenda items per year.

IRB Review Process - The UI IRB Metrics web page contains a flow chart of the IRB review process and a listing of the other committees that review applications, in addition to the IRB.

Length of Time for IRB Approval - There are also metrics to answer one of the most common questions from researchers, “How long does it take to get IRB approval?”  The answer depends on the board, the type of IRB review and can even vary by time of year for the initial submission.  We track the median time it takes from submission to the HSO\IRB to release to the researcher.  The application review charts illustrate the time forms spent with the study Principal Investigator (PI), how long they were with the IRB/HSO and the review time for the greater HRPP review, which includes other committees such as Pharmacy and Therapeutics, Medical Radiation Protection Committee, etc.

Research Funding Sources – There charts that reflect the type of funding sources associated with IRB approved research.  This could include federal, state & local, industry, private foundation, institutional, departmental, or no funding.  The charts illustrate variation in the type of funding across the three IRBs over the past four years.  It varies some by board but there has been an increase in unfunded or departmental funded research over the past several years.   

Submissions by college/department (largest number of submissions) – Research is submitted from colleges and departments all across the University.  Metrics are available to reflect those areas contributing the largest number of submissions to the IRB for review. 

Please take a few minutes to browse the updated metrics for the boards and the types of IRB review that apply to your area of research. Feel free to contact the Human Subjects Office if you have any questions about these records (PH: 319-335-6564 or E-mail:

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The IRB Advisor Newsletter, August 2016: NIH Clinical Center Riddled With Research Problems 
IRB Advisor Logo

An independent panel has reported on the state of research at one of the best research institutions in the world, and its conclusions are surprising. The National Institutes of Health Clinical Center in Bethesda, MD, came under fire after finding multiple problems that seemed to reflect systemic dysfunction in the institution’s policies to protect its human subjects. In response, NIH Director Francis Collins started an independent investigation to review policies and procedure. The draft report, now available on the NIH website, found many deficiencies in the regulatory process that lead to a lack of emphasis placed on the safety of research subjects. It also recommended multiple steps to take to improve its oversight process, including setting up an Office of Research Support and Compliance that would evaluate IRB workings to ensure standards are met as well as supervising compliance activities.

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.

The August issue also includes articles about:

  • The upcoming issuance of the NIH’s IRB of Record Policy Guidance
  • IRBs around the nation preparing for the NIH’s new IRB of Record Policy
  • Unanswered questions in the NIH Policy
  • Steps to take to make transition to central IRB agreements easier
  • The past, present, and future of online research and the IRB

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 ( 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.

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