19th Edition - July 10, 2019

Maintaining accurate and appropriate records of research is an essential
component of the process for any research project. Such records are
necessary to support and substantiate findings, to protect intellectual
property rights, to facilitate management of the research program by the
University, and to ensure compliance with federal regulations and University
policies. Over the last decade, many funders and publishers have begun to
require that the data underlying published findings are made publicly
available, when appropriate. In an increasingly complex research
environment, these changing expectations are putting heavier demands on
researchers. The purpose of this document is to provide researchers with
clear guidance about best practices for managing their research data in a
rapidly changing digital environment. This guidance can serve as a tool for
fostering discussion of data management issues and strategies within teams.
It can also facilitate discussion of needs and solutions between research
teams and the system administrators of research storage and computing
services.

This guidance builds upon existing university policies such as DM-01 and DM-02 to describe clear expectations for the management of research
data at IU. It was developed in consultation with the University Information
Policy Office, Office of Research Compliance, the University Data Stewards,
as well as others engaged in research support at IU.

Contact Heather Coates, University Data Steward, for Research Data, hcoates@iupui.edu questions or feedback related to the IU Research Data Management Guidance document and operational Data Management Plan template.

Successful international collaborations are critical to the teaching, research, and service missions of Indiana University.  However, when engaging in these relationships, representatives of the university must be mindful of disclosure and other legal restrictions that may apply.  The Director of the National Institutes of Health (NIH), Francis Collins, M.D., Ph.D., has issued a “Foreign Influence Letter to Grantees.” He offered a reminder to “disclose all forms of other support and financial interests, including support coming from foreign governments or other foreign entities...in accordance with the NIH Grants Policy Statement, [on] all applications and progress reports.” The following is a list of key research compliance reminders to keep in mind when engaged in international projects:

• You must disclose your outside professional activities and financial relationships, whether compensated or uncompensated, through the Conflict of Interest/Commitment form. Such disclosures must include all work for, or financial interests received from, a foreign institution of higher education or the government or a quasi-governmental organization of another country.
• Journals and professional organizations have various, often broader, standards for financial interest disclosure than the university. Review those standards for each relevant journal or organization and disclose appropriately.
• Ensure compliance with U.S. export control regulations when doing any of the following: accepting publication restrictions on research; traveling internationally and attending conferences; participating in international collaborations; working with international staff and students; hosting international visitors; shipping materials internationally; and engaging in other international transactions. Learn more about export control at IU and, if needed, contact IU’s Export Control Office, export@iu.edu, at within the Office of Research Compliance.
• Pay special attention to any travel or research collaborations involving sanctioned or embargoed countries, including: the Western Balkans, Belarus, Burundi, Central African Republic, Democratic Republic of the Congo, Crimea Region of the Ukraine, Cuba, Iran, Iraq, Lebanon, Libya, North Korea, Somalia, South Sudan, Sudan, Syria, Venezuela, Yemen, and Zimbabwe. Travel to, or activities involving, these countries may require explicit government approval. Learn more.
• Coordinate with the Offices of Research Compliance and Research Administration regarding any prospective sponsored research agreement or gift. Although this is true generally, it is especially important if the agreement or gift involves a foreign entity or person.
• Remember that individual researchers may not make any arrangements or commitments with a prospective partner or funding source that would contractually bind the university without going through the appropriate university offices and administrative procedures. Learn more.
• Promptly disclose intellectual property to the Innovation and Commercialization Office and remind your group members to do the same.
• Comply with the Foreign Corrupt Practices Act, which, among other things, limits gifts and payments to foreign government officials.

If you have any questions please feel free to contact Eric Swank (edswank@iu.edu), Executive Director, Research Compliance.

Effective July 1^st, the biomedical IRBs at IU have been restructured.  Previously, IU had four biomedical IRBs, which each met once monthly.  These four IRBs have been consolidated into a single biomedical IRB that meets approximately twelve times per month, on most Tuesday, Wednesday, and Thursday mornings.  Items requiring full board review are assigned to the next available, appropriate IRB meeting after the pre-review process is completed.  If you have questions about timing of review of a full board item, please contact Avril Pitt, Assistant Director for the Full Board team, at avrua@iu.edu.  Note that items are still provided to IRB members approximately one week in advance of the meeting.  IU’s other IRBs will continue on their previous schedules unchanged.

In late August, the HRPP will launch a process to serve as Privacy Board even when IRB review and approval is not required.  A Privacy Board is the body that has authority to grant a waiver of HIPAA Authorization when protected health information (PHI) will be used for research purposes.  In some cases, a waiver is needed even when IRB approval is not required, for example, when IU/IUH faculty and staff are accessing PHI for research purposes, but are not engaged in the research project.  The ability to request a waiver of HIPAA authorization in these cases will be added to the Not Human Subjects Research (NHSR) application in KC IRB.  If you are accessing PHI for non-clinical purposes and don’t have an existing IRB approval which covers this use/access, you may need to submit a NHSR application.

If you know of a new PI coming to IU and who has existing research studies that he/she will be transferring to IU, we can help!  Please contact us to discuss transfer of studies, whether reliance requests or new submissions here at IU are the best option, and how we can support the PI during the transition.  We can start these conversations before the PI arrives to make the transition go as smoothly as possible.  Email us at irb@iu.edu, and we’ll be happy to help.

The consent process is an exchange of information that provides the prospective subject with adequate information pertaining to the research study; sufficient opportunity to consider aspects of the research, including the risks and benefits, and whether to participate; and the opportunity for the subject to ask questions and receive answers to those questions.  The informed consent document (or study information sheet) is generally used to guide the consent discussion and provides the subject with information that can be referenced later.  Because informed consent is an ongoing process throughout the subjects’ participation, researchers may need to repeat the consent process during the course of the study. 

In some situations, in addition to repeating the consent process, you may need to obtain a new consent signature from the subject.  New subject signatures are most commonly required when:

• the consent form is revised to include or remove information that might impact subjects’ willingness to participate, such as new or different study procedures, risks, or benefits; or
• a subject’s ability to consent for themselves changes, including minor subjects reaching the age of majority, or adult subjects whose capacity to consent might be lost or regained.

In these situations, a new, full consent process must occur. The consent form (or study information sheet) should be reviewed with the subject, and if changes have been made since the previous consent process was conducted, those changes should be discussed.   Subjects’ questions should be answered, their voluntary agreement to continue participation should be documented through a new signature, and subjects should be provided with a copy of the new consent form to keep. 

Even if the study’s consent document has not changed and a new subject signature is not required, there may still be times when repeating the consent discussion might be appropriate.  The Office of Human Research Protections (OHRP) recommends repeating the consent process when a prolonged period of time has passed between initial consent and the start of study procedures.  As OHRP notes, “the prospective subject may no longer be interested in participating, may no longer meet the eligibility criteria, may no longer find the risks acceptable, or may no longer have the time to complete all study-related activities” when study procedures are delayed following initial consent.  This may also be considered when a long period of time passes between study visits or your interaction with subjects.   For example, if a study invites subjects to participate in a variety of phases or components over several years, a subject may complete some procedures quickly after initial consent but may not be asked to return for a prolonged period of time, when they may no longer recall the details of participation. While there is no regulatory requirement to repeat the process in these delay scenarios, investigators are encouraged to consider  doing so based on their own study and participant experience.  See OHRP FAQs on Informed Consent for more information about this recommendation and other helpful information.

Each time the consent process is repeated, the study team should document this activity in the research notes, even if a new subject signature is not required at that time.