Office of Research Integrity (ORI) to release a video simulation of research intergrity

A video simulation on research integrity, entitled "The Lab", will be released within the next month on the ORI web site and as a DVD. This simulation focuses on a hypothetical research misconduct case that causes lab to lose funding, create bad publicity for the university, and eventually causes the withdrawal of a multi-million dollar endowment.

Like the popular "Choose Your Own Adventures" stories, "The Lab" will allow viewers the opportunity to undo the damage by assuming the roles of a graduate student, post doc, principal investigator,
and a research integrity officer and make decisions to prevent misconduct from occurring unnoticed. The interactive video addresses the handling of misconduct, data management, authorship, mentoring, work-life balance, and other issues that today's researchers face. A fully-functional online version will be available on the ORI site in January, with a DVD version expected to ship PHS funded institutions before February 2011.

A trailer of the video can be viewed at http://ori.hhs.gov/TheLab

News from Ofiice for Human Research Protections (OHRP)- January 5, 2010

Information relayed from OHRP-L@LIST.NIH.GOV:

OHRP has moved two guidance documents to its archive of guidance documents no longer in effect. The two documents are “Local IRB Review of Multicenter Clinical Trials” and “Local Institutional Review Board (IRB) Review of Multicenter Clinical Trials Sponsored by the Division of Aids (DAIDS) National Institute of Allergy and Infectious Diseases (NIAID).”

These documents have been archived because OHRP’s policy regarding local IRB review has changed and they no longer represent OHRP’s policy. OHRP policy continues to be that a reviewing IRB should have knowledge of the local context for studies it reviews, but that review by a local IRB is not favored over review by a non-local IRB.

All archived OHRP documents may be accessed on the OHRP Web site at:
http://www.hhs.gov/ohrp/policy/archive.html.

International Compilation of Human Subject Protections

The 2010 edition of the International Compilation of Human Subject Protections has just been released by the Office of Human Research Protections. The 2010 version details over 1,100 laws, regulations, and guidelines on human subject protections from 96 countries, including five new countries: Dominica, Guatemala, Honduras, Kyrgyzstan, and Qatar.

View thus document at:
http://www.hhs.gov/ohrp/international/HSPCompilation.pdf.

Guidance on Engagement of Institutions in Human Subjects Research

When an institution is engaged in non-exempt human subjects research that is conducted or supported by HHS, it must satisfy HHS regulatory requirements related to holding an assurance of compliance and certifying institutional review board (IRB) review and approval.

Before engaging in human subjects research that is not exempt, an institution must hold or obtain an OHRP-approved Federalwide Assurance and certify to the HHS agency conducting or supporting the research that the research has been reviewed and approved by an IRB.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. A human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. An institution is defined in 45 CFR 46.102(b) as any public or private entity or agency (including federal, state, and other agencies).

In other words, institutions are considered engaged in an HHS-conducted or -supported non-exempt (EXPEDITED OR FULL BOARD) human subjects research project when the involvement of their employees or agents in that project falls into various examples including:

Institutions whose employees or agents intervene for research purposes with any human subjects of the research by performing invasive or noninvasive procedures

Examples of invasive or noninvasive procedures include drawing blood; collecting buccal mucosa cells using a cotton swab; administering individual or group counseling or psychotherapy; administering drugs or other treatments; surgically implanting medical devices; utilizing physical sensors; and utilizing other measurement procedures.

Institutions whose employees or agents intervene for research purposes with any human subject of the research by manipulating the environment

Examples of manipulating the environment include controlling environmental light, sound, or temperature; presenting sensory stimuli; and orchestrating environmental events or social interactions.

Institutions whose employees or agents interact for research purposes with any human subject of the research

Examples of interacting include engaging in protocol dictated communication or interpersonal contact; asking someone to provide a specimen by voiding or spitting into a specimen container; and conducting research interviews or administering questionnaires.

For more information and other examples, go to http://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html.

Student Research Within a Faculty Advisor’s Approved Protocol

Student researchers will, at times, develop ideas for research projects as part of a senior thesis, master’s project or doctoral dissertation. that involve using data collected on a faculty advisor’s IRB approved protocol. The IRB will allow this provided the level of risk does not change, no additional benefits are realized by participants, and the scope of the student’s research project does not significantly differ from the parent protocol.

Rather than burden a student researcher with completing a full application for review and approval, the IRB has developed a Thesis, Masters or Dissertation Research Notification form. This form will assist the IRB in monitoring if the planned activities of the project are already part of a previously IRB approved protocol and/or if there will be any modifications (to risks, consent processes, use of identifiers, etc.) during the course of the research project that will change the provisions of the approved protocol.

If you have a project that falls within this category, download this form (http://www.umbc.edu/irb/tmdr_application.doc) and follow the directions.

Contact HARPO at 5-2737 or HARPO@umbc.edu with any questions.

Who signs a consent form?

Federal regulations (45 CFR 46.117) require written informed consent, one that is approved by the IRB and signed by the participant or the participant's legal representative and the principal investigator (or his/her delegate). The delegated responsibility can fall to members of the investigator's “research team”, provided the team members have been trained by the investigator and had also taken the UMBC Collaborative Institutional Training Initiative (CITI) web-based course.

Consent forms should be signed by the person actually administering consent, at the time consent is administered, attesting to the informed consent conversation. At no time should the consent forms be pre-signed by the members of the research team.

Further details about the consent process may be found at http://www.umbc.edu/research/HARPO/IRB/consentassent.html

IRB applications and team members

The applications for IRB review now request that you list the principal investigator, faculty adviser as well as the research team members associated with the research project. The list of all pertinent individuals in the application does two things: 1) it shows the IRB who is associated with the research and that these individuals have completed the CITI training and 2) provides for the necessary documentation in who may be involved in the participant consenting process.

The later point is important for, when we in HARPO go and review protocol files, we find that only those associated with a research project are involved in the consent process and have the necessary knowledge to inform participants about the purposes and intent of a study. Plus, it's a good measure for primary investigators to maintain quality control over how the research is being conducted.

So, fill in all names you, as the primary investigator know will be associated with the study. If you don't know at the time of application (waiting for grad students to come on board or are waiting for those helpful undergrads to sign up for study), send an email to the HARPO office (HARPO@umbc.edu) with the names. We'll at the minimum verify these individuals have completed the CITI training.

IRB Protocol audits (this is not the IRS)

Many faculty and students have received notices over the past several weeks regarding the post approval protocol monitoring (PAPM), or as it may be better known as a "protocol audit".

Because an investigator is chosen for an "audit" or PAPM, it doesn't mean he/she has done anything wrong. UMBC required by federal regulation to exercise "appropriate oversight mechanisms" to make sure the policies and procedures designed for protecting the rights and welfare of human participants are being followed and that participant's well being is safeguarded.

So, in addition to complying with procedures, the PAPM is used to educate researchers about human subject protection issues and improve the quality of research by finding potential errors or omissions as research is performed.

It's good for the researcher and good for the university.

If you get the email or phone call about a PAPM, don't fret; it's all done to make your research experience easier and hopefully less complicated.

Read more about Protocol Audits .

HARPO presentations

The staff from the Human and Animal Research Protections office are available to meet with faculty at departmental meetings or speak to students in informal or formal (research methodology classes) to better educate and inform about research compliance issues. Contact the HARPO office at HARPO@umbc.edu or 410-455-2737 for more information or to schedule a time for your group or class. The current schedule of presentations may be found at this link.