What does HARPO do? (a refresher)

HARPO main mission is to assist the UMBC research community in following federal and state compliance regulations, provide guidance on regulatory issues, educate the research community on compliance requirements and serves as the administrative hub of the Institutional Review Board and Institutional Animal Care and Use Committee provides central administration to the Institutional Board (IRB) and the Institutional Care and Use Committee (IACUC).

We do this by communicating with investigators regarding committee decisions, maintaining records and facilitating on-going auditing of approved protocols. We also perform pre-review of protocols and consent forms to identify potential problems and suggest ways to make them better, provide education and training on the protection of research subjects, and provide assistance with the use of IRB and IACUC guidelines and research forms.

Give a us ring or send an email:

Tim Sparklin 410-455-2737 sparklin@umbc.edu

Mary Lilly 410-455-3958 lilly@umbc.edu

Student investigators

How, when and why do student investigators have to apply for human and animal compliance committee (IRB or IACUC) review and approval?

Let's break this down:

How: Both the IRB's and IACUC's protocol submission procedures are found on the web.

The IRB has procedures and guidelines regarding student initiatied research -http://www.umbc.edu/irb/studentinitiatedresearch.htm. While the student may take on the role as the principal investigator of human research study, faculty advisors play an important role is in the student's design and development of human participant research project. The IRB hold the faculty advisor ultimately responsible for the protection of the subjects.

The IACUC's protocol submission procedures do not allow for a student to serve as a principal investigator of an animal research study, but may fully participate as a member of the research team. Review these procedures further at http://www.umbc.edu/iacuc/submissionreviewapproval.htm.

When: Protocols must be submitted as soon as possible to allow time for the members of the committees to adequately and appropriately review and approve the research. A few more specifics:

IRB

Exempt review may be submitted at any time, preferably two (2) weeks before an investigator intends to begin a project

Expedited review may be submitted at any time, preferably four (4) weeks before an investigator intends to begin a project

Full board reviewed research is considered at a convened meeting of the IRB and must be submitted four weeks before a scheduled meeting

IACUC

Animal research protocols are only reviewed at a convened meeting of the IACUC (other conditiions apply) and must be submitted at least 45 days before the scheduled meeting.

Why: In addition to the descriptions above, it's the right thing to do. Being a responsible researcher program encourages integrity in the pursuit of scientific investigation and discourages potential research misconduct and questionable research practices.

Reporting and managing conflicts of interest

Have an interest in learning more about the regulations regarding the standards and procedures involving the reporting of financial conflicts of interest? Sure you do! The NIH has compiled answers to the most frequently asked questions regarding the the regulations.

Go to http://grants.nih.gov/grants/policy/coifaq.htm for more information.

Why is training needed?

Investigators conducting research with people are considered "key personnel" who are "engaged in " research with living human beings, using human tissue samples or working with identifiable private information. As such, investigators must be informed about and stay abreast of the regulatory and ethical requirements of such research. UMBC's use of the Collaborative IRB Training Initiative (CITI) is an educational program for the protection of human subjects in research meets that need. The core course in CITI were developed by experts in the IRB community and focuses on studies in sociological, psychological, anthropological or educational phenomena including observational and survey research.

The CITI program also offer training required of all persons using and caring for laboratory animals at UMBC, including scientists, research and animal care personnel. Completion of this training fulfills the IACUC's requirements to conduct studies using specified animals and techniques.

Completing this training is a necessary hoop to jump through before starting a research project - more importantly if external funding from grants or contracts are involved.

See the HARPO training link for more information.

New IRB members

Please welcome the following new members to the UMBC Institutional Review Board, beginning in the Fall of 2008:

Gina Fitzmaurice, Undergraduate student member, Health Administration & Policy Program

Satarupa Joardar, Graduate student member, Biological Sciences

The updated roster of Board membership is available on the IRB website.

Questions participants should ask before agreeing to participate in a research study

Investigators are always on the look out for participants to enroll in a study; without them, how could you collect valuable data?

When approaching/recruiting potential participants, provide lots of information about your study but also encourage them to ask questions. Full disclosure about the study and honest answers to questions will make life easy for you, the investigator, as well as your participants.

Some questions participants should ask (courtesy of OHRP - http://www.hhs.gov/ohrp/outreach/questions.html):

• Why is the research being done?

• What will be done to me as part of the research?

• How will I benefit from the research?

• Could the research hurt me?

• What will the researcher do with my information?

• Will the research cost me anything?

• Who pays if I�m unexpectedly injured in the study?

• How long will the study last?

• What happens if I decide to leave the study early?

• Who should I call if I have a question about the research?

Slide shows that explain CITI compliance training registration

Everyone likes a slide show, right? Except, maybe, for Uncle Harry's bonanza of 400 slides of his trip to the Grand Canyon.

Well, never fear. We at HARPO would rather not put you sleep, but make your introduction and registration with the compliance training programs with the Collaborative Institutional Training Initiative (CITI ) a bit easier.

Currently, there are several compliance training programs to take, including Human Participant Use, Animal Care and Use and Responsible Conduct of Research.

Click on the http://www.umbc.edu/HARPO/training.htm to view the program that interests you or are required to review before conducting research. Select the slide show to view; additional registration instructions are available for download.

Let us know at HARPO@umbc.edu or 410-455-2737 if you have any questions or need more information.

P.S. - we won't tell Uncle Harry you left the room!