Updates to IRB consent templates

To continue our outreach and providing the most up to date templates for our investigators to use, please click on the ORPC Consent Template page to download the most current versions. Please contact us if you have any questions.

Updated IRB forms and applications

Always remember to keep checking back on the IRB web site for the latest forms and applications that are used by the IRB. The most recent updates include revisions to the Expedited and Full Board Review forms, updates to wording on the Informed Consent form and a new form - a short descriptive form for theses, master's and doctoral dissertation research. This form tracks master's or dissertation students own lines of inquiry that was developed under a faculty mentor’s IRB approved protocol. A seperate, full blown application is not required, but the IRB will want to keep track of any and all research that occurs.

See those updates and new forms at http://www.umbc.edu/irb/irbforms.htm

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

who should a participant contact

The contact information (telephone, email, address) should be listed for the principal researcher/investigator and HARPO office.

First and foremost, state to the participant in the consent process and on the consent form how they can reach the researcher/investigator at the time of the study and after the study is completed in case they have any questions, concerns, or complaints. List the contact information for a faculty advisor if applicable.

The staff of the HARPO office, who represents the IRB, must also be listed as a contact point to provide assistance to participants to about the IRB review process or that person's rights as a research participant.

The consent form must clearly state who and how to contact both. Use the consent form examples on IRB web site to create this form.

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.