Below are several frequently asked questions and answers regarding HIRB policies and procedures. For more information, consult HIRB Standard Operating Policies & Procedures and the HIRB Investigator’s Manual or contact the HIRB office at 410-516-6580 or firstname.lastname@example.org.
How do I know if my project needs to be reviewed by the HIRB?
The HIRB is responsible for reviewing projects or studies that involve human participants. Human participant research is research that involves a living individual about whom an investigator (whether faculty member, staff member, or student) obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information.Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the participant or the participant’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and participant.
Private information includes (1) information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and (2) information disclosed for specific purposes by an individual which the individual can reasonably expect will not be made public (e.g., school and medical records). Private information must be individually identifiable (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for the collection of information to constitute human participant research.Since the regulations define a human research participant as a living individual, research involving the deceased is not human participant research and does not require review and approval by HIRB. HIRB must review and either exempt or approve all research under its jurisdiction that meets the definition of human participant research.
How much time is needed for review of new applications?
Most applications are reviewed within two to six weeks after HIRB receives a complete application. Studies involving special populations (e.g., children), international sites, and/or multiple sites often require additional review time to ensure compliance with Federal regulations. Investigators undertaking these types of studies are urged to contact the HIRB office as soon as possible to facilitate the review process.
Can HIRB approval of my research be extended beyond the expiration date?
The maximum period Federal law allows for approval of a study is one year. Investigators must apply for continuing review before the expiration of the approval period in order to be re-approved. If HIRB approval expires before the study is completed, Federal regulations require that all work be suspended and a new application for IRB approval be submitted. In such cases, the study cannot resume until HIRB approval is obtained.
Can graduate students be Principal Investigators (PIs)?
No, a student cannot be a PI on a study that requires HIRB approval. A faculty or senior staff member is required to serve as the PI and oversee the student's progress. Students are encouraged to collaborate with the PI, usually their faculty advisor, in composing the application for HIRB approval. Students also must complete human research participant protections training prior to submission of an application to HIRB.
Do ALL members of the research team need training in the protection of human research participants — even when one or more members of the team have already been certified?
Yes, ALL research team personnel (investigators, collaborators, consultants, subcontracts, students, staff, and others) who interact with participants or are involved in data collection or data analysis must be certified in the protection of human research participant protections. Certification for all research team personnel must be on file with HIRB or submitted with a HIRB application. HIRB will not review applications until the training of all research team personnel in the protection of human research participants has been verified. JHU researchers are required the take the Collaborative Institutional Training Initiative Program's (citiprogram.org) training in Human Subjects Research. Consult the HIRB Standard Operating Policies and Procedures and the Investigator’s Manual for more details about training requirements.
Can I design my own consent form instead of using the consent form template on the HIRB website?
Yes, you can design your own consent form as long as it includes all required elements of informed consent and is understandable to and appropriate for your participants. Required elements include description of the following: research purposes and procedures, including the expected duration of participation and identification of experimental procedures; risks and discomforts; anticipated benefits; any alternative procedures or treatments; any provisions for confidentiality and planned or required disclosure of identifying information; and any compensation or treatment for injury. A statement that research is voluntary is also required, and additional elements may be necessary. Consult the HIRB Standard Operating Policies and Procedures and the Investigator’s Manual for more details about informed consent requirements.
What is the difference between a consent form and an assent form?
Consent forms are legal documents that can only be signed by adults, and assent forms give minors (i.e., children) the opportunity to convey their own independent decision to participate in research. Oral assent is appropriate for children ages 7 to 11 years. Written assent is required for children ages 12 to 15 and must be written in language-level appropriate for children. Assent alone is not sufficient to enroll a child in a study. The permission of a parent or guardian, using a parental permission form, must be obtained as well. The requirements for parental permission forms are very similar to those for consent forms. For children ages 16 and 17, a special consent form designed for both the child and parent to read and sign is required. The special consent form is also an available alternative to the written assent/parental permission option for children ages 12 to 15. A regular consent form should be used for individuals who are 18 years of age and older and have the decision-making capacity to consent. The informed consent form must be written at a language-level appropriate for the potential participants; the HIRB recommends the consent be written at an 8th grade reading level. Consult the HIRB Standard Operating Policies and Procedures and the Investigator’s Manual for more details about assent, informed consent, and parental permission forms.