Any human subject research is subject to specific policies and procedures. However, you may have questions about topics like informed consent, enrolling non-English-speaking subjects and the research process.
To help guide your research study, Aurora Health Care has developed several Research Subject Protection Program (RSPP) guidance documents. This guidance documentation is intended to give you more information about clinical research involving human subjects.
All research subjects must be fully informed of the benefits, risks and purposes of studies they participate in. Each patient must then give informed consent to certify they were given this information.
Our RSPP guidance documents provide further details about disclosing relevant study information and obtaining informed consent. This helps ensure your study is both ethical and lawful.
Learn more about disclosing important information to human subject research participants:
Obtaining Informed Consent
These documents detail the physician’s role in obtaining informed consent, as well as the use of electronic informed consent:
Non-English Speaking Subjects
Download Enrolling Non-English Speaking Research Subjects [PDF] to learn more about enrolling non-English-speaking participants in your research efforts.
Find related forms by visiting the enrolling non-English-speaking subjects page.
In some situations, the financial and non-financial interests of Aurora or investigators may affect human subject research. Our RSPP guidance documentation about conflict of interest helps protect you and our organization:
To find additional documents and policies related to conflict of interest, visit our starting a research application page.
The following policies and procedures cover general administrative and organizational tasks performed by our RSPP and institutional review board (IRB):
Learn more about using patient records and confidential information in your human subject research:
Download this guidance on subject noncompliance vs. reportable noncompliance [PDF] to learn what constitutes noncompliance and when you should report this event in your study materials.
You may also find out what’s new with this RSPP SOPs: noncompliance and unanticipated problems [PDF] guide to get the latest information.
In some cases, external IRBs approve and review research studies involving human subjects. Learn more about ceded research, including process details and who you should contact: Guidance on the deferral/ceding of Aurora IRB oversight to an external IRB [PDF]
To find additional documents and policies related to external IRBs, visit our ceded research page.