Before You Submit
Human Subjects Protections Training
All personnel conducting research involving human subjects approved by the UA Human Research Protections Program must complete human subjects protections (HSP) training every three years.
The training requirement may be fulfilled by completing the appropriate Collaborative Institutional Training Initiative (CITI) Program training module for either medical or non-medical research. University of Alabama faculty, staff, and students can access the CITI Program’s Human Subjects Research Training through their existing myBama accounts. UA users should log into the myBama CITI Login Portal using their myBama username and password. All other non-UA investigators should go to www.citiprogram.org to access the training.
Please note the training listed below will not substitute for the CITI Program’s Human Subjects Research Training:
- The Responsible Conduct of Research (RCR) Training and the Good Clinical Practice (GCP) Training will not substitute for the basic human subjects training course.
Write Your Protocol
Protocol Templates
The following protocol templates are available to assist you in developing a standalone protocol:
- For Social/Behavioral Research, we recommend using the IRB Toolkit template, HRP-503a – TEMPLATE SBS PROTOCOL – Social/Behavioral Research
- For biomedical clinical investigations evaluating drugs and/or devices, we recommend using the IRB Toolkit template, HRP-503 – TEMPLATE PROTOCOL – Biomedical Research
Please attach a copy of the completed protocol template within the attachments folder in eProtocol.
View recorded protocol writing guidance
Gather Support Documents
Support documents may include the following:
Informed Consent Document
Use HRP-502 – TEMPLATE CONSENT DOCUMENT to create a consent document. You may continue to use your own consent template if it includes the elements found in HRP-502.
The consent document should be uploaded to the application in Word format, as this allows for reviewer edits and comments to be easily placed in the document.
Note that all long form consent documents and all summaries for short form consent documents must contain all of the required and all additional appropriate elements of informed consent disclosure. Review the “Long Form of Consent Documentation” section in HRP-314 – WORKSHEET – Criteria for Approval, to ensure that these elements are addressed. When using the short form of consent documentation, the appropriate signature block from HRP-502 – TEMPLATE CONSENT DOCUMENT should be used on the short form.
If your research study meets the requirements for an exemption and there are interactions with subjects, you may use an abbreviated process as noted within the Exempt Consent Information Sheet template.
General Recruitment Guidelines
The IRB reviews study recruitment methods (including advertisements and payments) to evaluate whether they will affect the equitable selection of participants, and to ensure that the proposed methods adequately protect the rights and welfare of participants.
The protocol document or application must include a description of the following: (1) the source of subjects for all study groups (intervention/case and control); (2) when, where, how, and by whom these potential subjects will be recruited; (3) the methods employed to identify potential subjects; and (4) the materials used to recruit subjects, including the use of email and text messaging. If this is a multi-center study in which subjects are recruited by methods not under the control of the local site, e.g., call center or national advertisements, describe those methods.
The IRB must review and approve the content of all recruitment and advertisement materials, including oral communications, before implementation.
When preparing your materials, refer to HRP-315 – WORKSHEET – Advertisements to ensure your documents meet IRB requirements.
Strategic Communications provides research solicitation flyer templates to help research teams quickly produce attractive recruitment flyers that are in compliance with UA and brand standards and principles of effective design. While the UA logos in the templates are locked in place, the text/photos can be edited or deleted in each template.
Data Transfer and Material Use Agreements
Study teams are responsible for ensuring required agreements for data or biospecimen transfer (e.g., data use agreements, material transfer agreements) are in place prior to The University of Alabama receiving or transferring data or biospecimens. Data Transfer and Material Use Agreements (DTUA and MTA) are separate from IRB review. The need for a DTUA and/or MTA is not affected by using a single IRB; these are institutional requirements that apply regardless of reviewing IRB. For more information, see HRP-103-Investigator Manual and HRP-309-WORKSHEET-Ancillary Review Matrix.
For assistance with a research-related contractual matter, please email The Office for Research & Technology Agreements (ORTA) at orta@ua.edu.
Guidance on External Sharing of Human Subjects Research Data
Contractual agreements may be required by law and/or University of Alabama policy in order to share individual level human subjects research data. The need for agreements stems from privacy laws (e.g. HIPAA, FERPA, GDPR), contractual obligations, and institutional policy requirements. These agreements establish terms and conditions to protect the interests of researchers and the institution, and importantly – to protect the confidentiality of the human subjects involved. Data sharing agreements cover a variety of important issues, including restrictions on permitted uses and further disclosures of data, authorship, attribution, warranties, confidentiality, liability, and intellectual property.
For assistance with a research-related contractual matter, please email The Office for Research & Technology Agreements (ORTA) at orta@ua.edu.
Special Documents for International Studies – International Research
Your application or protocol must include a description of the international research location and the levels of protection appropriate for the location (i.e., appropriate access, consent options, etc.). The IRB prefers that a local ethics committee or similar review board oversee the research in addition to The University of Alabama IRB to help ensure that the research is culturally acceptable. Please refer to Guidance: International Research for specific considerations that need to be addressed in your application or protocol.
Translator’s Declaration: This form should completed by the identified translator of any project related documents including but not limited to the IRB approved Informed Consent Form, or recruitment materials such as advertisements. This form is to be included along with the translated documents for all projects proposing to recruit and enroll individuals who may have limited English proficiency.
How to Submit
The University of Alabama uses the e-Protocol system is accessed via myBama. The link to eProtocol is located within the “Research Systems” section of the Research page.