Skip to main content
Office of Research and Innovation 
Research Administration and Compliance

IRB: Procedures and Guidance

The NC State IRB maintains a wealth of documentation and other resources to assist researchers throughout the IRB Lifecycle. Here, you’ll find all of the NC State IRB’s guidance documents on study design, methods and modes of data collection, and other considerations.

IRB Guidance

This section provides guidance on study design, methods and modes of data collection, and IRB considerations.

The IRB provides guidance for the most commonly asked questions, employed methods, and how to navigate the varying laws, regulations, and policies. Many of these guidance documents include or link to required forms, policies, and templates.

Using existing or future secondary data for research means that you want to use information or biospecimens — originally collected for non-research purposes — as data for your research project or you want to use information or biospecimens — originally collected for research purposes other than the project currently proposed — as data for the research project that you are now proposing. Data and materials do not have to exist at the time of your IRB application submission; they just need to be or have been collected or generated for purposes other than the research you are proposing. 

Sometimes, using secondary data/specimens subjects the study to additional requirements. These may be related to HIPAA, FERPA, GDPR, or require a Data Use Agreement or Material Transfer Agreement.

Forms and Templates

Qualitative research methods are used to understand the lived experiences of participants. Examples of qualitative research methods include but are not limited to interviews, focus groups, observations, action research, textual analysis (e.g., document review — including review of social media), or visual analysis (e.g., review of video or use of the method photo-voice).

Forms and Templates

Surveys involve asking questions of people. A survey can range in format from short and simple to in-depth and intensive — and there are multiple ways that surveys can be implemented, requiring different ethical and regulatory issues to be addressed throughout the study. Should the survey be implemented online, the suggested software for NC State researchers to use is Qualtrics. 

A benign behavioral intervention is brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and should give the researcher no reason to think the subjects will find the interventions offensive or embarrassing. Examples of benign behavioral interventions could include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. This method/mode of data collection can also include Augmented Reality (AR) or Virtual Reality (VR) as long as no data are collected from the participants’ bodies (e.g., eye tracking).

Genomics research usually generates identifiable information about an individual and those biologically related to them, within the same group in a region as them, or both. Genomics research can uncover information about a participant that has a direct bearing on their future or their family’s future. This information might be unsuspected and, therefore,  has both potentially wonderful and potentially harmful consequences to the individual or their relatives. Please note that the NIH Genomic Data Sharing Policy only applies to NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research.

Return to IRB Homepage