Human Research Protection Program (HRPP) of The New School (TNS) *** This is a primer, more information is found in the "Investigator Submissions and Procedures" document on the website, under the show/hide titled "Information for Researchers/Investigators" *** Human Subjects Research: Protocol Basics A protocol is a researcher's "how-to" manual for conducting the research study. The HRPP/IRB will review the protocol in accordance with applicable regulations and/or institutional policies. Providing a detailed protocol and all applicable attachments will result in the smoothest and fastest review possible. 1. Develop your human subjects protocol before filling in forms. Have a clear understanding of what you want to do, why you want to do it, and how you will do it. Your protocol will need to describe in detail the WHO, WHAT, WHEN, WHERE, WHY, and HOW of your project. 2. Appropriately assess and mitigate research risks, stresses, discomforts, and harms. As much as possible, researchers must try to minimize risks, stresses, discomforts, and harms that could negatively affect the welfare of subjects. Remember that harms may be social, behavioral, psychological, physical, economic, legal, or reputational. a. When unavoidable, researchers must plan their study to be scientifically sound to not unnecessarily expose subjects to the risks/harms. b. Researchers must explain why exposing subjects to these risks/harms is scientifically justifiable in relation to potential benefits (during the consent process). c. Generally, the principal risk of social and behavioral research is potential harm resulting from a breach of confidentiality. Researchers must ensure their data protection measures mitigate potential harms in the event of a breach (such as a lost or stolen laptop). i. The best measure to avoid harms from a breach is to not collect any identifiable data about the subject (even during consent) ii. When identifiable data must be collected, never having a link between the research data and identifiers is the next best option iii. If datasets must be correlated to the same subject over time, consider using a code that a subject self-generates based on instructions you provide at each time point (such as a survey every 3 months). Here is an example of a 6-digit code the subject can generate at each time point: the second letter of your first name, the last letter of your last name, the first letter of your birth-month, the last number of your zip-code, your 2-digit birthday = enj528 3. Write a detailed description for each research procedure. Regardless of the methodology, describe how you will conduct your research procedures. Detailed information about each procedure must include: i. the types of data you will collect (specific variables and characteristics) ii. what data gathering format will be used (e.g. hand-written notes, checklists, photos, audio/video recordings, via the internet, etc.) iii. when flexibility in conducting a particular procedure is needed, the parameters you will stay within while collecting information must be clearly described (so that you only collect the pre-determined types of data) – this information is needed to appropriately assess the risks of the research iv. the consent process to adequately inform subjects of the research b. Additional Information about common Social and Behavioral research procedures: The following specific information must be provided in addition to the items in #3 (above), when describing these research procedures: Page 1 of 2
Human Research Protection Program (HRPP) of The New School (TNS)
Questionnaires and Surveys: in addition to the items in #3 (above): o How will you distribute the questionnaires/surveys, (oral, paper, online)? o How will you verify your targeted subject population is completing the questionnaires/surveys (such as verifying age with online surveys)?
Observations (ethnographic or otherwise): in addition to the items in #3 (above): o Will subjects know they are being observed? Why or why not? o Will descriptive or private information about the subjects be recorded in the research data?
Interviews (structured or semi-structured): in addition to the items in #3 (above): o Instructions the researcher will follow o Instructions for the subject (including what information they should not provide, and what will happen if they veer outside of the parameters you have set) o All pre-determined questions and follow-up prompts
Focus Groups (FG): in addition to the items in #3 (above): o Instructions for the FG-moderator (how to steer the discussion and ensure subjects do not share information that would be outside of the specified data parameters), o Instructions for the FG-subjects (ground rules, confidentiality and its limitations, types of info they should avoid sharing), o FG questions and follow-up prompts o The consent process/form must clearly inform subjects that the research team cannot guarantee that fellow subjects in the group sessions will refrain from revealing information discussed during the group sessions o The following link is provided as a resource: How to conduct a focus group
4. Copies of all data-collection tools are provided. Please also ensure that you describe any special equipment needed to conduct your research. (Note that in some circumstances, you may be asked to provide a manual of the specialized equipment/device for IRB review.)
Resources for using the INTERNET for human subjects research: Association of Internet Researchers (AoIR): http://ethics.aoir.org/index.php?title=Main_Page Article: Paolacci, G., J. Chandler, and P.G. Ipeirotis. "Running Experiments on Amazon Mechanical Turk," Judgment and Decision Making, Vol. 5, No. 5, August 2010, pp 411-419.
Confidentiality of Data • The research plan should make adequate provision to safeguard information to ensure ongoing protection of subjects, for the full life cycle of the data: its collection, use, dissemination, retention and/or disposal. Security measures include physical, administrative and technical safeguards.
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