Resources and Guidance
These resources and tools are designed to help assist you in preparing your submission for review by the HRPP/IRB. They are based on federal and state regulations, Purdue University policies, and the HRPP SOPs. Answers to many investigator questions may be found in the HRP-103-Investigator Manual.
Assistance Using PERA IRB
Training, Instructions, Videos: PERA IRB Training
PERA IRB FAQs: pera.research.purdue.edu/faq/irb-faq
Exempt research still requires review and a final exempt determination by the Purdue HRPP/IRB and must abide by the principles in the Belmont Report. This includes ensuring that participants are adequately informed about the nature of the research and that participation is voluntary. Additional protections for privacy and confidentiality if collecting information that may pose risk to participants if disclosed outside of the research may be required.
Use of Protected Health Information (PHI) in research must comply with HIPAA. Purdue University will not waive HIPAA authorization for third parties and the use of PHI from covered entities outside of Purdue require a formal agreement. Please review the information on this page about the type of agreement that may be needed.
PHI from a Purdue covered component must comply with the guidelines and policies at www.purdue.edu/legalcounsel/HIPAA.
Purdue’s covered components should use the Authorization Form found on OLC’s website.
University students should not be the target population simply due to convenience. When using University students in your study, you will need to justify why you’re including them and how you will mitigate any undue influence to participate. Students should never be compelled to participate in research as part of a class requirement.
Investigators using Purdue University West Lafayette and Indianapolis students in the classroom may need to have a Student Data Agreement with the Purdue Registrar.
Investigators using PNW student educational records should contact Jennifer Williams, University Registrar, jmwillia@pnw.edu.
Investigators using PFW student educational records should contact Tara Lewis, Associate Vice Chancellor and Registrar, lewis651@pfw.edu.
Informed consent is an ongoing process, not a one time event. Consent can occur in many different ways, however, all written consent materials must be appropriately written for the population being studied in language that is understandable. Typically, this is around an 8th grade reading level.
Investigators obtaining consent are responsible for reviewing and following HRP-090 – SOP – Informed Consent Process for Research and HRP-091 – SOP – Written Documentation of Consent.
HRP-103 – INVESTIGATOR MANUAL has guidance on how to create consent and assent documents. Please refer to it, use the Templates, and be sure to review resources below when drafting your consent.
Templates
- HRP-502a – Non-Exempt Consent Form Template
- HRP-502b – Exempt Information Sheet Template
- HRP-502d – Assent Form Template
- HRP-502f – GDPR Participant Research Information Sheet
Resources
- Supplemental Consent Language
- Standardized Consent Form Language — this document will assist you in explaining common research interactions and interventions to participants.
- Online Tool to Assist with Readability
- How to check reading level in Microsoft Word
See HRP-103-Investigator Manual, “What if my research involves deception?”
Deception occurs during the consent process when an investigator deliberately misleads participants. This occurs by the researcher (a) withholding key information or (b) providing false information about the nature of the research. As a result, participants are not fully informed about the research when they consent to participate.
Deception is appropriate to use in research when it promotes scientific validity by enabling investigators to obtain unbiased data about certain attitudes and behaviors.
Examples of deception include:
- Participants complete a quiz and are falsely told that they did poorly, regardless of their actual performance.
- An anxiety study, in which participants are told to expect mild pain during the course of the study, but no painful procedures are administered.
- A stress induction, in which participants are told they will complete a laboratory task to evaluate verbal and nonverbal behavior, but which is actually designed to elicit a stress response.
- Participants are asked to take a quiz for research, but they are not told the research question involves how background noise affects their ability to concentrate.
- Participants are told they are completing a survey to evaluate customer service when the true purpose of the study is to correlate psychological responses with patient care satisfaction.
- Participants read a series of vignettes and are asked to evaluate them, when the true purpose is to study how the manipulation of specific words in the vignettes influences participants’ responses.
Does my study use deception?
- To assess whether deception is being used, consider whether information about the research is specifically omitted or falsely represented during the consent process because the inclusion of that information might affect a participant’s willingness to participate or might bias the data that they provide. If so, then deception is likely being used.
Can deception be used in exempt research? Deception is allowable in exempt research provided that prospective agreement is used. This requires that participants are informed beforehand that they are being misled regarding the nature of the research (i.e., during the consent process) and that the true nature of the research will be explained at the end of the study.
The justification for the appropriate use of deception must be clearly explained in all IRB protocols. Address the following points when preparing the protocol and appendices:
- Why deception is necessary: Explain why deception is necessary to achieve the goals of the study. If alternative methods not involving use of deception were considered and are not being used, explain why.
- Informed Consent: If the research is exempt, ensure that prospective agreement is obtained at the beginning of the study. This typically involves language in the Information Sheet indicating that the true nature of the research is being withheld and will be explained at the end of the study.
- Debrief: Explain the full process of debriefing, including when, how, and by whom participants will be debriefed. Provide copies of HRP-502e-Participant Debrief Post Consent Form to be given to participants or the script that will be used by the investigators to orally explain the study. Participants should generally be given the option to withdraw their data once the true nature of the research is revealed (e.g., post-session consent). The requirement to be debriefed may be waived when the debriefing itself would do more harm than good to participants.
- Risks: Explain if use of deception is likely to cause the participant psychological discomfort (e.g., stress, loss of self-esteem, embarrassment) while the deception is taking place. Explain how this risk will be minimized during the experiment and after the experiment is complete.
- Benefits: Describe how the potential benefits of the research justify the use of deception.
In most circumstances you must debrief the participant by giving them the pertinent information that was omitted from the informed consent process using HRP-502e-Participant Debrief Post Consent Form.
The HRPP encompasses many units at Purdue, including the IRB. HRP-309 – WORKSHEET – Ancillary Review Matrix will assist you in navigating additional reviews that may be required prior to IRB submission or approval.
Section 201(h) of the FD&C Act (21 USC 321(h)) provides that the term “device” means:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
The FDA provides guidance on how to determine if your device is a medical device here.
The IRB must know if you are using a medical device in your planned human research study, its FDA status, and how you are using the device. This must be appropriately documented in the Medical Device section of the PERA SmartForm regardless of how you are using the device or the device indications.
If you are studying the safety or effectiveness of a medical device, your study is likely subject to FDA oversight. You will need to complete HRP-593-Appendix-D-Devices and upload it along with your written protocol in the PERA SmartForm.
Studies using MRI
HRP-593-Appendix-D-Devices must be completed and uploaded in the PERA SmartForm. Please consult with the MRI facility you’re working with if you need assistance answering prompts on this appendix.
The HRPP staff and IRB use HRP-307 – WORKSHEET – Devices when reviewing research using medical devices.
All human research that is taking place internationally must show confirmation that the research fits within applicable national law and cultural norms. As such investigators are required to provide additional information to the IRB. Appendix A-13 Additional Requirements for International Research in HRP-103-Investigator Manual outlines investigator responsibilities and additional application requirements.
We also utilize HRP-380 – WORKSHEET – International Research when reviewing studies with participants located outside the US.
If you’re conducting research with participants located in the EU, UK, and/or China, you must comply with their privacy laws. Purdue’s Office of Legal Counsel may need to review for compliance with these laws.
Due to the low risk nature and the volume of exempt research at Purdue, we have an exempt consent (information sheet) that complies with GDPR: HRP-502f-GDPR Participant Research Information Sheet. All other studies must have consent language reviewed by Purdue OLC.
Research with participants located in Foreign Adversary Nations must be reviewed by Purdue’s Research Security and Export Controls group. The Purdue HRPP office will send the RSEC office your study after submission in PERA.
See HRP-309-Ancillary Review Worksheet for more information on these reviews, including associated Purdue policies.
Confidentiality Agreement Transcription and/or Translation Services — Required if IRB study data or documents must be translated or transcribed by an outside party or consultant.
The Purdue IRB must determine there are adequate provisions for protecting participant confidentiality before approving your study. In addition, your proposed data handling must be in alignment with Purdue IT Policy and Standards. Most research data collected from human participants will be classified as Sensitive Data (L2) or Restricted Data (L3).
Purdue’s Rosen Center for Advanced Computing has a Data Storage Solution Finder that can assist you in finding a solution that best meets your study needs.
Resources:
Studies that are enrolling non-English speakers must ensure that consent and interactions with participants are in a language understandable to them.
Complete and upload HRP-593-Appendix-H-Non-English-Speaking-Individuals in the PERA SmartForm with the study protocol document in Basic Study Information.
You may also need:
Confidentiality Agreement Transcription and/or Translation Services — Required if IRB study data or documents must be translated or transcribed by an outside party or consultant.