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Issues /
IRBTextExample text from approved IRBsThis document provides example of text from approved protocols for remote testing, in italics. Some IRBs invited temporary protocol modifications to accommodate the changing conditions associated with the COVID pandemic, whereas others required changes to the full protocol. This is an example of the former. 1. Changing language in all consent forms (except the parent permission for infant form) to say “you may sit in a sound booth…” instead of “you will sit in a sound booth…” given that we will be testing some participants remotely from their own homes.
2. Use WebEx to consent and test subjects remotely with the added ability to share the tester’s screen for subject signatures.
3. Add the ability to have subjects download testing software onto their personal computers for remote testing.
4. Add the ability to allow the subjects to remotely share their computer screen with the tester so that the tester can provide guidance during the software download and check computer settings.
5. Add the ability to mail a set of lab-purchased headphones to participants if required for the study, which they can keep after the conclusion for the study.
The risk of exposure to loud sounds may be increased in remote testing. Use of personal hardware and/or reduced control over hardware settings could results in uncomfortable or even dangerous sound levels. Strategies for addressing this risk in approved protocols include detailed instructions to the subject and provision of hardware that is unable to exceed safe levels. Because our studies involve listening to sounds, there is some mild risk of the sounds being too loud for you. To minimize this risk, all our sound-based tasks will instruct you to reduce the volume down to 25% of your device's full volume and then adjust up to a comfortable level as you listen to a calibration sound.
Subjects are instructed to administer the testing at a comfortable volume. A potential risk is that some subjects could potentially set the volume too high to a point of discomfort, but this risk is mitigated by the upper output level of the approved headphones.
Protocols may include additional documentation specifying hardware configuration, to reduce the likelihood of misunderstanding. The photo below is an example illustration of a hardware setup.
Reliance on video chat or audio recordings pose added risk to privacy for the research subject and for others in the remote test environment. For example, video recording in a home environment introduces a risk of recording events that are not directly related to the research being conducted. We will ask participants to ensure they are in a comfortable, quiet location prior to initiating the experimental session and ask them to explain to anyone else in their vicinity that we will be recording.
Conducting experiments remotely may not entail the same level of direct communication as in-person testing, introducing additional obstacles to obtaining informed consent. This may be addressed by providing a preview of the test protocol or actively encouraging participants to contact the experimenter when questions arise. Participants will be directed to a web page to hear the sounds used in experiments. The web page will only provide sounds, it does not record any information.
If you encounter any problems with our website or this study, you can contact the researcher anonymously via Prolific. We will respond to your messages within 3-4 days (usually faster).
In-person testing often entails procedures for sanitizing hardware and shared surfaces in the lab. These procedures may take on added importance when conducting remote research with immunocompromised participants or during the COVID pandemic. Protocols for remote testing may therefore pay special attention to sanitation. The tester or test assistant will sanitize the laminated instructions, headphones, and tablet entirely immediately before equipment is delivered and after equipment is retrieved, waiting for the solution to dry before placing it back in the testing kit bag. We will be sanitizing using MedPride Sterile Alcohol Prep Pads, or an equivalent cleaning wipe that contains at least 70% isopropyl alcohol. Several of these individually packaged pads will be kept in the testing kit at all times in case participants would like to use them on the equipment as well. This protocol will be briefly summarized in the consenting process so participants are aware of the procedures and can choose not to participate if they do not feel comfortable using the equipment.
When custom software is developed to run on personal hardware, there may be additional risks associated with downloading and installing experimental software that the participant should be made aware of. The host institution may also wish to clarify liability in the event that custom software results in damage. In this example, the name of the institution has been replaced with XXX. Limited Warranty. XXX assures you that using this software as instructed does not have any known flaws that may harm your computer. To the best of XXX’s knowledge, using this software as instructed does not violate the rights of any other organization. This limited warranty lasts until you have completed all steps the researcher asks of you. This warranty does not affect any legal rights as required by law.
Remote data collection often requires that data be transferred over the internet, sometimes using third party software. There are therefore additional considerations regarding data handling and procedures for ensuring security. Some institutions have specific policies and guidelines in this area. The following is an unusually detailed description of data handling procedures. We will use Gorilla (www.gorilla.sc) to host experiments and collect data for our study. Gorilla is a cloud software platform specifically for the behavioral sciences. Here are some key facts about their data security:
*Cyber Essentials: Certificate of Assurance - IASME-CE-004228
*Hosting: Gorilla is hosted on Microsoft Azure within the EU (Republic of Ireland) which is compliant with ISO/IEC 27001:2005
*Traffic Encryption: All traffic to and from Gorilla is encrypted (TLS/SSL)
*Database Encryption: The database is encrypted using industry-standard cryptography
*Data Ownership: The experiment owner owns the research data that has been collected using Gorilla and has complete control over it
*Data Protection: Gorilla is fully compliant with data protection legislation
*BPS: Gorilla is fully compliant with BPS guidelines.
*GDPR: Gorilla is fully compliant with GDPR.
*IP Address: IP addresses are not provided in the data download unless specifically included.
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