Research involving the use of social medial and the internet (i.e. Facebook, Twitter, MTurk etc.) has grown exponentially over the past few years.
It is imperative that the researcher be aware of the dynamic and evolving nature of utilizing these technologies in human subjects research.
Because this field is constantly evolving, it is impossible to identify every circumstance or type of research activity that may involve social media or the internet.
Social media is an internet-based mode of communication that allows users to interact with the medium (typically a website) and/or other users of the medium. Social media is a broad term that includes social networking (e.g. Facebook and Twitter), social photo and video sharing (e.g. Shutterfly and YouTube) and interactive websites.
Here is some guidance to help you create your protocol when utilizing the internet, social media, or mobile apps.
Data mining and passive information gathering often does not meet the federal definition of human subjects research because it lacks both interaction and intervention with the individual about whom the data is being collected. Examples of this would be public Twitter feeds, public Facebook profiles or wall postings, information from public/open chat rooms, etc.
If the individual or social media network site has not placed any restrictions on access to information, the researcher:
Deception research involves interaction with or intervention in the participant's environment and therefore meets the federal definition of human subjects research.
When using deception, researchers should:
Using the internet to recruit can help researchers cast a wide net when recruiting which can result in more reliable results. For the most part, the IRB will review internet recruitment the same way it would review in-person recruitment. Direct advertising for study subjects is the start of the informed consent and participant selection process. Researchers must submit an IRB application prior to using social media for recruitment. Please consider:
There are two types of social media recruitment:
1) Passive recruitment: Distributing recruitment materials (ads, posters, flyers) with the aim of attracting potential participants to contact the researchers for enrollment. For example, placing recruitment materials in patient support groups.
2) Active recruitment: approaching and interacting with specific individuals with the aim of enrolling them in research. For example, emailing or “friending” a member of a patient support website based on their online activity and membership in the group.
If you are creating a Facebook page for the research project, the researcher should place the following information in the “About” tab in Facebook:
Here is a great document explaining ethical use of social media with human subjects:
Researchers must submit an IRB application prior to using social media for recruitment. Please consider:
FDA regulates a subset of mobile apps which meet the definition of “mobile medical app” (MMA). The FDA has stated that the agency intends to exercise enforcement discretion with respect to mobile apps that may meet the definition of medical device but pose a low risk to participants.
High risk MMA examples –
Low risk MMA example –
There are five core areas to understand before designing research on or with mobile apps:
General Considerations and Risks
Some of these common and still pertinent risks include:
If the app being studied, or used in a study, is one which is created expressly for that research, since the app is custom built, extra precautions including adhering to best practices in software development should be in place. Commercially built apps remove the development burden from the researchers, however they present their own concerns.
Some high level concerns for technology include:
Data Security and Confidentiality
How is consent obtained?
2. Waived consent?
3. Written paper consent only?
Support and Training
Researchers should consider:
Information presented by Advarra, February 21, 2018 0 http://www.sairb.com/wp-content/uploads/2018/03/Mobile-Apps-Considerations-for-Use-in-Research-Involving-Human-Subjects-2-21-18.pdf
What is MTurk?
MTURK is a website run by Amazon that works as a readily available marketplace to match "workers" with available work from various "requesters". Amazon describes MTURK as, "a marketplace for work that requires human intelligence. The mechanical Turk service gives businesses access to a diverse, on-demand, scalable workforce and gives workers a selection of thousands of tasks to complete whenever it's convenient".
MTurk allows researchers to have access to a large population of willing participants for research studies. Researchers can generate a HIT (Human Intelligence Task) that gives MTurk users a title and description of the online task (recruitment announcement). The HIT includes:
What do academic researchers need to consider when submitting a MTurk study to the IRB?
Recruitment: The recruitment announcement (HIT) must be submitted to the IRB for review. Researchers should:
Consent: The first page of the online survey should include the consent document. Researchers will request a waiver of documentation of informed consent in Mentor IRB when submitting their IRB application. Consent will be verified by selecting "I agree" at the bottom of the survey page. If the participant selects "I do not agree" they will be taken to a page thanking them for their time. The NKU informed consent template has language specifically related to MTurk studies.
Debrief: If deception or incomplete disclosure is being used, the last page of the survey could include the debriefing information.
Confidentiality: MTurk for research purposes is considered confidential, not anonymous. Recent research shows that MTurk worker IDs can easily be linked to an individual’s Amazon profiles including the individual’s wish lists and previous product reviews. This means researchers must use caution in deciding what information to collect from participants. The default should be that participant MTurk worker IDs not be collected. If it is necessary to collect worker IDs, then the researcher should ensure that worker IDs are kept confidential and secure, are not linked by to study data and are deleted after use.
Excerpted from https://www.umass.edu/research/guidance/mturk-guidance
Source 2015: Quorum Review IRB presentation by Dominic A. Chiarelli, JD, CIP Regulatory Attorney