Human Studies Program Office of Research Compliance Vice Chancellor for Research and Graduate Education CTE DCS IRB Series – Event 3 December 1,2014 Denise.

Human Studies ProgramOffice of Research ComplianceVice Chancellor for Research and Graduate Education

Ethical Considerations When Designing and Conducting Internet-

Based ResearchCTE

DCS IRB Series – Event 3December 1,2014

Denise Lin-DeShetler

Human Studies ProgramOffice of Research Compliance

Why do we need to discuss internet research?◦ Research about internet and using internet is increasingly

popular and important◦ Federal regulations were written before internet became

universal They are currently silent about the use of internet for research

involving human participants Some guidance available, but they are ever-evolving; based on

FAQs

About Internet Research

Human Studies ProgramOffice of Research Compliance

“Internet Research” as a tool for research and as a locale or venue of research:

◦ Research involving study of information already available on the Internet

◦ Using Internet as a medium for recruiting or interacting with subjects

◦ Research about the Internet itself and its effects (e.g., popularity of social media types)

◦ Research about Internet users

◦ Internet used as an experimental intervention

Types of Internet-based research

Understanding Tool vs. Locale

As a tool… As a locale….

Research involving: Survey instruments, databases,

search engines, databanks May not involve direct

interaction with human participants, but PII may still be collected

Research (qualitative and quantitative) that utilizes Internet “spaces” such as:

Chat rooms, gaming world, other other simulated locales

But….

Research methods using Internet phoning, video conferencing or online chat (i.e., Facetime, Skype) can be both use as a tool and a locale.

Human Studies ProgramOffice of Research Compliance

Stages in a Research Project1. Recruitment2. Data Collection

As a tool….ObservationsData Mining

3. Publication of ResultsPossible re-recruitment

How is the internet used in research involving human participants?

Human Studies ProgramOffice of Research Compliance

Recruiting subjectsAdvertisingConsent ProcessEnrolling Participants

Human Studies ProgramOffice of Research Compliance

The recruitment material placed on the internet should follow similar rules of any other recruitment material:◦ Are not unduly coercive◦ Do not promise or imply favorable outcomes or other

benefits apart from what is written in the protocol◦ Do not communicate that the study product (or intervention)

is safe or effective for the purposes under investigation◦ Do not make claims that the product or intervention is known

to be equivalent or better to any other product or intervention

◦ Do not use language that regulatory authorities, such as the IRB, have approved the research

◦ Do not emphasize payment

Online Advertisements

Recruitment

IRB Should Review IRB Do Not Need to Review

Paid advertisements In-text advertisements Advertisements on

social networks Social network page

to promote study Any study-specific

direct advertisements via blog, blog post, tweet, or text

Advertisement of study-specific information limited to basic trial information (title, purpose, and study locations)

Communication that are education or provide generation information (i.e., podcast describing symptoms of HIV)

Study-specific publicity intended for general audience (i.e., news stories)

Human Studies ProgramOffice of Research Compliance

Types of internet-based recruitment methods:◦ Email◦ Online Advertising◦ Chatroom Postings

All recruitment materials need to be reviewed and approved before use.

General listings of research studies on websites that provides limited information do not need prior approval from IRB (e.g., SONA, Clinicaltrials.gov)1. Study Title2. Purpose3. Protocol Summary4. Contact information

Online Advertisements

Human Studies ProgramOffice of Research Compliance

Sending promotional messages (ads) about a study without using the medium in ways typical of a common user.◦ Is this appropriate use of the website?◦ Intrusive to potential participants?

Advertising in social network sites or Twitter groups, such as a cancer support group, may seem intrusive and inappropriate to members of that group

Should the researcher get permission from the owner of the website?

Human Studies ProgramOffice of Research Compliance

Appropriate methods for documenting consent should reflect the risk and complexity of the research◦ For minimal risk: waiver of consent whereby

participants click on the “I agree” statement on consent form to proceed to research activities Must meet the regulatory criteria for a waiver of informed

consent◦ For more than minimal risk:

Traditional signed consent, returned to PI who will then give consenting participants password to access research material

E-signatures Consent process through chat, email, or other online venue

Documenting Informed Consent over the Internet

Human Studies ProgramOffice of Research Compliance

Child participants:◦ Authentication of age with use of age verification systems◦ When research involves participation of minors, both child

assent and parental consent still applies, unless research meets appropriate criteria for waiver of parental permission

Readability◦ It is more difficult for investigators to discern whether or

not their participants understand the consent because process can be done asynchronous, and the opportunity to ask the researcher questions about the research is usually slim.

Special Considerations when obtaining Informed Consent

Human Studies ProgramOffice of Research Compliance

When obtaining consent over the internet, we assume that potential participants at least 18 years old◦ Age verification systems◦ Questions that are more easily answerable to one

who is at least 18 (i.e., identifying images of old items)

To authenticate identity when research involves more than one interaction:◦ Provide study participants PIN to be used for

subsequent computer and internet-based data collection.

Authentication

Human Studies ProgramOffice of Research Compliance

Observation of Internet Activity

Public vs. Private Domains

Human Studies ProgramOffice of Research Compliance

Collecting Data over the Internet

Data MiningInformational Risks

Human Studies ProgramOffice of Research Compliance

Case 2: A researcher wants to collect data from an HIV support group website on Facebook to examine how

much perceived support participants are receiving from participating in different types of support (chat groups vs. support group sessions vs. blogs) they learn from

subscribing to the website. The website allows users to make suggestions about the usability of the different

resources the website provides.

Does this study require IRB approval if no names or other identifiers are collected?

Can this study be done without PII?

Case Study: Data Mining

Human Studies ProgramOffice of Research Compliance

Per 45 CFR 46.101(b), research using only secondary data that is publicly available or

de-identified do not need IRB approval

However:Research that utilizes data from blogs, newspaper responses, and social media

networks should not have the same rules for IRB approval because the expectations of

privacy by participants varies depending on the venue

Data Mining

Human Studies ProgramOffice of Research Compliance

Is there unauthorized disclosure of illegal behavior, substance abuse, or chronic illness? Legality/ Criminal acts Stigmatization Financial Reputation

We look at identifiable information that is being collected: User posting on study-specific website in which user may be

sharing PII De-identified quotes gathered from blogs that can

inadvertently be traced back to individual Repurposed photograph of individuals or group posted on

website without permission

Informational Risks

Human Studies ProgramOffice of Research Compliance

Publicly available means:◦ Available at no charge to anybody with a

computer◦ Available to anybody willing to pay the requisite

fee◦ Available to anybody who meets the terms of a

use agreement Data that is publicly available qualifies for

exemption

What is “publicly available” data from the Internet?

Human Studies ProgramOffice of Research Compliance

Privacy: refers to individuals’ right to have control over access to themselves and their information

Confidentiality: refers to how information that is obtained from individuals is protected.

Privacy vs. Confidentiality

Human Studies ProgramOffice of Research Compliance

Private information (in research) is “information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonable expect will not be made public (e.g., medical records).

If the individual intentionally posts information on the internet, then this is public information, UNLESS the policies and/or terms of service of the entity hosting the information indicates this is “private.”

Some may assume their post is “private” but are in fact, not. If in doubt, always go conservative. That is, consider it

private information.

“Private Information” on the Internet