IRB Challenge: Research on the Internet

Transcription

1 IRB Challenge: Research on the Internet Jeffrey M. Cohen, Ph.D. HRP Associates Disclaimer Views Expressed in This Workshop are Those of the Speaker and Not Necessarily of the University of Kentucky Modified by Ada Sue Selwitz, M.A. University of Kentucky Objectives 1. To Describe Types of Internet Research 2. To Discuss Impact of Internet Methodology on Traditional IRB Review Criteria 3. To Suggest Changes in IRB Review Procedures Types of Research 1. Recruiting Over the Internet 2. Observation of Internet Activity 3. Gathering Data Over the Internet Types of Research: Recruiting Subjects Over the Internet* Similar issues as with any other recruiting tool: IRB needs to review information presented to subjects (see FDA Information Sheets) Examples: Recruiting rape victims from discussion groups, using diabetes Web site to recruit subjects. Need to determine that subjects are who they say they are, especially minors. Types of Research: Observation of Internet Activity* Gathering information about the use of the Internet, recording user information or users comments Example: Participant observation of grieving discussion group, using cookies to track sites visited IRB issues: consent/disclosure, public vs. private behavior/expectation of privacy J:\Master Outreach Documents\Survival Handbook\D - Guidance-Policy-Educational\55-Internet-Guide.pdf 1

2 Types of Research: Gathering data over the Internet* Having subjects submit data, e.g., survey data, over the Internet Example: survey on the use of WWW by college students; t internet t study of relationship issues IRB issues: consent, confidentiality (i.e., security issues, identifiers) and participation by minors Traditional IRB Review Criteria 1. Risk/Benefit 2. Privacy Consent 5. Participation by Minors Risk Three sources of harm: Participation in the research No direct contact with subjects Can t deal with individual reactions (intervention or debriefing) Invasion of Privacy Expectation of Privacy vs. Public Behavior Breach of confidentiality Primary source of harm in most internet research *Side Issue: Risk to Researcher Benefits Conducting research on the Internet raises concerns about the reliability and validity of the data. skewed subject populations ease with which subjects can mislead investigators difficulty in preventing multiple submissions Invalid research can have no benefit. inappropriate when there is risk to subjects Privacy Identifiable vs. Anonymous On-line Participants Usually Use Pseudonyms (Screen Names, Handles, Etc.) Although Not Publicly Linked to Actual Names, Identities Can Often be Readily Ascertained (E.g., Using Search Engine) People s On-line Identity May be as Important to Them as Their Actual Identity Privacy Public vs. Private Behavior Most On-line Activity is Open to the Public Federal Regulations Base the Definition of Private Information on the Subjects Reasonable Expectation of Privacy In Many Situations (E.g., Chat Rooms), Participants Expect Privacy and Don t Expect Their Activity to be Studied Determination of Privacy More Complicated Than it Seems J:\Master Outreach Documents\Survival Handbook\D - Guidance-Policy-Educational\55-Internet-Guide.pdf 2

3 Examples of Types of Internet Activities Homepages Blogs Public or Private? Chat Rooms s Listservs Google Searches Gaming Two potential sources of breach of confidentiality inadvertent disclosure Investigator who sent out research database to entire Listserv Investigator who s computer was stolen deliberate attempts to gain access No recorded incidents of hacking research data Technology can provide reasonable security but cannot guarantee absolute security Data transmitted via cannot be anonymous without the use of additional steps. Almost all forms of contain the sender's address. use an "anonymizer" - a third party site that strips off the sender's address Web servers automatically store a great deal of personal information about visitors to a web site and that information can be accessed by others. Web sites can leave Cookies, a small file left on the user s hard drive that is sent back to the web site each time the browser requests a page from that site. Cookies can record which computer the user is coming from, what software and hardware is being used, details of the links clicked on, and possibly even addresses, if provided by the user. Degree of concern over confidentiality depends on sensitivity of the information Since it is impossible to guarantee absolute data security over the Internet, some extremely sensitive research may not be appropriate for the Internet Consent IRBs can waive the requirement for consent where appropriate [45CFR46.116(d)]. If consent is required, IRBs can waive the requirement for documentation of consent where appropriate [45CFR46.117(c)]. J:\Master Outreach Documents\Survival Handbook\D - Guidance-Policy-Educational\55-Internet-Guide.pdf 3

4 Consent: Waiving Consent Deception Research Waiving Consent Researcher Wants to Publish Direct Quotes From On-line Postings Consent Where consent required but documentation is waived, a portal can be used to provide consent information. Subjects must click on Consent page to get to next page. Where written consent required, it is currently not possible to get a signed consent form over the Internet. Can have subjects submit signed consent form and get password for access to web site. Participation by Minors Where research qualifies for waiver of parental permission, no additional safeguards are required. Either minors can participate without permission or a simple statement in consent that participant is over 18 is sufficient Where parental permission required, see previous options for consent. Participation by Minors To screen out minors: use Internet Monitoring software (SafeSurf and RSACi ratings) use Adult Check systems None of these are foolproof. Since there is no guarantee that minors won t access research, some research may not be appropriate for the Internet. Suggestions to IRB Investigators are going to have to provide technical information on how they will deal these issues. Suggestions to IRB: Subject Recruitment IRB Reviewers need to review all of the materials that the research subjects will see. invitation it ti and reminder textt sender and subject lines Mixed media recruitment materials flyers, advertisements, letters, etc. J:\Master Outreach Documents\Survival Handbook\D - Guidance-Policy-Educational\55-Internet-Guide.pdf 4

5 Identification of Subjects IRB protocols need to clearly describe how survey data will be collected and handled, including: Anonymous vs. confidential participation Authentication of subjects - Access to survey vs. privacy of subjects - Personalized invitation and reminders - s only to non-respondents - Opt-out lists Questionnaire Issues Protocols need to include all survey items and address issues such as: Access to the survey web site Introduction ti to the survey/elements of consent Skip/branch patterns and forced-choice questions Survey Website Issues The protocol needs to include all materials that will be available on the survey web site, including: Introduction and Thank You pages Survey instructions and Pop-up help Graphics, audio, video content Links to other web sites/content Data Security Issues Protocols need to describe how data will be managed during and after the project, including: Transmission of data Access to data Storage of data Security of network, servers, workstations, laptops, USB drives Archival and destruction of data Suggestions to IRB IRBs need to have sufficient expertise on the technical aspects of the Internet in order to ask the right questions and evaluate the information provided. Objectives 1. To Describe Types of Internet Research 2. To Discuss Internet Impact of Methodology in Traditional IRB review Criteria 3. To Suggest Changes in IRB Review Procedures J:\Master Outreach Documents\Survival Handbook\D - Guidance-Policy-Educational\55-Internet-Guide.pdf 5

6 Resources American Psychological Association Report of the Advisory Group on the Conduct of Research on the Internet Available for Purchase at: obuy&id= AAAS Report on Internet Research /main.htm FDA Information Sheet on Subject Recruitment References Cohen, Jeffrey M., Research on the Internet: A Brief Guide for IRBs, 55-Internet-Guide Guide.pdf Cohen, Jeffrey M., Privacy and in Internet Research. PRIM&R Annual Conference, Orlando, Florida, November 2008 References Ess, Charles, Internet Research Ethics: Guidelines and Strategies. PRIM&R Annual Conference, Orlando, Florida, November 2008 Using the, Using the Internet to Conduct Research: What Investigators and IRB Members Should Know, 5 th Thursday IRB Education Presentation, August 31, ch_issues.ppt J:\Master Outreach Documents\Survival Handbook\D - Guidance-Policy-Educational\55-Internet-Guide.pdf 6