The Institutional Review Board Chris McCarty PHC6716 July 13, 2010 Purpose of the IRB • To protect the rights of human subjects in research • To ensure human subjects are informed of their rights as participants and understand the consequences of the research • The IRB is not charged with evaluating or modifying the science of a research project beyond protecting the rights of human subjects Abusive and unethical research led to the creation of the IRB • Tuskegee Syphilis Study (1932-1972) • Nazi experimentation during WWII • Thalidomide (1950s) Legal structure • 1974 -- The National Research Act (Public Law 93-348) created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research • 1979 -- Belmont Report outlined principles of ethical treatment of respondents • 1991 -- The Common Rule (Code of Federal Regulations Title 45, Part 46) adopted by multiple agencies • This covers all institutions receiving funding from or operating on behalf of the Federal government • In practice, all research involving human subjects is reviewed by the IRB, whether it is federally funded or not CFR Title 45 Part 46 • (a) Except as provided in paragraph (b) of this section, this policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the federal government outside the United States. Exemptions 1. Research on educational practices or for educational purposes 2. Educational tests and surveys of subjects cannot be identified 3. Educational tests and surveys of public officials 4. Research on existing data if it is public or deidentified 5. Quality assurance and evaluation 6. Taste and food quality evaluation and consumer acceptance studies (these are covered by the FDA) How do you know if it is exempt? • If it is not research it is exempt • What is research? – "systematic investigation ... designed to develop or contribute to generalized knowledge.“ (Code of Federal Regulations) – If you will publish from the data it qualifies as research • The IRB prefers to decide – The process of applying for an exemption is very similar to applying for IRB approval – Most research done by the UFSRC is not ever published Types of Review • Exemptions – See above • Expedited Review – Review by chair, vice-chair or external reviewer – Does not involve vulnerable population – Typically takes 2-3 weeks – Interaction between reviewer and PI • Full Board Review – Board meets monthly – Only when protocol is not straightforward • Indefinite plans – Instruments not yet developed – Funding not secured – Allows proposal submission to go through Where IRB fits in UF Organization How is IRB submission policed? • Within university research $$ monitored at Division of Sponsored Research – DSR 1 form has a field asking if human subjects are involved – If field is yes then disbursement will not be released without independent approval from IRB – PI is responsible for making this happen • Externally, federal research funding tied to proper IRB implementation The consequences of IRB failures (Why it is a big deal) • Johns Hopkins – June 2, 2001 – Ellen Roche died in a Hopkins asthma study – July 19, 2001 -- Office for Human Research Protections suspended all human subjects research at Johns Hopkins funded by the federal government until all protocols were reviewed again • Duke – Routine site visit in December, 1998 uncovered 22 administrative deficiencies (including inadequate documentation) – All NIH-funded activities were suspended until the deficiencies were addressed When do you need to submit an IRB protocol? • For collection of data from human subjects that will (or may) be used for publication or other research purposes – PI submitting a proposal – PI getting approval for work to be completed as part of a funded grant • This will often involve many submissions as one part of research feeds into others – Graduate or undergraduate student submitting proposal for thesis or dissertation data collection – Anyone using existing data in a way not covered under original protocol Process • Fill out IRB form – Example 1 – Brief submission – Example 2 – Long submission – Example 3 -- Revision Informed Consent • Written consent – Example • Verbal consent (over the phone) – The University is conducting research about economic conditions and other issues in Florida and we would like your opinion. Your phone number was selected at random by computer, and only your first name will be used to ensure confidentiality. You do not have to answer any question you do not wish to answer and I want you to know this call may be recorded for quality control purposes. Red Flags that may trigger a full board review • Issues relating to potential for coercion • Working with children • Working with prisoners • Working with mentally challenged • Offering excessive incentives Tips for IRB submission of a survey • Refer to prior protocols that were approved • Refrain from providing excessive documentation • Providing questionnaire is customary, but IRB should not suggest changes to question wording, only to IRB language prior to the survey • It is best to ask permission to interview slightly larger sample than you think you will need just in case. Also ask for more time than you think, although the UF IRB typically gives a year. • It’s easier to get a revision than a new IRB • Keep copies of IRB approval IRB position on web surveys • • • • Confidentiaility, and Anonymous On-Line Surveys Many studies are making use of third-party software to implement online surveys and other forms of data collection. In cases where sensitive information is being obtained from individuals, the protocol should be explicit about what software system or vendor is being used to implement the study (e.g., SurveyMonkey), and explain that system's privacy protections. For example, are IP addresses of respondents collected, then destroyed, or not monitored at all? It is often the case that data saved on vendor's servers is not as secure as you might hope, or they might claim. Data should be removed from the vendor's server as soon after collection as possible; if there is some need to maintain the data on the remote server, this should be explained in the protocol. On-line surveys can be administered anonymously given that the following precautions are taken: • • • confirm that the service provider for the web-based survey does not, or cannot, collect IP addresses of respondents in any way that could be connected with their participation or their data. no questions asking for identifying information, including e-mail address, should be sought in any of the online surveys. ensure that any code connecting responses at multiple occasions is participant generated and not tracable back to the participant. These can be unique, and easily and reliably generated by participants, and usually involve some combination of parts of family first names, letters of hometowns, etc. IRBs at UF • IRB-01 (Health Science Center) – All protocols from Health Science Center – All protocols involving use or collection of Personal Health Information (PHI) • What qualifies as PHI is somewhat ambiguous • The IRB will err on the side of caution • IRB-02 (Behavioral/Non-medical) – All protocols coming from the rest of campus, unless they involve the collection of PHI – http://irb.ufl.edu/irb02/index.html • IRB-03 – All protocols originating at the Jacksonville campus IRB when collaborating • When collaborating across institutions you will need IRB approval from each institution – Example – Fibromyalgia study • IRBs in other agencies (government and private) – Florida Department of Health has its own IRB – IRB has been used as a reason not to get a contract • IRBs in other countries – Not all countries have the equivalent of the IRB – WHO adopted similar policy as the U.S., but there is no real leverage for enforcement IRBs at other universities • While the guidelines for the creation of the IRBs are the same, the way they evolve across institutions, and even within institutions, can vary • Examples – UCLA did not allow social network projects where respondents reported about people they knew – The University of Cincinnatti at one time gave blanket approval for survey projects to be reviewed at the end of the year Independent IRBs • Some IRBs exist outside of institutions – Western IRB • Typically used when conducting research across institutions • Many universities will not allow this as a substitute UF Privacy Office • The privacy office is not the same thing as the IRB • The IRB used to handle privacy issues, but now these activities are separated • http://privacy.ufl.edu/ Interesting questions • Can different practices of IRBs at different universities create comparative advantages? – Be careful when negotiating with the IRB on certain points as they may become policy at that institution • Do journalists need to get IRB approval for investigative stories? • How are qualitative approaches handled by IRBs when the data collection is by definition open-ended? • Does it make sense to treat social science research the same as bio-medical research?