1	What TESOL students need to know about Human Subjects' Research Review Lynn Santelmann Applied Linguistics April 24, 2005
2	Previous Human Subjects’ Abuses & The Belmont Report Previous Abuses: Nuremburg & War Crimes Tuskegee Syphilis Studies Result: The Nuremburg Code & the Helsinki Report The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research Three major principles Respect for Persons Beneficence Justice
3	Respect for Persons Individuals should be treated as autonomous individuals Individual must be given choices, and those choices must be respected Individual must be given sufficient information to make an informed, considered decision Participants must enter into study voluntarily Persons with diminished authority or competence are entitled to special protection
4	What Respect for Persons means for YOU All human participants MUST give informed consent You must make sure that: Participants have sufficient information to be able to decide if they want to participate Information must be comprehensible to your participants Participation must be truly voluntary special care must be taken to avoid coercion special care must be taken if you are in a position of power over the participants (their teacher, for example)
5	Beneficence Persons need to be treated so as to secure their well-being Do no harm in your study Maximize the possible benefits Minimize the possible risks
6	What Beneficence means for YOU Your application for human subjects approval must contain: Assessment of Risks (physical, psychological and social) Some indication of the benefits benefits can be direct – participants benefit benefits can be indirect – future benefits to similar population or society as a whole There must be a favorable risk/benefit ratio
7	Justice Problem of Justice is the problem of who ought to receive the benefits of research and bear its burden? Both burden and benefits need to be equally distributed. Cannot study one population for benefit of another Cannot exclude population from studies with benefits because they’re hard to study
8	What Justice means for YOU Your human subjects proposal must justify your selection of participants Selection of Subjects must be: Non-discriminatory Consider the risks and benefits to protected classes (e.g., very low level students)
9	What is the committee looking for? Forms filled out completely, see: http://www.gsr.pdx.edu/compliance/human/ Investigator's Assurance Page = cover page. Requires: Your signature Your thesis chair's signature Departmental chair's signature
10	I. Project Title and Prospectus 500 word maximum Summary of the research project Major research questions and why they are important (helps establish beneficence) Major methods (how you are going to collect the data) This should NOT include Your literature review
11	II. Exemption Claim or Waiver of Review You must say which kind of review you think you qualify for Waived review Waived review means that the project will be reviewed initially If it meets the guidelines for ethical research and informed consent, further review will be waived Anonymous surveys often qualify for a waiver of review
12	Waived Review Projects qualify for a waiver of review, IF They involve commonly accepted educational practices or program evaluations approved by the program, AND The information collected cannot be linked directly back to the participants (i.e. the information is anonymous). AND The information collected does not expose the participants to possible penalties or risks
13	Expedited Review Expedited Review means that the project will be reviewed by a subcommittee of the full review board Projects will need to undergo continuing review until completed Most MA TESOL projects fall under expedited
14	Expedited Review Projects qualify for an expedited review IF They involve minimal risk for the participants AND They involve research on individual or group characteristics, such as.. language, communication, identity, motivation, perception, cultural beliefs or practices, cognition
15	Expedited Review Characteristics that usually accompany an expedited review: Project uses recording devices of any kind Projects need to collect participants names or other identifying information (e.g., to track participants) Project is not federally funded
16	Full Review Full review means that the project will be reviewed by the full HSRRC committee. Projects will need to undergo continuing review until completed. Projects need to undergo full review IF They are federally funded by any type of federal money OR They involve considerable risk to the participants
17	No Review Required Rarely applies to MA TESOL Form must be filled out showing that: There is no identifying information for the data AND There is no contact with the subjects AND Data was already collected by another investigator AND The data already exist
18	III. Subject Recruitment Describe how and where you are going to recruit subjects Discuss any criteria you have for including or excluding subjects It’s OK to restrict to certain language groups or proficiency levels, IF your research questions warrant this If you’re recruiting a sample of convenience, it may be best to say so
19	IV. Informed Consent This is the section that gets the most scrutiny by the committee. The committee is looking for participant to be: Truly voluntary subjects need to be able to withdraw at any time subjects need not be coerced into participating The research is presented so that it is understandable to the participants All the risks and the benefits are clearly outlined to the participants Written in the 2^nd person (you, NOT “I”)
20	Informed Consent: Some tricky situations What if I want to research my class? How do I avoid coercion? Avoid having only students who participate sign or fill out a consent Have EVERYONE fill out/sign the consent Have EVERYONE check whether or not they want to participate or allow you to analyze the data □Yes I want to participate □ No, I do not want to participate
21	Informed Consent: Some tricky situations What if I want to record a class and not everyone gives consent? Consider whether tape recording the class is really best way to gain data If it is, then you cannot avoid recording voices of non-participants, BUT you CAN promise only to transcribe and analyze people who have given consent you SHOULD agree to stop recording at any time someone asks you to
22	Informed Consent: Some tricky situations What if my participants don’t speak/read English well enough to read the form? Ideally administer informed consent in their native language Translate form into native languages AND back-translate it into English If they are not literate in native language, you can administer it orally
23	Informed Consent: Some tricky situations What if my participants are a protected class (children or not literate)? You should use the form for “high risk populations” for anyone where proficiency is an issue You must get written consent from guardians of minor children You must ALSO get written consent from children who are literate – see special form You must ALSO oral consent from children not literate You must get (and record) oral consent from adult participants who are not literate
24	Informed Consent: Waiver of signed consent What if the consent form would be the ONLY place participants’ names would be recorded? You can request a waiver of signed consent You STILL give subjects the informed consent information, BUT they do not sign it. They keep it. Filling out the survey becomes their consent to participate. This is NOT an option if you are doing any sort of audio- or video-taping
25	V. First Person Scenario Designed to see if you’ve REALLY thought through what it’s like to participate Should demonstrate that the research is comprehensible to the participants, voluntary and with minimal risks It should begin with the first contact by the researcher and continue through the entire process. It needs to include an accurate estimate of how much time it will take. It should include what it feels like to take part. It should NOT be "cutesy" or extol the virtues of your research
26	VI. Potential Risks and Safeguards This section gets the second most scrutiny by the committee NEVER, EVER, EVER write: “There is no risk to participating in this research.” Psychological and social risks are risks too. EVERY research project has some psychological or social risk associated with it
27	Common risks in Applied Linguistics Breach of confidentiality someone may find out whether a person participated, and what their responses were Psychological risks embarrassment, frustration or loss of self-esteem Social risks someone may find their relationships altered, suffer public embarrassment
28	Safeguards You MUST spell out the safeguards for each risk. To safeguard against breach of confidentiality Secure recordings and original data Give participants code names, numbers etc. Report only aggregate data (group data) Do not report group data for any group with less than 3-4 participants
29	Safeguards To safeguard against psychological risks Inform subjects that they may withdraw at any time Give subjects true opportunities to say “no” Inform subjects that they may skip any questions that they do not wish to answer Minimize the number of personal or intrusive questions
30	Safeguards To safeguard against social risks Inform subjects that if they chose not to participate, this will not alter their relationship with you Allow information to be collected privately or without others knowing whether they did or did not participate Provide follow-up services or referrals if there is a significant risk of questions raising trauma or embarrassment
31	VII. Potential Benefits There must be some benefit to the research or it won’t be approved Two types of benefits: Direct, i.e. the subjects themselves get something out of the research Indirect, i.e. participants might get future benefit or similar population learns or gains something from the research Most Applied Linguistics research has indirect benefits
32	VIII. Records & Distribution You are required by law to keep records for a minimum of 3 years You should say that you will keep these records in a secure location in your office/home You must discuss the procedures that you will use to safeguard identities and report on the data (code names, group reporting, etc.) You must discuss what will happen to the data after the 3 years is up, or your project is done, whichever comes later.
33	IX. Appendices and other info Any instruments you are using Need not be the absolute final version, but should be close Any cover letters or recruitment information you will give out The full and final informed consent form (in English) Forms in other languages, if applicable Save a tree don’t put a page separating each appendix single space the whole thing
34	When to file human subjects’ application? File as soon after your proposal meeting as you can Make sure that your method is finalized Make sure you allow 4-6 weeks for approval to go through “Lack of preparation on your part does not constitute an emergency on my part”
35	What happens after you submit your application? Your application goes to the administrator in charge Your application is distributed to TWO committee members if expedited, one if waived Your application may be approved as is The reviewers may request that you make changes – if they are minor you will received a “conditional approval” – you can go ahead as soon as you complete the changes
36	Need help? http://www.gsr.pdx.edu/compliance/human/ Forms and guidelines to download www.web.pdx.edu/~dbls This presentation Examples of human subjects proposals that were approved quickly