WHY DO WE HAVE IRBs? (see Hodge article).

History of global unethical research studies that led to the creation of IRBs (Nazi experiments WWII, 1932-1973 Tuskegee experiments, 1960s Thalidomide, 1963 Milgram studies, 1971 Stanford prison experiments).

(1932-1973) Tuskegee experiments. U.S. Public Health researchers intentionally withheld penicillin from 400 black males who were unaware of their positive diagnosis of syphilis. By the end of the study 28 men had died, their wives were now infected with syphilis, men were disabled from the disease, and their children had congenital disorders. In 1973 the study was stopped due to a federal investigation and the federal regulation of research was a direct result.
(1962) Kefauver-Harris Bill was passed to ensure greater drug safety as a result of the 12,000 thalidomide babies born missing limbs. This drug was given to pregnant women to control nausea, however, the women were not informed this was an experimental drug nor about the risks involved.
(1963) Stanley Milgram: obedience study and electric shock. Investigate power dynamics due to the common response from soldiers in WWII, Korea, Vietnam that they did what they did because they were just “following orders”. (going to show clip of a version of this study that was recently done: related to the “following orders” defense in the 2003 Abu Ghraib prisoner abuse/torture/murder scandal in Iraq at the hands of U.S. soldiers (photos and videos documented). )

As noted by Felicia Hodge in the article “No Meaningful Apology for American Indian Unethical Research Abuses”: Across Indian country there are cases where researchers stole indigenous medicinal knowledge of plants, cultural stories, songs, art… and even blood. In 1989 Arizona State University and the University of Arizona collected 400 blood samples from Havasupai tribal members for diabetes research, but those samples were used for unauthorized research on schizophrenia, eugenics, and DNA mapping. The researchers did not inform the Tribe. Hodge goes on to list countless other unethical research practices: sterilization of Lakota women, U.S. Air Force- giving radioactive Iodine to Alaska Natives, etc.

It was the combination of all these past unethical studies that led to the 1974 National Research Act (Public Law 93-348).
The legislation also created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research that, in 1979, issued the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects Research. The Institutional Review Board (IRB) process, formalized by the Commission, remains the present-day peer review method to ensure compliance with the basic ethical principles of the Belmont Report.
Current laws in place: 1974 National Research Act, 1991 Common Rule.

Some changes to the federal Common Rule as of Feb. 2016: 1) “harmonization”= one IRB for all federal agencies, 2) online review process, 3) more exemptions for ‘low risk’ studies, 4) clearer informed consent agreements that must include future uses of bio specimens---the changes are really as a result of the explosion of so many human genome/DNA projects and pharmaceutical drug testing in the U.S. over the past 25 years since the Common Rule was first adopted.)
My main concern is with “more” exemptions for “low risk” studies.
The Feds already deem studies approved by a Department or Agency head for “public benefit” as exempt.
Feds deem anything not “generalizable” as “not research”, low risk, and therefore exempt. So, a case study is automatically exempt. Indeed, most of you will receive a note back from our HSR reviewers at TESC that your study is “exempt” (why? Because we are federally funded). That’s fine because your faculty will have rigorously reviewed your HSR application first to make sure you are following ethical protocols. But just because a study isn’t “generalizable” doesn’t mean it can’t do harm.

IRBs are required for any research tied to federal funding.

There are 112 Federally approved IRBs in WA (behavioral, health, psych, medical, FDA: most are colleges, universities, and hospitals).
But only two are Indian centered. Northwest Indian College (Bellingham) & Swinomish Indian Tribal Community (La Conner).
Resource to search for IRBs: http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc

Sam Deloria stated in The Role of Tribal Government in Regulating Research: The federal government places conditions on the use of federal funds. But should Feds assume the full obligation of regulation or is there a necessary role for tribal governments?

Size makes a difference. A society of 323 million people can regulate research wholesale, but regulation of research affecting Indian communities is much more direct and personal. It is difficult to relate particular actions to general guiding principles because of the relatively small number of communities and individuals affected.

Tribes can act to ensure that the IRBs function as effectively as possible and reflect their needs and interests. But the fundamental responsibility to articulate the interest of Indian communities lies in these communities themselves, acting through their tribal governments, to articulate the conditions in which research will be permitted.

First, determine whether a particular tribal government has been given the power by its people to regulate research. Second, just like the Cynthia Pearson (UW) & Myra Parker (UW) article argues, train tribal leaders in research risk assessment. Make sure tribal leaders and staff have an understanding of research processes, methods, and cultural relevancy.

Starting a tribal IRB: https://depts.washington.edu/ccph/pdf_files/Start_a_Tribal_IRB.pdf

Questions: Can or should the Tribe obtain economic benefits from research? Must research show an immediate benefit (Wilson’s argument)? Do tribal members have an individual right to participate in research despite tribal opposition?

Argument: Use both processes (Fed IRB & Tribal review protocols). Fundamental that Tribal governments address research on their own in addition to the steps they take to ensure the effectiveness of federal regulatory efforts.

Make change from within a system as both an insider and outsider.

When we do have ethics codes institutionalized within Tribal government structures, the codes seem to focus on conflicts of interest, courts, patient health confidentiality, and handling money. Not research.

Title MCMLXXX (1980) - Code of Ethics
1980.01.01: Code of Ethics
Preamble
Summary
Article I
Authority
Article II
Policy
Article Ill
Enforcement
Article IV
Enforcement Procedure
Article V
Responsibility and Conduct
Section one --- Ethics
Section Two --- Conflicts of Interest
Section Three --- Conduct of Delegations
Section Four --- Misuse of (A) Funds (B) Equipment or (C) official Capacity
Section Five --- Misconduct
Section Six ---Work Habits
Article VI
Amendments
1980.01.03: Crimes
1980.01.05: Financial Disclosures

There is not a universal code of ethics for public administrators in Tribal governance.

http://ethicalgovnow.org/iseg/Symposium_files/Svara110711.pdf

If no code, is there a culture of ethics across Tribal governments?

http://www.governing.com/columns/smart-mgmt/col-culture-ethics-public-secto...

Photo: Quinault Tribal council

*See the emphasis on “culture” in the interpretive, critical, and IK paradigms. What does it mean to conduct Culturally Appropriate Research?:

Break “appropriate” down in 3 ways:

a) Culturally sensitive: uses terms/concepts as defined to be politically correct.
b) Culturally relevant: uses terms/concepts based on researcher membership (insider) in the response group.
c) Culturally responsive: researchers may adjust terms/concepts to respond to cultural influences and contexts shared by participants. Literally ask the participants of your study to define some of the key terms you’re using in your research. You will have some definitions from your lit review, but maybe these definitions won’t resonate with the community. Ask them to define what “climate change” means. Ask them what “traditional decision making” means.

---you might have to make adjustments as you collect your data in winter quarter. Example: conformity vs. adapt in my dissertation research.

Have their back. For me, ethical practices in public administration and in research are very similar to principles of allyship.

http://www.guidetoallyship.com/

The Don’ts
•Do not expect to be taught or shown. Take it upon yourself to use the tools around you to learn and answer your questions
•Do not participate for the gold medal in the Oppression Olympics
•Do not behave as though you know best
•Do not take credit for the labor of those who are marginalized and did the work before you stepped into the picture
•Do not assume that every member of a marginalized group feels oppressed

The Do’s
•Do be open to listening
•Do be aware of your implicit biases
•Do your research to learn more about the history of the struggle in which you are participating
•Do the inner work to figure out a way to acknowledge how you participate in oppressive systems
•Do the outer work and figure out how to change the oppressive systems
•Do amplify the voices of those without your privilege

There are 5 main rules of ethics in social science research agreed upon through Federal law and enforced by IRBs that use the Human Subjects Review (HSR) process. The rules are:
Ethical Responsibilities of the Researcher to Subjects:
1) Informed Voluntary Participation : subjects must voluntarily & informed consent to participate in research. The subjects must base their voluntary informed participation in research projects on a full understanding of the possible risks and benefits involved.
2) No Harm to Subjects : researchers must not inflict physical, psychological or emotional harm.
3) Guarantee Anonymity or Confidentiality : (not both!) Big difference between confidentiality and anonymity. Most common mistake is students try to guarantee "both". They don't understand it is one or the other or nothing. Anonymity : when nobody, including the researcher, can identify a particular response with a particular respondent. Confidentiality : when the researcher can identify the respondents, but others cannot. Either one can be waived by the subject, but it must be formally waived.
4) Deception : the researcher cannot deceive the subjects about who the researcher is or why they are there. If you are there to conduct research, you must make it known. However, this can be justified through HSR. If you must conceal your identity for the sake of the research (studying prison life for example) then the HSR may waive this rule.
Ethical Obligations of Researcher to Scientific Community:
5) Analysis and Reporting- make technical limitations of your research known. This includes reporting negative findings.

The Human Subjects Review (HSR) process is overseen by the Institutional Review Board (IRB). All institutions that receive federal funding and conduct any research involving human subjects, must have an IRB. The fundamental responsibility of the IRB review is to assure that the rights and welfare of the human subject are protected.
HANDOUT (TESC HSR application): How to respond to the 6 questions, cover letters, voluntary informed consent forms, letters of support.
When it comes to filling out the HSR application, it’s all about the form.
Use the samples provided on canvas! The language is extremely deliberate. Do not get fancy or try to reinvent the wheel here.
Use the word doc for HSR application that you read for tonight. This is what you will use for all your instruments (survey/interview/focus group questions), cover letters, consent forms.
HANDOUT. Review cover sheet for application packet:
Name, address, phone, e-mail: list only one person from your team.
Use is for: check off “Academic Program”
Quarter: check off “winter” and "spring" Year: write in 2018
Proposed project dates: The dates of your data collection should be January 1-June 15. (realistically you will collect your data during the first 2 weeks of winter quarter; you are really going to need to have your data collection completed when you come to class weekend 2 so we can spend time on analysis and reporting. But we have you write in a date until June so that you can have the option of going deeper into your research project for Capstone.)
Faculty sponsor: either one of us.
Funding agencies: None.
Indicate if the project involves any of the following: The only box that might get checked here is “a cooperating organization”. If this is the case, then you have to get a written letter of support from them, on letter head, that documents exactly what support they are promising you (ex. access to e-mail lists). A letter of support must be obtained from the appropriate authority within the Tribe. A letter of support should include a description of the research, a description of any resources that will be provided by the Tribe for the research project, and any promises made to the tribe by the study team. The letter of support must be obtained prior to submitting your HSR application to TESC.
Any resources that are required from the Tribe should be clearly outlined in the letter of support, i.e. meeting space, transportation, staff time, documents, e-mail listservs, addresses, phone numbers, etc.
Data ownership during and after the research study should be clearly considered in advance in collaboration with the tribe. Who stores raw data, owns it, for how long? Intellectual Property Rights (IPRs). Be very clear about this and do not speak for a Tribe. Follow the OCAP principles of Tribal ownership, control, access, and possession.
Plan for review of the findings by the tribe should be outlined in the letter of support.
Each Tribe is unique and has their own rules and procedures regarding research within their communities.
E-sign, E-date. (just the one person on the team listed at the top of the page)
No hard copy! We do not need a hard copy. We will submit what you upload on canvas to the Deans Area electronically. Our e-mail message will serve as our faculty signature.

HSR 6 questions (review HANDOUT):
1. Abstract= 150 words or less. Right here is where you state 3 very important points: a) if your study is generalizable or non-generalizable (case study), b) your role as a researcher and your respondents role, c) so what?--- the purpose of your research.
2. Procedures= when, where, and how will you do your research? Your plan. Attach your data collection instruments (survey/interview/focus group questions) to the HSR application. (add as an appendix to the document.)
3. Recruitment= Who & How. Who are you going to ask questions, how are you going to contact them, and how are you going to get people to participate in your study? This is where you write about your sampling approach (which we will cover next weekend). For example, “using an in-person survey directed at a non-probability convenience sample of adults in downtown Olympia on xxx dates and yyy times,…” or “an online survey sent by the COO of Little Creek Casino will be distributed via employee e-mails using a non-probability (non-random) targeted sample of part-time employees only in xxx unit.”
4. Risks= This is where you are clear about what risks participants may be subjected to by participating in your study: embarrassment, awkwardness with questions, self-reflection, reflection upon society, frustration. DO NOT write that a risk could be losing their job. If you seriously think this is a risk then we are going to need to modify your research project. DO NOT write that there are no risks. There are always risks in any research project. Ex. Big picture risks: The Tribe may not be ready for the results of your research. The Tribe may have higher priorities for the limited staff.
Mitigate Risk: Write that respondents can skip any question they prefer not to answer. They can also stop or exit the survey/interview/focus group at any time.
Anonymity vs. Confidentiality: I doubt any of you will be able to guarantee anonymity (meaning that even you don’t know who the respondents are). Most of you will be able to guarantee confidentiality (no personal identifiers asked, or you will clean/code the data so any personal identifiers are not public).
Waiver: If identifying the people in your study is important to the findings (Ex. research on leadership among Mayors in WA and you are going to make a documentary with videotaped interviews that will show their name and title.), then you can write in that you will ask respondents to waive their confidentiality.
5) Benefits to justify the risks= provide participants with right to review initial findings plus give them a copy of the final full report, invite them to your final presentation, note social impacts. OCAP principles: "Ownership, Control, Access, Possession". Key is to not just take data and run. Always give back to the participants and community. This is also where you need to explain if there are Tribal policies or plans already in motion about your topic and how your research will benefit them.
6) How will the info be used= academic and/or agency use only, not published. Explain how the raw data will be secured and how will destroy the raw data at the end of the project or given to Tribe. *Disclaimer: think this through in case you want to use it for other reasons in the future.


Link to Video: https://www.youtube.com/watch?v=7PCkvCPvDXk