No wool over our eyes: Navajo Nation Human Research Review Board Process

Christine Ami

Thoughts on how to submit a socio-cultural project to the Navajo Nation Human Research Review Board.

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There are a few more research related details that I need for my NEH sponsored book manuscript project (check out my nifty flyer to participate!). In order to do this, I needed to go through the NNHRRB. I know... lots of letters; they stand for the Navajo Nation Human Research Review Board. The first time I started NNNHRRB process I was completely daunted by the process ... but I reached out to some good friends from the Navajo Oral History Project and they helped me out (Thanks, Dr. Grier!). This time around I was way more confident in the process.

So, in celebration of my 2nd approved NNHRRB research project - I thought that I would cover the process and procedure of how to secure permission from the NNHRRB to conduct ethnographic work with our Navajo community members residing within the Navajo Nation. Now, I know you may be thinking - can't I just go to their website? Well, sure you can and here is the link:  Navajo Nation Human Research Review Board. But if you are anything like me, you may just need a little more guidance 🫣.

Navajo Nation Human Research Review Board Purpose
As explained in a 2006 Science and Engineering Ethics Journal article, “Protecting the Navajo people through tribal regulation of research” by Doug Brugge and Mariam Missaghian, through a review board, follows a process and procedure specifically created for biomedical research conducted with Navajo people. Here is where it gets a little tricky for people like me -  qualitative, ethnographic oriented - because the NNHRRB is primarily concerned with clinical and biomedical projects. But fear not - I am here to share what I know on submissions of socio-cultural projects for NNHRRB review.

Word of caution - the following is based off my experience; my Navajo collaborators are all 18 years or older and are not identified as "high risk."  For direct instructions that are specific to your research and your participants, contact the NNHRRB. You can't blame me for tabled or denied projects; but I'll accept some credit if your project is approved and you complete some awesome, ethical research 😎. 

Who Needs to Submit to the NNHRRB
First, figure out if your project needs NNHRRB approval. You would think that this is an easy question ... If you are working with Navajo People - you go through the NNHRRB ... but people/institutions/programs/organizations and even the NNHRRB itself make it tricky.

At the core, if you are coming to the Navajo Nation to conduct research (qualitative, quantitative, clinical, biomedical of any kind) with Navajo people who live on the Navajo Nation, ✅ you definitely need approval. Even if your own institution or agency expedites your project through their IRB, ✅ you still need NNHRRB approval - this includes multi sited projects (i.e., comparison of the Navajo people to another tribe).

Now, if your project is working with "Native Americans" who are in locales off the Navajo Nation and there happens to be Navajo people in your random sampling, 🚧 often it is left up to the Principal Investigator (PI) and the sponsoring institution to decide if NNHRRB approval is needed. In scenarios such as this, for socio-cultural projects, more often than not, PIs will indicate that their project include qualitative research with a "sensitive" population, list "Native Americans," address how they will mitigate risk factors at their institution's level and forgo the NNHRRB process. Now - I am not saying this is correct or incorrect, I am only reporting on how I have seen projects completed by colleagues and other scholars 🫣.

But if you are researching on the Navajo Nation and you are working with Navajo people - this means even if you an enrolled Navajo individual and working with your own family - ✅ YOU WILL NEED TO RECEIVE APPROVAL FROM THE NNHRRB and, if you aren't doing any funny business, you should honestly want to. FYI: There is an exception for enrolled Diné College and Navajo Technical University students enrolled in research classes at those institutions - but I will address that later in this blog so pay attention for that.

Okay... now that that's settled....

What is Your Project's Classification
Depending on your project classification, you will have a  different set of requirements to submit. Here are the three project classifications that the NNHRRB has outlined on their NNHRRB New Application Checklist Document.

1. Community
2. Health / Medical Facility
3. Education / State Schools, BIE, Contract Schools
   

Be sure to check out this document to see the distinctions between these projects as well as the requirement distinctions.

Submission Requirements for Community Projects
In terms of actually submitting NNHRRB proposals, I am only familiar with the Community Checklist. So that is what I have outlined below - Once again - As a word of caution .... I am pulling together the various resources (from scattered NNHRRB pages) and utilizing my experience submitting to the NNHRRB. It is YOUR RESPONSIBILITY to contact the NNHRRB office for any official guidance that you may need.

1. Navajo Nation Human Research Review Board Cover Sheet

• This document is pretty self explanatory. Print page 5 of the NNHRRB Guidelines "Cover Sheet", fill it out and slap that bad boy right on top of your packet.

2. Table of Contents

• Your second page is your table of contents. Nothing frilly here. When I submit, I include the required abstract, the 6 main sections (see #3), including the appendix (which is Part 6: Attachments). Just make sure that the page numbers match the sections to your packet. I say this not only because it helps out the NNHRRB Committee Members during review but also because if there are any questions during the official meeting about missing information or clarification, you can simply refer to the page number in your packet. Take a look at my Table of Contents  - and yes, my final packet was 39 pages: ➡
  

3. Abstract

• This is where you put the who, what, where, when, why, and how elevator pitch in a neat 2 page document. Although I have all hope that every NNHRRB committee member reads the applications thoroughly 🧐 - (if they don't) this page provides an overview of what you intend to cover and how you are going to do it. Check out page two of their guidelines here but if you are too lazy for that - I copied and pasted below:
  • The name of the proposed study, A general description of the study population, The geographical area where data will be collected, The number of the subjects to be recruited for the study, The gender of the subjects to be recruited for the study, The proposed benefits to the subjects, The proposed benefits to the Navajo Nation, The proposed personal benefits to the Principal Investigator, The proposed time period for the study to complete the twelve-phase process. (If you don't know what the 12-phase process is check out this document by the NNHRRB: "PI Guidelines")
• This abstract document actually became quite useful for me. For example, I submitted it to entities such as IHS, Chapters, Agencies and Navajo Nation Historic Preservation Department for the purpose of securing the NNHRRB approval. So In all my requests for support, I just attached this abstract and kindly directed them to the attachment in my request for permission/support (i.e.: "Please see the attached project abstract for additional details related to my proposed research project").

4. Navajo Nation Human Research Review Board Application

• This is the nitty gritty of your project. There are 6 formal sections to this application in which you will provide narrative of the details to your project. Each section has several questions, with a total of 17 detailed responses required and a whole lot of attachments. Go to page 6- 8 for all the questions in the NNHRRB provided "Guidelines". My suggestion is to literally type out the question in bold and respond directly below in TNR 12 font. Be sure to reference supplemental documents directly through your outlined appendix.

1. Part 1: Community Involvement (Questions 1-5)
2. Part 2: Benefits to the Navajo Nation (Questions 6- 9)
3. Part 3:  Research Project Description (Questions 10-16)
4. Part 4: Informed Consent (Question 17) For the informed consent I typically put "Refer to Appendix B: Informed Consent" and reference page number in the application packet.
5. Part 5: Certification by the Principal Investigator Go to  page 9 of the NNHRRB Guidelines - just print, read, sign, and include. I personally just include it under the section: Part 5 and not as an additional attachment. But it's up to you.
6. Part 6: Attachments: Following the completion of the NNHRRB Application 17 questions, you will need to provide an elaborate appendix with several documents. These attachments  will vary depending upon the role and type of research (Community, Health / Medical Facility, Education / State Schools, BIE, Contract Schools). Here are the requirements for a community lead project:
   

• • A. PI Resumé: Update your latest Resumé and include this as part of your attachments. I would tailor your resume to your academics and research.
  • B. Subject Informed Consent Form: The NNHRRB had a solid example of an Informed Consent on their NNHRRB Resource page. Check "Sample Consent Form" here. Be sure to indicate the primary contact as Dr. Rebecca Izzo-Manymules, NNHRRB  Chair 928-871-6929, [email protected], followed by the secondary contact as the P.I. (aka you).
  • C. Approved IRB Resolution or Approval Letter from Affiliated University and/or Funding Institution: Good practice will require that you have an approved IRB or Approval Letter from your university, funding, or research institution. Unless you are truly an independent researcher with your own funding you will need this letter before you even start to present at chapter and council levels. It demonstrates the approval of ethics and methods at a superficial level and creates the beginning of good trust between you and community members.
  • D. Community Resolution(s): This part take some time and lots of lots of planning. Part of the NNHRRB process includes community engagement. There are two ways to secure this (1) Navajo Nation Chapter Resolution (targeted in one chapter) or (2) Navajo Nation Agency Council Resolution; (if with involving multi-sites or chapters). On the Navajo Nation there are 110 chapter (local levels of governance) and 5 agencies (regional levels of governance). For my project, I have a multi chapter project so I have resolutions from each of those chapters (shout out to Teec Nos Pos, Chinle, Tsaile/Wheatfields/Blackrock, and Hard Rock Chapters) and I also have a Navajo Nation Agency resolution from the Chinle Agency.
    • Chapter Resolutions: The chapters meet every month. For every chapter resolution, you will need to (1) attend the planning meeting - this meeting is where you will present to the chapter officials and request permission to be put on the monthly meeting. After you attend the planning meeting you will need to (2) attend the monthly meeting - this meeting is where you will present to the community and the community will vote on your project (approve/deny/abstain).  Here is a useful document the NNHRRB put together with chapter contact information.
      
    • Agency Resolutions: For every agency resolution, you will need to contact the agency secretary to be placed on the quarterly meeting. Yup, you read that correct - they meet 4 times a year... so plan ahead! At this meeting, you will present to the regions chapter officials and they will vote on your project (approve/deny/abstain). Here is another useful document provided by the NNHRRB with agency contact information.

• • E. Tribal College IRB Approval Letter(s): If your project proposes to work with Navajo Nation tribal college communities (students, staff, faculty, administrators), you will need the tribal college's IRB approval IN ADDITION TO the NNHRRB. The NNHRRB will want to see the approval from the tribal college level first. There are two (2) Navajo Nation Tribal Colleges with IRBs: Diné College IRB and/or Navajo Technical University IRB. (My next blog will cover the Diné College IRB. I'm on the IRB committee so I have some insight).
    • Another word of caution - I have seen several scholars/researchers from other institutions try to use the tribal college IRB as a way to avoid the NNHRRB. 🤔 Don't be like them. The tribal college IRBs only fully cover DC/NTU student research projects. If you are not an active DC or NTU student currently registered and attending a research class at DC or NTU, you still have to go through NNHRRB. Even me... as a tribal college faculty - I still need both DC and NNHRRB IRB approvals because my project engages Diné College community members.

• • F. Navajo Historic Preservation Department Permit: For ethnographic/ historical projects, you will need to be reviewed by the Navajo Nation Historic Preservation Department. Here is their contact information:
    • Navajo Historic Preservation Department
      P. O. Box 4950
      Window Rock, Arizona 86515
      Telephone Number: (928) 871-7198/7153
      
• For this petition, you could mail it in, walk it in, or you could email the department with your request to conduct ethnographic work. In my request, I also provided them with the abstract that I used for this application (go back to #3 in this blog). They read through your project and (if warranted) issue you a Permit - C. The permit is good for 1 year and the request for continuation is straight forward - email them.  If you have a multi-year project, you will need to request continuations from the NNHPD as well as the NNHRRB. You will include the permit in your application.
• G. Navajo Nation Certificate of Confidentiality: The guidelines indicate "that the principal investigator(s) apply for the Certificate of Confidentiality from the Federal Agency to ensure maximum protection for their study participants regarding their privacy."  This is distinct from Part 5: Certification by the Principal Investigator. I found the NIH Grants and Funding "How to Get a Certificate of Confidentiality" most helpful. From that page I went to the "Get your CoC" link. You must demonstrate that you have petitioned for a CoC to the NNHRRB. So I completed the request, printed it out and included the request document in my NNHRRB packet.
• H.  Privacy Act Statements:  Here is the link the NNHRRB provides for the Privacy Act itself: NN Privacy Act.  Read it! After which, in your application, you must provide copies of the letters you submitted to (1) the Navajo Area IHS Director, the Navajo Area Office, (2) the Privacy Act Coordinator and (3) the CEO of 638 Hospital on the Navajo Nation attesting to the understanding of and willingness by the Principal Investigator to abide by the provisions of the Privacy Act. So three letters. Page 3 of the NNHRRB Application will give you addresses and phone numbers that you can contact to find out who these individuals are. You can send a hard copy of your abstract and a letter stating who you are, your project description, and a statement disclosing your agreement to adhere to the NN Privacy Act or you could email them your statements. In the latter option, print out the email correspondence and include that.
  
• I. Budget Statements: You need to include your budget break down. If you have a grant funding you, just include your budget from that grant. If you do not have a budget, you still include a statement declaring that there is no budget associated to this project.
• J. Research Tools: Here is where you put your surveys - the actual tools going to be handed out to collect data. Any surveys or measures (qualitative or quantitative) to be used must be placed here. This allows for the NNHRRB committee to see exactly what will be asked

There may be other supporting documents that you will need for community socio-cultural projects. I do not have experience as my project did not need these areas of support. I would call the organization itself and ask to present at an official meeting. Also ask them if they have a template that you can use for resolutions. That will save both you and them a lot of time. Lastly, be sure to include your abstract (see #3) in your initial request and have a couple copies on hand when you go to present.

• • K.  School Board Resolutions
  • L.  Navajo Medicine Man Association or Dine’ Hataalii Association Supporting Resolution
  • M. Azee’ Bee Nahagha Association (Native American Church)
  • N. Other Navajo Nation Council Subcommittee: Heath, Education, Human Services, Law and Order, Natural Resources

Here are some additional components that I include in the Attachments but are not on the NNHRRB checklist. If you don't include these and your project gets tabled.... don't say I didn't tell you 🥲:

• • O. CITI Training Certificates: I am not sure if this is an actual requirement, but I complete my CITI training and include my certificates in the NNHRRB process. I have to have it completed for the Diné College IRB application, so why not include it here.
  • P. Advertisements: Once again, I didn't see any official requests for advertisements, but I needed it for the Diné College IRB application, so I just include it in my NNHRRB process.

Time to Submit
You are feeling good - you have everything ready to rock and roll... You are ready to submit. You must check the deadline for submissions - but in short, your project application must be received a month before the scheduled meeting. You can find that information on the NNHRRB home page. Go to the downloadable file labeled 2022 Meeting Schedule file. Typically, proposal submission deadlines are on Friday afternoons.

The NNHRRB has yet to go online with their application so you will need to send or drop of 11 (Eleven) copies to the NNHRRB office: 1 original and 10 copies. The NNHRRB Coordinator, Mike Winney, will then mail out the copies to the NNHRRB Committee Members.

I always drive into Window Rock to drop off my application packet. For me, it's a great excuse to grab some chicken pot pies from KFC. But I assume you can snail mail a box to Mr. Winney as well.

Mailing Address:
Navajo Research Program – NDOH
P.O. Box 1390
Window Rock, AZ 86515

Physical Address:
Navajo Research Program – NDOH
Window Rock Blvd., Administration Bldg. #2
Window Rock, AZ 86515

Meeting Time
If you mailed in your project, I would request a tracking number and then call Mr. Winney to confirm the application's arrival to the NNHRRB office. Once the application is received, Mr. Winney will put your project on the meeting schedule.

Typically, the NNHRRB meets every 3rd Tuesday, starting at 9am. The meeting can last all day - so prepare yourself. As of late, all NNHRRB have been held virtually - which I appreciate.

At the meeting you will be given a brief amount of time to present, followed by time to answer any and all questions posed by the NNHRRB Committee Members. So questions are for clarifications, others are about missing information. After the question/answer portion, the Committee will vote according to Robert's Rules of Order - so be prepared to be Tabled as well.

Other Thoughts about the NNHRRB Application Process
Tabled Projects: As of late, I have seen projects tabled because their application is missing either one big component or a lot of small components (missing timelines, missing resolutions, missing support letters, missing measures, etc). Best way to be prepared is for you to be as organized as possible. If your project isn't prepared by the submission deadline, don't rush - just wait to submit at the following meeting. Your first impression should be one of preparation and organization. So my suggestion is to start your preparation way in advance - I suggest at least 3 months prior to the submission date (4 months prior to formal presentation to the NNHRRB). I know this is difficult because some of you are graduate students (and others are just impatient lol) but, as I tell my students - the more solid your IRB project packet presentation the better prepared you are for actually implementing the project. It will make your presentation much smoother. The presentation itself then becomes a training ground for you to talk about your project. The more you talk about it with audiences such at the NNHRRB, the more real your project becomes. 

Academic Discipline Notes: The NNHRRB committee is composed primarily of experts from biomedical and clinical professional/academic backgrounds. This makes the presentation of socio-cultural projects a bit challenging at times. The first time I presented the committee wanted to push my project into an Animal Science realm, when I work in the area of Animal Studies (they are very distinct). Don't get upset, wait for them to finish their commentary and respond with clarification. As with all presentations to general audiences (grants, fellowships, IRBs), avoid discipline specific jargon.

Emic Cultural Notes: If you are well attuned to a specific cultural area, (1) do not assume you know all - be open to hearing what some of these individuals share (even if they are taking you down a worm hole) and also (2) do not hold back on your own areas of cultural knowledge - just like you don't know everything, the same goes with the committee members (everyone is here to learn). I have been fortunate to learn from a few of the committee members and they have hopefully also learned from me. I have also been on the other end of that spectrum as well. With that said...

Discrimatory Notes: If you feel that you are being discriminated for whatever reason - make that declaration, document, and submit a complaint. I have, in previous years, experienced and seen race and gender of the PI be questioned, and as a result, the entire project put under scrutiny.  Now - there are times when gender or culture does play a role in research, access to cultural content, or data analysis. But when projects are tabled or denied merely based on the race of the PI and the biases of individual committee members, there is an ethics violation that require immediate legal review.

Honest Notes: Although I have some disagreements with the process and procedure, especially during COVID (you can check out the ICT article for more info on that), I must confess, this past time around was much smoother than my previous experience. I feel like the committee is better prepared for socio-cultural projects now than they were 10 years ago when I first presented to the NNHRRB. I also speak the Navajo language better and I am firmly grounded in my community and profession. Additionally, I am now on the Diné College IRB so I am starting to fully understand the intricacies of IRBs. Because of all these factors - and the change of atmosphere/leadership of the NNHRRRB - my project was reviewed for ethics, which is the purpose of the NNHRRB, and the committee members were professional, curtious, and helpful. Finally, like butchering - the more you do it, the familiar the knife becomes in your hand.

Last Note:  CONTACT THE NNHRRB COORDINATOR FOR ASSISTANCE. This blog is not an official 'how to' document  approved by the NNHRRB . This are just my thoughts and my experiences.

If you have any more guidance, be sure to put them in the comments! Your experience can help others navigate what is often considered a tedious and often stressful part of the research process. It doesn't have to be :)