NOTE: Approval by the SKC IRB must be obtained prior to starting any research activities including recruitment. Researchers may be required to destroy data obtained without prior approval of the IRB.
The SKC IRB does NOT accept review by other institutional review boards.
Starting May 1, 2019, the SKC IRB conducts IRB reviews for a fee of $300. This fee is waived for SKC faculty, staff, and students as well as researchers who are employed by the Confederated Salish & Kootenai Tribes. Bonafide graduate students from another institution or certain institutional partners may apply for a waiver of this fee by submitting a signed Request for Fee Waiver form available on the SKC IRB website Forms and Templates webpage.
The SKC IRB uses the research definition contained in the Common Rule:
Federal Regulations define research as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge1” (45CFR46.102(d)).
A human subject is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (45 CFR 46.102(f)(1),(2)).
Cultural Intellectual Property is defined as traditional cultural knowledge, cultural expressions, sacred cultural material, historical traditions and understandings, ways of knowing, and property such as natural resources or traditional arts or practices that occur on the Flathead Indian Reservation or are held by members of the Confederated Salish & Kootenai Tribes.
To apply for Review for the SKC IRB:
- All researchers, including students, must complete training in Human Subjects Protection. A copy of a training certificate completed within the last three years must be submitted with the IRB protocol.
- The SKC IRB accepts ONLY electronic materials. Materials should be submitted to:
- A complete IRB protocol should contain the following materials:
- A complete and signed IRB Application. The application must provide clear and complete responses to all sections of the template.
- Copies of all recruitment materials including flyers, posters, emails, etc.
- A copy of the Informed Consent Form. The SKC IRB may accept Informed Consent Forms using templates from other institutions if the template follows current regulations. Note that requirements for informed consent changed with the revision of the Common Rule in 2017; researchers must use a current template. The Informed Consent Form must be written at a comprehension level appropriate for the proposed research participants.
- A copy of the Minor Assent Form and Parental Consent Form if the study involves minors (individuals less than 18 years of age).
- Copies of all interview protocols, surveys, or other research materials.
- Letter or letters of permission from research sites or from CSKT Tribal Council, Culture Committees, or other tribal entities.
- If collecting biospecimens or biological materials, plans for collecting, storing and/or destroying specimens as appropriate to the research.
Contact the IRB with any questions about these materials.
Additional FAQs for Review of IRB Applications
- Reviews by the SKC IRB take between 7 days and 6 weeks, depending on the complexity of the review. Exempt reviews typically require 7 days from date of receipt. Expedited reviews require 7 to 14 days. Full Board reviews require 4 to 6 weeks depending on date of submission.
- Faculty members who supervise students conducting research are responsible for assessing whether the student projects or classroom activities involving human participants require IRB review and assuring that the research is conducted ethically. Instructors who teach research methods courses should ensure that students are educated about relevant ethical issues. Faculty members should follow the Procedures for Classroom Projects included on the Forms and Templates page.
- The SKC IRB will not implement the provisions of Broad Consent contained in 45 CFR 46 as tracking requirements are burdensome.
- The SKC IRB does not keep copies of human subjects training certificates on file. Copies of training certificates should be submitted with each IRB application.
Amending an Approved Protocol
Federal regulations and Salish Kootenai College Policy require IRB approval before implementing changes in an approved IRB protocol. Change means any change to the study, including but not limited to the population to be included in the study, research methods, consent form, research materials such as surveys, recruitment materials, a change in primary investigator, or altered research sites.
To request approval of an amendment to an approved protocol, use the Request for Amendment of Approved Protocol Form on the SKC IRB Forms and Templates page. Submit the completed and signed form to firstname.lastname@example.org prior to implementing any changes
Requirement for Continuing Approval
Research that is not exempt from review must be reviewed at least annually from the date of IRB approval. Complete and sign the Continuing Review Form and send to email@example.com at least two weeks prior to the date of approval. IRB approvals expire one year from the date of approval contained on the approval letter. Only analysis of deidentified data may proceed after the expiration date.
Final Closure Reports
When the study is complete, researchers must submit a final report using the Continuing Review or Final Report Form. A Final Project Report should only be submitted when all the following criteria are met:
- Research is permanently closed to the enrollment of new participants.
- All participants have completed research interventions (e.g., tests, physical or psychological exams, administer medications or treatments, etc.) including collection of data for follow-up.
- When individually identifiable data are no longer being collected on subjects (e.g., letters, phone calls, interviews, re-contacting, etc.)
- Data analysis indicates no new information needs to be provided to enrolled participants
- There is no need to re-contact enrolled subjects to obtain additional research information
- Data analysis is completed or is continuing on only de-identified data.
A Final Closure Report Form is available on the SKC IRB website. A completed and signed form should be sent to firstname.lastname@example.org. Failure to submit the Final Closure Report may result in administrative closure of the research, delay or inability to submit future applications to the SKC IRB, and/or further sanctions.
The following websites may be helpful in developing IRB protocols:
- Office of Human Research Protections (OHRP): https://www.hhs.gov/ohrp/
- Gunning Fog Index (an easy-to-use method of estimating the reading level required to comprehend Informed Consent or Assent forms): http://gunning-fog-index.com/
- The United Nations Declaration on the Rights of Indigenous People (contains definitions and explanations of cultural intellectual property rights): https://www.un.org/development/desa/indigenouspeoples/wp-content/uploads/sites/19/2018/11/UNDRIP_E_web.pdf