1. Human Subjects Research at Mines Colorado School of Mines New Faculty Orientation November 20, 2015

2. Human Subject Research ‣ What is Human Subjects research? ‣ Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. ‣ Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information. ‣ What does IRB Approval mean? ‣ Your project has to be reviewed and approved before research starts by an independent group, the Institutional Review Board (IRB). ‣ Types of approval: Exempt, Expedited, Full Board

3. Types of IRB Approvals ‣ Exempt Approvals – research conducted in established or commonly accepted educational settings, involving normal educational practices. – research involving educational tests, survey procedures, interview procedures, or observations of public behavior. – research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. – taste and food quality evaluation and consumer acceptance studies. ‣ Expedited Approvals – Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture – Collection of data from voice, video, digital, or image recordings made for research purposes – Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. – Prospective collection of biological specimens for research purposes by noninvasive means. Examples: hair and nail clippings in a nondisfiguring manner ‣ Full Board – Anything else

4. CSM Human Subjects Team, COMIRB & Reciprocity Agreements ‣ CSM Human Subjects Team – Registered with OHRP to grant exempt approvals only – Reviews and approves exempt applications. If a study cannot be approved as exempt, the team will assist the researcher in seeking expedited or full board approval – Reviews requests from outside researchers to use Mines’ population as research subjects. ‣ COMIRB – Mines has an agreement with COMIRB to provide all our researchers with expedited or full board approval for a discounted cost. (These costs are allowable in your project budgets!) – Mines researchers will submit directly to COMIRB via their on-line system ‣ Reciprocity Agreements – If a Mines researcher has a Co-PI at another institution with a full IRB, we can establish an agreement to cede IRB review to the other institution 4

5. Keys to a successful application ‣ Take the Human Subjects Training before working on your application ‣ Think through all aspects of human subjects protection before planning your project. ‧ Clearly defined research plan, specifically surrounding the interaction with the subjects ‧ Subject Population / Recruitment / Incentives ‧ Subject Consent – Will it be done in person or online? ‧ What data/information will you be collecting? ‧ Do you have copies of your surveys? Interview questions? Etc.? ‧ How will you protect the confidentiality of the subjects? ‧ Are there any conflicts of interest with the research team? If so, how did you mitigate them? ‧ Are you working with a protected population? Minors, prisoners or pregnant women? ‧ Does your study have an international element? ‣ Submit your exempt application at least 4-6 weeks before you need to start collecting data to humansubjects@mines.eduhumansubjects@mines.edu 5

6. Human Subjects Training ‣ Mines requires all researchers involved with human subjects to take an on-line training course offered by CITI at least every 2 years. ‣ “Social & Behavioral Research - Basic/Refresher” ‣ http://www.citiprogram.org/ http://www.citiprogram.org/ – Login instructions: http://www.citiprogram.org/citidocuments/ADMIN/Steps%20to%20register%20with% 20CITI.ppt http://www.citiprogram.org/citidocuments/ADMIN/Steps%20to%20register%20with% 20CITI.ppt 6

7. Questions? Contact the Human Subjects Team: humansubjects@mines.edu Website: hsr.mines.edu Want more information? http://www.hhs.gov/ohrp/index.html http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html 7 10/27/2008Tackling Our Energy Challenges