Human Subjects Research
Clarkson University maintains an Institutional Review Board (IRB) with the mandate of protecting the rights and welfare of humans who participate in research. All activities related to human subjects research must initially be reviewed and approved or exempted by the Clarkson University IRB whether they are conducted by faculty, staff, assistants, students, or any other research collaborator.
To conduct human subjects research in which Clarkson University is a participant, follow these steps:
Read the Clarkson University Policy on Research With Human Subjects in sections 6.4 Research and Consulting and 6.5 Research Involving Human Subjects of the Clarkson University Operations Manual and applicable sections of the Clarkson University Human Research Protection Program Policy and Procedure Manual.
When familiar with Clarkson's policy, Take the CITI Human Subjects Research Training Course. You must successfully complete the appropriate training course to conduct human subjects research at Clarkson. For help in identifiying the appropriate course to take see the CITI Human Subjects Training Research Instructions.
After you have read Clarkson's policy and completed the Human Subjects Research Training Course, prepare your IRB protocol using the form and guidelines provided below and submit it to Rebecca Thatcher, IRB Administrative Assistant, CU PO Box 5630, or at email@example.com. Please use this e-mail for any and all correspondences regarding the IRB. You may also cc Dr. Johndan Johnson-Eilola, Chair of the IRB, at firstname.lastname@example.org.
IRB Meeting Dates - Spring 2015
Protocols must be submitted to the Division of Research by noon, at least two weeks prior to the selected meeting date below in order to allow the IRB Chair time to pre-review protocols. Protocols with significant issues may require revision before being accepted for review by the full IRB. Please note that any required revisions, as a result of the pre-review, would need to be completed no later than one week prior to the selected meeting date.
IRB Protocol Form NEW 10/30/2014 (.doc 42 KB)
IRB Protocol Guidelines NEW 10/30/2014 (pdf 177 KB)
Exemption Request from Full IRB Review NEW 10/30/14 (.doc 87 KB)
Investigational Device Exemption (IDE) Request 12/07/07 (.doc 62 KB)
Adverse Event and unanticipated Problem Report Form 10/12 (.doc 37 KB)
Project Modification Request 05/26/09 (.doc 36 KB)
Continuation Request 10/11/11 (.doc 34 KB)
Continuation with Modification Request 09/01/09
Human Subjects Research Determination Form 4/10/14 (.doc 142 KB)
IRB Study Closure Form 05/29/12 (.doc)
Collaborating Investigator Agreement 06/10/2013 (.doc)
Clarkson University Policies, Procedures, and Guidelines
Clarkson University Policy on Research With Human Subjects
Clarkson University Human Research Protection Program Policy and Procedure Manual
Internet Recruitment of Subjects Guidance 02/15/11 (.doc 28 KB)
IRB Audit Procedure
Clarkson University Conflict of Interest Policy
Clarkson University Conflict Disclosure Form
Human Subject Payment Procedure
Human Subject Payment Log
Federal Regulations and Guidelines
Terms of Clarkson Univeristy's Federalwide Assurance with DHHS OHRP
Federal Regulations 45 CFR Part 46 (DHHS, Common Rule)
The American Psychological Association's Ethical Code, Ethical Principles of Psychologists and Code of Conduct
21 CFR Part 50 (FDA) - Regulations for the Protection of Human Subjects
21 CFR Part 56 (FDA) - Institutional Review Boards
21 CFR part 812(FDA) - Investigational Device Exemptions
Health Information Portability and Accountability Act (HIPAA)
New York State Article 24-A Protection of Human Subjects
The Office for Human Research Protections (OHRP) - Click here for the OHRP Decision Tree
NIH Guidance for Research Involving Human Subjects - Click Here
NIH Guidance on Research Involving Human Specimens - Click Here
Research Involving Private Information or Human Specimens - Click Here for NIH Decision Tree
OHRP Guidance on Coded Private Information or Biological Specimens
NIH FAQs for Research Involving Human Specimens, Cell Lines, or Data - Click Here
The Office for Human Research Protections (DHHS) has developed an International Compilation of Human Subject Research Protections. The compilation lists the laws, regulations, and guidelines of over 50 countries where DHHS funded or supported research is conducted.
The compilation provides direct web links to each country's Key Organizations and laws, whenever available. OHRP believes this compilation will help IRB's, researchers, and others to meet the regulatory requirements to assure that research comply with applicable law.
The compilation can be accessed on the OHRP Web site. To use the compilation, go to page three and then click on the country of interest.
Education and Training
Take the CITI Human Subjects Research Training Course
Clarkson Human Subjects Research Workshop Presentation
Human Subjects FAQ's and Sample Scenarios
OHRP FAQ's - Click Here
Why is review necessary?
Review protects people from being subjected to scrutiny, measurements, procedures, or other interventions that violate their basic human rights or otherwise put them at unacceptable risk. Review also protects you, the researcher, and Clarkson University from repercussions of placing subjects at risk. Finally, in an atmosphere of increasing public concern about research with human subjects, review protects the very existence and viability of such research. Review assures the public (from whom study populations are recruited) that the study they are about to participate in has been overseen by the institution supporting the research, in accordance with recognized ethical principles. Research that has not undergone review will be refused funding from public sources.
How does Clarkson comply with requirements for review?
The federal government sets forth procedures, guidelines and practices to be followed by institutions receiving federal research support. In most cases, for the reasons outlined above, institutions follow these guidelines and practices for research with human subjects whether or not federal funding is involved. Each institution is responsible for appointing members to and maintaining the records of an Institutional Review Board (IRB) and for maintaining an official Assurance of Compliance on record with the Department of Health and Human Services. Clarkson University's Assurance document can be viewed on file in the Division of Research. In addition, each institution is responsible for providing training in the responsible conduct of research with human subjects. For most institutions of Clarkson's research make-up, this means providing a link to an online course, making training materials available and generally providing guidance on regulations.
What does review involve?
Clarkson's IRB meets monthly, on dates which are set in advance of each term, usually in the second half of each month. Faculty members or students wishing to conduct research with human subjects complete an application (research protocol) which describes the project in full, in terms understandable to lay readers (that is, all abbreviations are spelled out in full, non-specialist language is used, etc.). The IRB Coordinator can give guidance on appropriate language. The protocol is submitted to the Division of Research at least one week in advance of the IRB meeting date (some members are located off-campus, and protocols need to be copied and mailed to them). The members meet, discuss questions they may have, and vote on approval, non-approval, or approval-pending-resubmission of the protocol. The IRB Coordinator then forwards a decision memo notifying the researcher of next steps, if any are needed.
What research should be reviewed?
"Research" means any data collection through any means (surveys, performance on tests, observation and the like), which is used to make generalizable statements (generally speaking, this means that the data or results are published, in any form, via the world wide web, poster presentation, or scholarly paper). It also refers to data, the source of which can be identified. In other words, if you collect names, birth dates, student ID numbers or any other identifying information that could allow you to trace the data back to their source, you are conducting research that will need review at least on some level. Research involving certain degrees of risk (information collected might damage economic status or employability, for example) to subjects also requires review.
What research does not need review?
To ensure adequate oversight of research with human subjects, you should not make this call yourself; consult the IRB Chair, or the IRB Coordinator, who can make a determination for the institution. Generally, "research" does not refer to data gathering in order to improve teaching or education-related practices limited to your own class or project. It also does not refer to market research, the sole purpose of which is to improve a specific process or product (unless, of course, that research will be made public). Studies of public officials or behavior observable in everyday public life is also exempt, if no identifiers are used.
Are there any special cases?
Research conducted on students, except to improve your own teaching, is in a category of its own. Surveys or questionnaires administered to Clarkson students must be approved by the Vice President for Student Affairs, and, if identifiers are used, by the IRB.
What does this mean in practice?
Here are some examples. These examples do not cover every case. If you are unsure about any aspect of review, please contact the IRB Coordinator.
Professor Dokainish does research on his class:
Professor Firaz Dokainish wants to find out if his class is understanding the material he taught them last week. He administers a quiz. This is collection of data to improve his own teaching, and it will not need full review. Professor Dokainish can proceed with the quiz, collect and analyze the results. The following term, Professor Dokainish decides he'd like to use this (now archival) test data and he'd like to gather fresh data from his new class for comparison purposes, because he'd like to publish a paper on the technique he used to teach the first class. He can use the archival data without seeking full review; however, he needs to submit a protocol to full review to administer the test to the new class.
Sophomore student does research on her dorm mates:
Ramona Lions, a sophomore E&M student, decides to administer a survey to students in her dorm on their uses of tobacco. She plans to leave the surveys in a lounge, with a cardboard box beside them for anonymous collection, and will not gather any information (name, room number, student number, birth date) that could allow her to trace the data to its source. She will not observe students filling out the survey. In this case, Ramona needs to seek review by the Vice President for Student Affairs. She does not need full IRB review.
Professor Smith gathers data at town meetings:
Professor Louise Smith wants to gather data for a paper she's writing on speech-making by public officials. She'll attend several public forums and town hall meetings, and will observe these officials in action. She'll record, by means of pen and paper and a camcorder, what they say, how they sound, look and behave. Professor Smith does not need full IRB review for research on public officials.
Professor Halberstam collects data with a team of students:
Professor Michael Halberstam is conducting research with a team of undergraduates who'll help him collect data. He is measuring, through the use of calipers, the ratio of fat to muscle on two groups of pre-menopausal women who have never had children. His study must be submitted to full IRB review.
MBA student does customer research:
Norris Jones, an MBA student, seeks to learn more about customer behavior. He plans to share his results with his colleagues in his honor society by posting the outcome on the society web site. He will interview children at local middle schools about their candy purchases. He will record their names and ages. Norris needs to seek full IRB approval for his study.
Assurance and Registration
Having trouble deciding which CITI human subjects training course to take? Check out the new CITI Human Subjects Research Training Instructions.
Please note that several IRB forms have recently changed. Be sure to download the most recent version for all submissions as using older versions of IRB forms will delay the review process. Recently revised forms are identified as "NEW".