- Decision Charts
- Chart 1 : Is an Activity Research Involving Human Subjects?
- Chart 2: Is the Human Subjects Research Eligible for Exemption?
- Chart 3: Does Exemption 45 CFR 46.101(b)(1) (for Educational Settings) Apply?
- Chart 4: Does exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) Apply?
- Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply?
- Chart 6: Does Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service Programs) Apply?
- Chart 7: Does Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance Studies) Apply?
- Chart 8: May the IRB Review Be Done by Expedited Procedures?
- Chart 9: May the IRB Continuing Review Be Done by Expedited Procedures?
- Chart 10: May Informed Consent Be Waived or Consent Elements Be Altered under 45 CFR 46.116(d)?
- Chart 11: May Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?
- Policies/Guidance Documents
- Human Subjects Certification
- Protocol Submission Guidance
- International Research
- Announcement: Human Subjects International Researcher Guidance and Procedures
- IRB Guidance and Procedures: Evaluation of the Local Research Context for International Studies
- Appendix C: Full/Expedited Studies Involving International Research
- Appendix D: Exempt Studies Involving International Research
- Regulatory Guidance
- Contact Us
- RBHS IRB
Human Subjects Certification Program
In cooperation with the IRB, the ORSP compliance staff has developed a web-based education program, the Human Subjects Certification Program (HSCP), for all principal investigators and other key personnel who are named on protocols that involve human subjects. The program, which is mandated by the Office for Human Research Protections and the National Institutes of Health, has been available since September, 2000.
Why was the education program implemented?
To obtain or renew an assurance of compliance, which allows an institution to receive federal funding for research involving human subjects, the federal Office for Human Research Protections (OHRP) has strongly recommended that principal investigators and other key personnel involved in human subject protocols participate in education designed to increase understanding of the regulations, policies, and ethical standards governing the protection of human subjects. The Federal wide Assurance (FWA00003913) between Rutgers University and OHRP extends federal regulations pertaining to human subject protection to all research involving human subjects at Rutgers, regardless of funding source.
The education program also provides the means to satisfy the education requirement of the National Institutes of Health (NIH), which became effective on October 1, 2001. All principal investigators and key personnel who are involved in human subject research for which funding by NIH is requested or has been awarded must participate in education on the protection of human subjects in research. Certification of successful completion of the education program is required before NIH funds will be awarded for competing applications or contract proposals involving human subjects. Investigators submitting non-competing renewal applications for grants or annual reports for contracts that involve human subject research must also include the certification in their annual progress reports.
What is the Office for Human Research Protections (OHRP)?
OHRP is the office of the federal Department of Health and Human Services that oversees efforts to protect human subjects in biomedical and behavioral research. In September, 2000, it replaced the Office for Protection from Research Risks (OPRR) which was part of the National Institutes of Health (NIH) and had authority over NIH-funded research.
Who are considered to be key personnel?
Key personnel are defined as all individuals responsible for the design or conduct of the study. Everyone who has contact with human subjects, with confidential data about human subjects, or data that was obtained from human subjects, for research purposes is included.
What is the format of the program?
The course is an on-line Sakai program, with a mandatory on-line examination at the conclusion, which can be accessed at the convenience of the individual researcher. All of the information is presented on line in small sections. Participants may enter and exit the program at their convenience and attempt the test an unlimited number of times. The test may be started and stopped repeatedly. As long as the participant saves each individual response, the selections will be retained until the next attempt. Tests will not be scored until the participant indicates that the test should be submitted for grading.
To go to the Human Subjects Certification Program on Sakai, click here.
What material is covered in the HSCP?
Issues important in conducting research involving human subjects are covered, including the definition and history of human subjects research, ethical principles for conducting human subjects research, informed consent, confidentiality and privacy of data and patient records, risks and benefits, preparation of a research protocol, institutional review boards, adherence to study protocol, proper conduct of the study, special protections for vulnerable populations, and institutional policy.
How will I know if I passed the test at the end of the program?
You will be able to see your score on-line after you submit the test for grading. Several attempts to take the test will be permitted and the highest grade will be used.
Will I be given a letter of certification for successful completion of the HSCP?
A certification letter can be retrieved on-line available immediately after successfully completing the test. Just click on the "Print Human Subjects Certificate" button on the left. If the certificate does not print properly on your printer you can use the printer friendly version.
Note: If you took the test using the WebCT system (before August 1, 2007), please click here for more instructions.
For how long will my certification be valid?
The term of approval for the certification was not specified in the NIH policy. The Office of Research Integrity (ORI) is in the process of developing a PHS Policy on Instruction in the Responsible Conduct of Research that includes the protection of human subjects in research and will eventually supercede the NIH mandate. It is clear that the intent of both policies is to keep investigators and key personnel current in their knowledge of the responsible conduct of human subjects research to maximize the protection of human subjects. As such, participation in continuing education will be required, and the term of each certification will be announced when the ORI policy is released.
Will the education course be tied to my protocol approval?
Effective January 1, 2001, IRB policy states that the Notice of Approval for a new protocol submission or continuing review will not be issued until the principal investigator (PI) has successfully completed the education program. If the PI is certified, but other key personnel are not, the Notice of Approval will be issued, but will contain a condition that personnel who are not certified may not participate in the study until they obtain the certification. In accordance with IRB policy, faculty advisors must also be certified prior to issuance of the Notice of Approval, if the PI is a student.
It is strongly recommended that all principal investigators and key personnel named on a protocol involving human subjects complete the education program as soon as possible. This will help to eliminate delays in protocol approval which will be contingent upon successful completion of the education program by the PI and all key personnel.
What are the specific NIH requirements regarding certification for human subject education?
If your research is supported by NIH funds, each individual identified as the PI or “key personnel” must receive the certification prior to submission of non-competing renewal applications for grants or annual reports for research and development contracts that involve human subjects research after October 1, 2000.
If NIH funding has been requested, each individual identified as the PI or “key personnel” in the proposed research must receive the certification before funds will be awarded for competing applications or contract proposals beginning on October 1, 2000.
I have a Notice of Exemption for my protocol. Am I required to participate in the HSCP?
Protocols that have received exemption from IRB review involve procedures that pose less than minimal risk to human subjects and meet the criteria for one of the six eligible categories of research. The OHRP policy applies to all protocols that involve human subjects, regardless of the risk level. Therefore, principal investigators and key personnel named on these protocols are required to participate.
What if I pass the education program, but my key personnel do not?
The Notice of Approval for a protocol will not be issued until the principal investigator (PI) has successfully completed the education program. If the PI is certified but key personnel are not, the Notice of Approval will be issued with a condition that personnel who are not certified may not participate in the study until they have successfully completed the education program. It is the responsibility of the PI to notify the IRB when this requirement has been met.
How can I obtain instructions, a password, and a UserID to access the Human Subjects Certification Program?
As a result of upgrades at the institutional level, Rutgers personnel may now self-register for the course by using their Net ID username and password. Non-Rutgers personnel can register with a guest account using their email address. For more instructions click here.
How are investigators and their key personnel kept up-to-date regarding changes to the HSCP?
The IRB maintains an email list-serve by which a periodic Rutgers University IRB Newsletter is distributed. The list-serve includes the email addresses for all personnel named on protocols submitted for review. Revisions to IRB policy and procedures, relevant human subject research information, and HSCP updates are transmitted to research personnel via the list-serve.
Individuals who do not fit the description of key personnel but are involved in human subject research and would like to receive the newsletter may request to be added to the list-serve by sending a message to: firstname.lastname@example.org.