Purpose of Human Studies Education
Knowledge obtained through research provides vital gains in medicine and health care. Loma Linda University and government regulations require that those conducting this research first and foremost protect the welfare and respect the rights of the subjects whose participation make human research possible.
Loma Linda University maintains an education program to help everyone involved in human research with the duty to protect research subjects. The Certificate in Human Research Subject Protections is evidence that learners are current with institutional requirements for obtaining appropriate training.
LLU Human Studies Education Certification has 2 components:
Training that earns the Basic Certification provides researchers with a foundation in the history, ethics, regulatory requirements, and institutional policies for protecting research subjects. Basic Certification is required under 2 circumstances:
- Initial Certification
Initial training is required when the learner has not previously received any Human Studies Education training at Loma Linda University.
Training previously taken at another institution may satisfy this requirement, depending on the type of training and how recently it was completed (see Equivalency).
- Re-instatement of Expired Certification
Those who have been previously certified at Loma Linda, but whose certificate has expired for longer than 6 months may also be required to take the Basic Training. This can be avoided by taking the required Renewal Certification on a timely basis as described below.
If your certification expired more than 6 months ago, or if you have never been certified at LLU but took human subjects protections training at another institution, please contact the Research Education Coordinator at Ext. 87463 or 909-558-7463 to discuss your options.
Helpful Links & Tools:
The expiration date of Basic Certification depends on the training option you choose:
- NIH Training: 1 year from completion date
- CITI Training: 2 years from complete date
- “IRB 101” lectures taken as part of classroom requirements: 1 year from completion date
PLEASE NOTE that the LLU Human Studies Education program is structured as a continuing education program. Learners must take training for Renewal Certification by the time their Basic certificate expires to maintain valid certification status.
Example #1: A learner completes training (either through NIH or an "IRB 101" lecture) for Basic Certification on May 15, 2012. Since NIH certification lasts for 1 year, this learner's certificate will expire on May 15, 2013. He/she must take training for Renewal Certification by this date in order to maintain valid certification status:
Example #2: A learner completes training (through CITI) for Basic Certification on May 15, 2012. Since CITI certification lasts for 2 years, this learner's certificate will expire on May 15, 2014. To maintain valid certification status, he/she must take training for Renewal Certification by this date:
Learners must take a “refresher” training course before their current certificate expires, ideally 2-8 weeks prior to the expiration date. The purpose of this training is to:
- Refresh what has previously been learned, and
- Provide an opportunity for investigators to study select topics of interest.
Helpful Links & Tools:
Renewal Certificates expire on the "anniversary" date that a learner completed his/her Basic training at Loma Linda University.
Example: A learner completes training (through CITI) for Basic Certification on May 15, 2012. This learner's certificate will expire on May 15, 2014. To maintain valid certification status, he/she should take Renewal training before this date for the next certification period. The Renewal Certificate will expire in May 15, 2015, by which time he/she should take Renewal training for the next certification period:
Therefore the expiration date of Renewal Certification is unique to each learner and stays the same from year to year. PLEASE NOTE the important implications of this:
- If you take the Renewal training after your expiration date, you will have less time before you must take the next cycle of training.
- When a certification remains expired for more than 6 months, it generally means that the learner must re-take the training for Basic Certification:
Example: A learner takes Renewal training after his/her certificate has been expired for 3 months. Since the expiration date remains the same every year, he/she will only have 9 more months to complete training for the next certification period. This is one reason why it is important to meet the continuation requirement in a timely manner:
Please contact the Research Education Coordinator with any questions.
Training in human research subjects protections that is received at another institution within the last 2 years may be considered equivalent to LLU requirements. Contact the Research Education Coordinator and provide documentation of completion and information about the content.
The certification date will be based on when the training was taken.
Example: 7 months ago, you completed the NIH training course at a previous school. You now become involved in a project here and are told to obtain certification. Your certification will be issued with a start date of 7 months ago and have 5 months remaining before you need to complete a "refresher" training to keep it valid.