Training

Education in Responsible Conduct of Research

An Institutional Review Board (IRB) is required to ensure that appropriate safeguards exist to protect the rights and welfare of research subjects [21 CFR 56.107(a) and 56.111].

The National Institutes of Health (NIH) recommends formal training of personnel involved in the conduct of human subjects’ research. Guidelines for specific training and certification in the protection of human subjects for all personnel conducting human subject research have been developed. The Essentia Health IRB will authorize the training and issue the certificates. The Essentia Health IRB accepts the NIH HSPT on-line training program, and may accept other training that the Essentia Health IRB finds to be equivalent. The Essentia Health IRB has designated that training and certification must be completed every five years.

Who needs to complete the training?
All staff engaged in research sponsored by Essentia Health including human, epidemiological, behavioral or basic science. Staff includes:

• Principal investigators, co-investigators, and study contacts named in research protocols
• Institutional officials administering research
• Research staff, including staff scientists; clinical research managers, supervisors, nurses, associates, and assistants; biostatisticians and data management staff
• IRB members
• IRB staff
• Others identified by the IRB or by investigators as requiring human subject protection training.

Curriculum
According to U.S. Public Health Service and NIH the following elements must be included in the curriculum: 

    1. Human subjects protection

• Ethical principles
• Informed consent
• Investigation of drugs and devices
• Behavioral research
• Children as research subjects
• Women as research subjects
• Under-represented minority groups as research subjects
• Decision-impaired subjects
• Record-based research
• Research integrity

    2. Data acquisition, management, sharing, ownership 
    3. Publication practices and responsible authorship 
    4. Research misconduct 
    5. Conflict of interest and commitment

Complete the Training and Obtain Certification
To complete the training and obtain certification, please complete the following steps.

1. Go online to http://phrp.nihtraining.com/users/login.php.
2. Click on "New User Registration".
3. Enter your email address as the Username and beginning training date, such as 01112011 (for January 11, 2011) as the Password. If necessary, you may interrupt your training and re-enter the site later to resume your session or reprint your completion certificate.
4. When completing the registration form, be sure to use Essentia Institute of Rural Health for the “Institutional Affiliation.”
5. Before beginning the first module, take a moment to read the Overview page.
6. Upon completion, you will return to the Main Menu. Be sure to click on “Get Certificate” and save it to your own hard drive.
7. Email Sherry King at sking@eirh.org. The following information must be included in the body of your email. Attach your certificate to the email:

• Your Name, plus your Position and/or Role in Research
• EH Region, Location, and Department
• Reason(s) for completing the HSPT course:
• Y/N New Board Member ( EIRH Board, IRB, SRB)
• Y/N New to Research
• Y/N iRIS access is needed for ________________ study (provide ACRONYM)
• Y/N Required to take HSPT, but do NOT require iRIS access
• Y/N Renewal of expiring HSPT
• ____ Other (please explain):

You will receive a certification letter from Research Administration as well as your certificate back for your records.

You will receive a certification letter from Research Administration as well as your certificate back for your records.

If you have any questions, contact Sherry King at 218-786-3575.