All Things Helsinki

What is a Helsinki

The Helsinki, also known as IRB or REB, is an ethical approval from an institution’s Ethics Review Board that confirms that the research being done meets their ethical codes. Each institution has its own Ethical Board that approves their projects. If research is conducted without a prior approval, the researcher can face penalties and the research may be rejected from being published. Submitting a Helsinki application is a complicated process and follows a very specific format with a lot of red tape. Because of the complexities involved, many departments have a research coordinator who applies for the approvals.

In regards to the Thesis, a Thesis proposal will not be accepted unless it has a valid Helsinki (see the rulebook https://teamsthesis.blogspot.com/ ).

Because of the complicated and intricate process of obtaining the approval, Dr. Levy has been known to strongly recommend against taking a project that doesn’t yet have a Helsinki approval.

One last point, the student’s name does not have to be on the Helsinki (and they won’t let you put your name on it unless you have taken “Good Clinical Practice” (GCP) training, which students are not required to take). But you may have to sign a form committing yourself to ethical conduct.

For info regarding Helsinki’s at Rambam please see https://www.rambam.org.il/en/research_and_innovation/clinical_trials/helsinki_committee/

For general info regarding Helsinkis https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

For info about exemptions from Helsinki’s here is a nice little overview of guidelines from BU. Please note that since it is from a different institution rules may vary.  https://www.bu.edu/researchsupport/compliance/human-subjects/determining-if-irb-approval-is-needed/

Important Points Regarding the Helsinki

I have recently heard from a number of students that that their proposal/Thesis has been rejected or  that their research project has been delayed for months because of problems with their Helsinki.

Based on these accounts, I would like to recommend the followin before you accept a project:

1-Make sure to ask your PI/Mentor if they have a Helsinki- you’d be surprised how many don’t yet have and either plan on submitting for an approval, or hope that the student will do the submission work for them. I have heard from numerous students that they wasted months trying to get a Helsinki approval and many of their projects ended up falling through after lots of work. Dr. Levy has been known to strongly recommend against taking a project that doesn’t yet have a Helsinki approval. So even if it is an amazing project, if it has not yet been approved, consider finding something else.

2-Make sure the PI’s name is on the Helsinki and it is from their current institution.

3-Make sure the Helsinki is current. We recently had a student whose project was rejected because the Helsinki was old, (I think it was more than 5 years old).

4- Make sure that the PI/Mentor has full permission to use the data.

5- Assume that any project needs a Helsinki unless proven otherwise, especially if the data involves anything to do with humans.

A lot of these just sound like common sense, but I have heard of students getting messed up on each of the aforementioned points, so keep them in mind.

P.S. I have been told by students that if you have a Helsinki pending, you can still submit your proposal, just inform them.