Digital Narrative Bibliotherapy as a Scalable Intervention for Suicidal Thoughts: A Randomized Controlled Trial (Testing Whether Selected Blog Posts Can Improve Well-being)
Phase: NA
Conditions: Suicidal Ideation
Sponsor: Harvard University

University Area IRB http://cuhs.harvard.edu
Harvard Longwood Campus IRB http://www.hsph.harvard.edu/orarc
HRP-510h: Template v5/15/2020
Harvard University-Area
Committee on the Use of Human Subjects
44-R Brattle, Suite 200 (2nd floor)
Cambridge, MA 02138
IRB Registration - IRB00000109
Federal Wide Assurance - FWA00004837
Notification of Modification / Update Approval
November 20, 2020
Peter Franz
pfranz@g.harvard.edu
Protocol Title:
Testing whether selected blog posts can improve well-being
Principal Investigator:
Peter Franz
Protocol #:
IRB19-0843
Submission #:
MOD19-0843-02
Funding Source:
Matt Nock's seed fund
Review Date:
11/20/2020
MOD Effective Date:
11/20/2020
IRB Review Type:
Expedited
IRB Review Action:
Approved
The Institutional Review Board (IRB) of the Harvard University-Area approved this 
Modification / Update.
The purpose of this study modification is to increase enrollment numbers, update compensation, 
and remove sharing of results with participants.
The documents that were finalized for this submission may be accessed through the IRB 
electronic submission management system at the following link: IRB19-0843
The IRB made the following determinations: 
•    Risk Determination: No greater than minimal risk
While the below message may not be applicable to this study, we are including this message on all 
study actions so that the Harvard research community is aware of current guidance.
 
The resumption of in-person research will occur in phases with timing based on governmental policies 
and the state of the disease, the health care system, and society at large. The principal investigator (PI) of 
a research program/study will be required to craft a plan outlining the COVID-19 precautions that will be 
undertaken for their research. The researcher’s plans will be subject to School/Departmental review and 
approval. No in-person research can begin until a researcher’s plan receives School/Departmental 
approval. 

University Area IRB http://cuhs.harvard.edu
Harvard Longwood Campus IRB http://www.hsph.harvard.edu/orarc
HRP-510h: Template v5/15/2020
 
Instructions on how to get approval for in-person research from your School/Department may be 
found here -  https://cuhs.harvard.edu/instructions-returning-person-human-subjects-
research?admin_panel=1  You will also find on this site an outlined process, guidance, templates, and 
standard operating procedure examples to assist researchers and their Schools/Departments to get in-
person human subjects research up and running.
 
NOTE!
 
Should a researcher receive approval from their School/Department for in-person human 
subjects research and their study is taking place at a location outside of Harvard, it is 
important that these studies follow any guidelines or instructions from the specific facility 
where in-person research would occur. As some research may occur in another state, with 
another institution, or under the direction of another IRB (as in a reliance agreement 
situation), this is especially important.  It is the responsibility of the Study Team to 
keep apprised of potential restrictions and conduct their study accordingly.
 
Harvard Affiliates should note any travel and other restrictions that are in place by 
visiting the Harvard COVID-19 website - https://www.harvard.edu/coronavirus.  
 
Please know that the default for all research involving in-person contact is to be paused. To the 
extent possible, study activities that can be done remotely by telephone or electronically, such as 
screening or follow-up, should be done in this way.
 
Should further restrictions pertaining to contact with study subjects be imposed at any time, it is 
the responsibility of the study team to follow guidance regarding when to pause a study and contact 
the HUA IRB.
 
Monitor the HUA IRB website <https://cuhs.harvard.edu/questions-about-covid-19-and-your-research> 
for updates. 
Please contact me at 617-496-1185 or mikaela_niemasz-cavanagh@harvard.edu with any 
questions.
Sincerely,
Mikaela Niemasz-Cavanagh
IRB Administrator