The following approvals and certifications may be or are required with each proposal submission. Please review the details of each before submitting your proposal to the applicable pre-award office for review.

Human Subjects in Research
Use of Animals in Research
Biohazardous Materials
Conflict of Interest Disclosure
Participation Agreement

Human Subjects in Research     back to top

All research using human subjects must be reviewed or designated as exempt from review by a Harvard Institutional Review Board (IRB). Currently, there are three IRBs: one each in SPH, HMS and FAS, with the FAS IRB providing oversight for human subject research at University area schools and affiliates.

Each IRB has established its own policies and procedures. See below for links to IRB sites.

School/Tub Policies/Procedures Location FAS Use of Human Subjects in Research http://www.fas.harvard.edu/~research/hum_sub/index.html FAS Statement of Policies and Procedures Governing the Use of Human Subjects in Research at Harvard University http://www.fas.harvard.edu/~research/greybook/humsubs.html SPH Human Subjects Committee http://www.hsph.harvard.edu/hsc/ SPH Federal wide Assurance of Compliance with DHHS Regulations for Protection of Human Research Subjects http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm HMS HMS/HSDM Committee on Human Studies http://www.hms.harvard.edu/orsp/human/human.html HMS Guidelines for Investigators in Scientific Research http://www.hms.harvard.edu/integrity/scientif.html

Typically, a sponsor requires that proposed studies with human subjects be approved by the requisite IRB at the time the award is made. Some require that this approval be in hand at the time a proposal is submitted or, at a minimum, in process. Prior to submitting a proposal one should review the sponsor’s human subject requirements. This information is generally available on the sponsor’s web site or in the RFP.

The NIH requires that all key personnel working on human subjects studies complete training. The SPH and HMS extended this requirement to all personnel involved in human subject study design, execution or interpretation, regardless of funding source.

Harvard has created HETHR: Harvard Ethics Training in Human Research, for use in satisfying the training requirement. HETHR, an interactive online training program, is also available to outside collaborators on Harvard projects, as well as to the general public, free of charge.

For more information on the NIH requirement, Harvard policy and access to the University's online training program:

Link to General FAQ about the Human Subject Training Requirement
Link to HETHR Training
Link to HETHR FAQ

Use of Animals in Research     back to top

All use of animals in research or teaching must be reviewed and approved by the appropriate animal committee. Currently there are two committees, one for the University area, and one for the Longwood area.

• Harvard University/Faculty of Arts and Sciences (HU/FAS) Standing Committee on the Use of Animals in Research and Teaching
  
  Animal Research Studies Administrator
  Science Center Director’s Office
  One Oxford Street
  Cambridge, MA 02138
  
  
• Office for Research Subject Protection – HMS/HSPH/HSDM, NEPRC and Brigham and Women’s’ Hospital
  
  Gordon Hall, Suite 411
  25 Shattuck St.
  Boston, MA 02115

Typically, a sponsor requires that proposed studies with animals be approved by the appropriate committee at the time the award is made. However, some may require the approval at the time of proposal submission. Please review the individual sponsor requirement prior to submitting a proposal.

Use the following links for information on procedures, guidelines, and forms:

School/Tub Policy Location University area Use of Animals in Research and Teaching http://fas.harvard.edu/~research/Animals.html HMS/HSPH/HSDM Standing Committee on Animals http://www.hms.harvard.edu/orsp/animal.html

Biohazardous Materials     back to top

In keeping with Federal regulations, before a scientific project can begin, the laboratory must be “certified” to work with radioactive materials, recombinant DNA, infectious agents and/or select agents. Some sponsors require a copy of an environmental health and safety approval letter signed by an authorized institutional official or head of the University’s Environmental Health and Safety Department. Other sponsors may require that the PI complete a checklist.

Please refer to links below for more information.

School/Tub Policy Location University - wide Use of Hazardous Biological Agents http://www.hms.harvard.edu/orsp/coms/IBC/COMS-1977-1978.pdf/ University-wide Committee on Microbiological Safety, Office of Research Protection http://www.hms.harvard.edu/orsp/coms/

Conflict of Interest     back to top

Both the NIH and the NSF require that the Principal Investigator and other project staff disclose any significant financial interests (salary, stocks, royalty income, etc.) that could appear to affect their research.

For the full text of these requirements:

NIH

NSF

Thus, each school within the University has established a Conflict of Interest disclosure policy and procedure to meet these regulatory requirements, in addition to the University’s own Conflict of Interest policies.

At the proposal stage PIs are required to certify that

• disclosure forms are on file for themselves, and where appropriate for other project personnel the
• information is still accurate for the proposal under submission.

For specific school requirements and forms, refer to the links below. If your school /program is not listed, please contact your Dean or Director’s office for guidance.

School/Tub Policy Location FAS Conflict of Interest and Conflict of Commitment FAS and University Policies FAS Affirmation of Awareness Principal Investigator (PI) Certification Form http://www.fas.harvard.edu/~research/policy/coi.html KSG Conflict of Interest Disclosure Form See KSG Office of Research for guidance http://www.ksg.harvard.edu/research/onlineforms.html HGSE Conflict of Interest Disclosure Form (federal proposals) See GSE Office of Sponsored Research and Projects for guidance http://www.gse.harvard.edu/~hgseosr/ HMS/HSDM Policy of Conflict of Interest and Commitment http://www.hms.harvard.edu/integrity/conf.html SPH HSPH Faculty Handbook http://www.hsph.harvard.edu/facultyhandbook/facpol1.htm#coi

Additional information is available from the Office of Technology and Trademark Licensing:

School/Tub Policy Location OTTL Harvard Policies – Conflict of Interest http://www.techtransfer.harvard.edu/Policies.html#COI

Participation Agreement (PA)      back to top

The President and Fellows of Harvard College adopted, on March 17, 1986, an amended "Statement of Policy in Regard to Inventions, Patents and Copyrights." This Policy, as amended from time to time, applies to all members of the University, and in particular to anyone who participates in externally sponsored programs. Also, Federal policy requires the University to obtain written agreements from professional staff members of Federally sponsored programs regarding their obligations for reporting and assignment of inventions.

One signed PA is needed per individual, and is good indefinitely for all projects.

The PA is required at the award stage, or when new Key Personnel are added.

Go to the Participation Agreement.

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