Attachment 2_Institutional CertificationTemplate

Sample Institutional Certification
[DATE]
[NAME OF GPA]
GWAS Program Administrator
[INSTITUTE], NIH, DHHS
[ADDRESS]
Bethesda, MD 20892-7395
Re: Institutional Certification of [NAME OF INSTITUTION] to Accompany Submission of the Dataset for
[NAME OF STUDY] to the NIH Database of Genotypes and Phenotypes (dbGaP).
Dear [NAME OF GPA],
The [name of institution] hereby certifies that submission of data from the study entitled [name of study]
to dbGaP meets the following expectations, as defined in the Policy for Sharing of Data Obtained in NIH
Supported or Conducted Genome-Wide Association Studies (GWAS) (Notice Number: NOT-OD-07-088):



The data submission is consistent with all applicable laws and regulations, as well as institutional
policies.
The appropriate research uses of the data and the uses that are specifically excluded by the
informed consent documents are delineated.
Data Use Limitation(s): _________________________________________________________




The identities of research participants will not be disclosed to dbGAP.
An Institutional Review Board and/or Privacy Board, as applicable, reviewed and verified that:
o The submission of data to dbGaP and subsequent sharing for research purposes are
consistent with the informed consent of study participants from whom the data were
obtained;
o The investigator’s plan for de-identifying datasets is consistent with the standards
outlined in the policy;
o It has considered the risks to individuals, their families, and groups or populations
associated with data submitted to the NIH GWAS data repository; and
o The genotype and phenotype data to be submitted were collected in a manner consistent
with 45 C.F.R. Part 46.

Sincerely,
Authorized Institutional Official:
Name: ____________________________________ Title: ________________________________
Signature: _________________________________ Date: ________________________________
Investigator:
Name: ____________________________________ Title: ________________________________
Signature: _________________________________ Date: ________________________________