Human Subjects Protection Training
Information and Frequently Asked Questions For Principal Investigators on NIH-Supported Research
Effective October 1, 2000 the NIH initiated a requirement for education on the protection of human research participants for all investigators supported by NIH grant or contract funds. Training is required for all Key Personnel with human subject responsibilities.
Harvard has developed a new Web-based training program, Harvard Ethics Training in Human Research (HETHR), to meet the NIH training and certification requirements. HETHR received partial support from an NIH Human Subjects Enhancement grant. You may access HETHR through the OSP Web site ( or through your Institutional Review Board’s (IRB) Web site.
- Faculty of Arts and Sciences and all other non-medical schools:
- MedicalSchool and School of Dental Medicine:
- School of Public Health:
Different human subjects requirements apply to different types of NIH applications. To assist you, we have assembled a list of Frequently Asked Questions and information for each category of application or proposal:
- General Information and New/Competing Continuation Applications and Contact Proposals
- Non-Competing Continuation Applications/Proposal Annual Reports
You can also find the following resources below:
- Sample PI Documentation Letter
- Description of the Harvard Training Program
- Where to Go For Additional Help/Information
- HETHR FAQ Page
You may access the full text of the NIH policy announcement at
General Information and New/Competing Continuation Applications and Contract Proposals
Q: I am submitting a new grant application/contract proposal to the NIH. Are Key Personnel required to complete training prior to submission?
A: No. Investigators and Key Personnel are not required to complete training prior to submission of a new proposal. Training must be completed, however, before funds are awarded.
Q: When should Key Personnel complete training?
A: If your application receives a score that falls within the anticipated success range, we strongly recommend that Key Personnel complete training when you receive your NIH score. Waiting until the NIH formally requests the information through the pre-award office could delay processing your award. The earlier you complete training, the better.
Q: Do individuals identified as Key Personnel who are not involved with the human subjects portion of my project have to comply with this requirement?
A: It depends on your School’s human subjects training requirement Each “tub” and its IRB have a requirement for who must obtain training. Please check with your IRB office or its website.
Q: Am I required to include any special information as part of my grant application or contract proposal?
A: Yes. When routing your application/proposal through your School/Faculty, you should include a cover letter that identifies the Key Personnel with human subject responsibilities. This information is used internally and is helpful when it comes time to process your award. You should also include a description of the Harvard training program in the body of your letter and indicate where and when key personnel were trained.
Q: What documentation does the NIH require?
A: The NIH requires a letter that includes the names of the Key Personnel responsible for the design and conduct of the study, the title of the education program completed by each named individual, plus a one sentence description of the program and date of program completion. This letter must be signed by the PI.
Q: Where can I get a description of the Harvard training program?
A: Immediately below this FAQ is a full description of the Harvard Ethics Training in Human Research (HETHR).
Q: Will funds be awarded without training?
A: No. The NIH will not award funds until it receives documentation, signed by the PI and co-signed by the appropriate Harvard institutional official, that all Key Personnel with human subjects responsibilities have completed training.
Q: How do I get the necessary certification?
A: Once an individual who logs into HETHR via HUID/PIN has completed the program, s/he can click on a button to view and print out a certificate. In addition, an automatic message will be sent to the Harvard IRB database, updating the individual’s human subjects training information. (For trainees without HUID/PIN: please see the HETHR FAQ.)
Q: I am submitting a new proposal that includes other institutions. If our application is successful, the award will include subcontracts for these collaborating institutions. Does the NIH requirement apply to Key Personnel on subcontracts?
A: Yes. The requirement applies to Key Personnel on domestic and foreign subcontracts. If possible, they should complete training at their home institutions. The Sponsored Programs Office at your School/Faculty will need evidence of completion of training by all Key Personnel with human subjects responsibilities before funds can be released.
Q: My project includes consultants with human subject responsibilities. Does this requirement also apply to them?
A: Yes, for NIH purposes, if they are listed as Key Personnel with human subjects responsibilities on the proposal. Non-Key Personnel with human subjects responsibilities may also be required to complete human subjects training per local IRB policy; check with your IRB office.
Q: My consultant does not have an institutional affiliation. What should I do?
A: Consultants and other collaborators can take the HETHR training by registering as new users on the main login screen. (If they have previously taken training for Harvard-related purposes, they may have already been assigned a username and password for HETHR – please check with your IRB.) Non-Harvard trainees will not receive certificates until the IRB is given their names, so that they may add them to the Harvard IRB database.
Q: My project includes a foreign collaborator under a subcontract whose home institution does not offer human subject protection training. What should I do?
A: Please see the answer to the question directly above. In addition, your IRB office can advise you about equivalent training programs available in languages other than English.
Q: I recently completed human subject protection training at another institution. Is this training acceptable in lieu of Harvard's program?
A: You may substitute training at another institution upon submission of a letter to your IRB administrator that includes a brief description of the program, certifies your completion, and is signed by an official of the other institution who is authorized to certify completion of human subject protection education.
Q: I will be participating in a NIH-funded project at another institution. Will my completion of Harvard's program satisfy that institution's training requirement?
A: You should check with the other institution. We expect that many peer institutions will accept Harvard's program.
Q: How frequently does documentation of the required education for each individual need to be reported?
A: Only once for each grant or contract, at this time.
Q: How should I notify the NIH about new Key Personnel who are added to the project after the budget period begins or after I have submitted a progress report?
A: New Key Personnel must complete the training before undertaking human subject research. Documentation should be submitted to the NIH at the time of the next progress report.
Q: What about institutional training grant applications?
A: If you are submitting an institutional training grant application that includes projects with human subject research, the NIH requirements apply to the appropriate Key Personnel, both mentors and trainees.
Q: What about NRSA fellowship applications?
A: If the fellowship includes human subjects research, the NIH requirements apply to the trainee and the mentor.
Q: My School/Faculty does not have its own IRB and IRB administrator. With whom can I work on training issues?
A: If you are a member of the Graduate School of Education, Kennedy School of Government or another non-medical professional school or institute, your human subjects proposals are reviewed and approved by the University Area IRB (Committee on the Use of Human Subjects in Research). Any questions about training, or other human subjects issues, should be referred to the FAS IRB administrators whose names appear at the end of this page, or you can write to for assistance. Questions regarding submission of certification to the NIH and other application/proposal processing questions should be referred to the OSP contact who handles pre-award activity for your School/Faculty.
Non-Competing Continuation Applications/Proposal Annual Reports
Q: I am submitting a non-competing continuation application/contract proposal annual report for NIH projects that include research with human subjects. Are Key Personnel required to complete training prior to submission?
A: Yes. All Key Personnel with human subject responsibilities must complete the training prior to their involvement with human subjects, and appropriate documentation must be submitted to the NIH with your application/annual report.
Q: What documentation does the NIH require?
A: The NIH requires a letter that includes the names of the Key Personnel responsible for the design and conduct of the study, the title of the education program completed by each named individual, plus a one-sentence description of the program and date of program completion. This letter must be signed by the PI.
Sample PI Documentation Letter
Name of NIH Contact
NIH Institute
Address
Dear :
Re: Project title, NIH number, and PI's name
Please be informed that the Key Personnel and/or consultants listed below have human subject responsibilities and have completed the required NIH training.
The training program they have completed is entitled Harvard Ethics Training in Human Research [HETHR]. This is a Web-based program that presents important issues related to the conduct of research involving human subjects with sections devoted to historical examples, ethical principles (including the Belmont Report), University and federal rules, Harvard’s IRBs, roles and responsibilities, informed consent and related issues, use of tissues, human tissue samples, survey research, deception, and research with students.
List names
*** If anyone has completed a non-Harvard program for which you have submitted the required documentation, then you should add the following:
Insert name(s) has/have completed the training requirement at Insert name of institution. The title of this program is Insert name. Add one sentence description of the program and date of completion
*** If you are also documenting completion of training by Key Personnel and/or consultants on subcontracts, this information should also be included in your letter.
Yours truly,
PI’s signature
Name and title
Description of the Harvard Ethics Training in Human Research (HETHR) Program
The Harvard Ethics Training in Human Research (HETHR) is a Web-based tutorial accessible to all Investigators with human subject research responsibilities. It is also available to Investigators at other institutions participating in Harvard research projects, and to the general public on-line. The program was developed by faculty and staff from the Faculty of Arts and Sciences, HarvardMedicalSchool, Harvard School of Public Health, Office for Sponsored Programs, and the Office of the Provost. Support for HETHR came in part from the NIH.
The program presents a survey of important issues relating to the conduct of research involving human subjects with sections devoted to
- background and definitions;
- historical examples;
- ethical principles, with special attention to the Belmont Report;
- University and federal rules regarding the use of human subjects, with special attention to the requirements of each school’s Institutional Review Board;
- roles and responsibilities;
- informed consent and related issues (confidentiality, privacy, anonymity, and vulnerable populations); and
- use of human tissue samples, survey research, deception, and research with students
Investigators may access the program through the Office for Sponsored Programs web site or through their school’s IRB web site. Individual certificates are generated upon completion of the program and can be viewed and printed out by the individual trainee.
Non-Harvard Key Personnel will complete similar training at their home institutions, or may use the HETHR program.
Please see the following link for important tips on using the HETHR program:
HETHR FAQ Page
Where to Go For Additional Help/Information
If you have questions we have not answered here, please contact your IRB administrator.
FAS and other University Area Schools:
Jane Calhoun (617-495-5459)
Dean Gallant (617-495-2628)
Emiko Saito (617-496-2618)
MedicalSchool and School of Dental Medicine:
Carolyn Connelly (617-432-0651)
Pamela Greiff (617-432-2597)
School of Public Health:
Sarah Putney (617-384-5482)
Lia Haley (617-384-5481)
Allison Nagy (617-384-5485)
Office of the Provost
Rebecca Rousselle (617-384-5486)