Human Subject Protection Training
Frequently Asked Questions
and Other Helpful Information
For NIH Principal Investigators
15 September 2000
Effective October 1, 2000 the NIH will require 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 Web-based training program to meet the NIH training and certification requirements. You may access the Web-based program through the OSR Web site (http://vpf-web.harvard.edu/OSR/RA/) or through your Institutional Review Board’s (IRB) Web site (Medical School and School of Dental Medicine: http://www.hms.harvard.edu/orsp; School of Public Health: http://www.hsph.harvard.edu/hsc ; Faculty of Arts and Sciences and other non-medical schools: http://www.fas.harvard.edu/~research/humsub.html ).
Before beginning the Web-based training, please review the Helpful Hints for Viewing the Human Subject Training Program at the end of this document. An essential component of the program is the email-based certification. Your browser must be configured correctly for the email notification to work.
HMS faculty may also satisfy the NIH requirement by attending a half-day seminar sponsored by the Medical School and PRIM&R (Public Responsibility in Medicine and Research) to be given on September 25th. For information on the PRIM&R program, please contact Penny Rothberg ()
There are different NIH submission requirements for different types of applications. To assist you in determining what is required of you as a Principal Investigator, we have assembled a list of Frequently Asked Questions for each category of application or proposal.
You may access the full text of the NIH policy announcement at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
General Information and
New/Competing Continuation Applications and Contract Proposals
Q: I am submitting a new grant application/contract proposal to NIH on October 1, 2000. Are Key Personnel required to complete training prior to submission?
A: No. Principal Investigators and other Key Personnel are not required to complete training prior to submission of a new proposal. However, training must be completed before funds are awarded.
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: No.
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 covering note that identifies the Key Personnel with human subject responsibilities. This information will be used internally and will prove helpful when it comes time to process your award. You should also include a description of the Harvard training in the body of your application/proposal.
Q: Where can I get a description of the Harvard training program?
A: Appended to this document is a full description of the Harvard program.
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: 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 have completed training.
Q: How do I get the necessary certification?
A: Once an individual has completed the Web-based program, verification will be emailed to the individual, the project PI (if different), the appropriate IRB administrator, and the sponsored research office that handles the PI's pre-award activities. For those HMS investigators who complete the PRIM&R seminar, certification will be provided at the end of the seminar.
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 new 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 research office responsible for processing your School/Faculty's awards must obtain the necessary certifications before it can obligate funds.
Q: My project includes consultants with human subject responsibilities. Does this requirement also apply to them?
A: Yes.
Q: My consultant does not have an institutional affiliation and therefore cannot obtain training. What should I do?
A: Contact your IRB administrator, who will work with you to provide this individual with access to the Harvard program.
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: Contact your IRB administrator, who will work with you to provide this individual with access to the Harvard program.
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: We expect that many peer institutions will accept Harvard's program but you should check with the institution to be sure. We do know that the hospitals in the Partners Healthcare system have a "no substitutions" policy.
Q: How frequently does documentation of the required education for each individual need to be reported?
A: Only once for each grant or contract.
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 are applicable 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 are applicable to the trainee and mentor.
Q: Unlike FAS, HMS/HSDM, and HSPH, my School/Faculty does not have its own IRB and IRB administrator. With whom should 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, the Faculty of Arts and Sciences IRB (Committee on the Use of Human Subjects in Research) is authorized to review and approve your human subjects protocols. Training-specific questions should be referred to the FAS IRB administrators whose names appear at the end of this document. Questions regarding submission of certification to the NIH and other application/proposal processing questions should be referred to the Assistant Director in OSR/Awards Management 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 on October 1, 2000 and others after that date for NIH projects that include research with human subjects. Are Key Personnel required to complete training prior to submission?
A: Yes. It is crucial that your projects' Key Personnel with human subject responsibilities complete the training as soon as possible to enable the sponsored research administrators to assemble the certification and include the appropriate documentation to the NIH with your application/annual report. The web-based training will be available on September 15th.
Q: What documentation does the NIH require?
A: According to a notice dated September 14, 2000, 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. This letter must be signed by the PI and co-signed by an institutional official.
Q: How do I get the necessary Harvard signature?
You should include your letter with the continuation application packet/contract annual report packet you route through Harvard. Your OSR/Awards Management Assistant Director will secure the Harvard signature.
Proposals Already Under Agency Review
Q: I submitted an application/proposal before October 1, 2000 and expect to be funded after that date. Does the new NIH requirement apply to my project?
A: Yes. The sponsored research office responsible for processing your grant and contract awards will be contacted by the NIH before funds are awarded and will be asked to provide the necessary certification. OSR/Awards Management will contact you to request the letter required by the NIH. You will find sample language at the end of this document. If you expect an application or proposal to be funded shortly, we encourage you and any Key Personnel with human subjects responsibilities to complete training as soon as possible.
Q: What documentation will the NIH require?
A: According to a notice dated September 14, 2000, 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. This letter must be signed by the PI and co-signed by an institutional official.
Q: How do I get the necessary Harvard signature?
Your OSR/Awards Management Assistant Director will secure the Harvard signature and submit your letter to the NIH.
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 University Human Subject Protecting Training Program. This is a Web-based program that presents a survey of important issues related to the conduct of research involving human subjects with sections devoted to historical examples, ethical principles (the Belmont Report), University and federal rules, Harvard's IRBs, roles and responsibilities, informed consent and related issues, and use of tissues, genetic 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.
*** 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 signtature
Name and title
***OSR/Awards Management will insert the name of the individual co-signing your letter.
Description of the Harvard Training Program
The Harvard University Human Subject Protection Education Program 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. The program was developed by faculty and staff from the Faculty of Arts and Sciences, Harvard Medical School, Harvard School of Public Health, and Office for Sponsored Research/Awards Management. Version 1.0 will be available on September 15, 2000.
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 tissues, genetic samples, survey research, deception, and research with students
Investigators may access the program through the Office for Sponsored Research web site or through their school’s IRB web site and complete a program that covers all of the topics listed above, tailored for their particular School or Faculty. E-mail certificates are generated upon completion of the program.
Investigators based at the Harvard Medical School may elect to participate in a one-time only seminar developed by PRIM&R (Public Responsibility in Medicine and Research), which will cover the same topics in detail and will satisfy the requirement for education in human subjects research.
Non-Harvard Key Personnel will complete similar training at their home institutions.
Helpful Tips for Viewing the Web-based
Human Subject Protection Training Program
· The program will run on Netscape only. We recommend that you use Netscape 4.6 or higher.
· The program is both Mac and PC-friendly.
· Completion of the program triggers an email confirmation that is essential for processing your award. Thus, we recommend that before you begin the program you check your Browser under Preferences to determine whether it is configured to process email.
· Once you have opened Preferences, open Mail and Newsgroups and then open Mail Servers. You will be asked to insert the name of your Outgoing (SMTP) Mail Server and your Outgoing Mail Server User Name. This information varies across the university depending on the email server you use. If you do not know the name of your email server, contact your departmental/school systems administrator or lab/department administrator. Again, do not begin the program until Netscape has been configured for email.
· For optimal viewing, we recommend that you set your monitor to 800x600.
· Throughout the program there are links to obtain additional information. These links will open a new window. Closing the new window will return you to the Training Program. Or, you can click on the Training Program box on the Task Bar (PC users), or click on the title bar of the Training Program window (Mac users).
· If you experience technical problems or are having difficulty viewing the program, technical assistance is available from the Office for Sponsored Research during regular working hours. Please contact Valerie Belmonte at 496-3330 or Diane Baldwin at 496-3335.
Where to Go For Additional Help/Information
If you have questions we have not answered here, please contact your IRB administrator.
FAS and other non-medical Schools:
Jane Calhoun (495-5459) or
Dean Gallant (495-2628)
Medical School and School of Dental Medicine:
Carolyn Connelly (432-0651)
School of Public Health
Angie Foss (432-4513)