11. What do I have to do to process the payments I make to Human Subjects? 

12. What happens if the FWA of an institution that holds an HSPH subcontract expires? 

Walking:
From the HSPH Kresge Building at 677 Huntington Avenue continue up Huntington Avenue towards Francis Street. Take a left at the first light onto Tremont Street. Go past the Stop & Shop and Bank of America and continue up the hill until you arrive at 1552 Tremont Street. Ring the doorbell and a staff member will let you in.

For a map to our office please visit Mapquest Map

By Bus:

The 66 bus stops on Tremont Street near the office. Get off at the intersection of Carmel St. and Tremont St., going in either direction, and walk a short distance (see directions above).

By T:

Take the Green Line E train to the Brigham Circle stop, which is on Huntington Avenue. Walk west to the intersection of Huntington and Tremont (Stop & Shop Plaza with Citizens Bank and Bank of America is on the corner you want). Walk south/east on Tremont Street (past Dunkin’ Doughnuts on your left) for 2.0 blocks. Cross St. Alphonsus Street and look for #1552 on the right hand side of Tremont, next door to O’Connor Funeral Home, the big church/parish building is directly across Tremont from #1552.

By Car:
Mapquest Directions

 
2. How should HSPH instructors and faculty deal with class-based exercises that may or may not qualify as research with human subjects?

Please read these Guidelines.


3. How does the HSC assign file numbers?

In May 2003, the HSC adopted a new file numbering system. Our database, HIRBERT, assigns a number to each new appliation we receive. Prior to the new system, the HSC assigned file numbers using four digits from month and year of approval and the first four letters of an application's title (e.g. 0205COMM).

Protocols approved before May 1, 2005; therefore, have two file numbers (one old and one new).

We have posted a Cross-Reference Index of Old and New Protocol Numbers on our website's Forms & Tools page. If you know the PI's name and either the old or new (HIRBERT) number, you can find out the other number using this tool. Please note that:

(a) the PI names are listed alphabetically by first name.

(b) Applications submitted on or after May 1, 2003 have only a new (HIRBERT) number. (On May 1, 2003, the HSC staff ceased assigning both an old and a new number to incoming new applications.) Prior to that date, we were still in a transitional period and operated with two numbering systems.

If you need further assistance identifying a study by its new or old number, please contact our office at (617) 384-5480.

4. Can I get another institution's IRB to review my study for HSPH or
vice versa?

Maybe. The answer would be yes in the following scenarios:

(a) If HSPH has an existing IRB Authorization Agreement with the other institution and your study is covered by its scope. The scope of such agreements may be study-specific, investigator-specific, or otherwise defined through negotiations between the institutions. These agreements must be signed by the Dean of Faculty and authorized signatory officials of the institution's Federal Wide Assurance or their designees. Principal Investigators cannot enter into these agreements on their own behalf or on behalf of the School.

Currently, HSPH has an IRB Authorization Agreement with Partners Healthcare System, which allows the HSC to rely on the IRBs for the Massachusetts General Hospital or the Brigham & Women's Hospital if certain eligibility criteria are satisfied.

The HSPH also has an IRB Authorization Agreement whereby Partners Healthcare Systems may rely on the HSC for the review of research involving prisoner subjects.

For more information on the PHS-HSPH IRB Authorization Agreement, click at this link and visit our Forms & Tools page:

Memo Re: PHS-HSPH IRB Authorization Agreement

(b) If the other institution has a Federal Wide Assurance, and both HSPH and the other institution agree to execute an IRB Authorization Agreement with each other. In this scenario, typically the PI requests that the HSC pursue an agreement for a specific study. Please note that the success of the HSC's efforts to obtain an executed agreement is not guaranteed, as it depends on many factors, including the interest and efforts of the other institution.

(c) Another route to obtain an IRB authorization arrangement is for the Office of Financial Services to negotiate it as a provision within a contract or subcontract. If this route interests you, please talk with your OFS grants and contracts administrator or HSC Assistant Director, Leslie Howes, at (617) 384-5487.

And when is the answer no?

(A) At this time, HSPH will not rely on a foreign (non-U.S.) IRB.

(B) We cannot do an IRB Authorization Agreement if the other institution does not have a Federal Assurance.

(C) If the other institution's program, policies and procedures for the protection of human subjects do not inspire trust and confidence.

5. How can I reliably check the reading level of the consent forms for
my study? 

Please use the Readability Tool provided by Microsoft Word to assess the reading level of any document to be used with human research participants. Instructions on how to use this tool are now at our Forms & Tools page. If you have questions about how to use the tool, feel free to contact Leslie Howes at (617) 384-5487 for assistance.

Once you use this tool to achieve the appropriate reading level (average for Americans is 5th or 6th Grade), please give the HSC office a copy of the results (appropriately identifying the study and document assessed). This gives us a valuable metric for use in our reviews of your study, and ensures that researchers are communicating key information clearly and effectively with participants. You should also keep a copy in your study files.

6. Does the HSC require a readability check for consent forms?

 Yes. Beginning September 1, 2006, the HSC will require a copy of the readability results of a standard program for each consent form. The results should ideally show a 6th Grade reading level. See FAQ #5 below for instrucations on using the Word Readability Tool.

We understand that it can be difficult to achieve the 6th Grade reading level using a computer program like Word's. Some words - especially unusual proper names and non-English words that should not be deleted can keep the reading level higher because the program does not recognize them. The HSC makes exceptions for this sort of case.

A higher grade reading level may also be acceptable for subject peopulations with high levels of education (e.g., physicians, nurses, hospital executives).

7.  What Conflict of Interest policies apply to my research with human subjects at HSPH?

Several COI policies may apply. We provide links here so you can review and download the full text.

• The HSPH policy
• The HSC policy supports the HSPH policy and the DHHS Final Guidance, issued May 5, 2004.

Internally, the HSC policies and procedures require a review of investigators' confidential COI disclosure information to identify any real or potential conflicts with applications submitted for IRB approval. When a conflict appears to exist, the HSC Chair and Director refer the matter to the School's COI management committee, chaired by the Dean for Academic Affairs, in the strictest confidence. The HSC reviews the COI management plan before granting approval of the affected study. With respect to IRB members and the potential for conflicts on their part with respect to applications under review, the HSC Chair reminds our members at the beginning of each convened meeting of the need to disclose and manage any real or apparent COIs. Members recuse themselves from discussion and voting whenever appropriate.

• Sponsoring agencies:
  • PHS regulations, as interpreted by the NIH
  • FDA rules, as interpreted by FDA guidance
  • NSF policy
• For collaborative research, check the policies of the other institution(s) involved. The general rule is to follow the higher, stricter standard.

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This page is maintained by HUMAN SUBJECTS COMMITTEE. To contact us with suggestions, comments, and questions, please e-mail: hsc@hsph.harvard.edu.

Human Subjects Committee
1552 Tremont Street, Boston, MA 02120
Phone: (617) 384-5480
Fax: (617) 384-5484