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Office for Human Research Protections (OHRP)

About the Office for Human Research Protections

Mission

The Office for Human Research Protections (OHRP) provides leadership on human research subject protections and implements a program of compliance oversight for Department of Health and Human Services (HHS) regulations for the protection of human subjects - Title 45, Part 46 of the Code of Federal Regulations (45 CFR part 46).

OHRP:

  • establishes criteria for and approves assurances of compliance for the protection of human subjects with institutions engaged in HHS-conducted or -supported human subject research,
  • provides clarification and guidance on involving humans in research,
  • develops and implements educational programs and resource materials, and
  • promotes the development of approaches to enhance human subject protections.

Organization/Structure

OHRP works to support and strengthen the nation's system for protecting those who volunteer to participate in research that is conducted or supported by agencies of HHS. To carry out its mission, OHRP has formal agreements with more than 10,000 federally funded universities, hospitals, and other medical and behavioral research institutions in the U.S. and abroad wherein they agree to abide by the human subject protection regulations found in the Code of Federal Regulations (45 CFR part 46).

Compliance
OHRP evaluates all written substantive allegations or indications of noncompliance with HHS regulations. The relevant institution is notified of the allegation and is asked to investigate the basis for the complaint. The institution then provides a written report of their investigation, along with relevant institutional IRB and research records, to OHRP which determines what, if any, regulatory action needs to be taken.

Education and Development
OHRP provides guidance to IRB members and staff as well as to scientists and research administrators on the complex ethical and regulatory issues relating to human subject protections in medical and behavioral research. The office conducts national educational workshops in partnership with other related federal agencies and organizations. OHRP also provides on-site technical assistance to institutions conducting HHS-sponsored research. In addition, OHRP helps institutions assess and improve their systemic protections for human subjects through a quality improvement program.

International Activities
OHRP provides quality improvement consultation and research ethics training to domestic and foreign institutions involved in international biomedical and behavioral research to help ensure that recognized ethical protections are afforded to persons participating in research conducted in countries outside the United States.

Policy and Assurances
OHRP prepares policies and guidance documents as well as interpretations thereof on human subject protections and disseminates this information to the research community. In addition, every institution engaged in human subjects research conducted or supported by DHHS must obtain an assurance of compliance approved by OHRP.


Contact Information

Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852

Toll-Free Telephone within the U.S. (866) 447-4777
Telephone: (301) 496-7005
Fax: (301) 402-0527
e-mail: ohrp@osophs.dhhs.gov


Visitor Information

The Office for Human Research Protections is located on the 2nd floor of the Tower Building, at 1101 Wootton Parkway, Rockville, Maryland 20852. For a view of the Tower Building, see http://www.towerbuilding.com/towerb_w/files/home.htm

Visitor parking is available to the right of the main entrance to the building.

Traveling to OHRP

Public Transportation

Driving Directions:

Ground Transportation from Local Airports:


 

Public Transportation

Taking the Metrorail
Take Metro's Red Line to the Rockville Station. If you arrive between 6:00 AM and 9:00 AM, or between 3:15 PM and 6:15 PM, take the Ride-On bus, Route 81. As you exit the barriers within the station, turn right to reach the bus area. For departure and return times, the Route 81 schedule can be found at http://www.dpwt.com. Select Bus Information. Select Ride-On Schedules. Scroll to Route 81: Rockville-White Flint and select.

If you arrive between 9:00 AM and 3:15 PM, take a taxi to the Tower Building, approximately 3 miles southwest of the Rockville Metro station.

Driving Directions

From Rockville, MD
Take Wisconsin Avenue/Rockville Pike (Route 355) north. Turn left at Wootton Parkway. Proceed through the third stoplight at Tower Oaks Blvd. Go immediately to the far-right lane, which leads to the Tower Building. Visitor parking is located to the right of the main entrance to the building.

From Bethesda, MD
Take Wisconsin Avenue/Rockville Pike (Route 355) north. At the point where Route 355 passes over I-495 (Capital Beltway), take the second exit to the left, I-270 North. Continue approximately 4 miles to Exit 4A, Montrose Road/Tower Oaks Blvd, East. Follow the sign for Tower Oaks Blvd. That leads to the left. At the next stoplight, turn left (north) onto Tower Oaks Blvd. Turn left at the next stoplight, Wootton Parkway. Go immediately into the far right lane, which leads to the Tower Building entrance.

From Washington, D.C.
From Constitution Ave. go west toward Virginia. Continue over the Potomac River on the Roosevelt Bridge. Get into the far right late and take the exit ramp to the right onto George Washington Parkway North. At I-495 (Capital Beltway), take the ramp to the right onto the inner loop toward Maryland. Continue over the American Legion Bridge into Maryland. After the River Road overpass, take the left exit (Exit 38) for I-270 North. After approximately 4 miles, take Exit 4A, Montrose Road/Tower Oaks Blvd, East. Follow the sign for Tower Oaks Boulevard that leads to the left. At the next stoplight, turn left (north) onto Tower Oaks Blvd. Turn left at the next stoplight, Wootton Parkway. Go immediately into the far right lane, which leads to the Tower Building entrance.

From Baltimore and all points northeast of Washington, D.C.
Take I-95 south toward Washington, DC. At I-495 (Capital Beltway), head west toward Silver Spring/Bethesda. From the Beltway (I-495), take Exit 38, I-270 North. Continue approximately 4 miles to Exit 4A, Montrose Road/Tower Oaks Blvd, East. Follow the sign for Tower Oaks Blvd. that leads to the left. At the next stoplight, turn left (north) onto Tower Oaks Blvd. Turn left at the next stoplight, Wootton Parkway. Go immediately into the far right lane, which leads to the Tower Building entrance.

From Frederick, MD, and all points northwest of Washington, D.C.
Take I-270 south toward Washington, D.C. Take Exit 4A, Montrose Road East. Go immediately into the left lane. At the first stoplight turn left onto Tower Oaks Blvd. Turn left at the next stoplight, Wootton Parkway. Go immediately into the far right lane, which leads to the Tower Building entrance.

From Virginia and all points south of Washington, D.C.
Take I-95 north toward Washington, DC. At I?495 (Capital Beltway), head north toward Silver Spring/Bethesda. From the Beltway (I-495), take Exit 38, I-270 North. Continue approximately 4 miles to Exit 4A, Montrose Road/Tower Oaks Blvd, East. Follow the sign for Tower Oaks Blvd. that leads to the left. At the next stoplight, turn left (north) onto Tower Oaks Blvd. Turn left at the next stoplight, Wootton Parkway. Go immediately into the far right lane, which leads to the Tower Building entrance.

Ground Transportation from Local Airports

From Ronald Reagan National Airport
Head North on the George Washington Parkway for approximately 5 miles. Exit onto I-495 (Capital Beltway), heading north to Maryland. From the Beltway (I-495), take Exit 38, I-270 North. Continue approximately 4 miles to Exit 4A, Montrose Road/Tower Oaks Blvd, East. Follow the sign for Tower Oaks Blvd. that leads to the left. At the next stoplight, turn left (north) onto Tower Oaks Blvd. Turn left at the next stoplight, Wootton Parkway. Go immediately into the far right lane, which leads to the Tower Building entrance.

From Dulles International Airport
Head east on the Dulles Airport Access Road for approximately 13 miles. Exit onto I-495 (Capital Beltway), heading north to Bethesda/Baltimore. From the Beltway (I-495), take Exit 38, I-270 North. Continue approximately 4 miles to Exit 4A, Montrose Road/Tower Oaks Blvd, East. Follow the sign for Tower Oaks Blvd. that leads to the left. At the next stoplight, turn left (north) onto Tower Oaks Blvd. Turn left at the next stoplight, Wootton Parkway. Go immediately into the far right lane, which leads to the Tower Building entrance.

From Baltimore-Washington International Airport (BWI)
Take the Baltimore-Washington Parkway south toward Washington, DC. At I-495 (Capital Beltway), head west toward Silver Spring/Bethesda. From the Beltway (I-495), take Exit 38, I-270 North. Continue approximately 4 miles to Exit 4A, Montrose Road/Tower Oaks Blvd, East. Follow the sign for Tower Oaks Blvd. that leads to the left. At the next stoplight, turn left (north) onto Tower Oaks Blvd. Turn left at the next stoplight, Wootton Parkway. Go immediately into the far right lane, which leads to the Tower Building entrance.


FOIA Requests - Freedom of Information Act

If you would like information about OHRP documents, files, and records, including compliance cases, you may file a Freedom of Information (FOI) request, unless all or parts of the documents are protected from disclosure.

Please send your request via mail or FAX to:

Public Health Service FOIA Office
Parklawn Building, Room 17A-46
5600 Fishers Lane
Rockville MD 20857

Phone: (301) 443-5252
Fax: (301) 443-0925

Be sure to include in your request:

  • Your name and mailing address
  • Your phone number or e-mail address
  • The subject of your request, or the specific documents you would like to receive.

For further information about FOIA requests, please see http://www.psc.gov/do/foia/guide.html




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