Botswana Harvard AIDS Institute Partnership (BHP) as a Regulatory Department that mainstreams regulatory communication between BHP and the Institutional Review Boards(IRB) or Ethics Committees(EC). The department ensures that all studies conducted at BHP have been reviewed and accordingly approved by IRBs/Ecs and it oversees adherence to ethical conduct of research by investigators/research teams. The unit also oversees training and documentation of Good Clinical Practice (GCP) and human subjects protection/ethics for all study staff.

Reporting Research Misconduct

Botswana Harvard AIDS Institute (BHP) has incorporated into its policies and procedures the following approach for dealing with and reporting possible research misconduct when USPHS funds are involved.

1. BHP will designate an official to receive allegations and develop procedures for use by research employees or others who wish to make an allegation of research misconduct involving USPHS funds. This designated official will notify the U.S. office of Research Integrity (ORI) when an allegation of research misconduct involving USPHS funds is received. Phone: (240) 453-8800. Fax: (301) 594-0043. E-mail: ORI_Assurance@hhs.gov.

2. BHP will then work with ORI or other appropriate offices of the U.S. Department of Health and Human Services (HHS) to develop and implement a process for responding to the research misconduct allegation that is consistent with U.S. Federal regulation, 42 CFR Parts 50 and 93.

3. BHP will submit appropriate reports (in English) to ORI that describe the process followed in conducting the investigation, the evidence on which the conclusions of the investigation are based, and if a finding of research misconduct is made, the administrative actions that are taken against the respondent.

4. BHP will inform research employees about the official who is designated to receive allegations and the procedures for the employee or other individuals to make an allegation of research misconduct involving USPHS supported research. This information will also be posted on the organization’s website.

5. BHP certifies that this statement will be a permanent amendment to the institution’s procedures for responding to allegations of research misconduct.

6. BHP will submit the “Annual Report on Possible Research Misconduct” to ORI by April 30^thof each year. The report is submitted electronically through the ORI web site at http://ori.hhs.gov.

Name of Organization: Botswana Harvard AIDS Institute

Address: Private Bag B0320, Gaborone, Botswana

Phone: (+267) 3902671

Responsible Official’s Name: Dr. Joseph Makhema

Responsible Official’s Title: Chief Executive Officer

Contacts for Reporting Research Misconduct