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Case Case Studies: Studies: Research Research Integrity Integrity and and Ethics Ethics Barbara E. Bierer, M.D. Senior Vice President, Research, BWH Director, Office for Research Careers (ORC) Director, Center for Faculty Development & Diversity February 23, 2010 So, what to do? • • • • • Approach Policies and Procedures A few ‘Best Practices’ re:data Educational Directives Culture of Compliance Resources Available • Your most friendly compliance officer: Allison Moriarty APMoriarty@partners.org (617) 732-8335 • Partners Compliance Hot line (anonymous): (800) 856-1983 www.partners.org/complianceline Policies and Procedures • • • • • • Clear Complete Readable and understandable Transparent Communicated Monitored This is the updated HMS website/policy: http://hms.harvard.edu/public/coi/policy/integritypolicy.html But, some policies aren’t written. If policies are written, some can’t be found. If policies are written, individuals rarely (if ever) read them. And, if read, individuals rarely remember. HMS Integrity in Science website http://hms.harvard.edu/public/coi/policy/integritypolicy.html Help Do you know: • Your Research Integrity Officer (RIO) • Your Authorship Dispute Officer (ADO) • Gretchen Brodnicki, JD Gretchen_Brodnicki@hms.harvard.edu (617) 432-2496 Your RIO • • • • • • • • • • BIDMC BWH CHB DFCI HMS HSPH Joslin McLean MGH Spaulding Randy Mason Barbara E. Bierer Carleen Brunelli Beverly Ginsburg Cooper Gretchen Brodnicki Bernita Anderson Dianne McCarthy Peter Paskevich Richard Bringhurst Roberta Nary Federal regulations and guidance • We must follow Federal regulations. We can’t make them up and we don’t have a choice. • You must (not should) also follow the Federal regulations.  Both ORI and NIH have regulations regarding integrity • If you are doing clinical trials:  Your IRB administrator will become, or is, your best friend.  Your other best friend is your RIO. • If you are not doing clinical trials:  Your best (but not only) friend is your RIO. Concerns, among others Research Misconduct • Falsification (making up results and reporting them) • Fabrication (manipulating research materials, data, or processes; or manipulating data such that the research is not accurately represented in the record) • Plagiarism (the appropriation of another person’s ideas, results, or words without giving that person appropriate credit) In proposing, performing, or reviewing research, or in reporting research results. The regulations require perpetrators to act intentionally. And Sloppiness And it’s the right thing to do. Federal regulations on research misconduct • • • First promulgated in 1990’s – 42 CRF Parts 50 and 93 Requires institutions that receive PHS research support to have policies and procedures for reporting and responding to allegations of research misconduct Have a number of definitive provisions and definitions:  Provisions:  Confidentiality  Protections  Stages of investigation  Definitions: Complainant means a person who in good faith makes an allegation of research misconduct. (Emphasis on “good faith.”) Respondent means the person against whom an allegation of research misconduct is directed or the person who is the subject of a research misconduct proceeding There can be more than one respondent in any inquiry or investigation. • • • Both complainant and respondent have rights that must be respected. The regulations are very general. The institutional policy is not. Any investigation must be timely and fair. Federal Regulations on Research integrity investigations Involvement of complainant and respondent in the (PHS) process: • Inquiry stage:  Institution must provide respondent with opportunity to comment on report;  Not the complainant • Investigation stage:  Institution must notify the respondent whether an investigation is warranted; Institution may inform the complainant  Institution must interview each complainant  Institution must provide respondent with copy of the draft report; Institution may provide complainant with a copy of the draft report. • First step: contact the institutional research integrity officer (RIO) • Our inquiries and investigations are performed in cooperation with Harvard Medical School. Institutional Policy Provisions • The first step: contact your friendly research integrity officer (RIO) • Partners policy - reporting:  All individuals “should report observed or apparent research misconduct, or where there are reasonable grounds to suspect research misconduct, to RIO.”  If individual is unsure, can call upon RIO to discuss situation informally, get consult and “will be counseled about appropriate procedures for reporting allegations.” • • • • Confidentiality maintained and respected: Don’t talk to anyone else. Fair process: Do maintain evidence if any such evidence exists. Protection against retaliation for complainant. Reputation, livelihood and professional life should be restored. Data Management • Data records:  Methodology notebook  Written  Web (Intranet/Internet) application  Privacy  Experimental notebook • Some laboratories keep a laboratory master log annotating individual research projects. • Some laboratories maintain a data selection file containing data selected for publication and documents for each publication and paper resulting from a study. • Many institutions and laboratories establish standards for accurate collection and recording of data and for storing data. There are lots of ways to manage data, and these are not prescriptive. Critical Record Keeping Practices • Common language (use English unless discussed) • An accurate reflection of process:  Ideally in ink, no skipped pages, no deletions  Deleted or crossed out information initialed  Not six months later: “I think I can. I think I can” • • • • • Legible and understandable by others All experiments recorded, not just those that work Primary data kept in or adjacent to the notebook Mice breeding and housing, and reagent sources recorded Reagent location recorded, especially for items that aren’t commercially available. • Each notebook with front index and dates • Life is long PI Responsibility • • • • Ensuring data validity Maintaining and reviewing notebooks and, if they exist, laboratory master logs Ensuring that notebooks are clear, interpretable, and maintained Meeting with the research and staff associates to review progress and data at some frequency and periodicity  PIs should establish clear practices for maintaining laboratory notebooks  Some PIs initial and date laboratory (experimental) notebooks Look at the data Look at the notebook Question what you see And, if you don’t have time… Assign the responsibility to someone who does Conclusions • • • • • • A culture of compliance An environment of honesty, integrity, and openness No question is too stupid No manuscript is worth it Life is long (and science is small) Get help when you need it. http://ori.hhs.gov/education/