Archive: Women’s Reproductive Health Research Training Program (WRHR)

Provide each WRHR scholar with a core curriculum in statistical methods, research design, conduct of research, scientific publishing, grant writing and additional tools necessary to become a successful independent investigator in women’s health. This is considered Phase I training.

Provide each WRHR scholar with a suitable mentor/investigator who can provide the guidance and expertise to assure successful academic development and skills as an independent investigator. This is considered Phase II training.

Provide the research infrastructure (research assistants, laboratory equipment, core facilities, data managers, statistical support) and adequate protected time to create an environment conducive to investigation into women’s health.

All scholars in the Women’s Reproductive Health Research (WRHR) program are required to receive training in bioethics, the ethical conduct of research and protection of human subjects. At a time when ethical issues are gaining increased attention and scrutiny in academia and society at large, it is vital that scholars are formally exposed to information about accepted practices and invited to participate in ongoing debate.

All WRHR scholars will be required to complete the Course in the Protection of Human Subjects (CITI) Certification Program, designed to meet the new National Institutes of Health (NIH) requirements for training and education on the use of human subjects in research. The program includes online training on regulatory issues and policies and procedures associated with the use of human subjects in research, including a test designed to demonstrate knowledge of the materials. The certification program consists of the following modules: 1) History and Ethical Principles; 2) Basic Institutional Review Board (IRB) Regulations and Review Process; 3) Informed Consent; 4) Social and Behavioral Research for Biomedical Researchers; 5) Records-Based Research; 6) Genetic Research in Human Populations; 7) Research With Protected Populations — Vulnerable Subjects; and 8) FDA-Regulated Research.

All WRHR scholars will also be required to complete the HIPAA certification program, which is an online educational program for researchers covering federal regulations and other issues regarding privacy rights of patients and the handling of Protected Health Information. Ethical and Legal Issues in Clinical Research is a required course for all fellows. In addition, journal clubs and research seminars include discussions and presentations that focus on ethics and morality, as well as instruction in data collection, management and reporting. The goal of these discussions and presentations is to avoid misconduct resulting either from unintentional neglect or malicious plagiarism and fraud.

As part of the WRHR program, we will provide a yearly lecture series (four to five one-hour sessions) with handout materials, books, videos and open interaction between fellows and mentors about aspects of ethical conduct of research. A variety of topics will be covered, including:

• Humans as research subjects: The human subjects review process, the informed consent process, right-to-know issues, confidentiality of data, patient’s right to refuse participation, what happens if a patient refuses to participate, appropriate use of patient incentives and other pertinent topics.
• Inclusion of women, minorities and children in research involving human subjects: Policy of the NIH to include women and members of minority groups and their subpopulations in all NIH-supported biomedical, behavioral and health services research projects involving human subjects; policy of the NIH that children must be included in all research conducted or supported by the NIH unless there are scientific and ethical reasons not to include them.
• General issues germane to the conduct of science (humans, animals or solely bench research): These issues will also be dealt with explicitly including confidentiality of data, policies regarding authorship, the peer-review process, the trainee-mentor relationship, use of trainees in research, academic freedom and scientific misconduct.

The interactive lecture series on the responsible conduct of research will be given on a yearly basis. Lectures are based on several resource materials including: The AAMC Handbook, Instruction for Teaching the Responsible Conduct of Research, the booklet On Being a Scientist — Responsible Conduct in Research, and a video series called Integrity in Scientific Research (American Association for the Advancement of Science, 1996).

A final component of the training in the responsible conduct of research will include attendance at several IRB meetings. After observing a meeting, a “debriefing” or discussion between the scholar and mentor will occur to record observations and emphasize important points and lessons learned from the experience. This interaction will also include a brief assessment of the scholar’s understanding of major principles in the responsible conduct of research. Results will be documented in writing and placed in the scholar’s file. This assessment will evaluate whether the scholar has acquired the necessary knowledge and understanding to become an independent and ethical investigator.

Scientific writing

• Principles of Manuscript Writing (Nelson, 1 hr)
• Publish or Perish (Moley, 1 hr)

Grants proposals

• Research Question (Schwartz, 2.5 hrs)
• NIH Grants: Types and Composition (Schwartz, 2.5 hrs)
• The Art of Sucessful Grant Writing (Giudice, 2.5 hrs)
• Getting Funding (Guidice, 2.5 hrs)

Manuscript and grant reviews

• The Peer Review Process (Peipert, 1.5 hrs)
• NIH Study Sections (Macones, 1.5 hrs)

Academic development

• The Academic Ladder and Promotion (Sprong, 2 hrs)
• Career Development (Sprong, 2 hrs)
• Leadership and Management (2 hrs)
• Administration (2 hrs)

Clinical epidemiology

• Overview of Research Design (Macones, .5 hrs)

Experimental studies seminar

• Randomized Controlled Trials (Macones, 1 hr)

Observational studies

• Cohort, Case-control Cross sectional and Ecologic Studies (Macones, 2 hrs)

Systematic reviews of medical evidence

• Decision Analysis (Macones, 3 hrs)
• Economic Analysis (Macones, 3 hrs)
• Meta-analysis and the Cochrane Collaboration (Peipert, 3 hrs)
• Outcomes and Health Services Research (Peipert, 3 hrs)

Outline of evidence-based medicine

• U.S. Preventive Services Task Force Levels of Evidence (Peipert, .5 hrs)

Tools of epidemiology and evidence-based assessments

• Epi-Info 6.0, Cochrane Library and Other Data Sources (Peipert, 1 hr)

Exploratory analysis and data reduction

• Summary Measures (mean, median, sd, etc.) (Allsworth, 1 hr)
• Graphical Representation of Data (Allsworth, 1 hr)

Principles of estimation and testing

• Point Estimates and Standard Errors (Macones, 1 hr)
• Confidence Interval Estimation (Macones, 1 hr)
• Hypothesis Testing (p-values, type I and type II errors, sample size calculation) (Macones, 1 hr)

Measuring and testing association

• Continuous Variables: Pearson and Spearman Correlations, T-tests, Rank Sum Test, Log Rank Test) (Peipert, 2 hrs)
• Categorical Variables: Odds Ratios, Relative Risks, Pearson’s Chi Square, Fisher’s Exact Test (Peipert, 2 hrs)

Principles of regression

• Continuous Data: Linear Regression (Allsworth, 3 hrs)
• Binary Outcomes: Logistic Regression (Allsworth, 3 hrs)
• Survival Analysis and Proportional Hazards Regression (Allsworth, 3 hrs)
• Assessing Model Fit and Checking Validity of Assumptions (Allsworth, 3 hrs)
• Dealing with Missing Data, Loss to Follow-up, etc. (Allsworth, 3 hrs)

Special topic

• Dealing with Missing Data, Loss to Follow-up, etc. (Allsworth, 1 hr)

The Central Dogma

• DNA to RNA Protein (Moley, 1 hr)
• Conceptual Aspects (Moley, 1 hr)

Basic techniques in recombinant DNA technology 

• Manipulation of Nucleic Acids (Moley, 1 hr)
• Common Expression Vectors (Nelson, 1 hr)

DNA cloning

• Genomic and cDNA Libraries (Schedl, 1 hr)
• Expression Cloning (Schedl, 1 hr)
• Homologous Screening (Schedl, 1 hr)
• Strategies / Examples / Pitfalls / Troubleshooting (Schedl, 1 hr)

Common techniques for detection of quantitation of gene expression

• Northern Blotting (1 hr)
• Reverse Transcription – Polymerase Chain Reaction (RT/PCR) (1 hr)
• Rnase Protection Assays (1 hr)
• Concepts / Dos ad Don’ts / Pros and Cons (1 hr)

DNA protein interactions

• Electrophoretic Mobility Shift Assays (Nelson, 1 hr)
• DNA Footprinting (Nelson, 1 hr)

New techniques

• Yeast One and Two Hybrid Screenings (Schedle, 1 hr)
• Differential Display and Subtraction Hybridization (Schedl, 1 hr)

Transgenic models

• Knock-outs or Disruptions (Moley, 1 hr)
• Knock-ins (Moley, 1 hr)
• Transgenic Over-expression (Moley, 1hr)

Functional genomics

• Non-invasive Imaging (Moley, 1 hr)
• Non-invasive Molecular Probes (Moley, 1hr)

Application requirements:

• hold an MD degree or its equivalent;
• have completed a postgraduate residency training in obstetrics and gynecology;
• be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development; and
• be a U.S. citizen or non-citizen national (or be able to verify legal admission as a permanent resident).

Individuals on temporary or student visas are not eligible.

WRHR scholar applicants may not have served as the principal investigator or equivalent on a National Institutes of Health research project (R01), Mentored Clinical Scientist Development Award or its equivalent (K08), a subproject of a program project (P01) or center grant (P50), or equivalent Public Health Service research grant awards.

Application instructions:

Applicants will be required to review the website, which will describe the areas of investigation and potential research areas. From this introduction, the candidate must identify a potential mentor or investigator with extensive research experience in an area of interest to the candidate. We recommend the applicant contact the mentor to discuss a project and write an abstract of the proposed project.

Applicants will need to submit:

• a cover letter
• a curriculum vitae
• three letters of recommendation
• an abstract of the proposed research, and
• a personal statement describing the reasons for applying to the WUSM program, specific areas of interest in women’s health research, and proposed length/content of the applicant’s training program.

All applications received will be reviewed by the program director and PI. Candidates who demonstrate the greatest promise for research and a career in academic obstetrics and gynecology based on past experience, previous research, training and recommendations will be invited to the program for an interview. All scholars coming for interviews will meet at least three members of the advisory committee including the proposed mentor. Scholar candidates will then be independently scored by the PI, program director and faculty who interviewed the candidate based on the listed criteria. A final rank list will be created based on the scores and the potential fit with the WUSM program and the faculty mentors.

Scholars selected to the WUSM program will have an academic appointment at Washington University. This may be either at the level of instructor or assistant professor based on the degree of training. The Department of Obstetrics and Gynecology has a Committee on Appointments and Promotions, and it will make a recommendation to the Advisory Committee and the chairman as to the level at which the scholar should enter. Salary will be consistent with levels recommended by the School of Medicine and will be based on board certification status, level of training, academic appointment and subspecialty area. Salaries listed in the budget and budget justification will be supplemented as need be with revenue from clinical income generated by the department and by hospital funds to ensure that salaries are within an equitable range to similarly trained faculty in the department.