Policies & GuidanceGetting-Started-With-a-Study-FAQ

Getting Started with a Study FAQ

May I recruit participants before I receive IRB study approval?

No. Potential participants are not to be contacted until IRB approval has been obtained.

What do I need to know about informed consent?

Federal regulations mandate that human subjects in research receive informed consent in a manner and style that is clear and easy to understand. The Informed Consent section of this website provides information on the informed consent process and guidance to writing consent forms that meet federal and IRB plain language standards.

What do I need to know about HIPAA regulations and other compliance issues?

Please contact Compliance@kpchr.org for your compliance/HIPAA questions. Please note that no data collection and/or data transfer may occur for your project until all compliance documents are on file with the Research Compliance office.

What do I need to know about genetic privacy?

Genetic testing is an analysis of human DNA, RNA, chromosomes, proteins, or metabolites (this does not include tumors or viruses) that detects a genotype, mutation, or chromosomal change. Oregon Law provides for special protections for use of genetic information and DNA samples. Genetic information is uniquely private and personal information that should not be collected, retained, or disclosed without informed consent.

Oregon law also requires that individuals be given the option to request that their biological sample or health information not be used for coded or anonymous genetic research. If you are doing coded or anonymous genetic research, you may request a waiver of informed consent from the IRB; however, you must check any potential participant against the genetic exclusion database. Please contact Compliance@kpchr.org in the KPNW Research Compliance office for assistance if you are doing research that uses genetic information.

Information about Oregon law to protect the privacy of personal genetic information and prevent the misuse of genetic information in clinical, research, employment, and insurance settings can be found at the Oregon Genetic Privacy Law.

Do I need to complete any human subjects protection (HSP) training?

Yes. All Kaiser Permanente NW (KPNW) investigators or co-investigators, as defined for regulatory purposes, on a research study are required to complete the Collaborative Institutional Training Initiative (CITI) HSP training modules. For non-KP investigators, documentation that they have completed their institution's required training is accepted if it is comparable to the KP module available on CITI.

Investigator, as defined for regulatory purposes, means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research.... which may include, for example, collaborators or consultants.

PIs will need to ensure that their study staff take appropriate training before they are involved in interactions with participants or their data.

Email IRB staff or phone 503-528-3945 (tie-line 60-3945) for more information about Human Subjects Protection training.

What do I do if I am conducting interregional research?

See SOP KP-004: IRB Review of Interregional Research for policies and procedures pertaining to IRB review of research conducted in more than one Kaiser Permanente (KP) region.

Please see Facilitating Interregional IRB Review: Guidance Document for Kaiser Permanente Investigators and IRBs for additional guidance on the conduct of interregional research at KP.

The Center for Health Research (TCHR) Universal Investigator Guidelines are designed to assist a TCHR investigator who is planning to act as a Universal Investigator in one or more of TCHR regions. The TCHR regions are KP Georgia, KP Hawaii, and KP Northwest.

Interregional Research Application Cover Sheet

What is a Certificate of Confidentiality and when is it used?

Certificates of Confidentiality are issued for studies that collect individually identifiable sensitive information whose disclosure could have adverse consequences for subjects or damage their social or financial standing, employability, or reputation. Examples of sensitive research involving sensitive information include studies:

  • Collecting genetic information
  • Collecting information on subjects’ psychological well-being or mental health condition or history
  • Collecting information on subjects' sexual attitudes, preferences, or practices

Please see the Toolkit: Certificates of Confidentiality for KP Investigators and IRBs for more information about Certificates of Confidentiality (Certificates), including the application process.

Is there a procedure for contacting study participants for media interviews?

Yes. The purpose of this procedure is two-fold. First and foremost, it is to protect the confidentiality of study participants, to approach them with requests for media interviews in a manner that is not coercive and that stresses that agreement to be interviewed is voluntary, and to conduct a process that ensures informed, written consent. The second purpose is to make a thorough effort to find study participants who are willing to volunteer to be interviewed by members of the media.